AKH Inc. Advancing Knowledge in Healthcare RSS Feed

AKH Inc. is on the move!

Lee Adams — Wed, 06 Jan 2010 16:00:00 GMT

AKH Inc, Advancing Knowledge in Healthcare (AKH) is pleased to announce the formation of a strategic alliance with Leadingstar, Inc. of Jacksonville, FL to provide education, meeting management, and association management services nationally. This joint effort by both organizations will promote and enhance existing services offered by AKH, Compass Management and Consulting, and Leadingstar Events and Media, Inc.

AKH is an accredited provider of continuing education for licensed healthcare professionals, which has built a reputation for high quality programs that adhere to education and accreditation standards. We offer a variety of continuing education (CE) methods and topics, designed for physicians, pharmacists, nurse practitioners, nurses and other health care professionals. Established in the 1980s, AKH has become a leader in live and enduring educational activities designed to meet the varied and changing needs of the healthcare professional.

Leadingstar companies include Compass Management & Consulting, Leadingstar Events& Media, Inc., and Engageon LLC. Compass Management has an outstanding record of serving the non-profit medical association with essential management expertise. They provide meeting planning, corporate fundraising, accounting, administration, and legislative and socioeconomic review services. Their clients include the National Lipid Association, the American Retina Foundation, and the Florida Society of Ophthalmology among other notable national and statewide entities. Leadingstar Events is a full-service meetings, events and multimedia services company, focusing on small custom education programs to full scale congress level programs. Engageon LLC is a worldwide consulting and software development company focused on social media and web domain architecture for organizations and associations.

This strategic alliance will advance the design and delivery of educational initiatives in support of medical associations and the healthcare professionals involved within these associations. Both companies believe that they will benefit from collaboratively planning and designing educational initiatives and applications. AKH will continue to work with accredited and non-accredited organizations to design, market and offer quality programming through co- and joint-provider relationships.

AKH brings to our co- and joint-sponsors over 50 years of combined healthcare education experience, knowledge of various and changing accreditation regulations, experience in content development and project management, skill in course design, development and implementation, and knowledge of commercial support guidelines.

With AKH’s multiple accreditation status, we are able to provide a variety of continuing education options. AKH joins with our educational partners to ensure that the educational activities meet the needs of the target audience, are grounded in clinical evidence, and are free of commercial bias – making education of healthcare professionals the foremost priority.

AKH is approved as a provider of continuing education through the following agencies:

American Council for Continuing Medical Education (ACCME)
American Nurses Credentialing Center’s Commission on Accreditation (ANCC). AKH is also approved as a provider of continuing education in California and Florida.
American Academy of Nurse Practitioners (AANP).
Accreditation Council for Pharmacy Education (ACPE).
American Psychological Association (APA).
Commission on Dietetic Registration CDR).
Florida Board of Radiation

The staff at AKH wishes all of you a very merry Christmas and happy holidays.

Please note our new addresses:
Orange Park Office: 585 Golden Links Drive, Orange Park, FL 32073
Jacksonville Office: 6816 Southpoint Parkway, Suite 1000, Jacksonville, FL 32216
Mailing Address: P.O. Box 2187, Orange Park, FL 32067-2187
904-264-0674
Fax: 904-215-0534
Service Hours: Monday through Friday 10 am to 4 pm
www.AKHealthcare.com

6-Jan-10 11:00 AM

5/12/07 The Great 100 Nurses of Northeast Florida Celebration

Lee Patrick Adams — Fri, 30 Mar 2007 15:00:00 GMT

The Great 100 Nurses of Northeast Florida gathered together for their biennial celebration honoring 100 of the area’s top nurses. This wonderful event took place Saturday, May 12th at Jacksonville’s prestigious Hyatt Hotel, in conjunction with National Nurses week. Professional colleagues, family members, patients, and community members were invited to nominate exemplary nurses to be one of the Great 100 Nurses of Northeast Florida awardees.

AKH Inc. is honored to announce our very own Great 100 Nurses award recipient, Virginia "Ginny" McCarty, RN, CIC, LHRM. Ginny work as the CE Coordinator for AKH Inc. We would like to express a special congratulations to her and all of the other 99 Great 100 Nurses of 2007.

This superb evening composed of dining, video presentations, music, and an awards ceremony was promoted through various media outlets which served to educate the community on the work of the registered nurse, the extent of the nursing shortage, and available programs. Community supporters included all of the major nurse employers – hospitals, public health departments, colleges and schools of nursing. Attendance at the event and organization awareness has grown with each celebration.

To learn more about this event and the Great 100 Nurses of Northeast Florida, click here.

30-Mar-07 11:00 AM

AKH Inc, Advancing Knowledge in Healthcare (AKH) is pleased to announce the formation of a strategic alliance with Leadingstar, Inc. of Jacksonville!

noemail@akhealthcare.com — Mon, 04 Jan 2010 14:00:00 GMT

AKH Inc, Advancing Knowledge in Healthcare (AKH) is pleased to announce the formation of a strategic alliance with Leadingstar, Inc. of Jacksonville, FL to provide education, meeting management, and association management services nationally. This joint effort by both organizations will promote and enhance existing services offered by AKH, Compass Management and Consulting, and Leadingstar Events and Media, Inc. AKH is an accredited provider of continuing education for licensed healthcare professionals, which has built a reputation for high quality programs that adhere to education and accreditation standards. We offer a variety of continuing education (CE) methods and topics, designed for physicians, pharmacists, nurse practitioners, nurses and other health care professionals. Established in the 1980s, AKH has become a leader in live and enduring educational activities designed to meet the varied and changing needs of the healthcare professional. Leadingstar companies include...

AKH is on the move! Please note our new addresses:

noemail@akhealthcare.com — Mon, 04 Jan 2010 14:00:00 GMT

Orange Park Office: 585 Golden Links Drive, Orange Park, FL 32073

Jacksonville Office: 6816 Southpoint Parkway, Suite 1000, Jacksonville, FL 32216

Mailing Address: P.O. Box 2187, Orange Park, FL 32067-2187

904-264-0674

Fax: 904-215-0534

Service Hours: Monday through Friday 10 am to 4 pm

www.AKHealthcare.com

AKH Inc. has been awarded a 2 year provisional accreditation from the American Psychological Association to provide continuing education for psychologists

noemail@akhealthcare.com — Thu, 17 Apr 2008 14:00:00 GMT

AKH Inc. is proud to announce that it has been awarded a 2 year provisional accreditation from the American Psychological Association to provide continuing education for psychologists. We wish to thank Jennifer Haythornthwaite, PhD for Johns Hopkins who serves as our advisor/reviewer.

We now offer services that provide certified continuing education to the following national audiences:

Physicians – ACCME
Pharmacists – ACPE
Nurses – ANCC
Nurse Practitioners, AANP
Psychologists – APA

AKH Inc. is proud to announce the launch of their new division, Invisible Walls.

noemail@akhealthcare.com — Wed, 07 Nov 2007 18:00:00 GMT

AKH Inc. is proud to announce the launch of their new division, Invisible Walls.
This new division specializes in three major areas of service: Production, which includes personalized and commercial production, Website Design, and Image Marketing. Invisible Walls is managed by Lee and Elizabeth Adams.

As the creative director for Invisible Walls, Mr. Adams capitalizes on over 10 years experience in radio and television. He assists clients with creating and implementing innovative marketing plans which include website development and graphic design.

With a degree in Arts Management, Ms. Adams serves as the project manager for Invisible Walls. Her knowledge in website design, marketing, event coordination and association development allows her to match the right solution for clients’ promotional needs.

From special project development, to single meeting or small conference management, and graphic design to video or audio production services, Invisible Walls allows for innovative marketing campaigns, original web content, and effective branding techniques.

AKH Inc. is celebrating its 10 year anniversary!

noemail@akhealthcare.com — Tue, 06 Nov 2007 14:00:00 GMT

AKH Inc. is please to announce it is in their 10th year as an accredited provider of continuing education for licensed healthcare professionals.

In 1997, AKH Consultant was acquired by Helen Holman Consulting, Inc. Its owners, Helen and Jon Holman began with state-based providerships for nurses in Florida, and expanded the company’s services to include the provision of nationally accredited continuing education for pharmacists, physicians, nurse practitioners and nurses.

The business began in 1997 with 3 employees, in a 400 square foot building in Bay Meadows. Since then, it has moved 3 times, ending up in a new 2,600 square foot building, with 11 employees, and an additional division (see Invisible Walls).

In 1999, they worked with CE City to offer web based educational activities. They continue to add additional programming, as well as teaming up with Fox Learning to provide video based educational programs.

AKH Inc. continues to consult on educational design, course objectives, content, teaching methods, evaluation methods, and speakers. AKH Inc. brings to its co- and joint-sponsors over 50 years of combined healthcare educational experience, knowledge of various and changing accreditation regulations, experience in content development and project management; skill in course design, development and implementation; and knowledge of commercial support guidelines.

It has built a reputation for high quality programs that adhere to education and accreditation standards, and will continue for years to come.

On-line Courses:

Tue, 09 Mar 2010 19:51:49 GMT

Please select from one of the Nurse Practitioner courses below. Credit hours and fees are listed for each program. HELPFUL HINTS to consider before you start a course: CREDIT - Healthcare professionals are responsible for ensuring the continuing education programs they take meet the requirements for professional licensure as mandated by their state boards. Please read through the front matter of the course you select to determine if it has the appropriate accreditation statement, provider information and contact hours required for your licensure. POST-TEST - Once you access the test portion of the program please be prepared to complete it in one sitting. You may access the post-test prior to the program expiration using your username and password as long as you have not already SUBMITTED it for maximum tries allowed (once or twice as noted in the course’s method of participation). Please note and use the same username and password for program access and to facilitate...

On-line Courses:

Tue, 09 Mar 2010 19:50:39 GMT

Please select from one of the Physician courses below. Credit hours and fees are listed for each program. HELPFUL HINTS to consider before you start a course: CREDIT - Healthcare professionals are responsible for ensuring the continuing education programs they take meet the requirements for professional licensure as mandated by their state boards. Please read through the front matter of the course you select to determine if it has the appropriate accreditation statement, provider information and contact hours required for your licensure. POST-TEST - Once you access the test portion of the program please be prepared to complete it in one sitting. You may access the post-test prior to the program expiration using your username and password as long as you have not already SUBMITTED it for maximum tries allowed (once or twice as noted in the course’s method of participation). Please note and use the same username and password for program access and to facilitate accurate...

On-line Courses:

Tue, 09 Mar 2010 19:46:32 GMT

Please select from one of the Pharmacist courses below. Credit hours and fees are listed for each program. HELPFUL HINTS to consider before you start a course: CREDIT - Healthcare professionals are responsible for ensuring the continuing education programs they take meet the requirements for professional licensure as mandated by their state boards. Please read through the front matter of the course you select to determine if it has the appropriate accreditation statement, provider information and contact hours required for your licensure. POST-TEST - Once you access the test portion of the program please be prepared to complete it in one sitting. You may access the post-test prior to the program expiration using your username and password as long as you have not already SUBMITTED it for maximum tries allowed (once or twice as noted in the course’s method of participation). Please note and use the same username and password for program access and to facilitate accurate...

On-line Courses:

Tue, 09 Mar 2010 19:43:22 GMT

Please select from one of the Nursing courses below. Credit hours and fees are listed for each program. HELPFUL HINTS to consider before you start a course: CREDIT - Healthcare professionals are responsible for ensuring the continuing education programs they take meet the requirements for professional licensure as mandated by their state boards. Please read through the front matter of the course you select to determine if it has the appropriate accreditation statement, provider information and contact hours required for your licensure. POST-TEST - Once you access the test portion of the program please be prepared to complete it in one sitting. You may access the post-test prior to the program expiration using your username and password as long as you have not already SUBMITTED it for maximum tries allowed (once or twice as noted in the course’s method of participation). Please note and use the same username and password for program access and to facilitate accurate...

On-line Courses:

Thu, 28 Jan 2010 14:31:30 GMT

Please select from one of the Nurse Anesthetist courses below. Credit hours and fees are listed for each program. HELPFUL HINTS to consider before you start a course: CREDIT - Healthcare professionals are responsible for ensuring the continuing education programs they take meet the requirements for professional licensure as mandated by their state boards. Please read through the front matter of the course you select to determine if it has the appropriate accreditation statement, provider information and contact hours required for your licensure. POST-TEST - Once you access the test portion of the program please be prepared to complete it in one sitting. You may access the post-test prior to the program expiration using your username and password as long as you have not already SUBMITTED it for maximum tries allowed (once or twice as noted in the course’s method of participation). Please note and use the same username and password for program access and to facilitate...

Welcome to AKH Inc. Advancing Knowledge in Healthcare

Thu, 07 Jan 2010 19:26:32 GMT

AKH Inc, Advancing Knowledge in Healthcare is an accredited provider of continuing education for licensed healthcare professionals which has built a reputation for high quality programs that adhere to education and accreditation standards. We offer a variety of continuing education (CE) methods and topics, designed for physicians, pharmacists, nurse practitioners, nurses and other health care professionals. This educational option provides a convenient, quick method of learning; reviewing the course content, completing the post-test assessment, and receiving a statement of credit are all done on-line.

Additional courses available through our affiliate 360Training

Wed, 06 Jan 2010 18:28:14 GMT

AKH is pleased to offer to its customers access to additional Laboratory and Radiology courses offered through our affiliate, 360Training.

PLEASE NOTE:
Should you choose to continue, you will be leaving the AKH website and will be directed to a page offering AKH programs through 360Training. These programs are certified for credit through 360Training. Courses purchased through this site are separate from courses purchased through AKH. You will be asked to set up a username and password. Any shopping cart transaction in this site will be separate from AKH and you will see 360Training on your credit card statement.

Once you are finished browsing and/or purchasing these additional courses, just close the window and you will be returned to AKH. If you had made choices in our AKH list, your choices will still be available in your shopping cart.

To receive a 15% discount on any courses purchased through our affiliate site, please enter this discount code upon checkout: AKHINC

Contact Us

Wed, 06 Jan 2010 15:25:02 GMT

Course Completions: You are encouraged to complete your courses as soon as possible, as courses are updated regularly. Please review the accreditation and course approval information on the inside cover of the test booklet. Certain accrediting bodies issue course expiration dates. We consider the content of our courses to be timely and accurate for 2 years. We will honor course completions for 2 years from date of purchase unless the professional accrediting body has issued an expiration date. AKH attempts to renew all approvals prior to their expiration. Passing Score: AKH Inc. considers a score of 70% or better as passing (unless indicated on post-test). If you score below the required passing score, you will be issued an answer sheet that highlights the questions you missed; you must re-take only the questions you missed. This is a one-time service only, at no charge. Reporting of Continuing Education Credit: The healthcare professional is responsible for their...

Continuing Education Programs:

Tue, 29 Dec 2009 20:24:57 GMT

Please note: Customers are responsible for ensuring that the programs they purchase are approved and accepted by their licensing or certification boards for continuing education credit. If your profession is not listed, contact your board for a list of approved providers. AKH is open Monday-Friday from 10:00 am to 4:00 pm EST. All orders submitted outside of this time period will be mailed the next business day. Laboratory Affiliate Programs - NEW COURSES AVAILABLE Radiology Affiliate Programs - NEW COURSES AVAILABLE Nursing Nurse Practitioner Certified Nursing Assistant Clinical Social Worker Marriage and Family Therapist Mental Health Counselor Laboratory Occupational Therapy Physical Therapy Radiology (Please Note: The Florida Bureau of Radiation Control and ARRT will not accept repeat courses even if taken in a different licensure period.) Pharmacy Physician CME Psychologist Click HERE for a .pdf document of the Florida Professions...

Contact Us

Tue, 29 Dec 2009 20:23:15 GMT

Orders for home-study courses may be made by using our convenient shopping cart option, secured through Verisign. Service hours: Monday through Friday (10am to 4pm EST) Phone: (904-264-0674) Fax: (904-215-0534) Once you receive your order, review the materials you have received. Each course should contain course content (booklet, book, CD, etc.), test questions, answer sheet, evaluation, and return envelope. Study the course material. The questions are taken from the course content and should guide your study. Please follow instructions on the test. You may use either pen or pencil. (If you intend to fax us your answer sheet please mark your answers dark & legible in blue or black ink. Red pens or highlighter markers do not transfer over fax.) Complete the entire test answer sheet and evaluation form. Please legibly print all information requested on these forms so that we may provide an accurate certificate. Use this form for any questions or concerns you may have. Mail or Fax...

Pain Management Update 2009

noemail@akhealthcare.com — Sat, 01 Aug 2009 12:00:00 GMT

Objectives:

Release Date: 1-Aug-09 8:00 AM
Expiration Date: 31-Aug-11 8:00 AM
Please answer the following questions by clicking the appropriate rating.

Disposal of Unwanted Medications: What Health Providers Should Tell Their Patients

noemail@akhealthcare.com — Fri, 01 May 2009 17:00:00 GMT

Objectives:

Release Date: 1-May-09 1:00 PM
Expiration Date: 31-May-11 1:00 PM
Please answer the following questions by clicking the appropriate rating.

ASTHMA: An Update on Management

noemail@akhealthcare.com — Wed, 01 Apr 2009 12:00:00 GMT

Objectives:

Release Date: 1-Apr-09 8:00 AM
Expiration Date: 30-Apr-11 8:00 AM
Please answer the following questions by clicking the appropriate rating.

Preventing Medical Errors Clinician 2009-2011 Evaluation sheet

noemail@akhealthcare.com — Thu, 01 Jan 2009 22:00:00 GMT

Objectives:

Release Date: 1-Jan-09 5:00 PM
Expiration Date: 31-Jan-11 5:00 PM
Please answer the following questions by clicking the appropriate rating.

HIV/AIDS 2 Hour Update for Kentucky Health Professionals 2009-2011 Evaluation Sheet

noemail@akhealthcare.com — Thu, 01 Jan 2009 15:00:00 GMT

Objectives:

Release Date: 1-Jan-09 10:00 AM
Expiration Date: 31-Jan-11 10:00 AM
Please answer the following questions by clicking the appropriate rating.

OSHA 2009 Reguations for Bloodborne Pathogens Evaluation sheet

noemail@akhealthcare.com — Thu, 01 Jan 2009 13:00:00 GMT

Objectives:

Release Date: 1-Jan-09 8:00 AM
Expiration Date: 31-Jan-11 8:00 AM
Please answer the following questions by clicking the appropriate rating.

Medication Errors: Prevention is the Key Evaluation sheet

noemail@akhealthcare.com — Thu, 01 Jan 2009 12:00:00 GMT

Objectives:

Release Date: 1-Jan-09 7:00 AM
Expiration Date: 31-Jan-11 7:00 AM
Please answer the following questions by clicking the appropriate rating.

Preventing Medical Errors for Allied Health Professionals 2009-2011 Evaluation sheet

noemail@akhealthcare.com — Thu, 01 Jan 2009 12:00:00 GMT

Objectives:

Release Date: 1-Jan-09 7:00 AM
Expiration Date: 31-Jan-11 7:00 AM
Please answer the following questions by clicking the appropriate rating.

Domestic Violence Evaluation

noemail@akhealthcare.com — Thu, 01 Jan 2009 10:00:00 GMT

Objectives:

Release Date: 1-Jan-09 5:00 AM
Expiration Date: 31-Jan-09 5:00 AM
Please answer the following questions by clicking the appropriate rating.

HIV/AIDS 4 Hour 2009-2011 Evaluation sheet

noemail@akhealthcare.com — Thu, 01 Jan 2009 05:00:00 GMT

Objectives:

Release Date: 1-Jan-09 0:00 AM
Expiration Date: 31-Jan-11 0:00 AM
Please answer the following questions by clicking the appropriate rating.

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Preventing Medical Errors: The CNA''s Role

2009-01-01T13:00:00Z

Instructor: Ginny McCarty, RN, CIC, LHR

Preventing Medical Errors The CNA'S Role By: Virginia McCarty To download a .pdf version of this course click here! Faculty Virginia McCarty, RN, CIC, LHR Ms. McCarty serves as a CE Coordinator and is a diploma graduate nurse with certification in infection control and healthcare management. A member of the Association for Professionals in Infection Control and Epidemiology (APIC) and Florida Risk Managers Association, Ms. McCarty has extensive background in teaching healthcare professionals the principles of infection control, OSHA bloodborne pathogens, hazardous waste management, risk management and documentation. In 2007, Ms McCarty was the recipient of a Great 100 Nurses of Northeast Florida award. OBJECTIVES Upon completion of this course, the participant will be able to: Recognize the seriousness of medical errors. Explain the importance of reporting medical errors. List the causes of medical errors. Describe the CNA's role in preventing medical errors. Discuss ways to promote patient safety. Introduction In 1999, the Institute of Medicine (IOM) published a report about medical errors This report declared that it is simply unacceptable for patients to be harmed by the same system that is supposed to offer healing and comfort. The primary goal of this home study course is to enable the CNAs to recognize and change situations that can lead to medical errors. Since its publication in 1999, this landmark report has initiated ways to provide increased safety for patients in healthcare facilities. Often the proposed safety solutions are not realistic in the work setting. For example, a detailed description of how to walk with a patient may be very accurate, but it still fails to acknowledge the effect of a lot of interruptions and distractions within a hectic work environment. Nationally recommended practice changes have not always been readily accepted by working health care professionals. A primary goal of this home study course is to help you to be able to actually reduce errors by using practical methods while you work. Statistics estimated deaths in hospitals from medical errors are 44,000 to 98,000 people.1 1.3 million people are injured by medical errors.1 medical error and resulting complications have become America's leading cause of death 1 Null G, Dean C, Feldman M, Rasio D, Smith D. Death by Medicine Part 1. HealthE Living News. 2003-2005. These are estimates of death and injury and only from medical errors that occur in hospitals. Errors also occur in other healthcare settings including extended care facilities and outpatient areas. These estimates are taken from data on documented errors such as errors related to medications. Many errors are not documented because they do not end up harming the patient or are prevented prior to the error occurring (these are termed near-miss errors). In calculating this astounding number, authors considered preventable deaths attributed to reported medical error along with deaths that were linked with adverse drug reactions, bedsores, infection, malnutrition, outpatient error, unnecessary procedures and surgical complications. Impact estimations of significant cost to individuals, families, organizations and society as a whole individuals encounter needless pain and countless losses related to functional health status and financial stability. duplicate testing, repeated procedures, prolonged treatment and extended recovery time. estimates the annual dollar cost of preventable medical error at $282 billion.1 1Institute of Medicine, Division of Health Care Services Committee on Quality of Health Care in America (1999). To err is human: Building a safer health system. Washington, DC: National Academy Press. Because of medical errors, there is lost productivity, disability, and increased costs of personal care. Unacceptably, thousands will die each year. Countless others, along with their family and friends, will have lost their trust in our health care system. The potential for experiencing harm while receiving health care threatens every American and as the IOM report noted, Americans shouldn't be harmed by the very people that are trying to care for them. What are the errors? Diagnostic oriented Treatment oriented Performance oriented Preventative Other As a CNA, you are probably looking at this list and thinking, I don't do that. However, let's to look at your role in each of these categories and see how you are involved in each example. Patient diagnosis is primarily the physician's responsibility. However, if as part of the diagnostic process, you fail to collect a urine sample or keep a patient NPO for a scheduled test, then you are part of the error in timely diagnosis. Treatment oriented errors have a lot of potential for a medical error occur. Examples that may involve a CNA are not properly wrapping an ice pack to prevent skin injury or not taking vital signs as ordered. Performance oriented errors are related to either doing something wrong or not doing it at all such as assisting a resident with eating or walking. Most errors fall in the preventative class and are not necessarily related to people but to the system in place. Other errors include failures in communications, equipment failure, and other types of system failure. Even when these failures do not directly cause medical error, they are often linked to the circumstances surrounding error. Why do they occur? Human Error Invisibility of Error System Error Reasons why people make errors have been studied for many years. While there is no single answer, it is generally recognized that no one intentionally makes a mistake. However, it is generally agreed that humans tend to perform best when they stay focused and alert, concentrating on the required tasks or decisions. Anything that decreases one's attention or creates a distraction will predictably increase the chance of error. Typical distractions come from physiological (things affecting the body), psychological (things affecting mental and emotional states), or environmental (your work area) sources. Physiological factors include fatigue, illness, loss of sleep, alcohol, and drugs. Psychological factors include various personal problems and stress. Environmental factors include distraction from other activities, discomfort from work place conditions, and interpersonal relations. Medical errors are often surrounded by secrecy and shame allowing others to remain unaware of their existence. Embarrassment, fear of retribution and the fear of losing your job, keep many from revealing their mistakes. When errors are silenced and covered they also remain undocumented and unreported, and this keeps them invisible. Most errors occur as a result of a chain of events set in motion by faulty system design that either induces errors or makes them difficult to detect. In other words, mistakes usually happen because of the system - not the people! 1 1 Leape LL, Bates DW, Cullern DJ et al. Systems Analysis of Adverse Drug Events. JAMA. 1995;274:35-43. Responsibility of CNAs Attitude Observation Job performance Correction of identified issue Communication Reporting As a CNA, you are in contact with residents, other employees, and the environment within the facility. The first thing people will notice about you is your attitude which effects your work on all levels including how well you observe others and the actions around you. NEVER do any task that you have not been taught how to do. If you see a situation that could result in harm to anyone, you should correct it immediately if you can. If not, take the appropriate steps to prevent injury while you notify your supervisor of the situation. Preventing medical errors requires you to communicate what you see and hear and do and to report appropriately any and all potentially harmful situations. Let's look a little more at each of these areas. ATTITUDE First Impression You never get a second chance to make a good first impression You never get a second chance to make a good first impression---don't forget that. The attitude you portray is the initial impression you make on people. A smile says that you are friendly and willing to help whereas a sullen expression says to others, leave me alone. In your role at the nursing home, you are the person having a significant amount of contact with the residents. They and their families need to feel comfortable in the knowledge that you will provide for their needs and do so with a helpful and pleasant demeanor. Think about your own reaction to people. If you are in a store and need help, you are going to approach the person who is smiling and seems friendly, not the one looking straight ahead and appearing disinterested. Your attitude will go a long way in making residents and their families feel comfortable and co-operative. It will encourage others to ask questions which may prevent an error from occurring. Observation Residents Environment Visitors Fellow employees You observe or see many different things in the course of a day including people and things. You must pay attention to your resident regarding their diet, activity, and changes in their mental status, personality, or physical changes. Physical changes include their ability to walk or a change in how they walking, changes in their appearance, and/or any type of injury that you notice. Changes in skin such as redness or swelling can indicate pressure that can cause a bedsore. Such an observation must be reported to your supervisor and evaluated to prevent a bedsore. Environmental observations include safety issues such as potential trip hazards, fire doors not staying closed, or frayed cords on electrical equipment. Never leave a resident in an unsafe situation. Visitors include anyone who is not employed by the facility including physicians, families, and vendors. You should be aware of your fellow employees and nicely remind them if you observe them doing things that do not follow policy or can cause harm to themselves or others. JOB PERFORMANCE Job description Policies Procedures Safety To prevent yourself from making a medical error, you need to know what your job duties are. Do not perform any procedures or treatments for which you have not been trained. If you are uncertain, consult your supervisor. Be familiar with the policies and procedures of the facility in which you work. These documents will protect both you and your residents and prevent you from making a medical error. Always think safety for yourself and others. Ask for help rather than take any safety risk such as leaving a resident who requires assistance to walk in order to do something else. Correction of the issue or INTERVENTION DO something when situations aren't right Decide what is wrong If it can be fixed immediately, fix it If you need help, get it Communicate Report In addition to having a good attitude and observing what is happening, intervening at the time an issue or situation is identified is extremely important. Prevention of medical errors within a facility requires the attention of everyone as no one person can be the eyes and ears for the entire facility. Whenever you recognize that either a danger exists or a situation has developed that can lead to an accident or injury, you should decide what's wrong and then act. Again, never use electrical equipment that has a frayed cord or is not working as it should. Sometimes fixing the situation is easy like wiping up spilled water that is on the floor to prevent a someone from falling. Other times, the problem is more complex as seen here. Suppose a patient that can't chew is given steak for dinner. You know the patient chokes easily and usually gets soft food. Don't just decide that his diet has changed. Check before you let the resident eat the food. If you need help to correct a situation, get it. Another example is a patient who you is trying to get out of bed but needs help. If the person is in no immediate danger of falling, check to find out if the resident needs a walker or a wheelchair or perhaps two people to help get them up. Knowing what is needed can prevent errors in care. Communicate with other staff members and residents as appropriate. File a report with the supervisor as indicated. COMMUNICATION Safety issues A change in resident physical, emotional or behavioral condition Signs of neglect, injury, or abuse There are many things that should always be reported but one of the most important are safety hazards. No matter the chain of communication, the resident always comes first and ensuring their safety is your primary goal. A change in resident condition is a reportable event. Even the most minor observations regarding a change can prevent the development of a major health issue. Give the nurse the opportunity to decide whether it needs to be communicated further or not. Don't take it upon yourself to make that decision. If you suspect that a resident is being abused, report it to your supervisor. This includes physical, emotional and financial abuse whether it involves the resident's family or your co-workers. Residents Families Visitors Fellow employees In addition to communicating about the residents, you must communicate to the resident. If you are informed of changes that are going to affect the resident, be sure to tell them. Always tell the resident what you are going to do if it involves them BEFORE you do it. Communication prevents confusion and increases co-operation and can prevent falls from occurring when assisting a resident. Also, if a resident is going to have to be taken to another facility for a test and won't get any breakfast, make sure they know they won't be eating and why. Additionally, families must be given this information. Failure to communicate could result in the test not being able to be done or in having to be repeated. Communication with fellow employees needs to be done also and usually facilities have signs to notify others of situations like this one. Summary Medical errors must be prevented as they are a major cause of death and injury causing needless pain, a distrust of our healthcare system, and high costs. Errors must be reported so changes can be made to prevent them from occurring again. Medical errors result form human and system error and reoccur due to a tendency to hide them. CNAs responsibilities to prevent medical errors include having a good attitude, observation, job performance, communication, intervention in unsafe situations and reporting to supervisors. Healthcare facilities must provide safe systems and safe environments to prevent medical errors from occurring. PLEASE PROCEED TO TEST AND EVALUATION

HIV-AIDS 2 Hour Update: For Kentucky Health Professionals 2009-2011

2009-01-01T13:00:00Z

Instructor: Jonathan S. Holman, B.S., Pharm. D., CCMEP; Virginia McCarty, RN, CIC, LHRM

HIV/AIDS 2 Hour Update For Kentucky Health Professionals 2009 - 2011 Edition To download a .pdf version of this course click here! COURSE DESCRIPTION This is a 2 hour course designed for home study by healthcare clinicians. Successful completion of this course satisfies the 2 hour HIV/AIDS continuing education requirement for Kentucky health professionals. Information regarding the prevention, transmission, control, diagnosis and treatment of human immunodeficiency virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS) is provided. Other topics discussed include standard precautions, care of persons living with AIDS, workplace issues and legal aspects for health care professionals. COURSE OBJECTIVES Upon completion of this course, the learner should be able to: Describe the epidemiology and immunopathogenesis of AIDS. Identify methods of HIV transmission and reduction/prevention techniques. Describe the clinical management of HIV/AIDS. Discuss medications and therapeutic strategies used to treat HIV/AIDS. List laboratory tests utilized in the diagnosis and management of HIV/AIDS. Identify typical psychosocial consequences experienced by many persons living with HIV/AIDS. Outline legal considerations for health professionals regarding HIV/AIDS. FACULTY Jonathan S. Holman, B.S., Pharm. D., CCMEP is co-owner and continuing education administrator at AKH Inc. Dr. Holman has extensive experience as a clinical pharmacist in adult intensive care. He holds a Bachelor of Science degree from the University of Colorado and a Doctor of Pharmacy degree from the Medical University of South Carolina. Dr. Holman has no relevant financial relationships to disclose. Virginia McCarty, RN, CIC, LHRM is a diploma graduate nurse with certification in infection control and a licensed healthcare risk manager. She is a member of the Association for Professionals in Infection Control and Epidemiology (APIC) and Florida Risk Managers Association. Ms. McCarty has extensive background in teaching healthcare professionals the principles of infection control, OSHA bloodborne pathogens, hazardous waste management, risk management and documentation. She is currently employed by AKH Inc. as an Educational Consultant. Ms. McCarty has no relevant financial relationships to disclose. CONFLICT OF INTEREST STATEMENT It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflict of interest is resolved by AKH prior to accreditation of the activity. COMMERCIAL SUPPORT: This activity is NOT supported by a commercial educational grant. DISCLAIMER AKH Inc.'s courses are designed solely to provide healthcare professionals with information to assist in their practice and professional development. The courses are researched thoroughly, utilizing current literature and including practical experiences. AKH's courses are not to be considered a diagnostic tool to replace professional advice or treatment. The courses serve as a general guide to the healthcare professional, and therefore, they cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH educational courses do not endorse commercial products. The author(s) and the publisher specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the courses. AKH further disclaims any responsibility for undetected errors, or from the reader's misunderstanding of the course. Copyright © 2008, AKH Inc. No part of this publication may be produced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical photocopying, recording, or otherwise, without the prior permission of the publisher. TABLE OF CONTENTS INTRODUCTION EPIDEMIOLOGY Summary of US HIV/AIDS Data THE HUMAN IMMUNODEFICIENCY VIRUS HIV Life Cycle HIV/AIDS DISEASE PROCESS ROUTES OF TRANSMISSION HIGH RISK GROUPS DIAGNOSIS PREVENTION Preventing Sexual Transmission Preventing Injection Drug Transmission Preventing Perinatal Transmission Prevention - HealthCare Personnel Prevention Non-occupational Exposure Clinical Management Antiretroviral Therapy When to Initiate Antiretroviral Agents Regimen Revision Due to Treatment Failure Therapeutic Drug Monitoring Treatment Interruption or Discontinuation Opportunistic Infection Prophylaxis Future Trends in Management/Treatment Workplace Issues Standard Precautions The Handling & Disposal of Contaminated Materials The Psychosocial Dimension of AIDS Professional, Ethical and Legal Aspects Summary Kentucky Specific HIV/AIDS Information Community Resources References INTRODUCTION Acquired Immune Deficiency Syndrome, more commonly known by its acronym AIDS, is caused by the human immunodeficiency virus (HIV). A person is considered infected at the time HIV is acquired. Major medical symptoms are unlikely to develop until viral proliferation progresses and results in significant deterioration of the immune system and acquisition of opportunistic infections. Disease progression has no standard rate or pace. It is directly related to the destruction of crucial immune cells, the CD4+ T-lymphocytes, and can be dramatically delayed by antiretroviral therapies. More US citizens are living with HIV than ever before due in part to the efficacy of available therapies, but also from the occurrence of new cases, a sign that current preventive measures are not as effective as need be. EPIDEMIOLOGY Globally, an estimated 33 million people, half of which are women and 2.1 million children under 15 years of age, were living with HIV in 2007.1 There were approximately 2.7 million new infections that same year, including 370,000 children. Deaths due to AIDS totaled 2 million and included 270,000 children.1 Sub-Saharan Africa continues to be heavily affected, and accounts for 67% of those living with HIV infection and 72% of the deaths from AIDS.1 Financially, there continues to be a major difference in available resources and need, particularly in the middle- to low-income nations. While spending increased to $10 billion in 2007, the projected need was more than $18 billion. Consequently, many people living with HIV or at risk for infection do not have access to prevention, care and treatment.2 Within the United States, AIDS cases are reported to the CDC via local health departments. Epidemic trends are currently derived from data obtained from states and US dependent areas with confidential name-based HIV infection reporting. In 2008 HIV incidence estimates were further refined through the use of a serologic testing algorithm for recent HIV seroconversion (STARHS) which can differentiate recent from long-standing HIV infections.3 Summary of US HIV/AIDS Data4 The cumulative number of US AIDS cases reported to the CDC through 2006 was 1,014,797. Of these, 565,927 (56%) had died. Adult and adolescent AIDS cases totaled 1,005,641 with 783,786 (78%) cases in males. Through the same time period, 9,156 AIDS cases were reported in children (< 13 years of age). Half of the total cases are from only four states, New York, California, Florida and Texas. The annual incidence of new AIDS cases has decreased slightly from 2002 (39,250) through 2006 (37,852). Cases among children decreased by approximately 64% during this time period, but increased for those 13-29 years and those 45 and older. In 2006 the highest occurrence (approximately 20%) was in those 40-44 (7,298) years of age. New HIV infections for 2006 are estimated at 56,300, a relatively stable rate since 1999. As many as 21% of those infected are unaware of their status.5,6 , More than 1.1 million people are living with HIV/AIDS and 73% of adults and adolescents are male, 47% black, 34% white, and 17% Hispanic. Minorities are disproportionately affected considering that blacks compose only 12% of the US population and Hispanics 15%. THE HUMAN IMMUNODEFICIENCY VIRUS HIV is the infectious agent that causes AIDS. It consists of genetic information in the form of two single strands of ribonucleic acid (RNA) enclosed within an envelope.7 HIV is classified as a retrovirus since its method of replication involves reverse transcription of its genetic information into double-stranded deoxyribonucleic acid (DNA). Based on biologic features, HIV is further classified as a lentivirus - a virus associated with a long interval between infection and the onset of symptoms. The DNA containing HIV's genetic information eventually becomes part of the host cell's genetic information (DNA provirus). Consequently, retroviruses exist in two forms, a DNA provirus and an infectious RNA virion (RNA-containing envelope). Two forms of HIV have been identified, HIV-1 and a serologic variant HIV-2. While their structure, transmission and resulting opportunistic infections are similar, HIV-1 is responsible for the majority of infections worldwide while HIV-2 is found mostly in western Africa. HIV has several characteristics that contribute to its survival.7 It has great genetic diversity, allowing it to survive biological attack by simply adopting a new genetic characteristic. This virus also has the quality of latency, with its genetic information residing in the host chromosomal DNA as DNA provirus. This enables the virus to lie dormant for a long time, thus resisting recognition and treatment. Finally, HIV specifically affects CD4+ T-cells and macrophages thus reducing` the host's defense mechanisms. HIV Life Cycle Understanding HIV's life cycle8 helps one appreciate many of the developments in the quest to control and hopefully one day eradicate its infection. Novel treatment strategies that target the processes required for successful viral infection and proliferation have been developed. Two phases compose HIV's life cycle. The first phase (figure; steps 1-5) involves viral attachment, entry, reverse transcription, entry into the nucleus, and integration of the double-stranded DNA (provirus). The second phase (figure; steps 6-10) involves the remainder of the infected cells' life and the production of viral proteins plus new infectious virions as directed by the viral and cellular proteins. HIV must invade a host cell to replicate. Examples of drug category and process interrupted by currently available antiretroviral drug therapies are: fusion inhibitor and CCR5 coreceptor antagonist (Step 2), nucleotide-, nucleoside-, and non-nucleoside reverse transcriptase inhibitors (Step 4), integrase inhibitor (Step 5), and protease inhibitors (Step 10). HIV/AIDS DISEASE PROCESS Once in the body, HIV interacts with CD4 receptors on macrophages and T lymphocytes and coreceptors, CCR5 or CXCR4, to invade and rapidly replicate. As new viruses are released the CD4+ T cells are disabled and ultimately killed. The virus spreads to various organs and tissues. Lymphoid organs, such as the tonsils, adenoids, lymph nodes and spleen, are a primary target. During this period, generally 2-4 weeks after infection, roughly 70 percent of infected individuals experience an acute flu-like syndrome characterized by fever, malaise, lymphadenopathy, pharyngitis, headache, myalgia, and occasionally rash.8 A period absent of signs or symptoms follows. Carriers of HIV, regardless of manifestations, are capable of spreading the virus. A population of long-living latently infected T cells provides sites where the virus may hide and survive in a dormant state for an extended period of time.7 These cells are partially responsible for the failure of currently available therapies to eradicate the virus in an infected individual. Immune damage and extent of disease is indicated by the CD4+ T cell count. Significant reduction in these cells leads to susceptibility for opportunistic infections (OIs), malignancies, and neurologic dysfunction. Progression of HIV infection to actual AIDS has been greatly impacted by the introduction of highly active antiretroviral therapies (ART). Effective ART can suppress viral replication and restore CD4+ T cell counts in patients with AIDS and eliminate the need for OI prophylaxis. ART, when available, has been credited with extending life expectancy by more than 24 years.9 Despite successes with ART, OIs continue to occur. Treatments may fail for a variety of reasons including development of viral resistance, inadequate drug levels (due to drug interactions, inappropriate agent selection, etc.), or patient noncompliance. Some, for a variety of reasons, simply fail to receive ART. Sometimes care is provided by those who lack current knowledge of HIV infection and recommended therapies. Other times the infected individuals lack access to optimal care. Once HIV infection has reduced the number of CD4+ T cells to approximately 200/mm3 of blood, an infected individual enters an early symptomatic phase that may last months to several years. The most common signs and symptoms associated with active HIV infection are not life-threatening but may be debilitating and are typically persistent and are not due to other common illnesses. These symptoms include severe and chronic fatigue, anorexia, weight loss, fever with night sweats and/or chills, persistent or repeat yeast infections (oral, vaginal), lingering skin rashes or flaky skin, pelvic inflammatory disease in women that is refractory to treatment, and short-term memory impairment.8 The late symptomatic phase of HIV infection develops when the CD4+ T cells drop below 200 cells/mm3 of blood. At this stage of disease progression, any of 26 OIs and rare cancers may appear.8 The duration of this phase may last for months to years, but the cumulative effects usually result in death. ROUTES OF TRANSMISSION HIV is not transmitted from person to person through casual contact. It is spread primarily through unprotected sexual contact or by sharing needles and syringes with an infected person. The virus can enter the body through the membranes of the vagina, vulva, penis, rectum or mouth during sex. Studies suggest that the likelihood of both contracting and spreading HIV is 2-5 times higher in persons with other sexually transmitted diseases.10 Sharing of drug paraphernalia among IV drug users exposes participating persons to others' blood, and can spread the virus if one of the persons using it is infected with HIV. HIV-infected mothers may transmit the virus to their babies before or during birth, or from breast-feeding.11 Once a significant source of HIV infection, blood or blood products are rarely the cause due to current blood and donor screening. Current refinements in screening and collecting donor blood have reduced the risk to 1 in 2 million transfusions.12 In the healthcare setting exposure to contaminated materials from spills, sticks, splashes, or other means may potentially infect workers and or patients. The CDC has identified semen, vaginal secretions, and cerebrospinal, synovial, pericardial, pleural, amniotic and peritoneal fluids as capable of transmission of HIV. The virus has been found in saliva, sputum, tears, urine, stool, and vomitus, but scientific proof of transmission from these materials is lacking.7,8 HIGH RISK GROUPS The highest transmission categories and groups in the US for adults and adolescents with HIV/AIDS diagnosed during 2006 are listed in descending order: 1) male-to-male (MSM) sexual contact, 2) high-risk heterosexual contact for women, 3) high-risk heterosexual contact for men, 4) injection drug use (IDU) for men, followed by 5) female IDU.13 MSM continue to be disproportionately affected by HIV/AIDS and represent 50% of all new diagnoses.13 In the US, high-risk heterosexual transmission represents approximately 33% of those diagnosed in 2006. Categorized by gender, heterosexual transmission accounted for nearly 16% of cases in males and 80% in females.13 Injection drug users, a group considered high risk for HIV/AIDS, has seen a significant decline in cases over time with only 12% of new infections attributed to them in 2006.13 Race/ethnicity has risk implications in the US. Blacks accounted for 49% of all new HIV/AIDS diagnoses in 2006 and Hispanics 18%. Yet, they represent only 13% and 15% of the population respectively. Among women, black women represent approximately two-thirds of new HIV/AIDS diagnoses.4,6 DIAGNOSIS The diagnosis of AIDS is made, when in the presence of HIV infection, laboratory values indicate immunosuppression or actual opportunistic infections or cancers are present. For adults and adolescents it applies to those who are HIV positive and have a: CD4+ T-lymphocyte cell count less than 200 cells/mm3; or CD4+ T-lymphocyte percentage of total lymphocytes less than 14%; or any AIDS-defining condition (Table 1).14 Table 1. AIDS-Defining Conditions Candidiasis Cervical cancer (invasive) Coccidioidomycosis, Cryptococcosis, Cryptosporidiosis Cytomegalovirus disease Encephalopathy (HIV-related) Herpes simplex (severe infection) Histoplasmosis Isosporiasis Kaposi's Sarcoma Lymphoma, Burkitt's (or equiv.), immunoblastic (or equiv.) Mycobacterium avium complex Pneumocystis (carinii) jiroveci pneumonia Pneumonia (recurrent) Progressive multifocal leukoencephalopathy Salmonella septicemia (recurrent) Toxoplasmosis of brain Tuberculosis Wasting syndrome due to HIV Testing for HIV can be initiated at home through the use of a collection device, done through private physician offices or in public clinics. The most compelling reason to be tested is the existence of drug therapy that when appropriately initiated and managed can dramatically extend and improve the quality of an infected individual's life. Also, the person who tests positive has the opportunity to know and practice precautions to prevent the spread of HIV. CDC 2006 revised guidelines for testing recommends HIV screening for patients in all healthcare settings and specifies annual screening for persons at high risk for HIV infection.15 HIV testing should be included in routine prenatal screening tests for all pregnant women. Repeat screening is recommended during the third trimester for those in areas with elevated rates of HIV infection. The guidelines also state that one's general consent for medical care should encompass consent for HIV testing and that separate written consent for HIV testing should not be required. The usual laboratory method for detecting and diagnosing HIV infection in the US is through the use of enzyme immunoassay (EIA) screening, and confirmation with a more specific test such as the Western blot test. The EIA tests detect antibodies produced by the body's immune response to the infection, rather than the virus itself and are greater than 99% accurate. False positive results are possible in individuals with collagen-vascular diseases, chronic hepatitis, malaria, or certain HLA phenotypes. Individuals with infections too recent for antibody production, a period of a few weeks to as long as 6 months, might test false negative. A positive result should be re-tested. Currently, the standard confirmatory blood test is the Western blot test. An equivalent but seldom used test is the indirect immunofluorescent assay (IFA). The Western blot allows measurement of nine different antibodies that are likely to occur in the blood of people infected with HIV. Four rapid HIV tests, capable of results in less than 30 minutes, have been approved by the FDA. Their use is particularly relevant for women in labor who have not been tested during pregnancy, healthcare or emergency workers who are accidentally exposed to potentially infectious substances, and for the estimated 9,000 people who test positive at public testing sites each year and do not return for their results.16 Other tests used in the diagnosis, monitoring or investigation of HIV infection are: PCR (Polymerase Chain Reaction) -a sensitive technique used to detect and quantify HIV nucleic acids in a person's blood or lymph nodes. It is an FDA-approved test to measure viral load. NAT qualitative HIV-1 nucleic acid test used in the diagnosis of acute and primary HIV-1 infection; another method to confirm HIV-1 infection in those with tests repeatedly positive for HIV-1 antibodies. Viral culture - test utilized in diagnosing HIV infection in infants and in clinical research. P24-antigen - test detects a protein located in the viral core of HIV. It can be used in the diagnosis in infants and to routinely screen blood and plasma at collection centers. Orasure (saliva) and Home Access HIV-1 Test System: anonymous home collection systems for specimens that are mailed to laboratories to determine the presence of HIV antibodies. Note that many non-FDA approved home HIV tests are available for purchase through magazines and the internet. Their accuracy cannot be guaranteed. Specific tests for infants and children, as well as the classification of AIDS disease process is different from that for adults. Briefly summarized, the HIV antibody tests (standard EIA and Western Blot) are not reliable indicators of infection because of the presence of maternal antibodies in infants up to 15-18 months of age. The recommended test for exposed infants under the age of 18 months is the virus culture, PCR test, or p24 antigen assays. Diagnosis in a child over 18 months of age is usually determined by a positive EIA test confirmed by Western blot or IFA.17 PREVENTION The most effective means of HIV/AIDS prevention is avoidance of behaviors that place a person at risk for the disease. Behaviors to be avoided are primarily unprotected sexual activity and sharing needles and/or syringes for injecting drugs. Sexual Risk Scale for HIV Transmission SAFEST: Abstinence, Fantasy (phone/cyber sex) Mutual long-term monogamy between two uninfected non-IDU Hugging, massaging Kissing Body-to-body rubbing without penetration Mutual masturbation without sharing fluids SAFER: Oral sex with a barrier (condom or dental dam) Vaginal intercourse with a correctly used condom Anal intercourse with a correctly used condom UNSAFE: Oral sex without a barrier (especially risky for other STD) VERY UNSAFE: Vaginal intercourse without a condom Anal intercourse without a condom Preventing Sexual Transmission Avoiding unprotected sex is also termed safer sex and includes knowledge of sex partners, their sex practices, their possible drug experiences, and minimizing exchanges of blood, semen or vaginal secretions by following guidelines from abstinence to non-penetrative sex to the consistent use of latex or polyurethane condoms. Condoms have been shown to be 80% to 97% effective in preventing HIV transmission if used with each sexual encounter and if used correctly.18 Two types of condoms are available; one that is inserted into the vagina or rectum and another that is placed over an erect penis. The intent is to prevent HIV-infected semen from contacting the mouth, vagina or rectum or to protect the penis from HIV-infected vaginal fluids and blood in the mouth, vagina, or rectum. Condoms must be used as directed PRIOR to any contact that would expose critical sites of transmission to infected fluids. While abstinence is the ultimate protection from sexual transmission of HIV, monogamy in sexual relationships is a safer precautionary measure.19 Instructions for Using a Male Condom Check the expiration date of the condom, which is on the package. The condom package should look like a small inflated pillow. Look at the corners of the package and notice how they are filled with air. A condom with a broken seal will not do this. Open the package at the end so that you don''t damage the condom. Many condom packages have a notch in the edge of the packaging as a place to begin tearing. Condoms may stick to skin and hair so it is recommended to use them with only water-based lubricantdo not use condoms with spermicide, also known as nonoxynol-9. In people with an allergic reaction to the spermicide, nonoxynol-9 can result in little sores that make the transmission of HIV and sexually transmitted diseases (STDs) more likely. Be sure to check the label of any lubricant before using it. Put on the condom as soon as the penis is hard. Be sure the roll-up ring is on the outside facing away from the penis. Hold the tip while you unroll the condom along the length of the penis to the hair. Because a condom rolls down the penis, it can only go on one way. If you ever try to put a condom on with the wrong side onto the penis, throw it away and start with a new, unopened condom. Never unroll the condom before putting it on the penis. While unrolling the condom, be sure to leave some space at the tip to hold the semen - about one-half to one inch at the tip of the condom. Some condoms have reservoir tips. (If there is not enough room at the tip, the semen could break the condom.) Squeeze the tip gently so that no air is trapped inside. When putting the condom on, avoid tearing it with fingernails, jewelry, or anything else sharp or metallic. A condom fits rather snuggly on a penis, so rolling it down can be difficult. Be gentle, so as not to injure the penis or cause discomfort. It is important that the penis stay erect in order to apply the condom. Right after ejaculation the penis should be pulled out slowly while it is still hard. Hold the condom in place on the penis to avoid spilling semen. While holding the tip, roll the condom up only a portion of the way and then gently pull it off of the penis. You need to use a new condom every time that you have sexual intercourse. Never use the same condom twice. Dispose of used condoms properly. If possible, wrap them in something like a paper towel or tissue and dispose of them in a trash container. Do not flush condoms as they can easily clog plumbing. Do not throw them away on the ground where they can present a hazard to children and a litter problem. Instructions for Using a Female Condom Check the expiration date. Do not use if the package is broken, the female condom is brittle or dried out, the color is uneven or has changed, or it is unusually sticky. Use a new female condom each time you have sex. Use each female condom only once. Open the package carefully. Avoid tearing the condom with fingernails or using the condom with jewelry or anything else sharp or metallic. Use only water-based lubricants with female condoms. Make sure the inner ring is at the bottom closed end of the sheath, and hold the sheath with the open end hanging down. Find a comfortable position to insert the ring. Most women will do it lying on their back, squatting, or standing with one foot on a chair. With your free hand, spread open the outer vaginal lips. Squeeze the inner ring with thumb and middle finger (so it becomes long and narrow), and then insert the inner ring and sheath into the vaginal opening. Gently insert the inner ring into the vagina and feel it go up. Place the index finger inside of the condom and push the inner ring as far as it will go. Do not worry, it can''t go too far. Make sure the condom is inserted straight, and is not twisted inside the vagina. The ring at the open end of the female condom should stay outside the vagina and rest against the labia (the outer lip of the vagina). Once you begin to engage in intercourse, you may have to guide the penis into the female condom. If you do not, be aware that the penis could enter the vagina outside of the condom''s sheath. If this happens, you will not be protected. If the condom slips during intercourse, or if it enters the vagina, then you should stop immediately and take the female condom out. Then insert a new one and add extra lubricant to the opening of the sheath or on the penis. To remove the condom, twist the outer ring gently and then pull the condom out, keeping the sperm inside. Dispose of used condoms properly. Wrap the condom in the package or in tissue and throw it away. Do not put it into the toilet, since it can clog the plumbing. Do not throw used condoms away on the ground where they can present a hazard to children and become a litter problem. Preventing Injection Drug Transmission For injecting drug users who can't or won't stop injecting drugs, using sterile equipment is the safest means of preventing HIV transmission. Because of the illegality of needle exchange programs in many states (including Kentucky), IDU should be advised that needles can be purchased from most pharmacies. For those who persist in sharing injection paraphernalia, the use of bleach to cleanse and disinfect the needles and syringes has been suggested as a potential, but less reliable, method to prevent viral transmission.20 What Should We Tell IDUs? Education and outreach workers should stress the following messages when they talk to IDUs: The best way for you to prevent HIV, HBV, and HCV transmission is to NOT inject drugs. Entering substance abuse treatment can help you reduce or stop injecting. This will lower your chances of infection. Get vaccinated against hepatitis A and hepatitis B. You can prevent these kinds of viral hepatitis if you get vaccinated. If you cannot or will not stop injecting, you should: Use a new, sterile syringe obtained from a reliable source to prepare and divide drugs for each injection. Never reuse or share syringes, water, cookers, or cottons. Use sterile water to prepare drugs each time, or at least clean water from a reliable source. Keep everything as clean as possible when injecting. If you can't use a new, sterile syringe and clean equipment each time, then disinfecting with bleach may be better than doing nothing at all: Fill the syringe with clean water and shake or tap. Squirt out the water and throw it away. Repeat until you don't see any blood in the syringe. Completely fill the syringe with fresh, full-strength household bleach. Keep it in the syringe for 30 seconds or more. Squirt it out and throw the bleach away. Fill the syringe with clean water and shake or tap. Squirt out the water and throw it away. If you don't have any bleach, use clean water to vigorously flush out the syringe: Fill the syringe with water and shake or tap it. Squirt out the water and throw it away. Do this several times. Preventing Perinatal Transmission Identification of HIV positive pregnant women, their treatment, and perinatal prophylaxis efforts have dramatically reduced this type of transmission in the US. Women who do not use anti-HIV therapies transmit the disease to their infants at a higher rate (22.6%) compared to those who do (1.2-1.5%, with combination antiretroviral therapy).22 CDC Recommendations for Testing ALL Pregnant Women: HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women. HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Separate written consent for HIV testing is not required as long as the general consent for medical care sufficiently provides informed consent for HIV testing. Repeat screening in the third trimester is recommended in certain areas with elevated rates of HIV infection among pregnant women. Cesarean delivery has been associated with reduced perinatal HIV transmission as have perinatal antiretroviral agents, and ART regimens that reduce maternal HIV RNA to < 1,000 copies/mL. Currently, combined antepartum, intrapartum, and infant antiretroviral prophylaxis is recommended. Initial widespread efforts to prevent perinatal transmission of the virus entailed use of the Pediatric Aids Clinical Trials Group (PACTG 076) zidovudine regimen for the mother and/or newborn. Clinical experience has demonstrated additional value from expanded regimens in specific cases. Antiretroviral drug recommendations for HIV infected women that are pregnant or of childbearing age in the US are summarized as follows:22 Childbearing potential + indications for starting ART: initiate per adult guidelines; if inadequate contraception, avoid drugs with teratogenic potential such as efavirenz(EFV). Receiving ART + becomes pregnant: woman-continue current regimen, but no teratogenic drugs in 1st trimester or those potentially harmful to mother; if detectable viremia, test for drug resistance; in general, treat throughout entire pregnancy; add continuous IV zidovudine (ZDV)during labor; cesarean delivery @ 38 weeks gestation if viral count > 1,000 copies/mL near delivery. infant-ZDV x 6 weeks starting 6-12 hrs after birth. Pregnant, ART naïve + indications for treatment: woman-resistance testing prior to ART and if inadequate viral suppression after starting; start ART, avoiding EFV, include ZDV if feasible, and consider risk of hepatotoxicity from nevirapine (NVP) if CD4 count > 250 cells/mm3; start treatment ASAP, including 1st trimester if needed for mother's own health; ZDV as continuous IV infusion during labor; cesarean delivery @ 38 weeks gestation if viral count > 1,000 copies/mL near delivery. infant-ZDV x 6 weeks starting 6-12 hrs after birth. Pregnant, ART naïve + no indication for treatment: woman- resistance testing prior to ART & for suboptimal response after starting; ART recommended for prophylaxis, start after 1st trimester, avoid EFV and other potential teratogenic drugs or those potentially harmful to mother, include ZDV if feasible; may use ZDV alone for women with viral count < 1,000 and currently not taking ART; add ZDV as continuous IV infusion during labor; evaluate need to continue ART after delivery; cesarean delivery @ 38 weeks gestation if viral count > 1,000 copies/mL near delivery. infant-ZDV x 6 weeks starting 6-12 hrs after birth. Pregnant, ART experienced + currently not taking: woman-obtain ART history and evaluate mother's current need; resistance testing prior to start & for suboptimal response; start ART based on resistance testing and ART history, avoid teratogenic drugs 1st trimester or those potentially harmful to mother, include ZDV if feasible; add ZDV as continuous IV infusion during labor; evaluate need to continue ART after delivery; cesarean delivery @ 38 weeks gestation if viral count > 1,000 copies/mL near delivery. infant-ZDV x 6 weeks starting 6-12 hrs after birth. Pregnant + no ART prior to labor: 1) ZDV: woman as continuous infusion during labor & infant x 6 weeks, starting 6 12 hours after birth; OR 2) woman ZDV continuous infusion during labor + single dose NVP @ onset (may add lamivudine (3TC) during labor then ZDV+3TC x 7 days to reduce NVP resistance) and infant single dose NVP plus ZDV x 6 weeks. OR 3) woman ZDV continuous infusion during labor & infant ZDV + other ART as recommended by pediatric HIV specialist Infant + mother with no ART prior to or during labor: ZDV x 6 weeks starting ASAP after birth OR ZDV + other ARTas recommended by pediatric HIV specialist; evaluate mother's need for ART postpartum. Management information evolves rapidly. For the most recent information the participant is referred to the AIDSinfo Web site (http://AIDSinfo.nih.gov). Prevention - HealthCare Personnel In a work related setting, the use of measures to prevent exposure by healthcare personnel (HCP) to blood and body fluids is the primary method for preventing occupationally acquired HIV. OSHA requires certain work environment controls. Eating, drinking, smoking, applying cosmetics, and handling contact lens are not permitted in areas where blood and/or body fluids are present. Food and drinks are not permitted in refrigerators that contain blood, body fluids, or tissues. Suction equipment must be available to avoid mouth suctioning of blood, meconium, or respiratory secretions. Eyewash stations must be readily accessible for splashes to the eye. Appropriate barriers are the first line of defense in decreasing occupational exposure to HIV. Every patient is considered potentially infectious. Gloves should be worn whenever there is a potential for direct skin contact with blood such as during venipuncture, when coming into contact with mucous membranes, non-intact skin, or items and surfaces that contain blood or body fluid. Latex gloves provide more protection than synthetic gloves, and double gloving is always an option. Even with a needlestick puncture, gloves may decrease the amount of blood transferred. Masks, protective eyewear and face shields are to be used whenever blood or body fluids may splatter, splash, spray or become aerosolized. Gowns, lab coats, or aprons are to be used during procedures in which clothing may be soiled with blood or body fluids. Gowns, goggles and masks should not allow blood or body fluids to reach clothing, undergarments, and skin or mucus membranes. Gowns made of single-layer polyethylene film offer the greatest protection, and reinforced gowns offer adequate protection in most situations. Goggles should have solid side shields to fully protect the eyes. Masks may be purchased which include eye protection. Surgical caps or hoods are to be used when blood or body fluid may splash or spatter onto the head, and fluid proof shoe covers are to be used if shoes may become contaminated or soaked with blood or body fluids. Sharps should be respected. Where possible, needleless or needle-sheathing devices are recommended. Needles should never be recapped. If absolutely necessary, hollow-bore needles can be recapped by using a one-handed scoop method or with a mechanical recapping device. Needles, knife blades and lancets should be disposed of in closable, puncture-resistant, biohazardous-labeled containers. Needles should not be placed on food trays, in beds, or in routine waste containers. If these measures are breached, post-exposure prophylaxis (PEP) with antiretroviral medications can be considered. Current recommendations are derived from two factors 1) the risk for HIV infection based on type of exposure, and 2) what is known of efficacy and toxicity for various antiretroviral agents. Recommendations address evaluation of the infectious source, exposure type, monitoring, and management for possible and actual exposure to these viruses. The risk of HIV transmission after a percutaneous exposure to HIV-infected blood is relatively small (0.3%) and lower with mucous membrane exposure (0.09%).23 In an early retrospective case-control study of healthcare personnel, ZDV PEP was associated with a reduction in the risk of HIV infection of approximately 81%. Decisions regarding PEP should begin with the evaluation and classification of the exposure followed by the selection of a regimen suitable for the exposure (Table 3). Currently, regimens of two or more ART agents are recommended on the basis of the level of risk for HIV transmission presented by the exposure. A basic 4-week regimen of two drugs (zidovudine [ZDV] + lamivudine [3TC]; ZDV + emtracitabine [FTC]; tenofovir DF [TDF] + 3TC; or TDF + FTC) is recommended as PEP for most HIV exposures.23 Lopinavir and ritonavir are added to compose an expanded regimen for exposures that pose an increased risk for transmission. Various alternatives are listed in the guidelines. Drugs to which the source person's virus is unlikely to be resistant should be selected if resistance is known or suspected. HIV PEP recommendations are offered for two types of events, mucous membrane or non-intact skin exposures, and percutaneous injuries. Table 3. Reccommended PEP For Exposure Types Table 3. Recommended PEP For Exposure Type23 EXPOSURE TYPE PERCUTANEOUS INJURIES MUCOUS MEMBRANE AND NONINTACT SKIN EXPOSURES Less severe (e.g. solid needle, superficial injury) More severe (e.g. large-bore hollow needle, deep puncture, visible blood on device, needle used in patients artery or vein) Small volume (e.g. few drops) Large volume (e.g. splash) HIV-(+) class 1 (asymptomatic HIV infection, or viral load < 1,500 copies/mL) Recommend basic 2 drug PEP Recommend expanded 3 drug PEP Consider basic 2 drug PEP Recommend basic 2 drug PE HIV-(+) class 2 (symptomatic HIV infection, AIDS, acute seroconversion, or high viral load) Recommend expanded = 3 drug PEP Recommend basic 2 drug PEP Recommend expanded = 3 drug PEP Unknown HIV status of source (e.g. deceased source with no samples available) Generally, no PEP warranted. Consider basic 2 drug for source with HIV risk factors (discontinue if determined HIV-(-) Generally, no PEP warranted Generally, no PEP warranted. Consider basic 2 drug for source with HIV risk factors (discontinue if determined HIV-(-) Unknown source (e.g. needle from sharps container) Generally, no PEP warranted. Consider basic 2 drug PEP when exposure to HIV-infected persons likely Generally, no PEP warranted Generally, no PEP warranted. Consider basic 2 drug PEP when exposure to HIV-infected persons likely HIV-(-) No PEP warranted No PEP warranted If HIV PEP is initiated, it should be done as soon as possible (within hours). Since most occupational exposures do not result in transmission of the virus and PEP is potentially toxic, reevaluation of the exposure and source is encouraged within 72 hours. If the source is determined to be HIV-negative PEP should be discontinued. Resources that may assist with PEP issues include: PEPline at http://www.nccc.ucsf.edu/; telephone 888-448-4911; HIV Antiretroviral Pregnancy Registry at http://www.apregistry.com/index.htm; Address: Research Park, 1011 Ashes Drive, Wilmington, NC 28405. Telephone: 800-258-4263; Fax: 800-800-1052; E-mail: registries@Kendle.com; FDA (for reporting unusual or severe toxicity to antiretroviral agents) at http://www.fda.gov/medwatch; telephone: 800-463-6332; address: MedWatch, HF-2, Food and Drug Administration, 5600 Fishers Lane, Room 12B05,Rockville, MD 20857; CDC (for reporting HIV infections in HCP and failures of PEP) at telephone 800-893-0485; HIV/AIDS Treatment Information Service at http://aidsinfo.nih.gov. Prevention Non-occupational Exposure Based on the efficacy of PEP demonstrated in HCPs and other observational studies where non-occupational postexposure prophylaxis (nPEP) was utilized in situations of high-risk for HIV transmission, DHHS has offered recommendations for nPEP.24 Generally, treatment in these instances is determined by the risk of transmission from their exposure (Table 4), and the elapsed time since exposure. Persons deemed to have negligible exposure risk should not receive nPEP. Neither should those with a substantial risk exposure occurring more than 72 hours from when help is sought. Individuals with substantial exposure risk occurring within 72 hours should receive nPEP if the source is known to be HIV positive. If the source is of unknown HIV status and the exposure risk is substantial, the benefits and risks of nPEP should be evaluated on a case by case basis. Where appropriate, risk-reduction counseling and other intervention services should be provided in an attempt to decrease the risk for subsequent exposures. Therapy for nPEP consists of a 4 week course of highly active antiretroviral therapy. Table 4. Non-occupational HIV Exposure Risk Substantial Exposure of : vagina, rectum, eye, mouth, or other mucous membrane, nonintact skin, or percutaneous contact With : blood, semen, vaginal secretions, rectal secretions, breast milk, or any body fluid that is visibly contaminated with blood When : the source is known to be HIV-infected Negligible Exposure of : vagina, rectum, eye, mouth, or other mucous membrane, nonintact skin, or percutaneous contact With : urine, nasal secretions, saliva, sweat, or tears if not visibly contaminated with blood Regardless of : known or suspected HIV status of the source Clinical Management The clinical management of individuals who are HIV positive can be defined as the care, treatment, and services required indefinitely from the time of diagnosis. Due to differences in immune system development at the time of infection and changes in organ function, unique considerations are needed for HIV-infected infants and children. Refer to Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection at http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf for the most current treatment information for this patient population. A baseline medical evaluation to establish a reference point for recognizing early changes and signs of opportunistic infections and formulate a treatment strategy to delay disease progression is essential. A complete history and physical should be performed to assess for additional sexually transmitted diseases, tuberculosis, hepatitis B or C, mental health status, current nutritional needs, and any other appropriate referrals. Assessment and consideration of comorbid conditions must be factored into the long-term treatment plan. Education about HIV infection and the disease process enables the individual to be more knowledgeable about self-care. The patient should also be made aware of the importance of support groups and stress Management methods. Education on viral transmission is essential. Clinical management is influenced by the signs and symptoms the patient exhibits and to an increasing extent, is based on laboratory values. A complete blood count, chemistry profile (including serum transaminases and lipid profile), CD4+ T cell count, and plasma HIV RNA measurement is recommended.25 CD4+ levels provide information about the disease progression and the status of the immune system. This information is useful in determining the need for OI prophylaxis. Plasma HIV RNA measures the quantity of the virus in the blood and indicates the rate of its replication. It is a strong prognostic indicator in HIV infection. Reductions achieved with antiretroviral therapy correlate with clinical improvements. Since up to 16% of HIV infected patients naive to ART demonstrate drug resistance, genotypic drug resistance testing is recommended to assist with ART selection for both treatment-naive and experienced patients. Other tests for patient evaluation may include those: pertinent to the prevention of OIs: RPR or VDRL, tuberculin skin test, toxoplasma IgG serology, hepatitis virus B and C serology , and gynecologic exam with Pap smear, etc. clinically indicated: chest X-ray, cytomegalovirus (CMV) serology, ophthalmologic exam, etc. Antiretroviral Therapy The cornerstone of clinical management is the eventual use of ART. Goals for treatment are to reduce HIV-related morbidity and prolong survival; improve quality of life; restore and preserve immunologic function; maximally and durably suppress viral load; and, prevent vertical HIV transmission.25 Currently, treatment is the most dynamic aspect of disease management, but detailed presentation is beyond the scope and intent of this educational activity. Additionally, development of new treatments and strategies, and the accumulation of clinical trial and experience data continually reshape treatment recommendations. For complete information on treatment and related topics the participant is referred to the most current source of information, the AIDSinfo Web site (http://AIDSinfo.nih.gov). Appropriate ART selection, maximal adherence to the regimen, rational sequencing of drugs, preservation of future treatment options, and resistance testing are tools to accomplish the goals of therapy. ART selection must be effective, accommodate patient lifestyle and comorbidities, and avoid significant drug interactions. Patient involvement and education is a start to encourage regimen adherence but some may need additional support for issues with substance abuse or depression. Drug sequencing is necessary to preserve treatment options for salvage therapy when previous combinations fail and to minimize certain class-specific side effects. Efficacy of antiretroviral treatment is determined through plasma HIV RNA measurements which are expected to show a rapid decrease after 1-4 months treatment and no detectable virus at 3-4 months after treatment initiation. These numbers are not absolute as baseline viral load, CD4 count, and other patient factors will impact the degree of response. To date there are more than 20 FDA approved antiretroviral drugs, involving six different mechanisms of action, from which combination ART can be formulated. These include, in order of FDA approval, the nucleoside reverse transcriptase inhibitors (NRTIs), protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), fusion inhibitors, integrase inhibitors, and most recently a CCR5 antagonist (Table 5). Fusion and CCR5 inhibitors prevent HIV from entering healthy T-cells while all other drugs within these categories target actively HIV infected T-cells.25 ART has transformed a predictably fatal disease into one that is chronic and manageable for those in whom it is accessible.27 Table 5. Classes of Antiretroviral Options26 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) also known as nucleoside analogs (includes the nucleotide reverse transcriptase inhibitor tenofovir DF), interfere with the copying of HIV's genetic material to DNA through HIV reverse transcriptase enzyme inhibition. Generic Name/Abbreviation/ Brand Name®: abacavir / ABC / Ziagen abacavir + lamivudine / Epzicom didanosine / ddI / Videx e mtricitabine / FTC /Emtriva emtricitabine + tenofovir DF / Truvada lamivudine / 3TC / Epivir stavudine / d4T/ Zerit tenofovir DF / TDF / Viread zidovudine / ZDV,AZT / Retrovir zidovudine +lamivudine / Combivir zidovudine + lamivudine +abacavir / Trizivir Protease Inhibitors (PIs) block the enzyme protease which cleaves two large protein molecules produced early in HIV's life cycle to yield other proteins key to the completion of the cycle. This results in a noninfectious virus. Generic Name/Abbreviation/ Brand Name®: amprenavir / APV/ Agenerase atazanavir / Reyataz darunavir / DRV / Prezista fosamprenavir / f-APV / Lexiva indinavir / IDV / Crixivan lopinavir + ritonavir / Kaletra nelfinavir / NFV/ Viracept ritonaivr / RTV / Norvir saquinavir / SQV / Invirase tipranavir / TPV / Aptivus Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) inhibit reverse transcriptase like NRTIs, but these are not nucleoside analogs. Generic Name/Abbreviation/ Brand Name®: delavirdine/DLV/Rescriptor efavirenz/EFV/Sustiva Etravirine/TMC125/Intelence nevirapine/NVP/Viramune Fusion Inhibitors (FIs) work by preventing HIV from entering healthy T-cells. This mechanism of action is very different than most of the approved anti-HIV drugs which are active against HIV after infecting a T-cell. Enfuvirtide binds to the first heptad repeat (HR1) in the gp41 subunit of the viral envelope glycoprotein and prevents the conformational changes required for the fusion of HIV to cells. Generic Name/Abbreviation/ Brand Name®: enfuvirtide / T20 / Fuzeon CCR5 antagonists act as a viral entry inhibitor by blocking chemokine receptor 5 (CCR5) from binding to HIV. This coreceptor is necessary for HIV entry into cells. Generic Name/Brand Name Maraviroc/Selzentry Integrase inhibitors prevent insertion of HIV DNA into the human DNA genome, thus blocking HIV from replicating. Generic Name/Abbreviation/Brand Name Raltegravir/MK-0518/Isentress Miscellaneous Class Combinations Generic Name/Abbreviation/ Brand Name®: Efavirenz (NNRTI) + emtricitabine (NRTI) + tenofovir DF (NRTI) / EFV + FTC + TDF / Atripla When to Initiate Antiretroviral Agents The trend is for earlier initiation of ART based on data from clinical trials using newer effective and more tolerable therapies in infected individuals. Still antiretroviral therapies are complex, have major side effects and can be detrimental if adherence to therapy is incomplete due to the likely development of viral resistance. For these reasons initiation of ART is recommended for patients with history of AIDS-defining illness or CD4 T-cell count < 350 cells/mm3; pregnant women; patients with HIV-associated nephropathy; and patients coinfected with hepatitis B virus (HBV) and requiring treatment for hepatitis B. The necessity for patient adherence to long-term therapy has to be emphasized and potential barriers identified and addressed prior to starting ART. Patients not in a previously mentioned category with a CD4 T-cell count = 350 cells/mm3 may be considered for ART (Table 6) depending on the risks and benefits. Table 6. Considerations For Early ART in Asymptomatic Patients with >or= 350 cells/mm 3 CD4 T-Cell Count Potential Benefits: Maintenance of higher CD4 count; prevent potentially irreversible immune system damage Decreased risk for HIV-associated complications that may occur at higher CD4 T-cell counts Decreased risk of nonopportunistic conditions, such as CV, renal, and liver disease, and non-AIDS-associated malignancies and infections Decreased risk of HIV transmission to others Potential Risks: Treatment-related side effects and toxicities Drug resistance due to inadequate viral suppression and loss of future treatment options Insufficient time to learn about the condition and prepare for adherence to therapy Increased treatment time and possible treatment fatigue Incurring treatment before new drugs or combinations determined to be more effective and less toxic are available Transmission of drug-resistant virus by patients not maintaining full virologic suppression The expert panel for DHHS has identified antiretroviral drugs that are acceptable for treatment-naive patients (Table 7). The recommendations, which stem from amassed clinical experience, are for 2NRTI agents with either a NNRTI or a PI (with or without ritonavir boosting).25 Which among the preferred or alternate agents to use is determined by factors such as comorbid conditions, adverse drug effects, drug-drug interactions, pregnancy or its potential, drug resistance, gender and pretreatment CD4 T-cell count if considering nevirapine (increased serious hepatic events), HLA-B*5701 testing if abacavir to be used (genetic variation associated with hypersensitivity), and likelihood of patient compliance. Side effects are common with the antiretrovirals and depending on the agent may include gastro-intestinal intolerance, hematological alterations, neuropathies, rash, elevated blood sugar, elevated serum lipids, fat redistribution, hepatitis, kidney stones, and others. Side effects can be exaggerated with combination drug therapies possessing overlapping effects and toxicities. Side effects are most manageable with the NRTI class. They increase with the NNRTIs and are most frequent and bothersome with the PIs. Table 7: Recommended Initial Antiretroviral Options For Regimen: Select 1-NNRTI + 2 NRTI -or- PI +2NRT Preferred Components NNRTI efavirenz1 PI atazanavir + ritonavir (once daily)2 darunavir + ritonavir (once daily) fosamprenavir + ritonavir (2x/day) lopinavir/ritonavir3 (once or 2x/day) Dual NRTI Tenofovir/emtricitabine4 Alternative Components NNRTI nevirapine5 PI Atazanavir (unboosted once daily)6 fosamprenavir + ritonavir (once daily) fosamprenavir (unboosted 2x/day) saquinavir + ritonavir (2x/day) Dual NRTI abacavir/lamivudine7 didanosine/lamivudine (or emtricitabine)8 zidovudine/lamivudine9 1)Efaviranez is not recommended in the 1st trimester of pregnancy or in women not using effective contraception. Use cautiously in unstable psychiatric disease. 2)Use cautiously in patients taking gastric acid neutralizing or suppressing therapies; don't use if taking high dose proton pump inhibitor. 3)Don't use once daily lopinavir/ritonavir in pregnant women 4)Do not use with unboosted atazanavir. Use cautiously with nevirapine (possible early virologic failure) and in those with renal insufficiency. 5)Nevirapine should not be initiated in women with CD4+ T cell count > 250 cells/mm3 or in men with a count > 400 due to increased risk of symptomatic hepatic events. Don't use with moderate to severe hepatic impairment. Use cautiously with tenofovir/emtricitabine (or lamivudine) due to possible early virologic failure with this combination. 6)Do not use with tenofovir or didanosine/lamivudine. 7)Don't use if HLA-B*5701 positive. Use cautiously if HIV RNA > 100,000 (high virologic failure) orat high risk for cardiovascular disease. 8)Don't use with unboosted atazanavir or with history of pancreatitis or peripheral neuropathy. 9)May worsen pretreatment anemia +/or neutropenia. Toxic effects may result from ART and therapies used to manage other medical conditions (e.g. additive hepatotoxicity from select antihyperlipidemics, antihyperglycemics, antifungals, with antiretrovirals). Drug interactions are an increasingly significant issue. As new drugs and combinations are used, new interactions are discovered. Some are beneficial and can be utilized to optimize drug therapy. Such is the case with some combination protease inhibitors where pharmacokinetics are altered and plasma drug concentrations of one or both are increased, allowing for reduced frequency of administration and/or total daily dose (e.g. low dose ritonavir added to a PI such as amprenavir, atazanavir, indinavir, lopinavir, or saquinavir). Others can create toxicities or cause treatment failures from decreased serum levels. Practitioners must continually monitor for drug interactions and utilize contemporary resources to investigate the evolving issue of drug interactions. Antibiotic, antifungal, and other antiviral drugs are used for prophylaxis or treatment of opportunistic infections. Multiple other agents, such as anti-diarrheal drugs, analgesics, and appetite stimulants, are used to treat symptoms. Blood modifiers may be required to counter adverse effects of other necessary medications. Medications for children with AIDS do not include all of those approved for adults. Physicians may legally prescribe these drugs, but many have not been widely tested in children and pediatric data is lacking. Regimen Revision Due to Treatment Failure Failure rates for first-line antiretroviral therapy have been identified to be in the range of 10% to 60%.28 Consequently, eventual changes in ones antiretroviral regimen might be necessary. Treatment failure may be manifest by virologic failure, immunologic failure or by clinical progression. A sub-optimal reduction in plasma viremia (HIV RNA > 400 copies/mL after 24 weeks, >50 copies/mL after 48 weeks) or re-appearance of viremia after successful suppression is indicative of virologic failure.25 Immunologic failure occurs if treatment and viral suppression fails to increase CD4+ T cell count. Various measures are used but a threshold level of 350 or 500 cells/mm3 may be preferred.25 Clinical progression is defined as the occurrence or recurrence of HIV-related events after at least 3 months on an antiretroviral regimen.25 An HIV RNA and CD4+ cell count should be obtained every 3 to 6 months in patients on antiretroviral therapy. Causes for failure include noncompliance, pharmacokinetic factors, intolerability, virologic impotence, and resistance and the potential for each must be carefully evaluated. Resistance testing, while taking the failing regimen or within 4 weeks of discontinuation, is recommended for new regimen selection. Guidelines advise on appropriate regimen revision strategies depending on previous drug use and resistance. Referral to a clinician experienced in the care of HIV infected patients is strongly recommended.25 Therapeutic Drug Monitoring Antiretroviral therapeutic drug monitoring (TDM) is a possible strategy to navigate through concentration associated toxicities and treatment failures. Currently there is data supporting TDM for the NNRTI and PI antiretroviral drugs. These drugs exhibit concentration related responses (efficacy, toxicity) and also may have significant inter-patient variability among those taking the same dose. TDM may be a useful tool in evaluating toxicities or drug failure due to drug-drug or drug-food interactions, physiologic changes or pathophysiologic states, alternative unproven dosing regimens, or unexpected response, but are not recommended for routine use. Treatment Interruption or Discontinuation ART may be temporarily discontinued because of acute illness, drug toxicity, or surgery. Generally, if any antiretroviral is stopped, all agents should be discontinued simultaneously so as to decrease the emergence of resistant viral strains. Such patient's clinical and laboratory status should be followed closely and prophylaxis for OIs offered if CD4 cell counts warrant. Structured or supervised treatment interruptions (STI) have been evaluated for salvage therapy, auto-immunization to heighten ones immune control of HIV, and to decrease the total time on antiretroviral therapy. Data supporting STI is limited and doing so is not recommended in current published guidelines. The most compelling evidence discouraging this practice to date are the results from a randomized trial where episodic ART resulted in significantly increased risk of OI or death compared with continuous therapy.29 Additionally, no reduction in the risk of adverse events associated with ART was observed in the episodic therapy group. Opportunistic Infection Prophylaxis HIV-infected adults and adolescents, including pregnant women and those on ART, should receive chemoprophylaxis against opportunistic infections when the disease has impaired one's immune status as demonstrated by their CD4+ cell count and/or clinical presentation. OI prophylaxis with strong evidence for efficacy and substantial clinical benefit which should always be offered include:30 Cotrimoxazole to prevent Pneumocystis (carinii) jiroveci pneumonia (start when CD4+ < 200 or with occurrence of oropharyngeal Candidiasis). Cotrimoxazole for primary Toxoplasma gondii (start if positive Toxoplasma IgG antibody and CD4+ < 100). Azithromycin or clarithromycin are the agents of choice as prophylaxis for mycobacterium avium complex (CD4+ count < 50). Alternative agents can be considered should these be contraindicated or not tolerated. Future Trends in Management/Treatment ART, for those able to access it, has dramatically changed the face of AIDS and transformed it to that of a chronic, long-term illness. Treatment is not cheap. A recent estimate in US dollars of the cost for the lifetime HIV care of an individual is $618,900.31 Despite the advances with ART, several problems resulting in treatment failure, such as viral resistance and drug toxicities, persist. Research continues the quest for the development of an effective vaccine and novel therapies and mechanisms to suppress viral replication. Currently no vaccine is FDA approved and available for use, but more than 30 vaccines have been investigated.32 Possibilities continue to grow with the recent report of discovery of over 250 proteins that, if blocked, interfere with the undesirable effects of HIV.33 Multiple agents that interfere with the various stages of HIV's life-cycle as well as better tolerated and simpler therapies for existing treatment mechanisms continue to be developed thus broadening treatment options. Other research activities include a continued attempt to define the most appropriate time to start ART, and the impact of herpes simplex, hepatitis B, and hepatitis C co-infections on HIV management. Workplace Issues Healthcare workers must be familiar with the policies and procedures of the facility in which they work, especially related to accidental exposure to blood and body fluids. All needle stick accidents, lacerations, open wounds or exposure of eye, nose, or mouth to blood or body fluids should be reported. The issue of employees who contract HIV while at work is handled individually by the employers. Employers are mandated to provide personal protective equipment (PPE), which includes gloves, gowns, masks and goggles, for all employees.34 Appropriate sizes and other specialized PPE required to protect the employee should be provided. Employers are mandated to enforce use of protective gear and observance of universal or standard precautions. Standard Precautions In, 1996 the CDC offered guidelines, termed Standard Precautions, for isolation precautions to prevent transmission of bloodborne pathogens within a hospital. These guidelines apply to ALL patients receiving care in a hospital regardless of their diagnosis or presumed infectious state. Standard Precautions apply to: 1) blood; 2) all body fluids, secretions, and excretions except sweat, regardless of whether or not they contain visible blood; 3) non-intact skin; and 4) mucous membranes.35 Standard Precautions are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in hospitals. As an employee, know your facility guidelines and follow them to protect yourself from exposure while working. The Handling & Disposal of Contaminated Materials HIV is fragile outside the body. It succumbs to cleaning solutions and chemicals found in most homes and hospitals. CDC studies have shown that various chemicals, as well as bleach in dilutions of 1:10 to 1:100, depending on the amount of organic material present, inactivate HIV.36 General-purpose utility gloves may be used for housekeeping chores involving potential blood contact and for instrument cleaning. They may be decontaminated and reused if not cracked, punctured, torn, or deteriorated. All reusable equipment should be cleaned immediately after use and prior to sterilization or high level disinfection. Trash disposal will vary with city, county, and state regulations. The Public Health Service (PHS), or agencies with which you are affiliated, can advise you of pertinent regulations. The Psychosocial Dimension of AIDS In addition to its physical impact (sometimes subtle, sometimes very obvious), persons living with HIV infection suffer many psychosocial consequences. Individuals are living with an infectious disease that can be transmitted to others unless precautions are taken. Others are afraid, and persons with HIV/AIDS may experience social isolation. Often people living with HIV face discrimination from healthcare providers who allow their own values to interfere with patient encounters. Stereotyping, labeling, making assumptions, making judgments and discriminating are common examples. These reactions are due to lack of cultural knowledge/sensitivity, fear, denial, anger, and prejudice against groups (homophobia, racism). Often when healthcare workers review a case of AIDS, they bring up the risk factors of that patient. But in most cases, how a person became infected with HIV is not a concern for the caregiver. Unnecessary attention to the patient's risk attempts to point out the differences between the patient and the caregiver leading to exclusion, discrimination, and substandard healthcare. Be aware of your own feelings toward drug users and people who have different sexual orientations, cultural norms, beliefs, family structures, lifestyles or values. People with HIV deserve quality healthcare and to be treated the way the providers would want to be treated themselves (i.e. follow the golden rule). Lifestyles for the patients become altered, but not always by choice. Persons living with HIV/AIDS face the dual negative impacts of chronicity and fatality. They frequently react by feeling anger, uncertainty, and helplessness. Individuals often lack adequate knowledge about the disease process, handicapping them in their efforts to survive. There may be an alteration in self-esteem due to changes in body image (such as weight loss, altered fat distribution) and other changes due to medication side effects. They face financial stress associated with the costly medications. HIV infected persons with progressive disease will eventually experience all of the stages of death and dying. They often have spiritual needs that must be met. Healthcare professionals can best meet their needs by identifying psychosocial and spiritual needs as well as physical needs. Knowledgeable care, offered with compassion, provides healthcare professionals the opportunity to demonstrate their professional mission while providing personal safety for him or herself. Professional, Ethical and Legal Aspects Health professionals have varied involvement with individuals with HIV/AIDS and their personal information as they participate in aspects of treatment, counseling, testing, and/or referral to pertinent support services. Procedures for conducting these functions should assure confidentiality, avoid discrimination, and preserve their human rights. State and federal laws address these issues and also, in some cases, define reporting responsibilities. The Americans with Disabilities Act offers protection to individuals considered to have a physical or mental impairment that substantially limits one or more major life activities. Under this Act, protection from discrimination applies to persons with HIV/AIDS whether they are symptomatic or not. This is also extended to others discriminated on the grounds of association with HIV/AIDS, e.g. person fired based on rumor they had AIDS even if untrue, or person denied employment because their roommate has AIDS. The ADA prohibits employment discrimination against qualified individuals with disabilities. A qualified individual with a disability is a person who meets legitimate skill, experience, education, or other requirements of an employment position he or she holds or seeks, and who can perform the essential functions of the position with or without reasonable accommodation. Employers must provide reasonable accommodation. This is any modification or adjustment to a job, the job application process, or the work environment that will enable a qualified applicant or employee with a disability to perform the essential functions of the job, participate in the application process, or enjoy the benefits and privileges of employment. Examples of reasonable accommodations include: Making existing facilities readily accessible to and usable by employees with disabilities; Restructuring a job; Modifying work schedules; Acquiring or modifying equipment; Reassigning a current employee to a vacant position for which the individual is qualified. For more information about the ADA, contact the ADA Information Line for documents and questions at 800-514-0301 (Voice), 800-514-0383 (TDD). The health professional should be familiar with the applicable rules and regulations for dealing with HIV/AIDS patients and related information in the state in which they practice. Summary The continued presence of HIV/AIDS in our society presents ongoing challenges. If we have learned anything in public health, it is the unfortunate reality that the dissemination of information alone does not change human behaviors. Social struggles against drug use, alcoholism, tobacco use, mental illness, and several other health conditions including HIV/AIDS seek to educate and inform, but that is merely the tip of the iceberg in any effort to change one's behavior. The need to achieve increased awareness must take place on a number of levels and on an ongoing basis. Ironically, some believe advances in drug therapy (such as ART) may contribute to the occurrence of new cases. Effective medication regimens that suppress recognizable symptoms may give rise to a degree of complacency where preventative behaviors are concerned; some may tend to forget that transmission of the disease is still a very real danger. As treatment for HIV infection improves, people are living longer and associated care has transformed to that of a chronic, long-term illness. Researchers seek the development of an effective vaccine and other therapies to suppress viral replication, but the physical characteristics of this resilient virus have not made this an easy task. Healthcare professionals routinely encounter persons infected with HIV. This has great significance when considering our aging US population and their associated co-morbid health conditions. For optimal care of infected individuals, healthcare professionals should remain current with information on the disease process and basic clinical management. Kentucky Specific HIV/AIDS Information The following information is summarized from internet available material which can be accessed at http://chfs.ky.gov/dph/epi/hivaids.htm. The Kentucky Department for Public Health, HIV-AIDS Branch, promotes the prevention of HIV transmission and associated morbidity and mortality by (1) ensuring that HIV-AIDS surveillance is a quality, secure system; (2) ensuring that all persons at risk for HIV infection know their serostatus; (3) ensuring that those persons not infected with HIV remain uninfected; (4) ensuring that those persons infected with HIV do not transmit HIV to others; (5) ensuring that those infected with HIV are accessing the most effective therapies possible, and; (6) ensuring a quality professional education program which includes the most current HIV-AIDS information. Services of the Kentucky HIV/AIDS program include: 1) surveillance, 2) prevention, 3) counseling, testing, referral and partner notification program, 4) services program and 5) HIV/AIDS continuing education. HIV/AIDS Case Surveillance Program: This program documents and maintains the HIV/AIDS case reports data which is mandated by Kentucky Communicable Disease Reporting Regulations (902 KAR 2:020, Section 7-Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) Surveillance). (1) Physicians and Medical Laboratories shall report: (a) 1. A positive test result for HIV infection including a result from: (a) Elisa; (b) Western Blot; (c) PCR; (d) HIV antigen; or (e) HIV culture; 2. CD4+ assay including absolute CD4+ cell counts and CD4+%; 3. HIV detectable Viral Load Assay; and 4. A positive serologic test result for HIV infection; or (b) A diagnosis of AIDS that meets the definitions of AIDS established by the Centers for Disease Control and Prevention (CDC) guidelines and reported on the: 1. Adult HIV/AIDS Confidential Case Report Form; or 2. Pediatric HIV/AIDS Confidential Case Report Form. (2) An HIV infection or AIDS diagnosis shall be reported within five (5) business days and, if possible, on the Adult HIV/AIDS Confidential Case Report form or the Pediatric HIV/AIDS Confidential Case Report form. (a) A report for a resident of Jefferson, Henry, Oldham, Bullitt, Shelby, Spencer, and Trimble Counties shall be submitted to the HIV/AIDS Surveillance Program of the Louisville-Metro Health Department. (b) A report for a resident of the remaining Kentucky counties shall be submitted to the Kentucky Department for Public Health. (3) A report for a person with HIV infection without a diagnosis of AIDS shall include the following information: (a) Patient's full name; (b) Birth date, using the format MMDDYY; (c) Gender; (d) Race; (e) Risk factor, as identified by CDC; (f) County of residence; (g) Name of facility submitting report; (h) Date and type of HIV test performed; (i) Results of CD4+ cell counts and CD4+%; (j) Results of viral load testing; (k) PCR, HIV culture, HIV antigen, if performed; (l) Results of TB testing, if available; and (m) HIV status of the person''s partner, spouse or children. (4) Reports of AIDS cases shall include the information in subsections (1) through (3) of this section; and (a) The patient''s complete address; (b) Opportunistic infections diagnosed; and (c) Date of onset of illness. (5)(a) Reports of AIDS shall be made whether or not the patient has been previously reported as having HIV infection. (b) If the patient has not been previously reported as having HIV infection, the AIDS report shall also serve as the report of HIV infection. Prevention Interventions: This program is responsible for coordinating the planning, implementation and evaluation of prevention activities targeting men who have sex with men (MSM), minorities at risk (African Americans and Hispanics), injecting drug users (IDU), women at risk (WAR), youth at risk (YAR), sex-trade workers and the incarcerated. HIV/AIDS Counseling, Testing, Referral and Partner Notification Program: This program develops and monitors all counseling and testing sites in the state of Kentucky. Free anonymous or confidential HIV tests are available at county health departments and some professional agencies. HIV/AIDS Services Program (Kentucky's Ryan White & State funded Services): Kentucky HIV Care Coordinator Program (KHCCP) Purpose: The intent of the KHCCP is to facilitate the provision of quality care and services to HIV infected individuals and their families in a timely and consistent manner across a continuum of care. The program provides Care Coordinators in six regional sites through arrangements with 4 local health departments in the Barren River, Cumberland Valley, Lexington, and Northern Kentucky regions and 2 non-profit agencies in the Louisville and Purchase regions, in order to aid the client in identifying and accessing needed services. These regional sites allow for state wide coverage, and better local access to these services. KHCCP also acts as an umbrella program for other client assistance programs such as the Kentucky Health Insurance Continuation Program, Outpatient Health Care and Support Services, and the State Support Services Programs. (Continuation of all programs is contingent upon continued state and federal funding). Goals of KHCCP: To optimize the client's self-care capabilities by empowering him/her to direct his/her own life decisions. To identify the extent of the client's informal support systems. To assist the client in locating and accessing existing services in areas including entitlement benefits (Medicaid and/or Social Security Disability Services), medical care, housing, counseling, transportation, legal and nutrition services. To identify and establish a referral system with area healthcare and social service providers and community-based HIV organizations, and HIV counseling and testing sites. To ensure that duplication of services by formal and informal support systems does not occur. To provide the client with educational information regarding disease transmission and maintenance of a healthy lifestyle, and encourage and reinforce good health habits and secondary prevention methods over the course of case management. To identify and document patterns of service needs and advocate for effective policies and resource development. To facilitate the initial and on-going education of health care and social service providers to the issues surrounding HIV disease. To ensure that program funding is appropriately used to meet the documented needs of HIV+ persons throughout the State in a manner that coordinates funding streams and makes use of existing community resources and services. Basic Eligibility Criteria for Financial Assistance Programs: Household Income 300% of federal poverty level, or less. Household Resources cash assets of less than $10,000. Client Residency must be a resident of Kentucky. Medical Documentation HIV+ status must be confirmed with appropriate documentation. (For KADAP participation, medical documentation must also include CD4+ T cell count and viral load.) Lack of Other Third Party Payer must be ineligible for assistance from other third party payers for the assistance being requested. Financial Assistance Programs: Kentucky AIDS Drug Assistance Program (KADAP) - This program assists low-income, eligible Kentuckians with the purchase of AIDS-related medications prescribed for FDA-approved indications. Once approved, eligible applicants receive formulary medications through a mail-order pharmacy service provided by the U of L Outpatient Pharmacy. NOTE: Effective 2/1/00, a waiting list was established for this program. 1-866-510-0005 (toll free) Kentucky Health Insurance Continuation Program (KHICP) provides payments for the continuation of health insurance benefits for eligible individuals who are at risk of losing their employment-related or private-pay health insurance because of HIV disease. Kentucky Outpatient Healthcare and Support Services Programs provide assistance for eligible individuals with a wide range of community-based medical and non-medical support services, such as, but not limited to, physical and mental healthcare, housing, nutrition, and transportation services. From the list of eligible services, priority services are identified during each funding period, based on such factors as client and Care Coordinator input, needs assessment survey results, resource inventories, client satisfaction surveys, and funding limitations. Kentucky Ryan White & State Funded Services Programs Care Coordinator Program (Administrator) 502-564-6539 or 800-420-7431 Barren River Region 270-826-0200 Cumberland Valley Region 888-425-7282 Lexington Region 859-323-5544 Louisville Region 502-574-0161 Northern KY Region 859-363-2082 Purchase Region 270-444-8183 Dept. for Public Health, HIV/AIDS TTY # for hearing or speech impaired 502-564-6539 (For a complete list of community services in Kentucky contact the KY Cabinet for Health and Family Services 1-800-372-2973 (You can access more information at: http://chfs.ky.gov/dph/epi/hivaids.htm) Professional Education: This program is responsible for reviewing and approving/rejecting those continuing education courses and college curricula proposing to meet the criteria specified in KRS 214.610, KRS 214.615 and KRS 214.620. This course is approved by the state of Kentucky. Consent to test and confidentiality: Even prior to federal HIPAA regulations regarding confidentiality, the Kentucky Legislature General Assembly found that the public health would be served by facilitating informed, voluntary, and confidential use of tests designed to detect human immunodeficiency virus infection. A general consent form is to advise patients that they may be tested for HIV, hepatitis, or any other blood-borne infectious disease as part of a medical procedure if ordered by a doctor for diagnostic purposes. CDC now recommends opt-out testing of patients in all health care settings. In an emergency where informed consent cannot be obtained, there is no requirement to obtain a previous informed consent. No public health department or person in this state shall conduct a testing program for AIDS or HIV without first registering with the Cabinet for Health and Family Services and meeting all necessary requirements. A physician who orders the test must inform the patient of a positive result for HIV, as well as providing information and counseling concerning the infection and known medical implications. Confirmatory tests must be performed prior to informing the patient of a positive test result. No person in Kentucky shall perform a test to identify HIV, or its antigen or antibody, without obtaining informed consent from the patient except for emergencies situations where it is unobtainable. No person who has obtained or has knowledge of a test result shall disclose or be compelled to disclose the identity of any person upon whom a test is performed, or results of the test that permit the identification of the subject of the test, except to the following persons The subject of the test, or legal representative; Those designated in a legally effective release of the test by the patient; Physician, Nurse, or other provider with a legitimate need to know; Health care providers consulting between themselves regarding diagnosis and treatment; The Cabinet, in accordance with rules for reporting and controlling the spread of disease as required by state law; Health care provider which processes or uses a human body part from an infected person; or semen provided prior to July 13, 1990 for use in artificial insemination; Health facility staff committees, for purposes of evaluation; Authorized medical or epidemiological researchers; A parent, foster parent, or legal guardian of a minor, a crime victim, or a person specified in KRS 438.250; A person allowed access by a court order. For more information on Kentucky Law regarding confidentiality and consent to test access http://162.114.4.13/KRS/214-00/625.pdf Community Resources There are many national, regional, and state resources available to communities. A few of them are listed below. Departments of Public Health may be contacted for additional resources and the Internet offers a vast resource for HIV/AIDS related readings and concerned organizations. National Resources AIDSinfo (treatment, prevention & research) 1-800-448-0440 www.aidsinfo.nih.gov CDC INFO 888-232-6348 (TTY) 888-232-4636; cdcinfo@cdc.gov http://www.cdc.gov/hiv/contact.htm CDC National Prevention Information Network 800-243-7012 (TTY) 800-458-5231; info@cdcnpin.org http://www.cdcnpin.org/scripts/index.asp US National Library of Medicine HIV/AIDS Information http://sis.nlm.nih.gov/hiv.html MedlinePlus AIDS page: http://www.nlm.nih.gov/medlineplus/aids.html National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) http://www.niaid.nih.gov/daids/ HIV-Drug interactions, University of Liverpool www.hiv-druginteractions.org University of California, San Francisco HIV InSite http://hivinsite.ucsf.edu Johns Hopkins HIV GUIDE www.hopkins-aids.edu HIV Resource for Health Professionals www.thebodypro.com Kentucky Resources Kentucky community-based organizations (CBOs) Eastern area Harlan Countians for a Healthier Community 606-573-6115 Hazard Perry County Community ministries 606-439-1122 Lexington area AIDS Volunteers (AVOL) 859-225-3000 Bluegrass Farmworker Health Center (BFHC) 859-259-2635 Moveable Feast 859-252-2867 North Central AHEC/HETC 859-442-1191 Louisville area The AIDS Project 502-608-0586 American Red Cross 502-589-4450 House of Ruth 502-587-5080 SABSA (Sisters and Brothers Surviving AIDS) 505-213-3871 Volunteers of America, Inc. (VOA) 502-635-1361 WINGS Clinic and Support Services 502-561-8844 Northern area The I.N.D.Y (I'm Not Dead Yet) Project 513-343-9999 STOP AIDS 513-421-2437 University of Cincinnati Emergency Room 513-584-5700 Univ. of Cincinnati Hospital, Holmes Clinic 513-584-6977 Western area Owensboro Area HIV/AIDS Task Force, Inc. 270-683-6018 Heartland CARES 270-444-8183 Matthew 25 AIDS Services 270-826-0200 Westlake Primary Care 270-384-4764 References UNAIDS, 2008 Report on the Global AIDS Epidemic-Executive summary;2008. UNAIDS, Financing Resources Required to Achieve Universal Access to HIV Prevention, Treatment, Care and Support; September 2007. Centers for Disease Control and Prevention. HIV/AIDS Surveillance CDC HIV/AIDS Facts, July 2008. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report 2006. Vol. 18. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention. 2008;7-13. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ (Accessed 11/10/2008) Hall HI, Song R, Rhodes P, et al. Estimation of HIV incidence in the United States. JAMA. 2008;300:520-529. Kaiser Family Foundation HIV/AIDS Policy Fact Sheet (#3029-09). The HIV/AIDS Epidemic in the United States, October 2008. Streicher H, Reitz M & Gallo R. (2000) Human Immunodeficiency Viruses. In Principles and Practice of Infectious Diseases (Mandell, Douglas, & Bennett, Eds.), p. 1874. Philadelphia, PA: Churchill Livingstone. DHHS/NIAID. How HIV causes AIDS. http://www.niaid.nih.gov/factsheets/howhiv.htm. (Accessed October 12, 2008). Schackman BR, Gebo KA, Walensky RP, et al. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006;44:990-7. Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999;75:3-17. CDC. HIV and Its Transmission. http://www.cdc.gov/hiv/resources/factsheets/transmission.htm (Accessed 11/12/2008). Alter HJ, Klein HG. The hazards of blood transfusion in historical perspective. Blood 2008;112:2617-2626. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report 2006. Vol. 18. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention. 2008;11. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ (Accessed 11/10/2008) CDC. Guidelines for national human immunodeficiency virus case surveillance, including monitoring for human immunodeficiency virus infection and acquired immunodeficiency syndrome. MMWR 1999;48 (RR13):1-28. CDC. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. 2006;55(RR14);1-17. Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Current Infectious Disease Reports. 2006;8:125-131. Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected children. Guidelines for the use of antiretroviral agents in pediatric HIV infection. July 29,2008. AIDSinfonet.org. Fact sheet 153 Condoms. http://www.aidsinfonet.org/fact_sheets/view/153 (Accessed 11/25/2008) CDC. HIV/AIDS Basic Information Preventing Transmission. http://www.cdc.gov/hiv/topics/basic/index.htm#prevention (Acessed 11/13/2008) CDC. Syringe Disinfection for Injection Drug Users. http://www.cdc.gov/idu/facts/disinfection.pdf (Accessed 12/7/2008) Cooper ER, Charurat M, Mofenson L, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1 infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr Hum Retrovirol. 2002:29;484-94. Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States July 8, 2008 CDC. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR 2005;54(No.RR-09):1-17]] CDC. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR 2005;54(No.RR-2):1-16. Department of Health and Human Services (DHHS), Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, November 3, 2008. AIDSinfo. FDA-approved drugs. http://aidsinfo.nih.gov/DrugsNew/SearchResults.aspx?MenuItem=Drugs&DrugName=&DrugClass=All&DrugType=FDA-approved%20Drugs (Acessed October 17, 2008) Wainberg MA. Twenty-five years of AIDs: where are we now? Medscape General Medicine. 2006;8:21. Lee, K. Gulick, R. HIV therapeutic options in the treatment-experienced patient: Recent trials and future directions. Infections in Medicine. 2001;18(3):139-152. CD4+ count-guided interruption of antiretroviral treatment. The Strategies for Management of Antiretroviral Therapy [SMART] Study Group. NEJM. 2006:355:2283-2296. USPHS and IDSA recommendations. Guidelines for preventing opportunistic infections among HIV-infected persons 2002. MMWR. 51(RR-08);1-46. Schackman BR, Gebo KA, Walensky RP, et al. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006;44:990-7. International AIDS Vaccine Initiative. Progress toward and AIDS vaccine since 2000. http://www.iavi.org/viewpage.cfm?aid=13 (Accessed 11/30/06). DeNoon DJ. 272 new possible targets for HIV drugs. WebMD Medical News. January 10, 2008. OSHA. Revised Bloodborne Pathogens Standard 1910.1030 http://www.osha.gov/SLTC/bloodbornepathogens/index.html#revised_standard (Accessed 11/25/2008). CDC. Guidelines for isolation precautions in hospitals: Part I. Evolution of isolation practices. http://www.cdc.gov/ncidod/dhqp/gl_isolation_ptI.html (Accessed 12/4/2006). CDC. Use of bleach in prevention of transmission of HIV in health care settings http://www.cdc.gov/od/ohs/biosfty/bleachiv.htm (Accessed 11/25/08) PLEASE PROCEED TO TEST AND EVALUATION

Preventing Medical Errors: For Allied Health Professionals 2009-2010

2009-01-01T13:00:00Z

Instructor: Mary Kathleen Ebener PhD, RN; Peggyann Zaenger, B.S., PharmD

Preventing Medical Errors For Allied Health Professionals 2009-2010 To download a .pdf version of this course click here! Needs Statement: The 1999 Institute of Medicine report To Err is Human: Building a Safer Health System brought prominence to the issue of medical error in the US. Since that time multiple activities at various levels of private and regulatory arenas have targeted identification and resolution of medical error. The process is dynamic and health professionals need education of error reduction techniques so as to improve safety in their professional activities and work setting. Some regulatory agencies require specific medical error education for licensure/relicensure of health professionals. Course Goal: This educational monograph addresses the identification, reporting, monitoring and reduction of medical error. It is intended to make participants aware of the magnitude of the problem, of the many-leveled activities needed to resolve it, and the importance of each person's role in the national effort to reduce medical errors. Objectives: At the completion of this course the participant will be able to: Recognize the magnitude and far reaching effects of medical error. Categorize factors contributing to the occurrence of medical error. Describe the healthcare professional's role in identifying error prone situations. Explain the importance of reporting medical error. Specify at least two recommended practice modifications to promote safety and reduce the incidence of medical error. Review the processes of root cause analysis and failure mode and effects analysis when analyzing error. About the Authors: Mary Kathleen Ebener PhD, RN is employed by Community Hospice in Jacksonville, FL. Dr. Ebener also teaches courses in nursing, healthcare and statistical analysis at the University of Phoenix, Jacksonville, FL. She holds a BSN from Illinois Wesleyan University; an MSN from Andrews University, MI; and her PhD. is from the University of Florida, Gainesville. Dr. Ebener has no significant financial relationships to disclose. Peggyann Zaenger, B.S., PharmD, is associate CE Manager at AKH, Inc. Dr. Zaenger has a Bachelor of Science in Pharmacy from the University of Toledo and a Doctor of Pharmacy degree from the University of Michigan. Dr. Zaenger has no significant financial relationships to disclose. Conflict of Interest Statement: It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflict of interest is resolved by AKH prior to accreditation of the activity. Disclaimer: This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. and the author(s) specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through reader''s misunderstanding of the content. Copyright © AKH Inc. 2009 No part of this publication may be produced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical photocopying, recording, or otherwise, without the prior permission of AKH Inc. TABLE OF CONTENTS Introduction Why is it important? Statistics Impact What are the errors? Why do they occur? Human Error Invisibility of Error System Error How do we respond? Identifying Active vs. Latent Error Identifying Pre-Conditions What is being done? 1999 IOM Recommendations What can you do? Reporting Error Analysis Recognizing Potential Error Recommendations for Change Performance Improvement Conclusion References Introduction For those of us in healthcare, medical errors are nothing new. The possibility of their existence and their consequences were likely introduced to us early in our professional education and long before our licensure, certification or registration. Their reality became clear to us from the outset of professional practice. We know that errors can and do occur at various levels and with diverse significance and outcomes. The key is prevention. While our genuine desire to avoid errors is consistent, our response to them at the many levels of the healthcare industry is not. Too often nothing really changes. Mistakes are superficially addressed with contributing procedures and systems left unaltered thus leaving the stage set for the next incident. Often, individuals contributing to an error may not even be aware of their role in it. Other times, individuals are unjustly singled out to receive blame for matters beyond their control. A cycle of inaction, or nonproductive action, prevails. In November, 1999, the landmark report of the Institute of Medicine (IOM) To Err is Human: Building a Safer Health System initiated an unprecedented effort to break this cycle. Sobering statistics justified its recommendations and declaration that it is simply unacceptable for patients to be harmed by the same system one expects to heal and comfort. Effects of the report were widespread, evoking reaction from the public, from regulatory and governmental agencies, as well as from all segments of the healthcare industry. In the period following initiatives to reduce errors continue; some high-risk activities have been identified; processes have been researched and modified; monitoring and reporting is evolving; automation and technologic advances have been increasingly incorporated into distribution and decision making. Certainly awareness of errors by the many stakeholders in healthcare has been heightened. While some improvements have been made the process continues. Why is it important? Statistics The occurrence of medical errors and their associated costs are poorly understood by most. The reasons are many. They include an environment of secrecy characterized by absent reporting and documentation, as well as by a diluted perception of the problem. A disaster involving an aircraft that immediately claims many lives has a more emphatic impact on the public and safety officials than does a similar number of deaths attributable to medical errors that occur over a greater geographical area and longer period of time; knowledge of the latter are slow to emerge and difficult to discover. The study of error is not only in the highest degree prophylactic, but it serves as a stimulating introduction to the study of truth. Walter Lippmann (1889-1794) Clearer definition of the problem surfaced with the 1999 IOM report which estimates that 44,000 to 98,000 people die in hospitals each year as the result of medical errors.1 Even using the lower estimate, medical errors are the eighth leading cause of death in this country higher than motor vehicle accidents, breast cancer or AIDS.2 While these numbers are impressive, they are likely to be a significant underestimation of the problem. First, the two studies from which the statistics are extracted are believed to offer conservative figures. They were limited to injuries of a specified level of harm, required a high threshold to determine whether an adverse event was preventable or negligent, and included only those errors documented in patient records.3 Additionally, these statistics represent errors in hospitals only. More recently, Barker and colleagues observed a persistence of the problem in defining 19% of medication doses administered in healthcare facilities to be in error and 7% rated as potentially harmful.4 While much of the early data on medical errors focused on the hospital setting, a source of more readily available information, it is important to understand that errors can occur in any healthcare settings, such as physician offices, outpatient surgical settings, urgent care settings, nursing homes, hospices and community pharmacies. Impact The incidence of medical error has a substantial impact on the health and well-being of Americans. It is linked with estimations of significant cost to individuals, families, organizations and society as a whole. Affected individuals encounter needless pain and countless losses related to functional health status and financial stability. They may endure duplicate testing, repeated procedures, prolonged treatment and extended recovery time. Because of medical error, they may also experience lost productivity, disability, and increased costs of personal care. Unacceptably, thousands will die each year. Countless others, along with their family and friends, will have lost their trust in our healthcare system. The potential for experiencing harm while receiving healthcare threatens every American and as the IOM report noted, Americans shouldn't be harmed by the very people that are trying to care for them. Public perception, reflected by recent polls, is not favorable. Forty-two percent of respondents to a National Patient Safety Foundation poll indicated that they or a friend or relative had been affected by a medical error. Thirty-two percent noted the error had a permanent negative effect on the patient''s health. These respondents rated the healthcare system as a 4.9 on a 1 to 7 scale(1=not safe; 7= very safe).2 In an American Society of Health-System Pharmacists survey, 61% indicated they are very concerned about being given the wrong medicine (61%), receiving multiple medicines that might interact adversely (58%), and experiencing complications from a medical procedure (56%).2 An Agency for Healthcare Research and Quality (AHRQ) report indicates that most people believe that medical errors result from failures of individual providers. Seventy-five percent of respondents to a survey on medical errors respondents felt effective resolution could be achieved by preventing professionals with bad track records from providing care; 69% thought better training of health professionals was necessary. Five years following the IOM report the Kaiser Family Foundation conducted as survey which indicated the concern of the US public has not changed. Of those responding, 48% indicated that they are concerned about the safety of medical care they or their loved ones receive and 55% rate the quality of healthcare in this country as unsatisfactory.5 What are the errors? Most of us think of medical error in terms of medication mistakes or mishaps in surgery. Indeed, the 1999 IOM report estimated that medication errors alone led to as many as 7,000 deaths annually. Findings from a 2003 study published in JAMA documented 32,000, mostly surgery-related, deaths costing $9 billion and accounting for 2.4 million extra days in the hospital during 2000.5 However, many types of medical errors exist. They penetrate every process and system and affect every healthcare professional. Medical errors threaten every healthcare consumer and can occur even with the most routine task. Categorizing types of medical error can be accomplished by using several frameworks. Some methods might look at legal definitions while others might consider severity of injuries or types of healthcare services, settings, or providers. Leape categorized medical errors as diagnostic, treatment, preventative and other.6 These categories are still widely used but others could also apply. Diagnostic oriented Mistakes within this category include inaccurate or delayed diagnosis, failure to employ appropriate tests, use of outmoded tests or therapies, and failure to act on the results of monitoring or testing. According to the 1999 IOM report, diagnostic error is the major factor contributing to costly delays in treatment.1 An example would be the failure to diagnose breast cancer. According to the CDC,7 aside from non-melanoma skin cancer, breast cancer is the most common form of cancer in women. Despite this fact, delayed follow-up by practitioners still exists when women complain of a mass.8 The Physician Insurers Association of America (PIAA) did a series of studies on breast cancer claims. It was revealed that the younger women (40-49 years) had the highest rate of misdiagnosis error.9 Factors for the error were attributed to misinterpretation of mammography, inadequate medical record documentation, failures that occurred in office systems, and the all inclusive communication failures. Currently, the Board of Medicine in Florida identifies the 5 most misdiagnosed conditions as: cancer, cardiac, wrong-site surgery, timely diagnosis of surgical complications, and stroke and related cranial conditions.10 Treatment oriented Mistakes within this category include error in the performance of an operation, procedure, or test; error in administering the treatment; error in the dose or method of using a drug; avoidable delay in treatment or in responding to an abnormal test; inappropriate or not indicated care. Surgical errors comprise a high percentage of these errors. A post-operative patient with slow, insidious bleeding at the surgical site that goes untreated as the monitoring is interpreted as insignificant might be considered treatment oriented. An example of a treatment oriented error could also be those associated with acute myocardial infarction (MI). A delay in treatment that originates from admission delays can be labeled as this type of error. A misinterpretation of an ECG (diagnostic related) can lead to failure in treatment as some infractions may be missed.11 Nationally, up to 40,000 acute MIs are missed each year.12 Performance oriented Error of this type refer to those that occur while performing a wrong procedure or treatment. A primary example of this would be wrong site surgery. System breakdowns occur allowing the patient to be vulnerable to the system that can be busy, confusing, with numerous distractions or levels of possible failure. Medication oriented These are errors that arise specifically from prescribing, dispensing, administering, or monitoring patient medications. A patient that is prescribed a drug that is specifically contraindicated due to a pre-existing condition or allergy can be considered a medication oriented error. Preventative Errors within this category include failure to provide preventative treatment, or inadequate monitoring or follow-up of treatment. These are the kinds of errors that occur when information gets lost in the system or someone falls through the cracks. These types of error tend to occur whenever there is a high volume workload. In the fast paced emergency department, the patient that is discharged for follow-up with a general practitioner could fall under this type of error if they are not provided appropriate access for that evaluative care. Other Errors within this category include failures in communications, equipment function, and other types of system failure. Even when these failures do not directly cause medical error, they are often linked to the circumstances surrounding error. Healthcare professionals will acknowledge the above categories, but may have difficulty applying these concepts to their own practice setting. Unique circumstances and workplace scenarios contributing to error are embedded into each professional discipline's activities. Many will recognize some of these common examples. Physicians, physician assistants and nurse practitioners report that the potential for diagnostic or treatment error is present during virtually every patient encounter. Patients can be poor historians, records may be incomplete, and relevant information may be missed, omitted, misinterpreted, or discounted. Cost and time constraints also contribute to preventable error, and any combination of factors can set the stage for adopting a most likely diagnosis, prescribing the usually works treatment plan, or failing to pursue routine screening guidelines. Clinical laboratory professionals explain that the potential for diagnostic error is always present while collecting, labeling and processing specimens. Equipment failure and miscommunications are also common contributors to error. Clinical laboratory professionals typically work in fast paced, high volume environments that will quickly fail if patient and specimen identification is inaccurate or incomplete. Nurses indicate that the potential for diagnostic and treatment error most frequently involves one of two scenarios: 1) inadequate or inaccurate assessments, and 2) problematic medication administration. Because nurses monitor their patients' responses to illness and treatment, ongoing assessments with timely communication of findings become critical to patient safety. Nurses also devote much of their time to medication administration and multiple medications set the stage for potential error. Psychologists, Clinical social workers, mental health therapists and marriage and family therapists reveal that their potential for treatment error essentially revolves around the limited resources for behavioral health and the unpredictability of clients in crisis. Most community healthcare systems are simply unable to accommodate everyone's mental health needs and so the required prioritization of available resources inevitably leads to error when violent, homicidal or suicidal tendencies are missed. Physical therapists suggest that their potential for error is primarily related to unrecognized medical instability. Recommended or standard treatments may be contraindicated for those with unresolved cardiopulmonary problems, but a therapist relies on documentation to recognize these circumstances. Failed communications become primary contributors to error. The majority of events involving fainting, falling out, respiratory distress or cardiac arrest develop when underlying medical problems are unknown, unresolved, or not adequately appreciated. Pharmacists and pharmacy technicians report that medication errors may be viewed as an infarction of one of the five rights: right patient, right drug, right dose, right route and right time. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) defines a medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.13 It is important to note that this definition encompasses near misses, a feature that can help identify processes and events before they affect an actual patient. A near miss is defined as an event that could have resulted in an accident, injury or illness, but did not, either by chance or through timely intervention. Depending on work setting, various personnel other than pharmacists are involved with the handling of medications. Technicians and support personnel can be involved in one or more of the various activities associated with medication use such as ordering, storage, packaging, labeling, delivery, administration and even monitoring. All of the above examples have been reported by healthcare professionals responding to our invitation to comment on their own experiences with medical error. Why do they occur? Human Error Have you ever made a mistake? It happens, despite attempts to carefully double-check or review what has been done. Collectively, healthcare professionals all share a genuine desire to avoid error. Yet health professionals, being human, make mistakes. These mistakes occur despite how much we care, how hard we work, and how much we know. Consequently, systems that rely solely on error-free performance by humans are likely to fail. Reasons why people make errors have been studied for many years. While there is no single answer, it is generally recognized that no one intentionally makes a mistake. However, it is generally agreed that humans tend to perform best when they stay focused and alert, concentrating on the required tasks or decisions. Anything that decreases one's attention or creates a distraction will predictably increase the chance of error. Typical distractions come from physiological, psychological, or environmental sources.14 Physiological factors include fatigue, illness, loss of sleep, alcohol, and drugs. Psychological factors include various emotional states and distraction from other activities. These can be triggered by external factors such as overwork, interpersonal relations, or other forms of stress. Environmental factors such as temperature, noise level, lighting, and visual activity can also cause distraction. Invisibility of Error Have you ever been advised to forget an error or keep error-related information quiet? Medical errors are often surrounded by secrecy and shame allowing others to remain unaware of their existence. Embarrassment, fear of retribution and the potential of career-ending litigation keep many from revealing their mistakes. When errors are silenced and covered they also remain undocumented and unreported, and this keeps them invisible. A perceived lack of time also keeps many from reporting error. Comprehensive reporting requires added time that is simply not available and doing so may result in a missed lunch break, added time at the end of a busy shift, or an unwelcome shifting of priorities. This relative invisibility of error is dangerous because it prevents us from recognizing what went wrong and it keeps us from working towards resolution or improving conditions to prevent recurrence. Invisible errors also have a high probability of being repeated, and are likely to trigger a cascade of additional mistakes and inaccuracies that only compound the original error. The invisibility of error also leads to a generalized under-appreciation of its incidence and encourages a diluted perception of the medical error problem. No one wants to talk openly about iatrogenic mistakes; therefore, errors outside the scope of personal involvement are rarely noted. Limited access to the aggregate data on medical error is unnecessarily protective and blunts our comprehension of the bigger picture. This silent accumulation of error keeps us from fully appreciating its larger impact and even larger solution. Consider the unrelated example of a disaster involving an aircraft that immediately claims the lives of 200 persons. This one disaster is so visible it will elicit a more emphatic impact than the nearly invisible 200 deaths attributable to medical error. Because our knowledge of isolated errors and near misses accumulates over time and occurs over a large geographical area, we tend to respond more passively than we do when there is a single publicized disaster. System Error Whenever error does occur, have you ever been asked to isolate a human cause and then assign blame? This kind of response is common, yet extensive analyses reveal that most errors occur as a result of a chain of events set in motion by faulty system design that either induces errors or makes them difficult to detect.15 In other words, mistakes usually happen with system contribution - not just because of the people! Focusing on the unfortunate individual closest to the mistake does not address the system flaws or the complex organizational processes that allowed the error in the first place. In fact, neglecting system-wide influences sets the stage for repetition. Charles Perrow, in his analysis of the Three Mile Island nuclear accident, elaborated on how systems can cause or prevent accidents.16 He characterized organizations and systems according to their complexity and whether they are coupled loosely or tightly. Complex systems have multiple components that interact in a variety of unexpected and invisible ways, setting the stage for mistakes and accidents. Our current healthcare system qualifies as a complex system. The combination of system variability, professional specialization, continually evolving technology and layered governmental regulation produces a complexity that is often difficult to navigate. Coupling refers to the slack or buffer between steps in a process. Tightly coupled systems have more time-dependent processes and sequences; they accommodate less flexibility in how things can be accomplished. Tight coupling characterizes most of the quick paced events in healthcare. Here activities may happen so quickly that detection of error and intervention may be difficult. Recognizing that our healthcare systems are both complex and tightly coupled suggests that we should focus attention on organizational infrastructure and system re-design when addressing medical error. How do we respond? After categorizing and analyzing the multiple dimensions of medical error, it has become apparent that no single solution can be universally effective. Still, a unified approach to evaluation and response can guide appropriate action. How should we begin? Should we focus on the individual? Traditional responses focusing on individual error have relied upon naming, blaming and shaming,17 and then added education or training to correct poor performance. However, current evidence suggests that focusing on the individual limits the effectiveness of our response and is neither appropriate nor cost-effective. Individuals contributing to error may or may not even be aware of their participating role and some will be unjustly blamed for matters that were clearly beyond their control. Mandatory education and re-training is costly and is only partially effective within environments characterized by high employee turnover and evolving organizational changes. Should we focus on technology? Traditional responses to equipment malfunction, performance limitations and technical glitches have relied upon procedural revisions, product manual updates and continuous employee re-training. How effective are these responses when both the technology and the organizational needs keep changing? Traditional responses to human error often involve elaborate technological re-designs that can still be circumvented by frustrated employees. Current recommendations call for improved technology but with built in redundancies and added safety features to override human-generated errors.18 Should we focus on the organizational infrastructure? Traditional responses to problematic organizational and management systems have relied upon policy and procedural revisions, or targeted personnel replacement. How effective are these reactionary band-aids when new situations continually arise? Restrictive guidelines can never address every potential problem and broad-based policies allow for wide variations in interpretation. Instead, the Quality Interagency Coordination Task Force (QuIC) suggests system-wide solutions such as allocating adequate resources to error prevention and nurturing solutions that foster professional responsibility and accountability.19 Ultimately, we must focus appropriate attention on the system and not just the individual. Once we appreciate that error reduction and performance improvement requires proactive system-wide changes rather than reactive person-oriented strategies, we can begin to embrace what is now called a culture of safety. We must begin to appreciate the importance of developing a non-punitive workplace culture and promote a healthcare system with built in checks, safeguards and redundancies to protect against inevitable human failure. Initial steps in this process include differentiating error types and identifying those pre-conditions that are most likely to contribute towards error. Identifying Active vs. Latent Error Differentiating between active and latent errors helps guide a more effective response to error. Active errors are easily identified and occur at the level of the frontline worker. These errors are most often attributed to human error and their effects are felt almost immediately. Common active errors include administering the wrong medication or documenting on the wrong medical record. Latent errors tend to be removed from the direct control of the worker. These errors are less obvious, occur behind the scenes, and often remain undetected unless someone is actively investigating all the factors contributing to an active error. Typical latent errors are attributed to faulty systems and include things such as poor design, incorrect installation, faulty maintenance, bad management decisions, and poorly structured organizations.20 Latent errors and active errors are inevitably linked, supporting the assumption that no one sets out to intentionally make an error. A less threatening response to any active error involves focusing on the contributory latent errors. The following examples use different groups of healthcare professionals to illuminate some of the connections between active and latent error. Among physicians, physician assistants and nurse practitioners, well publicized examples of active error incidents involve wrong site surgery. Wrong site surgeries are most common among orthopedic procedures and associated risk factors include multiple surgeons involved in the case, multiple procedures performed during a single operating room visit, and unusual time pressures. Wrong site surgery represents the kind of mistake that provokes outrage, assigns blame to the operating surgeon, and results in costly litigation. Yet several latent errors contribute to the end result. For example, all operating room staff as well as the patient themselves have a role in verifying the correct surgical site. The patient's initial interview and verification in pre-op, surgical prep and draping of the wrong extremity, repeated failure to correctly verify the affected extremity, and inaccurate or inadequate preoperative documentation are all system errors that contribute to wrong site surgery. Among clinical laboratory professionals, an active error might involve the conscious decision to override scheduled, routine calibration checks. Routine calibration checks are required to assure test result accuracy, yet busy clinical laboratory workers may repeatedly prioritize the high volume of specimens over the performance of scheduled calibration checks on equipment. The latent errors in this example might include the timing of scheduled calibration checks, a lack of duplicate/back-up instruments, or instrument programming that allow over-ride functions. A nursing example of an active error is the erroneously free-flowing IV caused by incorrect loading of tubing into an infusion pump. When the free flow of fluid overloads the system or delivers toxic amounts of medication, the outcome can be particularly dangerous to the patient. The latent errors in this example might include the pump design that allowed the improper loading of the tubing, or the absence of technology that could prevent free-flow from occurring. Among psychologists, clinical social workers, mental health therapists and marriage and family therapists, a common example of an active error is the failure to adequately communicate a worsening symptom that could compromise safety. Counselors and therapists rely on communication alerts when suicidal and/or homicidal ideation is expressed, and discounting these indicators can endanger the lives of others. The latent errors in this example could include delays in transcription or inadequacies in procedure for communicating messages. A physical therapist example of an active error is the inappropriate choice of minimal documentation to describe a client's response to therapy. Detailed communication of any untoward client response is absolutely vital to successful rehabilitation; failure to adequately document client response sets the stage for potential harm during subsequent therapeutic sessions. The latent errors in this example might include time constraints because of a busy schedule, or documentation forms that discourage added therapy comments. Among pharmacists and pharmacy technicians, an example of an active error is the inaccurate filling of a medication order by dispensing a wrong medication or an incorrect dose. Pharmacists report that they carefully check filled prescriptions to avoid these types of error and yet they still occur. The latent errors contributing to this example might include drugs that look or sound alike, or a written prescription that is difficult to decipher. Identifying Pre-Conditions Another effective response to error involves identifying those factors or influences that set the stage for error. These pre-conditions could be the root causes of error or they might serve as stimuli that foster or encourage error. Once these pre-conditions are recognized and their links to error identified, specific remedies can be implemented. In a study examining preventable adverse events in a primary care outpatient setting, pre-conditions to error came from four distinct sources. Each source category was then labeled and described.21 Clinician factors, those pre-conditions directly attributable to the healthcare professional, include individual errors in judgment, procedural skills errors, failure to recognize signs/symptoms, forgetfulness, and execution related errors (stupid mistakes). Unfortunately, healthcare professionals in any setting will recognize these person-oriented contributions to medical error. Anticipated responses most appropriately focus on the individual, but every analysis should also look for system-wide problems that encourage human failures or fail to detect/prevent human error. Communication factors contributing to error include failure to understand, cultural and language difficulties, conflicting information, and delayed exchange of information. Since accurate and timely communication is essential within any healthcare organization, it is easy to understand how these pre-conditions influence and encourage medical error. When communication-oriented errors are identified, a diverse team representing all levels of personnel may be needed to adequately develop an improved communication process. Administrative factors contributing to error include a large number of system-wide problems that may or may not have already been known. Rushed personnel, missing charts and broken or unavailable equipment were most often identified in the study focusing on a family practice clinic. In other practice settings, administrative contributions to error might include scarce supplies, unresponsive management or unscheduled computer downtime. Think about how often a worker identifies a situation as a mistake waiting to happen, and then consider how and when the situation was remedied. Appropriate responses to these identified contributions will typically involve both short term and long term action plans in an attempt to limit their influence on error. Blunt end factors contributing to error include those influences that are outside the affected system's span of control. Examples might include physical size and location of the healthcare setting, or corporate level decisions affecting an individual facility or organization. An unusual example might include the occurrence of any community-wide disaster that limits access to usual resources, such as hurricane or flood. For many healthcare systems, it is the complexity of multi-layered interactions with outside insurance and government agencies that contribute to error. When identified contributions to error are external to the affected healthcare system, necessary internal adaptations are advised. What is being done? Actions to define and correct medication errors existed prior to the IOM report. In 1995, the United States Pharmacopoeia (USP) advocated the formation of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), an independent body comprised of 25 national and international organizations, to address medication error reporting and prevention.22 The 1998 report of the President's Advisory Commission on Consumer Protection and Quality in the Healthcare Industry identified medical errors as one of the four major challenges facing the nation to improve healthcare quality. As recommended by this report, the Quality Interagency Coordination Task Force (QuIC) was established to coordinate quality activities in federal healthcare programs, the largest purchaser and provider of healthcare services in the country. The QuIC includes the Departments of Health and Human Services, Labor, Veterans Affairs, Commerce, and Defense; the Coast Guard; the Bureau of Prisons; the Office of Management and Budget; the Federal Trade Commission; and the Office of Personnel Management. The QuIC is charged with coordinating the overall federal response to the IOM's report on medical errors. Federal government activities extended to the private sector with President Clinton's December 1999 memorandum requiring the more than 300 private health plans participating in the Federal Employee Health Benefits program to institute patient safety initiatives. Additionally, federal agencies administering health plans were to evaluate and, where feasible, implement the latest error reduction techniques. 23 Health providers are experiencing greater scrutiny and demand for safety improvement by the many oversight organizations, group purchasers, and professional groups. This responds to one of the recommendations by the IOM in its To Err Is Human report as a means to increase external pressure on providers to improve patient safety.1 Government officials at the state level are also interested. Twenty states require some form of medical error reporting. As an example, Florida requires reporting of mistakes that lead to serious patient injuries, such as life-threatening situations and epidemic outbreaks. Another class of reports involves serious adverse events, such as wrongful deaths, brain injuries, wrong limb removals, and incorrect surgeries.24 Additionally, the 2000 Florida Legislature created the Commission on Excellence in Healthcare to facilitate the development of a comprehensive statewide strategy for improving healthcare delivery systems through meaningful reporting standards, data collection and review, and quality measurement. As a further demonstration of their intent to advance this process, legislation (456.013) was passed in 2001 requiring 2 hours of continuing education study on medical errors by all healthcare professionals to qualify for initial Florida licensure and biennial renewal. 1999 IOM Recommendations The 1999 IOM recommendations for initiating the move to improve patient safety addressed the following four general areas: create a national center to oversee and direct medical safety efforts mandatory and voluntary error reporting safety performance standards for healthcare professionals safe practices at the delivery level Currently, the Center for Quality Improvement and Patient Safety (CQuIPS) is the primary group within the Agency for Healthcare Research and Quality (AHRQ) serving as a sustainable national driving force for patient safety. The Center is charged with conducting and supporting research on patient safety and healthcare quality issues, developing and disseminating reports and information, and collaborating with stakeholders to implement evidence-based practice.25 The call, initiated by the 1999 IOM recommendations and continued today, was for current knowledge on how to prevent errors to be identified and acted upon, and efforts to improve our understanding and develop other solutions to be intensified. The expectation of increased reporting is to identify errors and learn from them. This sounds simple, but in reality it is a complex and highly emotional subject that continues to be the focus of significant discussion. Because of reporting deficiencies we probably don't have an accurate grasp of the magnitude of the problem of patient safety. Nevertheless, for some errors we do know about we have failed to consistently bring about an effective resolution because of the way we evaluate and react to them. Through its recommendations the committee attempted to create an environment that encourages error identification, evaluation of their causes, and, finally, action to prevent future occurrences. To accomplish this task a national standardized method of reporting certain errors is to be mandated, and related information (type of errors, analysis, and resolution) is to be shared with the states. The IOM has provided a report describing a detailed plan to facilitate the development of data standards applicable to the collection, coding, and classification of patient safety information.26 It has also recommended legislation to protect peer review data related to patient safety and quality improvement. With less serious situations it advocates control of legal discoverability to make the environment more conducive for organizations to identify, analyze, and report errors. Early IOM recommendations included establishing performance standards and safety expectations for healthcare organizations and professionals. Many groups, including regulators, accreditors, public and private purchasers, and professional societies were solicited to encourage this. Perhaps the most obvious response to this recommendation for many of us, are activities within our specific organizations to comply with safety related JCAHO standards. In an attempt to extend the emphasis on safety to the delivery level, IOM recommendations called for implementation of specific programs in healthcare organizations and specified clearly defined executive responsibility. To health professionals, particularly those affiliated with hospitals, this recommendation is the most apparent because it spells out comprehensive safety related activities for organizations and the professionals affiliated with them. Its requirements include patient safety programs, non-punitive systems for reporting and analyzing errors, incorporation of well-understood safety principles, and the establishment of interdisciplinary team training programs for providers utilizing proven methods. Additionally, it states that healthcare organizations should implement proven medication safety practices. The Joint Commission has adopted standards that mirror these requirements. These, coupled with the Commission's Sentinel Event Policy, have stimulated patient safety activity within healthcare organizations so as not to jeopardize their accreditation. In 2003, the IOM was mandated by Congress to carry out a comprehensive study of drug safety and quality issues in order to provide a blueprint for system-wide change.26 Project meetings were conducted in 2005 and 2006, all culminating in the 2007 publication titled Preventing Medical Errors: Quality Chasm Series.27 The publication identified six (6) aims for improvement in healthcare. They are: Safety: avoiding injuries to patients from care designed to help them, Efficacy: providing evidence-based services to all who could benefit, and refraining from providing services to those unlikely to benefit (avoiding underuse and overuse). Patient centered: providing care that is respectful of and responsive to individual patient preferences, needs and values and ensuring that patient values guide clinical decisions. Timely: reducing waits and sometimes harmful delays for both those who receive and give care Efficiency: avoiding waste, such as waste of equipment, supplies, ideas and energy Equitable: providing uniform care regardless of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status What can you do? There is no single or best way to prevent medical error and improve patient safety, but it clearly becomes each healthcare professional's responsibility to actively work towards error reduction and error prevention. Major emphasis at the individual level relies on 1) willing participation in comprehensive and timely reporting of error, 2) collaborative analysis of individual and system practices designed to reduce error, 3) routine recognition of error prone situations and 4) voluntary adoption of recommended practice changes designed to minimize error. When each healthcare professional fully participates in these activities, the ultimate goal of improved patient safety can be realized. Reporting Each healthcare professional can substantially contribute to error reduction by consistently identifying and reporting actual errors, near misses, and flawed systems that can contribute to error. Reports can be submitted within an organization (internal) or to an outside agency (external) using either mandatory or voluntary reporting strategies. Mandatory reporting typically focuses on serious faults in performance, promotes provider accountability, and addresses public issues of safety and the public's right to know by disclosing serious inadequacies. Voluntary reporting is generally done in response to errors that result in minor or no injury, and the information generated is used to alter processes and systems to improve safety. Voluntary reporting is one of the largest safety related functions that delivery-level health professionals will encounter. It is the initial step in learning from past mistakes, and is vital to identifying system designs that can contribute to error. As previously mentioned, system problems that contribute to error are particularly harmful because they are difficult to recognize, and because they can combine with a multitude of events to cause more errors. As a delivery-level health professional, ask yourself the following questions: Do you feel your organization's error rate (medication variance, etc.) is accurate? When you discover an error, do you document all, some, or only those errors a supervisor tells you to report? When you identify and report an error do you feel it will result in: a) an improvement to a system or process that will make the error less likely to be repeated, or b) someone getting into trouble? Usual answers to these questions quickly identify the common barriers to reporting. We tend to name, blame and shame, and are often irregular about preparing reports. Authorities are aware of these obstacles. They acknowledge that our current culture of blame needs to be replaced by a culture of safety; they recognize that reporting needs to be non-punitive; they agree that documentation needs to be more streamlined. Working towards these goals will take time, yet many caution that more exhaustive reporting at the delivery-level will be required until there is a complete understanding of error. Error Analysis Practicing healthcare professionals need to actively participate in error analysis because one of the most effective ways to learn from past mistakes is to analyze all its contributing factors. Contributing factors may arise from faulty communication, other factors may come from the person, the system, or influences outside the system. The importance of analyzing all the contributing factors is underscored by the JCAHO's mandate for organizations to complete a thorough and credible root cause analysis (RCA) whenever a sentinel event occurs and whenever a critical effect is identified. Critical effects are defined as possible serious effects on the patient from failure or undesirable variation in a process. Critical effects are usually identified when conducting the Failure Mode and Effects Analysis (FMEA) process.27,28 Root Cause Analysis: Healthcare professionals routinely conduct intensive analyses of physical disease by exploring the condition at a cellular and/or chemical level to understand the root cause of the condition. Similarly, the RCA process allows us to explore and understand the reasons contributing to medical error. Through this cellular level scrutiny, system and practice modifications are made so that reoccurrence can be prevented. It is based on the premise and philosophy of the National Patient Safety Foundation that most errors result from faulty systems rather than human error and that people are in essence set up by them to make errors for which they are not fully responsible. Using RCA, events are dissected to discover: (1) the main reason an accident occurs (its proximate cause); (2) systematic problems that might lead to other mistakes (common causes); (3) contributors that could not have been foreseen or prevented (special causes); and (4) areas where the accident could have been avoided had things been done differently (risk points). Most Common Root Causes of Medical Error: The Agency for Healthcare Quality and Research recently categorized findings from multiple root cause analysis findings.30 They identified a diverse group of factors that cause medical error, and then developed the following categories: communication problems, inadequate flow of information, human problems, patient-related issues, organizational transfer of knowledge, staffing patterns or work flow, technical failures, and inadequate policies and procedures. Communication problems, the most common cause of medical errors, results in many different types of errors and involve all members of a healthcare team. These failures include both verbal and written communication amongst the many users of health related information and involve all types of medical information including physician orders, prescriptions, and laboratory results. These may exist between individuals in different agencies, facilities, departments or disciplines and can involve illegible, unintelligible, misspoken, misunderstood, lost, incomplete, or other failed communication. Inadequate information flow problems are those that prevent critical information from being available when prescribing decisions are made; delay or diminish reliability of critical test results; or fail to coordinate medication orders at points of interface or transfer of care. Human problems relate to how standards of care, policies, or procedures are followed. Examples include failure in following policies, guidelines, protocols, and processes. Such failures also include sub-optimal documentation and inadequate labeling of specimens. These human problems may be a related to lack of knowledge, but they are more often related to distraction and just not thinking. Patient-related issues can include improper patient identification, incomplete patient assessment, failure to obtain consent, and inadequate patient education. While patient related issues are listed as a separate cause by some reporting systems, they are often nested within other human and organizational failures of the system. Organizational transfer of knowledge can include deficiencies in orientation, education, or training for those providing care. This is of particular concern in areas where new employees or temporary help is often used and in academic medical centers where physicians in training often rotate through numerous centers of care. Staffing patterns/work flow can cause errors when work conditions become stressful due to insufficient staffing, high patient acuity, excessive volume, or when supervision is inadequate. Technical failures include device/equipment failure and complications or failures of implants or grafts. These events can cause great harm to patients. Instructions may be difficult to understand or even missing; device design may be poor. Frequently the fault of the device or equipment is not obvious, with blame focused on the operator, until a more thorough evaluation, such as RCA, is undertaken. Inadequate policies and procedures guiding the delivery of care can contribute to many medical errors when they are poorly designed, inadequate or adhered to variably. RCA has been used successfully for over twenty years in other settings, such as the nuclear and aviation industries. Justification to this labor-intensive process is improved outcomes and the avoidance of costly (and deadly) mistakes. Difficulties encountered when applying RCA to healthcare include inadequate staff, insufficient time, fear of retribution, and stopping the analysis too soon.28 Both people and time are scarce in contemporary healthcare settings, and everyone shares a wariness of discussing and documenting mistakes because they fear possible legal action. The JCAHO sentinel event policy has been described as a lawsuit kit for attorneys.31 JCAHO offers advice on how to minimize discoverability of these activities but admits that none are foolproof. Legislative protection has been suggested and recommended by the IOM but is currently not a reality. One method for avoiding or diminishing the fear of retribution is a thorough evaluation of near misses, errors that have the potential to cause patient harm, or errors that have occurred outside of one's organization. Failure Mode and Effects Analysis (FMEA): This bottom-up analysis is used in an organization's ongoing, proactive program to identify risks to patients' safety and reduce error. It is different from the RCA process because instead of focusing on what went wrong, the FMEA process focuses on what could go wrong.29 The FMEA process is outlined as follows: A team examines a process in detail, identifying all the functions that are supposed to occur. The team then identifies the ways in which those functions might go awry, i.e., the failure modes. Next, the consequences (effects) of each failure mode are identified Then the underlying causes (contributory factors) are elucidated. Sometimes an RCA is required for this. Each effect is rated in terms of its severity, and, Each contributory factor and/or failure mode is rated in terms of its frequency or likelihood of occurrence. Any existing controls (detection systems, mitigation systems, etc.) are then identified, and their impact is assessed, again via ratings. The three foregoing ratings yield criticality and/or other values from which the team decides which contributory for failure modes are the most critical for improvement efforts. Typically the team utilizes Pareto methodology to identify the classic 20% of issues that cause 80% of the process variability. This 20% can be considered to represent significant risk issues, e.g., the issues most important to address via improvement actions. It identifies courses of actions and establishes how those actions will be assessed for impact upon the process under analysis. FMEA is meant to be proactive so that processes, system designs, and performance can be analyzed using a sequential review process before error occurs. For example, FMEA can be used to analyze the error potential of a new drug being considered for formulary addition in the pharmacy. Does the drug under consideration have ambiguous or difficult to read labeling? Is the packaging potentially error-prone? Do product names have sound-alike or look-alike problems? Could there be any dosing confusion? Is there any special patient monitoring needs? How will the drug appear on a computer screen while performing varied processing functions? Recognizing Potential Error Individual healthcare professionals are advised to recognize error prone populations and error prone situations. Continuously evaluating risk and probability of error heightens awareness and reduces overall occurrence of medical error. 1. Vulnerable populations: When asked, most healthcare professionals immediately identify the very old and the very young as being particularly vulnerable to error. Individuals at these extreme ends of the age continuum are not as physically stable, their bodies are more significantly impacted by concomitant medical conditions, they metabolize their medications differently than the general adult population, and they often use alternative forms of communication to alert clinicians about impending problems. Additionally, each profession has defined unique sub-populations that are particularly prone to error. Clinical laboratory professionals focus much of their attention on obtaining adequate specimens for subsequent analysis. They indicate that their most problematic patients are subject to collection errors. These patients include the very obese, the very frail, those who are immune-compromised, and anyone who is in an emergently unstable life-threatened situation. Retail pharmacists have identified tourists (those having no available drug profile) and patients with multiple (and sometimes conflicting) drug files as those who are more likely to be involved with a pharmaceutical error. Pharmacists and pharmacy technicians also report a higher potential of error when working with anyone who cannot adequately communicate because of illiteracy or language barrier (cannot communicate in English) because it becomes difficult to verify and clarify relevant information. Psychologists, clinical social workers, mental health therapists and marriage and family therapists explain that their suicidal, homicidal and psychotic patients are most unpredictable and thus lead their list of those most vulnerable to errors in assessment and/or treatment. Aggressive or violent individuals pose the greatest threat to overall safety, but errors are also common when individuals conceal relevant information or offer conflicting information. Examples include persons with HIV disease, the chronically mentally ill, gay/lesbian persons, the uninsured and the homeless. Physical therapists are most concerned about error when working with depressed persons and those with impaired judgment (left sided CVA affecting frontal lobe). These individuals do not always respond appropriately during a therapeutic session, and so a therapist cannot rely on the patient to verify information or correct therapist assumptions. PT professionals also realize that clients receiving oxygen during therapy or those utilizing medicated topical ointments are at a higher risk for the development of untoward reactions. Nurses consistently indicate that their highest safety risk populations include those who are combative and/or confused, those who are critically ill (and thus subject to hundreds of medical interventions each day), and those who have no desire to survive (patient lacks incentive to participate in care). 2. Error-prone practice settings. Healthcare professionals also identify special situations and circumstances that are more likely to contribute to error. Human factors such as stress or fatigue can interfere with cognition. System inadequacies such as insufficient staffing, computer downtime or other technology failure can inject variability into routine processes or diminish anticipated capabilities. These and similar situations should clearly signal potential for mistakes and alert practitioners to take special measures. These might include seeking a second opinion from a co-worker, avoiding fatigue by delegating tasks, prioritizing activities, or utilizing additional reference materials. Of interest, healthcare professionals working in different practice settings all identify additional, unique practice situations that pose the highest risk for error. Physicians comment that their highest potential for error arises whenever they are asked to emergently consult an unstable patient, primarily because everyone is expecting the impossible: a quick response offering definitive treatment that will immediately resolve a complex medical situation. Clinical laboratory professionals report that the majority of their errors involve situations with improper or inadequate patient identification. Nurses report that most of their high risk situations are related to inadequate staffing and emergent patient circumstances, but they consistently identify medication administration errors as a primary situational risk, particularly among those with multiple medications. Psychologists, Clinical social workers, mental health therapists and marriage and family therapists explain that their potential for error is highest when they are asked to strategize a minimal solution that has few or any backup contingencies. Regarding personal safety, they are most concerned when practicing alone during evening or off hours because they are dealing with unstable patients and/or unstable family members. Physical therapists report that the highest risk situations involve patients with underlying conditions that are undetected, and patients receiving pharmacologic products that can precipitate untoward responses (hypotension, vertigo, nausea, impaired judgment). Pharmacy personnel indicate that some of their riskiest situations occur when there are computer failures, because they rely so heavily on computerized patient profiling and the automated identification of potential drug interactions. In addition, pharmacy personnel have identified the following contributing causes of medication errors independent of setting include Telephone interruptions General interruptions Prescriber's handwriting Look alike/sound alike drug names Prescription volume Fatigue Verbal orders Product labeling and packaging Abbreviations Recommendations for Change Individual healthcare professionals are asked to embrace the recommended practice changes that are designed to minimize error and enhance patient safety. America's nationally based safety initiatives are evidence driven, using both voluntary and mandatory reporting data that were collected by centralized agencies like JCAHO, the National Patient Safety Foundation (NPSF), the U.S. Pharmacopeia (USP) and AHRQ. Recommendations may not always seem necessary to every healthcare professional, but these reflect a genuine desire to change practices that have been repeatedly implicated in medical error. Primary opportunities for patient safety are identified within the broad categories of medication administration, patient practice, technology applications, and education (both professional and consumer). 1. Medication-related safety: Safety initiatives pertaining to medication errors are widespread because 1) medications are extensively utilized in healthcare and 2) the complexity of several interacting professions and systems offer substantial opportunities for error. Numerous contributors to medication-related error have been identified. Distractions and workload increases are consistently mentioned whenever individual error is identified, but many system-wide factors are also named. These include prescriptions and drug orders with poor handwriting, medications involving similar drug names, use of abbreviations, patient and/or healthcare professional misinterpretation of labeling, dosage miscalculations, lack of knowledge or skill, and incorrect administration practices.32 The Institute of Safe Medication Practices (ISMP) and JCAHO both warn against using dangerous dose designations, stemmed names, apothecary or mathematical symbols, and other abbreviations because of the high potential for error. ISMP published a listing of error-prone abbreviations, symbols, and dose designations in their biweekly newsletter Medication Safety ALERT!, and a few of the most problematic abbreviations and expressions are listed in Table 1, along with the suggested more appropriate substitution.33 The complete listing published by ISMP can be found on the ISMP website at http://www.ismp.org/tools/errorproneabbreviations.pdf . Healthcare professionals of all disciplines are impacted by these recommendations, most particularly within the disciplines of pharmacy, medicine and nursing. Clinicians working with medications are particularly advised to recognize high alert medications, the small number of medications that have a high risk of injury when misused. Medications are placed on this list not because of the high number of errors, but because of their serious consequences when not properly used. High alert medications include adrenergic agents, chemotherapy agents, neuromuscular blockers, IV heparin and warfarin, lidocaine, concentrated electrolyte injections, opiates and insulin.34 The National Coordinating Council on Medication Error Reporting and Prevention defines a medication error as any preventable event which may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer. This definition implies that patients and consumers also play a role in promoting medication safety. In 1999, the National Patient Safety Partnership (NPSP), a coalition of healthcare organizations, released a list of the 16 best practices in medication safety that all focused on encouraging patients and family members to participate in error prevention.35 Since then, nationally based agencies have continued to build public awareness and promote education on how each consumer can prevent medication errors. Most of NPSP's 16 best practices in medication safety are currently integrated into standard clinical practice, but they are listed because they illustrate the content driving added policy and procedural recommendations on medication safety. Patients and family members are encouraged to participate in their own safety. Best practice will inform and educate consumers about their role in preventing medication-related error: Tell physicians about all the medications they are taking and their responses/reactions to them. Ask for information in terms they understand before accepting medications. This information includes but is not limited to the following: Is this the drug my doctor (or other prescriber) ordered? What is the trade and generic name of the medication? What is the drug for? What is it supposed to do? How and when am I supposed to take it and for how long? What are the likely side effects? What do I do if they occur? Is this medication safe to take with the other over-the-counter and/or prescription medications or dietary supplements that I am already taking? What food, drink, activities, dietary supplements or other medication should be avoided while taking this medication? Table 1. Select Dangerous Abbreviations and Dose Expressions33 Abbreviation-Dose Expression Intended Meaning Misinterpretation Recommended Correction Apothecary symbols dram minim Misunderstood or misread (symbol for dram misread for 3 and minim misread as mL). Use the metric system. AU aurio uterque (each ear) Mistaken for OU (oculo uterque-each eye). Don't use this abbreviation. D/C discharge discontinue Premature discontinuation of medications when D/C (intended to mean discharge) has been misinterpreted as discontinued when followed by a list of drugs. Write out the words discharge and discontinue. MSO4 morphine sulfate magnesium sulfate Write out the word morphine o.d. or OD once daily Misinterpreted as right eye (OD-oculus dexter) and administration of oral medications in the eye. Use daily. TIW or tiw three times a week. Mistaken as three times a day. Don't use this abbreviation. qhs nightly at bedtime Misread as every hour. Use nightly. SC subcutaneous Mistaken for SL (sublingual). Use subcut. or write subcutaneous. U or u unit Read as a zero (0) or a four (4), causing a 10 fold overdose or greater (4U seen as 40 or 4u seen as 44). Unit has no acceptable abbreviation. Use unit. ss sliding scale (insulin) or ½ (apothecary) Mistaken for 55. Spell out sliding scale. Use one-half or use ½. Zero after decimal point (1.0) 1 mg Misread as 10 mg if the decimal point is not seen. Do not use terminal zeros for doses expressed in whole numbers. No zero before decimal dose (.5 mg) 0.5 mg Misread as 5 mg. Always use zero before a decimal when the dose is less than a whole unit. Healthcare providers are encouraged to practice more safely. Best practice will design and implement the organizational processes that will promote medication-related safety: Educate patients Put allergies and medications on all patient records Stress dose adjustment among children and older adults Limit access to high hazard drugs Use protocols for high hazard drugs Computerize drug order entry Use pharmacy based IV and drug mixing programs Avoid abbreviations to reduce misinterpretation Standardize drug packaging, labeling and storage Use unit dose drug packaging systems (drugs are packaged and labeled in standard patient doses) Healthcare purchasers are encouraged to provide safer products. Best practice will include the following recommendations: Require machine readable labeling (bar coding) Buy drugs with prominent display on name, strength, warnings Buy unit of use packaging (unit dose) Buy IV solutions with two sided labeling 2. Patient practice related safety. In 2001, AHRQ and the University of California at San Francisco-Stanford University Evidence-based Practice Center (EPC) evaluated and rated clinical safety practices based on evidence in the literature.35 Opportunities for improved patient safety were identified and healthcare professionals who accept these recommendations will actively contribute to patient safety and reduced medical error. Appropriate prophylaxis for venous thromboembolism in at-risk patients. Appropriate use of ß-blockers to prevent perioperative morbidity and mortality. Maximum sterile barrier use during central intravenous catheter placement to prevent infections. Appropriate antibiotic prophylaxis to prevent perioperative infections. Having patients recall and restate information given them during the informed consent process. Continuous aspiration of subglottic secretions to prevent ventilator-associated pneumonia. Pressure ulcer prevention with bedding material that relieves pressure. Central line insertion with real-time ultrasound guidance to prevent complications. Patient self-management of warfarin for appropriate outpatient anticoagulation and prevention of complications. Appropriate nutrition with particular emphasis on early enteral nutrition for critically ill and surgical patients. Prevention of catheter-related infections with antibiotic-impregnated central venous catheters. AHRQ and the EPC also identified and rated some patient safety opportunities that appear promising but require further research. The following rated most highly: Improved perioperative glucose control to decrease perioperative infections, Localizing specific surgeries and procedures to high volume centers. Use of supplemental perioperative oxygen to decrease perioperative infections. Changes in nursing staffing to decrease overall hospital morbidity and mortality. Use of silver alloy-coated urinary catheters to prevent urinary tract infections. Computerized physician order entry with computerized decision support systems to decrease medication errors and adverse events primarily due to the drug ordering process. Limitations placed on antibiotic use to prevent hospital acquired infections due to antibiotic-resistant organisms. Appropriate use of antibiotic prophylaxis in surgical patients to prevent perioperative infections. Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk. Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and post-surgical patients. Use of analgesics in the patient with an acutely painful abdomen without compromising diagnostic accuracy. Improved handwashing compliance (via education/behavior change; sink technology and placement; or the use of antimicrobial washing substances. Added opportunities to promote safe clinical practice include the utilization of evidence based clinical protocols, standardization of routine tasks and available equipment, and ongoing efforts to educate staff, patients and their families. Studies have shown that standardization of equipment, guidelines, and protocols have dramatically reduced error rates. For example, errors attributable to anesthesia were reduced from 25-50 per million to 5.4 per million through just such standardization.37 3. Technology enhanced safety. The use of advanced technology, computerized applications and sophisticated digitized equipment has grown exponentially over the last decade, impacting healthcare systems along with everything else in our environment. Positive changes include the increased consistency and readability of the computerized medication administration record (MAR) and computerized physician order entry (CPOE), safer intravenous infusion pumps, and real time documentation with inventory control using bar code technology. Some of the negative impacts include issues regarding the confidentiality of medical records, the cost of added hardware, software and information technology staff, and the ongoing training of all personnel. One of the biggest barriers to technology enhanced safety is the reticence of staff that cannot or will not embrace computerization. Healthcare professionals within every professional discipline and at all levels of healthcare delivery are actively contributing to error reduction and patient safety when they can accept and adapt to computerized technology. Reliance on outdated methods and old equipment may have worked in the past but they always had limitations that can now be overcome. Since healthcare professionals who cannot use the newer methods and updated equipment become a potential source of error themselves, their acceptance of newer technology becomes an ethical imperative. Examples of how technology enhanced systems can reduce error are provided below. Clinicians worry about caring for patients using a cookbook approach rather than individualizing care, and therefore want to resist the use of computerized decision support systems. However, using evidence based artificial intelligence to guide thinking (prompt, suggest and remind not demand) can improve both clinical and financial outcomes. Regional and/or cultural bias is minimized and evidence based strategies are promoted. Published evidence suggests that patients will significantly benefit when computerized decision support systems are used - with a better chance of survival.38,39 Physicians and other prescribing practitioners understand that hand written prescriptions may be misinterpreted with sometimes disastrous results. CPOE offers a clearly legible order that can be processed more efficiently. When combined with some sophisticated alerts programmed into the system, CPOE has demonstrated significant contributions to error reduction. Clinical laboratory professionals find that the time and resource constraints significantly increase opportunities for error, particularly human error. There may be misplaced or mislabeled test tubes, delayed turnaround time, or communication of erroneous test results. Replacing manual tasks with automated procedures (automated alliquotters, closed-tube sampling systems to eliminate manual uncapping and capping of test tubes, electronic auto-validation of results) contributes to error reduction and also results in improved productivity, worker safety, and cost savings. Nurses, mental health counselors, physical therapists and other direct care professionals recognize that documentation of care delivery is important, yet they have always encountered barriers when trying to complete all the required information. The electronic medical record (EMR) offers these professionals the opportunity to eliminate most barriers while documenting even more comprehensive and timely information. Additional technology such as voice recognition software and bar coding devices further optimize documentation by inputting real time data directly into the EMR and then populating all the required fields. Radiographers are required to adjust kilovoltage peak (kVp), milliamperage (mA) and exposure time based key variables such as on source to image receptor distance (SID), thickness and tissue type of the body part and pathology. Using automatic exposure control (AEC) technology reduces errors in film screen imaging and contributes to improved patient safety by limiting radiation exposure. 4. Education to Promote Safety. Promoting and enhancing awareness of medical error is the initial step in developing a culture of safety. The topic of medical error can no longer remain invisible, and so educational efforts focusing on patient safety must become clear, strong, and visible. Continuing education (mandatory and voluntary) using journal articles, live presentations and web-based programs all contribute needed knowledge and stimulate further discussion. Ultimately, it is the availability and promotion of ongoing education that becomes crucial in laying the foundation for collaborative initiatives that will reduce medical errors. This education is needed at the professional level, the support staff level, and the consumer level. Education of the general public is also needed to increase awareness of the consumer's role in providing safe medical care. Responsibility for solving the medical error problem does not lie solely with healthcare professionals. Patients, their families, and their lay advisers must also become active members of the patient's healthcare team. Clinicians can more easily accomplish this with automated patient education material that is appropriately distributed. Added educational approaches might include staff call-backs within 24 hours after facility discharge, consumer information hot lines, and frequently needed health information available using printed brochures and web site technology. JCAHO The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the nations predominate standards-setting and accrediting body in healthcare, has taken an active role in addressing medical errors. It began tracking sentinel events in 1995. A sentinel event is any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injuries specifically include a loss of limb or function. The phrase or the risk thereof includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. 40 Sentinel event data is used to trend safety concerns and is shared by the Commission to educate other participants. The intent of the Sentinel Event Policy is to address patient safety issues within the healthcare industry by (1) identifying significant medical errors, (2) performing root cause analysis to understand their causes, (3) making changes to reduce future occurrences, and (4) evaluating the effectiveness of those changes. Such activities compose lessons learned and are shared for the benefit of all. The Joint Commission produces and distributes a newsletter, Sentinel Event Alert, which informs organizations of sentinel events and how they can be prevented. Reporting to the Joint Commission is voluntary and is encouraged to expand its data base. The policy, however, identifies some functions by organizations responding to sentinel events as being subject to review by the Joint Commission. This means that for certain events the organization is required to perform a suitable root cause analysis, make revisions to prevent future occurrences, and demonstrate plans for evaluating the effectiveness of those changes. Continued accreditation requires that this be done within 45 days of the known occurrence of the event. The Joint Commission advises participants on methods to protect confidentiality and limit the risk of legal exposure of documents related to this process. So what is next? JCAHO has established multiple standards addressing patient safety in healthcare organizations in its chapters on Leadership, Improving Organization Performance, Management of Information, Education, Continuum of Care, and Management of Human Resources. Leadership's role in patient safety is specifically addressed and it is made accountable for all related activities. Leadership is responsible for integrating and coordinating all patient safety efforts. In 2002 JCAHO streamlined its patient safety requirements of accredited facilities by establishing a select list labeled National Patient Safety Goals (NPSGs). Each year an individual goal may be retained, expanded, or replaced by a new priority. The requirements are based on scientific evidence when available. In its absence, expert consensus and data from JCAHO's Sentinel Event Database provide the basis for the requirements. These can be viewed at the JCAHO website: http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/. The goals include requirements for organizations to improve accuracy of patient identification, effectiveness of communication, medication safety, reduce the risk of healthcare associated infections, reconcile medications, reduce falls, reduce the risk of influenza, and pneumococcal disease, reduce the risk of surgical fires, encourage patient involvement, pressure ulcer prevention, and identify safety risk for each institutions patient population.41 Performance Improvement During the 1990s many health organizations took to heart the teachings of business quality leaders by looking for ways to improve their complex systems. JCAHO recognized the benefit of such improvement efforts and mandated them in their standards. Many methods exist: FOCUS-PDCA, Six Sigma, Quality Related Events and Continuous Quality Improvement programs. National Recommendations The federal government has noted that this country's healthcare system is at least a decade behind other high risk industries (such as aviation) in its attention to ensuring basic safety.42 A review of the experience in non healthcare industries revealed the following characteristics: No tolerance for high error rates Development of tracking systems to expose error Reliance on abundant reports involving actual error and near misses Thoroughly investigating error Use of a systems approach embracing human, technical and organizational remedies Promotion of a non-punitive culture that enhances safety Allocation of adequate resources to error prevention Recognition that solutions sometimes come from unexpected sources Recognizing current inadequacies, the federal government promotes the following recommendations (many of which are already in existence): Hold national summits on medical error Endorse and support further research Develop and maintain an aggregate database on medical error Partner with other agencies to publish and enforce specific practice recommendations Collaborate with health professional licensing bodies to develop competency standards Work with drug and product manufacturers to maximize safety Endorse and support decision support systems and information technologies to enhance real-time decision support to clinicians Partner with other agencies to develop and articulate standardized procedures, checklists and protocols that are based on current research based evidence Medicare Decision effective October 2008 Beginning with hospital discharges on or after October 1, 2008, the Centers for Medicare and Medicaid Services (CMS) will no longer pay the extra costs of treating patients who develop eleven serious, preventable conditions after they have been hospitalized.43 That is, CMS will not pay more than it would have if the complication did not occur or was not present on admission. There are different definitions for these events, but in general, they are events or conditions that should not occur in hospitals. These conditions include: Foreign object retained after surgery Air embolism Blood incompatibility reaction Catheter associated urinary tract infection Pressure ulcer (stages III &IV) Vascular catheter associated blood stream infection Surgical site infection-mediastinitis after coronary artery bypass graft surgery Hospital acquired injuries including intracranial injury, crushing injury, burn, dislocations and other unspecified effects of external causes Manifestations of poor glycemic control Surgical site infections following certain orthopedic procedures and bariatric surgery for obesity Deep vein thrombosis/pulmonary embolism after total knee and hip replacement Conclusion Medical error continues to be a very serious and complex national concern. What we have learned is that error reduction strategies need to focus on system redesign rather than individual chastisement. We have also learned the importance of building a culture of safety in which people are not afraid to identify errors and learn from each other's mistakes. In this new culture of safety, there should be no retribution for reporting errors or near misses. Healthcare professionals have been identified as essential participants in the team approach to error reduction and remain central to the varied efforts promoting resolution. Through additional study of best practices, organizational guidelines and technical support strategies, our nation hopes to build a healthcare system that can offer the safest patient care possible. Please Proceed to Post Test and Evaluation References Institute of Medicine Division of Healthcare Services Committee on Quality of Healthcare in America. To Err Is Human: Building A Safer Health System. Washington, DC: National Academy Press; 1999. U.S. department of Healthcare Research and human Services: Agency for Healthcare Research and Study. Medical Errors: The Scope of the Problem. 2000 February. http://www.ahrq.gov/qual/errback.htm . Accessed 11/03/08. Andrews LB, Stocking C, Krizek T, et al. An alternative strategy for studying adverse events in medical care. Lancet. 1997;349:309-13. Barker KN, Flynn EA, Pepper GA et al. Medication errors observed in 36 healthcare facilities. Arch Intern Med. 2002;162:1897-1903. Zahn C, Miller M. Excess Length of Stay, Charges, and Mortality Attributable to Medical Injuries During Hospitalization. JAMA. 2003;290:1866-74. Leape LL, Lawthers AG, Brennan TA et al. Preventing Medical Injury. Qual Rev Bull. 1993;19(5):144-49. Centers for Disease Control and Prevention. Statistics. http://www.cdc.gov/cancer/breast/statistics/index.htm?s_pkw=1006breast1311 . Accessed 11/03/08. Strunk AL, Kenyon S. Medicolegal considerations in the diagnosis of breast cancer. Obstet Gynecol Clin North Am. 2002;29:43-9. Breast Cancer Study (3rd ed.). (2002). Physician's Insurer's Association of America, Rockville, MD. Florida Medical Association. http://www.floridashealth.net/mqa/medical/msg_chair.pdf . Accessed 12/14/08. Sullivan D, Zalenski R. Missed myocardial infarction: Minimizing the risk. Emergency Department Legal Letter, 1996;7:45-56. Misdiagnosed acute myocardial infarction. Risk Review. May 2006. http://www.riskreviewonline.com/RiskReviewOnline/Archives/May2006/ClaimReview/ . Accessed 12/14/08. National Coordinating Council on Medication Error Reporting and Prevention. NCCMERP Taxonomy of Medication Errors. Rockville, MD 1997. http://www.nccmerp.org/aboutMedErrors.html. Accessed 11/3/08. Leap LL. Error in medicine. JAMA. 1994;272:1851-57 Leape LL, Bates DW, Cullern DJ et al. Systems Analysis of Adverse Drug Events. JAMA. 1995;274:35-43. Perrow C. Normal Accidents. New York: Basic Books; 1984. Reason J. Human error: Models and Management. BMJ. 2000;320:768-70. AHRQ''s Patient Safety Initiative: Building Foundations, Reducing Risk. Rockville, MD: Agency for Healthcare Research and Quality; December, 2003. Interim Report to the Senate Committee on Appropriations. AHRQ Publication No. 04-RG005. http://www.ahrq.gov/qual/pscongrpt/. Accessed 11/3/08. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Report of the Quality Interagency Coordination Task Force (QuIC) to the President. Washington DC: Quality Interagency Coordination Task Force; February 2000. http://www.quic.gov/report/toc.htm. Accessed 12/14/08. Reason J, Human Error. Cambridge, England: Cambridge University Press, 1990. Elder NC, Dovey SM. Classification of medical errors and preventable adverse events in primary care: A synthesis of the literature. J Fam Pract. 2002;51(11):927-32. National Coordinating Council for Medication Error Reporting and Prevention http://www.nccmerp.org/aboutNCCMERP.html?USP Accessed 11/03/08. Statement on Medical Errors. John M Eisenberg, M.D., Director, Agency for Healthcare Research and Quality, before the Senate Appropriations Subcommittee on Labor, Health and human Services, and Education, December 13, 1999, Washington DC;. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/stat1213.htm. Accessed 11/12/08. Serafini MW. First, do no harm. Washington: National Journal, Feb. 19, 2000. AHRQ. Mission Statement: Center for Quality Improvement and Patient Safety. February 2004. http://www.ahrq.gov/about/cquips,cquipsmiss.htm. Accessed 11/12/08. IOM. Identifying and preventing medication errors. http://www.iom.edu/?id=35942. Accessed: 11/12/08. Aspden P, Wolcott J, Bootman J, Cronenwett L, editors. Preventing Medication Errors: quality Chasm Series. The National Academies Press; Washington, DC. 2007. Root Cause Analysis: Common Barriers to Conducting Effective Root Cause Analyses. Joint Commission Perspectives on Patient Safety. 2001;1(1):4-5. Wallace D, Hirsch K. Failure Mode and Effects Analysis (FMEA):Proactive - Root Cause Analysis (RCA):Reactive. Medical Risk Management Associates 2004. http://www.sentinel-event.com/process_optimization.htm. Accessed 11/3/08. AHRQ''s Patient Safety Initiative: Building Foundations, Reducing Risk. Rockville, MD: Agency for Healthcare Research and Quality; December, 2003. Interim Report to the Senate Committee on Appropriations. AHRQ Publication No. 04-RG005. http://www.ahrq.gov/qual/pscongrpt/ Accessed 12/14/08 Sentinel event policy changed, but it's still a lawsuit kit for attorneys. Health Risk Management, July 1998. Look alike, sound-alike drug names. Sentinel Event ALERT. 2001;19. ISMP's list of Error-Prone Abbreviations, Symbols, and Dose Designations. http://www.ismp.org/Tools/errorproneabbreviations.pdf Accessed 12/2/08. ISMP's list of high-alert medications, Institute of Safe Medication Practices Preventing Medication Errors http://www.ismp.org/Tools/highalertmedications.pdf. Accessed 11/18/08. Making Healthcare Safer: A Critical Analysis of Patient Safety Practices. Rockville, MD: Agency for Healthcare Quality and Research; July, 2001. Evidence Report/Technology Assessment No. 43. AHRQ Publication No. 01-E058. July 2001. Reducing Errors in Healthcare. Translating Research Into Practice. Rockville, MD: Agency for Healthcare Quality and Research; April 2000. AHRQ Publication No. 00-PO58. Rockville, MD. http://www.ahrq.gov/qual/errors.htm . Accessed 11/3/08. Medical Errors: The Scope of the Problem. Fact sheet, Publication NO. AHRQ 00-P037. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/qual/errback.htm . Accessed 12/14/08. Bates DW, Kuperman GJ, Rittenberg E, et al. A Randomized Trial of a Computer-Based Intervention to Reduce Utilization of Redundant Laboratory Tests. Am J Med. 1999;106(2):144-50. Morris AH. Protocol Management of Adult Respiratory Distress. New Horizons. 1993;1(4):593-602. JCAHO. Sentinel Event Policy and Procedures. Available at: http://www.jointcommission.org/SentinelEvents/PolicyandProcedures/ Accessed: 11/12/08. JCAHO. National Patient Safety Goals. http://www.jointcommission.org/patientsafety/nationalpatientsafetygoals/ . Accessed 12/14/08. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Washington DC: Quality Interagency Coordination Task Force; February, 2000. Report of the Quality Interagency Coordination Task Force (QuIC) to the President. http://www.quic.gov/report/toc.htm . Accessed 12/14/08. Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. http://www.cms.hhs.gov/HospitalAcqCond/06_Hospital-Acquired_Conditions.asp . Accessed 12/14/08. National Quality Forum Updates Endorsement of Serious Reportable Events in Healthcare. October 16, 2006. http://www.qualityforum.org/pdf/news/prSeriousReportableEvents10-15-06.pdf . Accessed 12/14/08.

Preventing Medical Errors for Clinical Health Professionals

2009-01-01T13:00:00Z

Instructor: Jon S. Holman, B.S., PharmD, CCMEP; Peggyann Zaenger, B.S., PharmD; Mary Kathleen Ebener PhD, RN

Preventing Medical Errors for Clinical Health Professionals To download a .pdf version of this course click here! Needs Statement: The 1999 Institute of Medicine report To Err is Human: Building a Safer Health System brought prominence to the issue of medical error in the US. Since that time multiple activities at various levels of private and regulatory arenas have targeted identification and resolution of medical error. The process is dynamic and health professionals need education of error reduction techniques so as to improve safety in their professional activities and work setting. Some regulatory agencies require specific medical error education for licensure or relicensure of health professionals. Course Goal: This educational monograph addresses the identification, reporting, monitoring and reduction of medical error. It is intended to make participants aware of the magnitude of the problem, of the many-leveled activities needed to resolve it, and the importance of each person's role in the national effort to reduce medical errors. Objectives:At the completion of this course the participant will be able to: 1. Recognize the magnitude and far reaching effects of medical error. 2. Categorize factors contributing to the occurrence of medical error. 3. Describe the healthcare professional's role in identifying error prone situations. 4. Explain the importance of reporting medical error. 5. Specify at least two recommended practice modifications to promote safety and reduce the incidence of medical error. 6. Review the processes of root cause analysis and failure mode and effects analysis when analyzing error. About the Authors: Mary Kathleen Ebener PhD, RN is employed by Community Hospice in Jacksonville, FL. Dr. Ebener teaches courses in nursing, healthcare and statistical analysis at the University of Phoenix, Jacksonville, FL. She holds a BSN from Illinois Wesleyan University; her MSN is from Andrews University, MI; and her PhD. is from the University of Florida, Gainesville. Dr. Ebener has no significant financial relationships to disclose. Peggyann Zaenger, B.S., PharmD, is associate CE Manager at AKH, Inc. Dr. Zaenger has a Bachelor of Science in Pharmacy degree from the University of Toledo and a Doctor of Pharmacy degree from the University of Michigan. Dr. Zaenger has no significant financial relationships to disclose. Jon S. Holman, B.S., PharmD, CCMEP, is co-owner and continuing education administrator at AKH Inc. Dr. Holman has extensive experience as a clinical pharmacist in adult intensive care. He holds a Bachelor of Science degree from the University of Colorado and a Doctor of Pharmacy degree from the Medical University of South Carolina. Dr. Holman has no significant financial relationships to disclose. Conflict of Interest Statement: It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflict of interest is resolved by AKH prior to accreditation of the activity. AKH planners and reviewers have no relevant financial relationships to disclose. Disclaimer: This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. and the authors specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through reader''s misunderstanding of the content. Copyright ©AKH Inc. 2009. No part of this publication may be produced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical photocopying, recording, or otherwise, without the prior permission of AKH Inc. Table of Contents Introduction Why is it important? Statistics Impact What are the errors? Why do they occur? Human Error Invisibility of Error System Error How do we respond? How should we begin? Identifying Active vs. Latent Error Identifying Pre-Conditions What is being done? 1999 IOM Recommendations What can you do? Reporting Error Analysis Recognizing Potential Error Recommendations for Change So what is next? Continuous Quality Improvement Programs National Recommendations Conclusion References An error the breadth of a single hair can lead one a thousand miles astray. Chinese Proverb Introduction For those of us in healthcare, medical errors are nothing new. The possibility of their existence and their consequences were introduced to us early in our professional education and long before our licensure. Their reality became clear to us from the outset of professional practice. We know that errors can and do occur at various levels and with diverse significance and outcomes. The key is prevention. While our genuine desire to avoid errors is consistent, our response to them at the many levels of the healthcare industry is not. Too often nothing really changes. Mistakes are superficially addressed with contributing procedures and systems left unaltered thus leaving the stage set for the next incident. Often, individuals contributing to an error may not even be aware of their role in it. Other times, individuals are unjustly singled out to receive blame for matters beyond their control. A cycle of inaction, or nonproductive action, prevails. In November, 1999, the landmark report of the Institute of Medicine To Err is Human: Building a Safer Health System initiated an unprecedented effort to break this cycle.1 Sobering statistics justified its recommendations and declaration that it is simply unacceptable for patients to be harmed by the same system one expects to heal and comfort. Effects of the report were widespread, evoking reaction from the public, from regulatory and governmental agencies, as well as from all segments of the healthcare industry. In the period following initiatives to reduce errors continue; some high-risk activities have been identified; processes have been researched and modified; monitoring and reporting is evolving; automation and technologic advances have been increasingly incorporated into distribution and decision making. Certainly awareness of errors by the many stakeholders in healthcare has been heightened. While some improvements have been made the process continues. Activities on the front lines of healthcare delivery frequently conflict with those discussed, labeled, and acted on by public authorities. It is the goal of this program to help address this conflict. Health professionals should be aware of the magnitude of the problem and of the many-leveled activities needed to resolve it. Awareness of the individual's personal role in the issue, and how they can effectively contribute to its resolution will be discussed. Why is it important? Statistics The occurrence of medical errors and their associated costs are poorly understood by most. The reasons are many. They include an environment of secrecy characterized by absent reporting and documentation, as well as by a diluted perception of the problem. A disaster involving an aircraft that immediately claims many lives has a more emphatic impact on the public and safety officials than does a similar number of deaths attributable to medical errors that occur over a greater geographical area and longer period of time; knowledge of the latter are slow to emerge and difficult to discover. The study of error is not only in the highest degree prophylactic, but it serves as a stimulating introduction to the study of truth. Walter Lippmann (18891974). Clearer definition of the problem surfaced with the 1999 IOM report which estimates that 44,000 to 98,000 people die in hospitals each year as the result of medical errors and that as many as 7,000 of those fatalities are due to medication errors.1 Even using the lower estimate, medical errors are the eighth leading cause of death in this country higher than motor vehicle accidents, breast cancer or AIDS.2 While these numbers are impressive, they are likely to be a significant underestimation of the problem. First, the two studies from which the statistics are extracted are believed to offer conservative figures. They were limited to injuries of a specified level of harm, required a high threshold to determine whether an adverse event was preventable or negligent, and included only those errors documented in patient records.3 Additionally, these statistics represent errors in hospitals only. More recently, Barker and colleagues observed a persistence of the problem in defining 19% of doses administered in healthcare facilities to be in error and 7% rated as potentially harmful.4 While much of the early data on medical errors focused on the hospital setting, a source of more readily available information, it is important to understand that errors can occur in any healthcare setting, including physician offices, outpatient surgical centers, urgent care offices, nursing homes, hospices and community pharmacies. The cost associated with errors is also enormous. They extend from the affected individuals to society as a whole. Not only do they result in higher overall healthcare expenses, but they also cause lost productivity, disability, and increased costs of personal care. Medication errors are costly to patients, their families, their employers and to hospitals, healthcare providers, and insurance companies. The annual costs of medical errors for the nation have been estimated at $37.6 billion with roughly $17 billion attributable to preventable errors. Of these expenditures, about half are for direct healthcare costs. 2 Impact The incidence of medical error has a substantial impact on the health and well-being of Americans. It is linked with estimations of significant cost to individuals, families, organizations and society as a whole. Affected individuals encounter needless pain and countless losses related to functional health status and financial stability. They may endure duplicate testing, repeated procedures, prolonged treatment and extended recovery time. Because of medical error, they may also experience lost productivity, disability, and increased costs of personal care. Unacceptably, thousands will die each year. Countless others, along with their family and friends, will have lost their trust in our healthcare system. The potential for experiencing harm while receiving healthcare threatens every American and as the IOM report noted, Americans should not be harmed by the very people that are trying to care for them. Public perception, reflected by recent polls, is not favorable. Forty-two percent of respondents to a National Patient Safety Foundation poll indicated that they or a friend or relative had been affected by a medical error. Thirty-two percent noted the error had a permanent negative effect on the patient''s health. These respondents rated the healthcare system as a 4.9 on a 1 to 7 scale (1=not safe; 7= very safe).2 In an American Society of Health-System Pharmacists survey, 61% indicated they are very concerned about being given the wrong medicine (61%), receiving multiple medicines that might interact adversely (58%), and experiencing complications from a medical procedure (56%).2 An Agency for Healthcare Research and Quality (AHRQ) report indicates that most people believe that medical errors result from failures of individual providers. Seventy-five percent of respondents to a survey on medical errors felt effective resolution could be achieved by preventing professionals with bad track records from providing care; 69% thought better training of health professionals was necessary. Five years following the IOM report the Kaiser Family Foundation conducted a survey which indicated the concern of the US public has not changed. Of those responding, 48% indicated that they are concerned about the safety of medical care they or their loved ones receive and 55% rated the quality of healthcare in this country as unsatisfactory.5 The Centers for Medicare and Medicaid Services requested that the IOM study the prevalence of medication errors and formulate a national agenda for reducing these errors. A report entitled Preventing Medication Errors was published in 2006. After analyzing medication error frequency and costs, the report outlined a comprehensive approach to decreasing the prevalence of these errors. This included a paradigm shift in the patient-provider relationship, using information technologies to reduce medication errors, and improved labeling and packaging of medications.6 What are the errors? Most of us think of medical error in terms of medication mistakes or mishaps in surgery. Indeed, the 1999 IOM report estimated that medication errors alone led to as many as 7,000 deaths annually. Findings from a 2003 study published in JAMA documented 32,000, mostly surgery-related, deaths costing $9 billion and accounting for 2.4 million extra days in the hospital during 2000.7 However, many types of medical errors exist. They penetrate every process and system and affect every healthcare professional. Medical errors threaten every healthcare consumer and can occur even with the most routine task. Categorizing types of medical error can be accomplished by using several frameworks. Some methods might look at legal definitions while others might consider severity of injuries or types of healthcare services, settings, or providers. Leape categorized medical errors as diagnostic, treatment, preventative and other.8 These categories are still widely used but others could also apply. Diagnostic oriented Mistakes within this category include inaccurate or delayed diagnosis, failure to employ appropriate tests, use of outmoded tests or therapies, and failure to act on the results of monitoring or testing. According to the 1999 IOM report, diagnostic error is the major factor contributing to costly delays in treatment.1 An example would be the failure to diagnose breast cancer. According to the CDC,9 aside from non-melanoma skin cancer, breast cancer is the most common form of cancer in women. Despite this fact, delayed follow-up by practitioners still exists when women complain of a mass.10 The Physician Insurers Association of America (PIAA) did a series of studies on breast cancer claims. It was revealed that the younger women (40-49 years) had the highest rate of misdiagnosis error.11 Factors for the error were attributed to misinterpretation of mammography, inadequate medical record documentation, failures that occurred in office systems, and the all inclusive communication failures. Currently, the Board of Medicine in Florida identifies the 5 most misdiagnosed conditions as: cancer; cardiac, wrong-site surgery, timely diagnosis of surgical complications, and stroke and related cranial conditions.12 Treatment oriented Mistakes within this category include error in the performance of an operation, procedure, or test; error in administering the treatment; error in the dose or method of using a drug; avoidable delay in treatment or in responding to an abnormal test; inappropriate or not indicated care. Surgical errors comprise a high percentage of these errors. A post-operative patient with slow, insidious bleeding at the surgical site that goes untreated as the monitoring is interpreted as insignificant might be considered treatment oriented. An example of a treatment oriented error could also be those associated with acute myocardial infarction (MI). A delay in treatment that originates from admission delays can be labeled as this type of error. A misinterpretation of an ECG (diagnostic related) can lead to failure in treatment as some infarctions may be missed.13 Nationally, up to 40,000 acute MIs are missed each year.14 Performance oriented Error of this type refer to those that occur while performing a wrong procedure or treatment. A primary example of this would be wrong site surgery. System breakdowns occur allowing the patient to be vulnerable to the system that can be busy, confusing, with numerous distractions or levels of possible failure. Medication oriented These are errors that arise specifically from prescribing, dispensing, administering, or monitoring patient medications. A patient that is prescribed a drug that is specifically contraindicated due to a pre-existing condition or allergy can be considered a medication oriented error. Preventative Errors within this category include failure to provide preventative treatment, or inadequate monitoring or follow-up of treatment. These are the kinds of errors that occur when information gets lost in the system or someone falls through the cracks. These types of error tend to occur whenever there is a high volume workload. In the fast paced emergency department, the patient that is discharged for follow-up with a general practitioner could fall under this type of error if they are not provided appropriate access for that evaluative care. Other Errors within this category include failures in communications, equipment function, and other types of system failure. Even when these failures do not directly cause medical error, they are often linked to the circumstances surrounding error. Healthcare professionals will acknowledge the above categories, but may have difficulty applying these concepts to their own practice setting. Unique circumstances and workplace scenarios contributing to error are embedded into each professional discipline's activities. Many will recognize some of these common examples. Physicians, physician assistants and nurse practitioners report that the potential for diagnostic or treatment error is present during virtually every patient encounter. Patients can be poor historians, records may be incomplete, and relevant information may be missed, omitted, misinterpreted, or discounted. Cost and time constraints also contribute to preventable error, and any combination of factors can set the stage for adopting a most likely diagnosis, prescribing the usually works treatment plan, or a failing to pursue routine screening guidelines. Clinical laboratory professionals explain that the potential for diagnostic error is always present while collecting, labeling and processing specimens. Equipment failure and miscommunications are also common contributors to error. Clinical laboratory professionals typically work in fast paced, high volume environments that will quickly fail if patient and specimen identification is inaccurate or incomplete. Nurses indicate that the potential for diagnostic and treatment error most frequently involves one of two scenarios: 1) inadequate or inaccurate assessments, and 2) problematic medication administration. Because nurses monitor their patients' responses to illness and treatment, ongoing assessments with timely communication of findings become critical to patient safety. Nurses also devote much of their time to medication administration and multiple medications set the stage for potential error. Psychologists, Clinical social workers, mental health therapists, and marriage and family therapists reveal that their potential for treatment error essentially revolves around the limited resources for behavioral health and the unpredictability of clients in crisis. Most community healthcare systems are simply unable to accommodate everyone's mental health needs and so the required prioritization of available resources inevitably leads to error when violent, homicidal or suicidal tendencies are missed. Physical therapists suggest that their potential for error is primarily related to unrecognized medical instability. Recommended or standard treatments may be contraindicated for those with unresolved cardiopulmonary problems, but a therapist relies on documentation to recognize these circumstances. Failed communications become primary contributors to error. The majority of events involving fainting, falling out, respiratory distress or cardiac arrest develop when underlying medical problems are unknown, unresolved, or not adequately appreciated. Pharmacists indicate that medications errors are their constant concern. Some health professionals view medication errors simply as an infraction of one of the five rights: right patient, right drug, right dose, right route, and right time. This, however, is an over simplification. The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)15 defines a medication error as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.15 It is important to note that this definition encompasses near misses, a feature that can help identify processes and events before they affect an actual patient. A near miss is defined as: an event that could have resulted in an accident, injury or illness, but did not either by chance or through timely intervention. Why do they occur? Human Error Have you ever made a mistake? It happens, despite attempts to carefully double-check or review what has been done. Collectively, healthcare professionals all share a genuine desire to avoid error. Yet physicians, nurses, pharmacists, and all other health professionals, being human, make mistakes. These mistakes occur despite how much we care, how hard we work, and how much we know. Consequently, systems that rely on error-free performance by humans are likely to fail. Reasons why people make errors have been studied for many years. While there is no single answer, it is generally recognized that no one intentionally makes a mistake. Cognitive psychologists have explored the way people think. Human-factor specialists have analyzed the interrelationships between humans, the tools they use, and the environment in which they live and work.16 Improved system and process designs have been implemented based on their findings. Human mental function occurs in two basic modes, automatic and problem-solving. Each mode has unique errors associated with it.17 Automatic mode, as its label implies functions quickly and requires little conscious effort. This mode draws on one's accumulated learning of situation recognition and response. Errors while in automatic mode are called slips and are typically due to distraction and breaks in attention at critical moments. Problem-solving mode requires greater concentration because information must be gathered, processed through comparison to stored knowledge, and then applied to some decision rule. Consequently, problem-solving processes are slower, sequential, demanding, and difficult to sustain. Errors in this mode are referred to as mistakes. They result from selecting the wrong rule or misapplying the correct rule. Various factors influence mistakes and affect our ability to solve problems. These factors include insufficient knowledge, pattern matching, biased memory, the availability heuristic, confirmation bias, and overconfidence. Lack of sufficient knowledge leaves us with no programmed solution, particularly in an unfamiliar situation. Pattern matching involves discovering patterns in situations so that previously thought out responses can be applied. Biased memory results from over generalizing and assuming that patterns have universal applicability, e.g. not verifying a potential allergy problem with the physician by assuming Dr. Always wants this patient with a history of severe penicillin allergy to get cefazolin pre-operatively because he always says to do so when he is asked about allergies. The availability heuristic is the tendency to use the first information that comes to mind, e.g. grabbing the amber vial to administer a diuretic without realizing you had grabbed a similar appearing multiple dose vial of epinephrine. Confirmation bias involves selection of data that supports the initial thinking and discards that which contradicts or fails to support it. Overconfidence is the tendency to favor the chosen action and evidence that supports it. Factors that decrease attention or create distraction can cause errors in both automatic and problem-solving activities.17 These factors may be physiological, psychological, or environmental. Fatigue, illness, loss of sleep, alcohol, and drugs are examples of physiological factors. Psychological factors include various emotional states and distraction from other activities. These can be triggered by external factors such as overwork, interpersonal relations, or other forms of stress. Environmental factors such as temperature, noise level, lighting, and visual activity can cause distraction. Many of these are accepted as a normal part of existing or just how things are without linking them as factors that might cause an error. The cause of error can have many dimensions, can be quite complex, and can result from the convergence of many contributing factors. As with other complex industries, safe healthcare has many requirements such as: good managerial decisions, reliable, functional, and well-maintained equipment; a skilled and knowledgeable workforce; reasonable work schedules and well-designed jobs; and clear guidance on desired and undesired performance. These requirements have been labeled preconditions and their absence or insufficiency can be viewed as latent failures embedded in a system, which through interaction of the system and the production process, can contribute to many unsafe acts.18 Invisibility of Error Have you ever been advised to forget an error or keep error-related information quiet? Medical errors are often surrounded by secrecy and shame allowing others to remain unaware of their existence. Embarrassment, fear of retribution, and the potential of career-ending litigation keep many from revealing their mistakes. When errors are silenced and covered they also remain undocumented and unreported, and this keeps them invisible. A perceived lack of time also keeps many from reporting error. Comprehensive reporting requires added time that is simply not available and doing so may result in a missed lunch break, added time at the end of a busy shift, or an unwelcome shifting of priorities. This relative invisibility of error is dangerous because it prevents us from recognizing what went wrong and it keeps us from working towards resolution or improving conditions to prevent recurrence. Invisible errors also have a high probability of being repeated, and are likely to trigger a cascade of additional mistakes and inaccuracies that only compound the original error. The invisibility of error also leads to a generalized under-appreciation of its incidence and encourages a diluted perception of the medical error problem. No one wants to talk openly about iatrogenic mistakes; therefore, errors outside the scope of personal involvement are rarely noted. Limited access to the aggregate data on medical error is unnecessarily protective and blunts our comprehension of the bigger picture. This silent accumulation of error keeps us from fully appreciating its larger impact and even larger solution. Consider the unrelated example of a disaster involving an aircraft that immediately claims the lives of 200 persons. This one disaster is so visible it will elicit a more emphatic impact than the nearly invisible 200 deaths attributable to medical error. Because our knowledge of isolated errors and near misses accumulates over time and occurs over a large geographical area, we tend to respond more passively than we do when there is a single publicized disaster. System Error Whenever error does occur, have you ever been asked to isolate a human cause and then assign blame? This kind of response is common, yet extensive analyses reveal that most errors occur as a result of a chain of events set in motion by faulty system design that either induces errors or makes them difficult to detect.19 In other words, mistakes usually happen with system contribution - not just because of people! Focusing on the unfortunate individual closest to the mistake does not address the system flaws or the complex organizational processes that allowed the error in the first place. In fact, neglecting system-wide influences sets the stage for repetition. Charles Perrow, in his analysis of the Three Mile Island nuclear accident, elaborated on how systems can cause or prevent accidents.20 He characterized organizations and systems according to their complexity and whether they are coupled loosely or tightly. Complex systems have multiple components that interact in a variety of unexpected and invisible ways, setting the stage for mistakes and accidents. Our current healthcare system qualifies as a complex system. The combination of system variability, professional specialization, continually evolving technology, and layered governmental regulation produces a complexity that is often difficult to navigate. Coupling refers to the slack or buffer between steps in a process. Tightly coupled systems have more time-dependent processes and sequences; they accommodate less flexibility in how things can be accomplished. Tight coupling characterizes most of the quick paced events in healthcare. Recognizing that our healthcare systems are both complex and tightly coupled suggests that we should focus attention on organizational infrastructure and system re-design when addressing medical error. How do we respond? After categorizing and analyzing the multiple dimensions of medical error, it has become apparent that no single solution can be universally effective. Still, a unified approach to evaluation and response can guide appropriate action. How should we begin? Should we focus on the individual? Traditional responses focusing on individual error have relied upon naming, blaming and shaming18 and then added education or training to correct poor performance. However, current evidence suggests that focusing on the individual limits the effectiveness of our response and is neither appropriate nor cost-effective. Individuals contributing to error may or may not even be aware of their participating role and some will be unjustly blamed for matters that were clearly beyond their control. Mandatory education and re-training is costly and is only partially effective within environments characterized by high employee turnover and evolving organizational changes. Should we focus on technology? Traditional responses to equipment malfunction, performance limitations and technical glitches have relied upon procedural revisions, product manual updates and continuous employee re-training. How effective are these responses when both the technology and the organizational needs keep changing? Traditional responses to human error often involve elaborate technological re-designs that can still be circumvented by frustrated employees. Current recommendations call for improved technology but with built in redundancies and added safety features to override human-generated errors.21 Should we focus on the organizational infrastructure? Traditional responses to problematic organizational and management systems have relied upon policy and procedural revisions, or targeted personnel replacement. How effective are these reactionary band-aids when new situations continually arise? Restrictive guidelines can never address every potential problem and broad-based policies allow for wide variations in interpretation. Instead, the Quality Interagency Coordination Task Force (QuIC) suggests system-wide solutions such as allocating adequate resources to error prevention and nurturing solutions that foster professional responsibility and accountability.22 Ultimately, we must shift our attention from the individual to the system. Once we appreciate that error reduction and performance improvement requires proactive system-wide changes rather than reactive person-oriented strategies, we can begin to embrace what is now called a culture of safety. We must begin to appreciate the importance of developing a non-punitive workplace culture and promote a healthcare system with built in checks, safeguards and redundancies to protect against inevitable human failure. Initial steps in this process include differentiating error types and identifying those pre-conditions that are most likely to contribute towards error. Identifying Active vs. Latent Error Differentiating between active and latent errors helps guide a more effective response to error. Active errors are easily identified and occur at the level of the frontline worker. These errors are most often attributed to human error and their effects are felt almost immediately. Common active errors include administering the wrong medication or documenting on the wrong medical record. Latent errors tend to be removed from the direct control of the worker. These errors are less obvious, occur behind the scenes, and often remain undetected unless someone is actively investigating all the factors contributing to an active error. Typical latent errors are attributed to faulty systems and include things such as poor design, incorrect installation, faulty maintenance, bad management decisions, and poorly structured organizations.23 Latent errors and active errors are inevitably linked, supporting the assumption that no one sets out to intentionally make an error. A less threatening response to any active error involves focusing on the contributory latent errors. The following examples use different groups of healthcare professionals to illuminate some of the connections between active and latent error. Among physicians, physician assistants and nurse practitioners, well publicized examples of active error incidents involve wrong site surgery. Wrong site surgeries are most common among orthopedic procedures and associated risk factors include multiple surgeons involved in the case, multiple procedures performed during a single operating room visit, and unusual time pressures. Wrong site surgery represents the kind of mistake that provokes outrage, assigns blame to the operating surgeon, and results in costly litigation. Yet several latent errors contribute to the end result. For example, all operating room staff as well as the patient themselves, have a role in verifying the correct surgical site. The patient's initial interview and verification in pre-op, surgical prep and draping of the wrong extremity, repeated failure to correctly verify the affected extremity, and inaccurate or inadequate preoperative documentation are all system errors that contribute to wrong site surgery. Among clinical laboratory professionals, an active error might involve the conscious decision to override scheduled, routine calibration checks. Routine calibration checks are required to assure test result accuracy, yet busy clinical laboratory workers may repeatedly prioritize the high volume of specimens over the performance of scheduled calibration checks on equipment. The latent errors in this example might include the timing of scheduled calibration checks, a lack of duplicate/back-up instruments, or instrument programming that allow over-ride functions. A nursing example of an active error is the erroneously free-flowing IV caused by incorrect loading of tubing into an infusion pump. When the free flow of fluid overloads the system or delivers toxic amounts of medication, the outcome can be particularly dangerous to the patient. The latent errors in this example might include the pump design that allowed the improper loading of the tubing, or the absence of technology that could prevent free-flow from occurring. Among psychologists, clinical social workers, mental health therapists and marriage and family therapists, a common example of an active error is the failure to adequately communicate a worsening symptom that could compromise safety. Counselors and therapists rely on communication alerts when suicidal and/or homicidal ideation is expressed, and discounting these indicators can endanger the lives of others. The latent errors in this example could include delays in transcription or an inadequate relay of messages. A physical therapist example of an active error is the inappropriate choice of minimal documentation to describe a client's response to therapy. Detailed communication of any untoward client response is absolutely vital to successful rehabilitation; failure to adequately document client response sets the stage for potential harm during subsequent therapeutic sessions. The latent errors in this example might include time constraints because of a busy schedule, or documentation forms that discourage added therapy comments. Among pharmacists, an example of an active error is the inaccurate filling of a medication order by dispensing a wrong medication or an incorrect dose. Pharmacists report that they carefully check filled prescriptions to avoid these types of error and yet they still occur. The latent errors contributing to this example might include drugs that look or sound alike, or a written prescription that is difficult to decipher. Identifying Pre-Conditions Another effective response to error involves identifying those factors or influences that set the stage for error. These pre-conditions could be the root causes of error or they might serve as stimuli that foster or encourage error. Once these pre-conditions are recognized and their links to error identified, specific remedies can be implemented. In a study examining preventable adverse events in a primary care outpatient setting, pre-conditions to error came from four distinct sources. Each source category was then labeled and described.24 Clinician factors, those pre-conditions directly attributable to the healthcare professional, include individual errors in judgment, procedural skills errors, failure to recognize signs/symptoms, forgetfulness, and execution related errors (stupid mistakes). Unfortunately, healthcare professionals in any setting will recognize these person-oriented contributions to medical error. Anticipated responses most appropriately focus on the individual, but every analysis should also look for system-wide problems that encourage human failures or fail to detect/prevent human error. Communication factors contributing to error include failure to understand, cultural and language difficulties, conflicting information, and delayed exchange of information. Since accurate and timely communication is essential within any healthcare organization, it is easy to understand how these pre-conditions influence and encourage medical error. When communication-oriented errors are identified, a diverse team representing all levels of personnel may be needed to adequately develop an improved communication process. Administrative factors contributing to error include a large number of system-wide problems that may or may not have already been known. Rushed personnel, missing charts and broken or unavailable equipment were most often identified in the study focusing on a family practice clinic. In other practice settings, administrative contributions to error might include scarce supplies, unresponsive management or unscheduled computer downtime. Think about how often a worker identifies a situation as a mistake waiting to happen, and then consider how and when the situation was remedied. Appropriate responses to these identified contributions will typically involve both short term and long term action plans in an attempt to limit their influence on error. Blunt end factors contributing to error include those influences that are outside the affected system's span of control. Examples might include physical size and location of the healthcare setting, or corporate level decisions affecting an individual facility or organization. An unusual example might include the occurrence of any community-wide disaster that limits access to usual resources, such as hurricane or flood. For many healthcare systems, it is the complexity of multi-layered interactions with outside insurance and government agencies that contribute to error. When identified contributions to error are external to the affected healthcare system, necessary internal adaptations are advised. What is being done? Actions to define and correct medication errors existed prior to the IOM report. In 1995, the United States Pharmacopoeia (USP) advocated the formation of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), an independent body comprised of 25 national and international organizations, to address medication error reporting and prevention.25 The 1998 report of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry identified medical errors as one of the four major challenges facing the nation to improve healthcare quality. As recommended by this report, the Quality Interagency Coordination Task Force (QuIC) was established to coordinate quality activities in federal healthcare programs, the largest purchaser and provider of healthcare services in the country. The QuIC includes the Departments of Health and Human Services, Labor, Veterans Affairs, Commerce, and Defense; the Coast Guard; the Bureau of Prisons; the Office of Management and Budget; the Federal Trade Commission; and the Office of Personnel Management. The QuIC is charged with coordinating the overall federal response to the IOM's report on medical errors. Federal government activities extended to the private sector with President Clinton's December 1999 memorandum requiring the more than 300 private health plans participating in the Federal Employee Health Benefits program to institute patient safety initiatives. Additionally, federal agencies administering health plans were to evaluate and, where feasible, implement the latest error reduction techniques.26 Health providers are experiencing greater scrutiny and demand for safety improvement by the many oversight organizations, group purchasers, and professional groups. This responds to one of the recommendations by the IOM in its To Err Is Human report as a means to increase external pressure on providers to improve patient safety.1 Government officials at the state level are also interested. Twenty states require some form of medical error reporting. As an example, Florida requires reporting of mistakes that lead to serious patient injuries, such as life-threatening situations and epidemic outbreaks. Another class of reports involves serious adverse events, such as wrongful deaths, brain injuries, wrong limb removals, and incorrect surgeries.27 Additionally, the 2000 Florida Legislature created the Commission on Excellence in Health Care to facilitate the development of a comprehensive statewide strategy for improving healthcare delivery systems through meaningful reporting standards, data collection and review, and quality measurement. As a further demonstration of their intent to advance this process, legislation (456.013) was passed in 2001 requiring 2 hours of continuing education study on medical errors by all healthcare professionals to qualify for initial Florida licensure and biennial renewal. Other states have subsequently followed with similar requirements. Clearly there is no single or best way to improve patient safety. It is a complex problem that in many ways remains ill defined and, for a variety of reasons, resistant to change. The existence of these qualities was apparent in the IOM's 1999 report and tended to drive its recommendations. The standards set by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and recommendations from the IOM have served as the most influential guidelines directing change for improved patient safety in healthcare today. Issues and actions identified by them have set the direction for related activities by regulatory, professional, and organizational groups. It is especially important that front line healthcare participants know and understand these activities because it is at their level where the ultimate goal of improved patient safety is realized. 1999 IOM Recommendations The 1999 IOM recommendations for initiating the move to improve patient safety addressed the following four general areas: create a national center to oversee and direct medical safety efforts mandatory and voluntary error reporting safety performance standards for healthcare professionals safe practices at the delivery level Currently, the Center for Quality Improvement and Patient Safety (CQuIPS) is the primary group within the AHRQ serving as a sustainable national driving force for patient safety. The Center is charged with conducting and supporting research on patient safety and healthcare quality issues, developing and disseminating reports and information, and collaborating with stakeholders to implement evidence-based practices.28The call, initiated by the 1999 IOM recommendations and continued today, was for current knowledge on how to prevent errors to be identified and acted upon, and efforts to improve our understanding and develop other solutions to be intensified. The expectation of increased reporting is to identify errors and learn from them. This sounds simple, but in reality it is a complex and highly emotional subject that continues to be the focus of significant discussion. Because of reporting deficiencies we probably don't have an accurate grasp of the magnitude of the problem of patient safety. Nevertheless, for some errors we do know about we have failed to consistently bring about an effective resolution because of the way we evaluate and react to them. Through its recommendations the committee attempted to create an environment that encourages error identification, evaluation of their causes, and, finally, action to prevent future occurrences. To accomplish this task a national standardized method of reporting certain errors is to be mandated, and related information (type of errors, analysis, and resolution) is to be shared with the states. The IOM has provided a report describing a detailed plan to facilitate the development of data standards applicable to the collection, coding, and classification of patient safety information.29 It has also recommended legislation to protect peer review data related to patient safety and quality improvement. With less serious situations it advocates control of legal discoverability to make the environment more conducive for organizations to identify, analyze, and report errors. Early IOM recommendations included establishing performance standards and safety expectations for healthcare organizations and professionals. Many groups, including regulators, accreditors, public and private purchasers, and professional societies were solicited to encourage this. Perhaps the most obvious response to this recommendation for many of us, are activities within our specific organizations to comply with safety related JCAHO standards. In an attempt to extend the emphasis on safety to the delivery level, IOM recommendations called for implementation of specific programs in healthcare organizations and specified clearly defined executive responsibility. To health professionals, particularly those affiliated with hospitals, this recommendation is the most apparent because it spells out comprehensive safety related activities for organizations and the professionals affiliated with them. Its requirements include patient safety programs, non-punitive systems for reporting and analyzing errors, incorporation of well-understood safety principles, and the establishment of interdisciplinary team training programs for providers utilizing proven methods. Additionally, it states that healthcare organizations should implement proven medication safety practices. The Joint Commission has adopted standards that mirror these requirements. These, coupled with the Commission's Sentinel Event Policy, have stimulated patient safety activity within healthcare organizations so as not to jeopardize their accreditation. In 2003, the IOM was mandated by Congress to carry out a comprehensive study of drug safety and quality issues in order to provide a blueprint for system-wide change. Project meetings were conducted in 2005 and 2006, all culminating in the publication titled Preventing Medical Errors: Quality Chasm Series.30 The publication identified six (6) aims for improvement in healthcare. They are: Safety: avoiding injuries to patients from care designed to help them, Efficacy: providing evidence-based services to all who could benefit, and refraining from providing services to those unlikely to benefit (avoiding underuse and overuse). Patient centered: providing care that is respectful of and responsive to individual patient preferences, needs and values and ensuring that patient values guide clinical decisions. Timely: reducing waits and sometimes harmful delays for both those who receive and give care Efficiency: avoiding waste, such as waste of equipment, supplies, ideas and energy Equitable: providing uniform care regardless of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status What can you do? There is no single or best way to prevent medical error and improve patient safety, but it clearly becomes each healthcare professional's responsibility to actively work towards error reduction and error prevention. Major emphasis at the individual level relies on 1) willing participation in comprehensive and timely reporting of error, 2) collaborative analysis of individual and system practices designed to reduce error, 3) routine recognition of error prone situations and 4) voluntary adoption of recommended practice changes designed to minimize error. When each healthcare professional fully participates in these activities, the ultimate goal of improved patient safety can be realized. Reporting Each healthcare professional can substantially contribute to error reduction by consistently identifying and reporting actual errors, near misses, and flawed systems that can contribute to error. Reports can be submitted within an organization (internal) or to an outside agency (external) using either mandatory or voluntary reporting strategies. Mandatory reporting typically focuses on serious faults in performance, promotes provider accountability, and addresses public issues of safety and the public's right to know by disclosing serious inadequacies. Voluntary reporting is generally done in response to errors that result in minor or no injury, and the information generated is used to alter processes and systems to improve safety. Voluntary reporting is one of the largest safety related functions that delivery-level health professionals will encounter. It is the initial step in learning from past mistakes, and is vital to identifying system designs that can contribute to error. As previously mentioned, system problems that contribute to error are particularly harmful because they are difficult to recognize, and because they can combine with a multitude of events to cause more errors. As a delivery-level health professional, ask yourself the following questions: Do you feel your organization's error rate (medication variance, etc.) is accurate? When you discover an error, do you document all, some, or only those errors a supervisor tells you to report? When you identify and report an error do you feel it will result in: a) an improvement to a system or process that will make the error less likely to be repeated, or b) someone getting into trouble? Usual answers to these questions quickly identify the common barriers to reporting. We tend to name, blame and shame, and are often irregular about preparing reports. Authorities are aware of these obstacles. They acknowledge that our current culture of blame needs to be replaced by a culture of safety; they recognize that reporting needs to be non-punitive; they agree that documentation needs to be more streamlined. Working towards these goals will take time, yet many caution that more exhaustive reporting at the delivery-level will be required until there is a complete understanding of error. Error Analysis Practicing healthcare professionals need to actively participate in error analysis because one of the most effective ways to learn from past mistakes is to analyze all its contributing factors. Contributing factors may arise from faulty communication, other factors may come from the person, the system, or influences outside the system. The importance of analyzing all the contributing factors is underscored by the JCAHO's mandate for organizations to complete a thorough and credible root cause analysis (RCA) whenever a sentinel event occurs and whenever a critical effect is identified. Critical effects are defined as possible serious effects on the patient from failure or undesirable variation in a process. Critical effects are usually identified when conducting the Failure Mode and Effects Analysis (FMEA) process.31,32 Root Cause Analysis: Healthcare professionals routinely conduct intensive analyses of physical disease by exploring the condition at a cellular and/or chemical level to understand the root cause of the condition. Similarly, the RCA process allows us to explore and understand the reasons contributing to medical error. Through this cellular level scrutiny, system and practice modifications are made so that reoccurrence can be prevented. It is based on the premise and philosophy of the National Patient Safety Foundation that most errors result from faulty systems rather than human error and that people are in essence set up by them to make errors for which they are not fully responsible. Using RCA, events are dissected to discover: (1) the main reason an accident occurs (its proximate cause); (2) systematic problems that might lead to other mistakes (common causes); (3) contributors that could not have been foreseen or prevented (special causes); and (4) areas where the accident could have been avoided had things been done differently (risk points). Most Common Root Causes of Medical Error: The Agency for Healthcare Quality and Research recently categorized findings from multiple root cause analysis findings.33 They identified a diverse group of factors that cause medical error, and then developed the following categories: communication problems, inadequate flow of information, human problems, patient-related issues, organizational transfer of knowledge, staffing patterns or work flow, technical failures, and inadequate policies and procedures. Communication problems, the most common cause of medical errors, results in many different types of errors and involve all members of a healthcare team. These failures include both verbal and written communication amongst the many users of health related information and involve all types of medical information including physician orders, prescriptions, and laboratory results. These may exist between individuals in different agencies, facilities, departments or disciplines and can involve illegible, unintelligible, misspoken, misunderstood, lost, incomplete, or other failed communication. Inadequate information flow problems are those that prevent critical information from being available when prescribing decisions are made; delay or diminish reliability of critical test results; or fail to coordinate medication orders at points of interface or transfer of care. Human problems relate to how standards of care, policies, or procedures are followed. Examples include failure in following policies, guidelines, protocols, and processes. Such failures also include sub-optimal documentation and inadequate labeling of specimens. These human problems may be a related to lack of knowledge, but they are more often related to distraction and just not thinking. Patient-related issues can include improper patient identification, incomplete patient assessment, failure to obtain consent, and inadequate patient education. While patient related issues are listed as a separate cause by some reporting systems, they are often nested within other human and organizational failures of the system. Organizational transfer of knowledge can include deficiencies in orientation, education, or training for those providing care. This is of particular concern in areas where new employees or temporary help is often used and in academic medical centers where physicians in training often rotate through numerous centers of care. Staffing patterns/work flow can cause errors when work conditions become stressful due to insufficient staffing, high patient acuity, excessive volume, or when supervision is inadequate. Technical failures include device/equipment failure and complications or failures of implants or grafts. These events can cause great harm to patients. Instructions may be difficult to understand or even missing; device design may be poor. Frequently the fault of the device or equipment is not obvious, with blame focused on the operator, until a more thorough evaluation, such as RCA, is undertaken. Inadequate policies and procedures guiding the delivery of care can contribute to many medical errors when they are poorly designed, inadequate or adhered to variably. RCA has been used successfully for over twenty years in other settings, such as the nuclear and aviation industries. Justification to this labor-intensive process is improved outcomes and the avoidance of costly (and deadly) mistakes. Difficulties encountered when applying RCA to healthcare include inadequate staff, insufficient time, fear of retribution, and stopping the analysis too soon.31 Both people and time are scarce in contemporary healthcare settings, and everyone shares a wariness of discussing and documenting mistakes because they fear possible legal action. The JCAHO sentinel event policy has been described as a lawsuit kit for attorneys.34 JCAHO offers advice on how to minimize discoverability of these activities but admits that none are foolproof. Legislative protection has been suggested and recommended by the IOM but is currently not a reality. One method for avoiding or diminishing the fear of retribution is a thorough evaluation of near misses, errors that have the potential to cause patient harm, or errors that have occurred outside of one's organization. Failure Mode and Effects Analysis (FMEA): This bottom-up analysis is used in an organization's ongoing, proactive program to identify risks to patients' safety and reduce error. It is different from the RCA process because instead of focusing on what went wrong, the FMEA process focuses on what could go wrong.32 The FMEA process is outlined as follows: A team examines a process in detail, identifying all the functions that are supposed to occur. The team then identifies the ways in which those functions might go awry, i.e., the failure modes. Next, the consequences (effects) of each failure mode are identified Then the underlying causes (contributory factors) are elucidated. Sometimes an RCA is required for this. Each effect is rated in terms of its severity, and, Each contributory factor and/or failure mode is rated in terms of its frequency or likelihood of occurrence. Any existing controls (detection systems, mitigation systems, etc.) are then identified, and their impact is assessed, again via ratings. The three foregoing ratings yield criticality and/or other values from which the team decides which contributory for failure modes are the most critical for improvement efforts. Typically the team utilizes Pareto methodology to identify the classic 20% of issues that cause 80% of the process variability. This 20% can be considered to represent significant risk issues, e.g., the issues most important to address via improvement actions. It identifies courses of actions and establishes how those actions will be assessed for impact upon the process under analysis. FMEA is meant to be proactive so that processes, system designs, and performance can be analyzed using a sequential review process before error occurs. For example, FMEA can be used to analyze the error potential of a new drug being considered for formulary addition in the pharmacy. Does the drug under consideration have ambiguous or difficult to read labeling? Is the packaging potentially error-prone? Do product names have sound-alike or look-alike problems? Could there be any dosing confusion? Is there any special patient monitoring needs? How will the drug appear on a computer screen while performing varied processing functions? Recognizing Potential Error Individual healthcare professionals are advised to recognize error prone populations and error prone situations. Continuously evaluating risk and probability of error heightens awareness and reduces overall occurrence of medical error. 1.Vulnerable populations: When asked, most healthcare professionals immediately identify the very old and the very young as being particularly vulnerable to error. Individuals at these extreme ends of the age continuum are not as physically stable, their bodies are more significantly impacted by concomitant medical conditions, they metabolize their medications differently than the general adult population and they often use alternative forms of communication to alert clinicians about impending problems. Additionally, each profession has defined unique sub-populations that are particularly prone to error. Clinical laboratory professionals focus much of their attention on obtaining adequate specimens for subsequent analysis. They indicate that their most problematic patients are subject to collection errors. These patients include the very obese, the very frail, those who are immune-compromised, and anyone who is in an emergently unstable life-threatened situation. Retail pharmacists have identified tourists (those having no available drug profile) and patients with multiple (and sometimes conflicting) drug files as those who are more likely to be involved with a pharmaceutical error. Pharmacists also report a higher potential of error when working with anyone who cannot adequately communicate because of illiteracy or language barrier (cannot communicate in English) because it becomes difficult to verify and clarify relevant information. Psychologists, Clinical social workers, mental health therapists and marriage and family therapists explain that their suicidal, homicidal and psychotic patients are most unpredictable and thus lead their list of those most vulnerable to errors in assessment and/or treatment. Aggressive or violent individuals pose the greatest threat to overall safety, but errors are also common when individuals conceal relevant information or offer conflicting information. Examples include persons with HIV disease, the chronically mentally ill, gay/lesbian persons, the uninsured and the homeless. Physical therapists are most concerned about error when working with depressed persons and those with impaired judgment (left sided CVA affecting frontal lobe). These individuals do not always respond appropriately during a therapeutic session, and so a therapist cannot rely on the patient to verify information or correct therapist assumptions. PT professionals also realize that clients receiving oxygen during therapy or those utilizing medicated topical ointments are at a higher risk for the development of untoward reactions. Nurses consistently indicate that their highest safety risk populations include those who are combative and/or confused, those who are critically ill (and thus subject to hundreds of medical interventions each day), and those who have no desire to survive (patient lacks incentive to participate in care). 2. Error-prone practice settings. Healthcare professionals also identify special situations and circumstances that are more likely to contribute to error. Human factors such as stress or fatigue can interfere with cognition. System inadequacies such as insufficient staffing, computer downtime or other technology failure can inject variability into routine processes or diminish anticipated capabilities. These and similar situations should clearly signal potential for mistakes and alert practitioners to take special measures. These might include seeking a second opinion from a co-worker, avoiding fatigue by delegating tasks, prioritizing activities, or utilizing additional reference materials. Of interest, healthcare professionals working in different practice settings all identify additional, unique practice situations that pose the highest risk for error. Physicians comment that their highest potential for error arises whenever they are asked to emergently consult an unstable patient, primarily because everyone is expecting the impossible: a quick response offering definitive treatment that will immediately resolve a complex medical situation. Clinical laboratory professionals report that the majority of their errors involve situations with improper or inadequate patient identification. Nurses report that most of their high risk situations are related to inadequate staffing and emergent patient circumstances, but they consistently identify medication administration errors as a primary situational risk, particularly among those with multiple medications. Psychologists, Clinical social workers, mental health therapists and marriage and family therapists explain that their potential for error is highest when they are asked to strategize a minimal solution that has few or any backup contingencies. Regarding personal safety, they are most concerned when practicing alone during evening or off hours because they are dealing with unstable patients and/or unstable family members. Physical therapists report that the highest risk situations involve patients with underlying conditions that are undetected, and patients receiving pharmacologic products that can precipitate untoward responses (hypotension, vertigo, nausea, impaired judgment). Pharmacists indicate that some of their riskiest situations occur when there are computer failures, because they rely so heavily on computerized patient profiling and the automated identification of potential drug interactions. They also identified multiple distractions and illegible prescriptions as major contributors to error. Recommendations for Change Individual healthcare professionals are asked to embrace the recommended practice changes that are designed to minimize error and enhance patient safety. America's nationally based safety initiatives are evidence driven, using both voluntary and mandatory reporting data that were collected by centralized agencies like JCAHO, the National Patient Safety Foundation (NPSF), USP and AHRQ. Recommendations may not always seem necessary to every healthcare professional, but these reflect a genuine desire to change practices that have been repeatedly implicated in medical error. Primary opportunities for patient safety are identified within the broad categories of medication administration, patient practice, technology applications, and education (both professional and consumer). 1.Medication-related safety: Safety initiatives pertaining to medication errors are widespread because 1) medications are extensively utilized in healthcare and 2) the complexity of several interacting professions and systems offer substantial opportunities for error. Numerous contributors to medication-related error have been identified. Distractions and workload increases are consistently mentioned whenever individual error is identified, but many system-wide factors are also named. These include prescriptions and drug orders with poor handwriting, medications involving similar drug names, use of abbreviations, patient and/or healthcare professional misinterpretation of labeling, dosage miscalculations, lack of knowledge or skill, and incorrect administration practices.35 The Institute of Safe Medication Practices (ISMP) and JCAHO both warn against using dangerous dose designations, stemmed names, apothecary or mathematical symbols, and other abbreviations because of the high potential for error. ISMP published a listing of error-prone abbreviations, symbols, and dose designations in their biweekly newsletter Medication Safety ALERT!36 A few of the most problematic abbreviations and expressions are listed in Table 1, along with the suggested more appropriate substitution. The complete listing published by ISMP can be found on the ISMP website at http://www.ismp.org/PDF/ErrorProne.pdf. Healthcare professionals of all disciplines are impacted by these recommendations, most particularly within the disciplines of pharmacy, medicine and nursing. Clinicians working with medications are particularly advised to recognize high alert medications, the small number of medications that have a high risk of injury when misused. Medications are placed on this list not because of the high number of errors, but because of their serious consequences when not properly used. High alert medications include adrenergic agents, chemotherapy agents, neuromuscular blockers, IV heparin and warfarin, lidocaine, concentrated electrolyte injections, opiates and insulin.37 The National Coordinating Council on Medication Error Reporting and Prevention defines a medication error as any preventable event which may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the health-care professional, patient, or consumer. This definition implies that patients and consumers also play a role in promoting medication safety. In 1999, the National Patient Safety Partnership (NPSP), a coalition of healthcare organizations, released a list of the 16 best practices in medication safety that all focused on encouraging patients and family members to participate in error prevention.38 Since then, nationally based agencies have continued to build public awareness and promote education on how each consumer can prevent medication errors. Most of NPSP's 16 best practices in medication safety are currently integrated into standard clinical practice, but they are listed because they illustrate the content driving added policy and procedural recommendations on medication safety. Patients and family members are encouraged to participate in their own safety. Best practice will inform and educate consumers about their role in preventing medication-related error: Tell physicians about all the medications they are taking and their responses/reactions to them. Ask for information in terms they understand before accepting medications. This information includes but is not limited to the following: Is this the drug my doctor (or other prescriber) ordered? What is the trade and generic name of the medication? What is the drug for? What is it supposed to do? How and when am I supposed to take it and for how long? What are the likely side effects? What do I do if they occur? Is this medication safe to take with the other over-the-counter and/or prescription medications or dietary supplements that I am already taking? What food, drink, activities, dietary supplements or other medication should be avoided while taking this medication? Healthcare providers are encouraged to practice more safely. Best practice will design and implement the organizational processes that will promote medication-related safety: Educate patients Put allergies and medications on all patient records Stress dose adjustment among children and older adults Limit access to high hazard drugs Use protocols for high hazard drugs Computerize drug order entry Use pharmacy based IV and drug mixing programs Avoid abbreviations to reduce misinterpretation Standardize drug packaging, labeling and storage Use unit dose drug packaging systems (drugs are packaged and labeled in standard patient doses) Healthcare purchasers are encouraged to provide safer products. Best practice will include the following recommendations: Require machine readable labeling (bar coding) Buy drugs with prominent display on name, strength, warnings Buy unit of use packaging (unit dose) Buy IV solutions with two sided labeling TABLE 1: Select Dangerous Abbreviations and Dose Expressions36 Abbreviation-Dose Expression Intended Meaning Misinterpretation Recommended Correction Apothecary symbols dram minim Misunderstood or misread (symbol for dram misread for 3 and minim misread as mL). Use the metric system. AU aurio uterque (each ear) Mistaken for OU (oculo uterque-each eye). Don't use this abbreviation. D/C discharge discontinue Premature discontinuation of medications when D/C (intended to mean discharge) has been misinterpreted as discontinued when followed by a list of drugs. Write out the words discharge and discontinue. MSO4 morphine sulfate magnesium sulfate Write out the word morphine o.d. or OD once daily Misinterpreted as right eye (OD-oculus dexter) and administration of oral medications in the eye. Use daily. TIW or tiw three times a week. Mistaken as three times a day. Don't use this abbreviation. qhs nightly at bedtime Misread as every hour. Use nightly. SC subcutaneous Mistaken for SL (sublingual). Use subcut. or write subcutaneous. U or u unit Read as a zero (0) or a four (4), causing a 10‑fold overdose or greater (4U seen as 40 or 4u seen as 44). Unit has no acceptable abbreviation. Use unit. ss sliding scale (insulin) or ½ (apothecary) Mistaken for 55. Spell out sliding scale. Use one-half or use ½. Zero after decimal point (1.0) 1 mg Misread as 10 mg if the decimal point is not seen. Do not use terminal zeros for doses expressed in whole numbers. No zero before decimal dose (.5 mg) 0.5 mg Misread as 5 mg. Always use zero before a decimal when the dose is less than a whole unit. 2.Patient practice related safety. In 2001, AHRQ and the University of California at San Francisco-Stanford University Evidence-based Practice Center (EPC) evaluated and rated clinical safety practices based on evidence in the literature.39 Opportunities for improved patient safety were identified and healthcare professionals who accept these recommendations will actively contribute to patient safety and reduced medical error. Appropriate prophylaxis for venous thromboembolism in at-risk patients. Appropriate use of ß-blockers to prevent perioperative morbidity and mortality. Maximum sterile barrier use during central intravenous catheter placement to prevent infections. Appropriate antibiotic prophylaxis to prevent perioperative infections. Having patients recall and restate information given them during the informed consent process. Continuous aspiration of subglottic secretions to prevent ventilator-associated pneumonia. Pressure ulcer prevention with bedding material that relieves pressure. Central line insertion with real-time ultrasound guidance to prevent complications. Patient self-management of warfarin for appropriate outpatient anticoagulation and prevention of complications. Appropriate nutrition with particular emphasis on early enteral nutrition for critically ill and surgical patients. Prevention of catheter-related infections with antibiotic-impregnated central venous catheters. AHRQ and the EPC also identified and rated some patient safety opportunities that appear promising but require further research. The following rated most highly: Improved perioperative glucose control to decrease perioperative infections, Localizing specific surgeries and procedures to high volume centers. Use of supplemental perioperative oxygen to decrease perioperative infections. Changes in nursing staffing to decrease overall hospital morbidity and mortality. Use of silver alloy-coated urinary catheters to prevent urinary tract infections. Computerized physician order entry with computerized decision support systems to decrease medication errors and adverse events primarily due to the drug ordering process. Limitations placed on antibiotic use to prevent hospital acquired infections due to antibiotic-resistant organisms. Appropriate use of antibiotic prophylaxis in surgical patients to prevent perioperative infections. Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk. Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and post-surgical patients. Use of analgesics in the patient with an acutely painful abdomen without compromising diagnostic accuracy. Improved handwashing compliance (via education/behavior change; sink technology and placement; or the use of antimicrobial washing substances. Added opportunities to promote safe clinical practice include the utilization of evidence based clinical protocols, standardization of routine tasks and available equipment, and ongoing efforts to educate staff, patients and their families. Studies have shown that standardization of equipment, guidelines, and protocols have dramatically reduced error rates. For example, errors attributable to anesthesia were reduced from 25-50 per million to 5.4 per million through just such standardization.40 3.Technology enhanced safety. The use of advanced technology, computerized applications and sophisticated digitized equipment has grown exponentially over the last decade, impacting healthcare systems along with everything else in our environment. Positive changes include the increased consistency and readability of the computerized medication administration record (MAR) and computerized physician order entry (CPOE), safer intravenous infusion pumps, and real time documentation with inventory control using bar code technology. Some of the negative impacts include issues regarding the confidentiality of medical records, the cost of added hardware, software and information technology staff, and the ongoing training of all personnel. One of the biggest barriers to technology enhanced safety is the reticence of staff that cannot or will not embrace computerization. Healthcare professionals within every professional discipline and at all levels of healthcare delivery are actively contributing to error reduction and patient safety when they can accept and adapt to computerized technology. Reliance on outdated methods and old equipment may have worked in the past but they always had limitations that can now be overcome. Since healthcare professionals who cannot use the newer methods and updated equipment become a potential source of error themselves, their acceptance of newer technology becomes an ethical imperative. Examples of how technology enhanced systems can reduce error are provided below. Clinicians worry about caring for patients using a cookbook approach rather than individualizing care, and therefore want to resist the use of computerized decision support systems. However, using evidence based artificial intelligence to guide thinking (prompt, suggest and remind not demand) can improve both clinical and financial outcomes. Regional and/or cultural bias is minimized and evidence based strategies are promoted. Published evidence suggests that patients will significantly benefit when computerized decision support systems are used - with a better chance of survival.40,41 Physicians and other prescribing practitioners understand that hand written prescriptions may be misinterpreted with sometimes disastrous results. CPOE offers a clearly legible order that can be processed more efficiently. When combined with some sophisticated alerts programmed into the system, CPOE has demonstrated significant contributions to error reduction. Clinical laboratory professionals find that the time and resource constraints significantly increase opportunities for error, particularly human error. There may be misplaced or mislabeled test tubes, delayed turnaround time, or communication of erroneous test results. Replacing manual tasks with automated procedures (automated alliquotters, closed-tube sampling systems to eliminate manual uncapping and capping of test tubes, electronic auto-validation of results) contributes to error reduction and also results in improved productivity, worker safety, and cost savings. Nurses, mental health counselors, physical therapists and other direct care professionals recognize that documentation of care delivery is important, yet they have always encountered barriers when trying to complete all the required information. The electronic medical record (EMR) offers these professionals the opportunity to eliminate most barriers while documenting even more comprehensive and timely information. Additional technology such as voice recognition software and bar coding devices further optimize documentation by inputting real time data directly into the EMR and then populating all the required fields. Radiographers are required to adjust kilovoltage peak (kVp), milliamperage (mA) and exposure time based key variables such as on source to image receptor distance (SID), thickness and tissue type of the body part and pathology. Using automatic exposure control (AEC) technology reduces errors in film screen imaging and contributes to improved patient safety by limiting radiation exposure. 4.Education to Promote Safety. Promoting and enhancing awareness of medical error is the initial step in developing a culture of safety. The topic of medical error can no longer remain invisible, and so educational efforts focusing on patient safety must become clear, strong, and visible. Continuing education (mandatory and voluntary) using journal articles, live presentations and web-based programs all contribute needed knowledge and stimulate further discussion. Ultimately, it is the availability and promotion of ongoing education that becomes crucial in laying the foundation for collaborative initiatives that will reduce medical errors. This education is needed at the professional level, the support staff level, and the consumer level. Education of the general public is also needed to increase awareness of the consumer's role in providing safe medical care. Responsibility for solving the medical error problem does not lie solely with healthcare professionals. Patients, their families, and their lay advisers must also become active members of the patient's healthcare team. Healthcare organizations should support consumer education by using different venues to communicate how consumers must share in preventing errors. The AHRQ has developed patient fact sheets that advocate consumer actions such as: 42 Informing all healthcare providers about all medicines and pseudomedicines that are being taken, including prescriptions, over-the-counter medications, dietary supplements, vitamins and herbal products Informing all healthcare providers about any allergies and adverse reactions to medications Reading all prescriptions written by the physician to ensure that the pharmacist will be able to properly dispense it Asking for information about prescribed medicines in laymen's terms In healthcare facilities, asking whether the direct care providers have washed their hands Asking the provider to explain the treatment plan Asking questions about any other pertinent concerns Finding out who is in charge of their care Asking for test results The JCAHO parallels these suggestions with their list of patient responsibilities for safe care. These include at least the following: Providing information Asking questions Following instructions Accepting consequences Following rules and regulations Education leads to empowerment, of both the professional and the lay public. When individuals are empowered they become involved and energetic in error prevention efforts. So what is next? Continuous Quality Improvement Programs During the 1990s many health organizations took to heart the teachings of business quality leaders by looking for ways to improve their complex systems. The JCAHO recognized the benefit of such improvement efforts and mandated them in their standards. Many methods exist: FOCUS-PDCA, Six Sigma, Quality Related Events and Continuous Quality Improvement programs. National Recommendations The federal government has noted that this country's healthcare system is at least a decade behind other high risk industries (such as aviation) in its attention to ensuring basic safety.43 A review of the experience in non healthcare industries revealed the following characteristics: No tolerance for high error rates Development of tracking systems to expose error Reliance on abundant reports involving actual error and near misses Thoroughly investigating error Use of a systems approach embracing human, technical and organizational remedies Promotion of a non-punitive culture that enhances safety Allocation of adequate resources to error prevention Recognition that solutions sometimes come from unexpected sources Recognizing current inadequacies, the federal government promotes the following recommendations (many of which are already in existence): Hold national summits on medical error Endorse and support further research Develop and maintain an aggregate database on medical error Partner with other agencies to publish and enforce specific practice recommendations Collaborate with health professional licensing bodies to develop competency standards Work with drug and product manufacturers to maximize safety Endorse and support decision support systems and information technologies to enhance real-time decision support to clinicians Partner with other agencies to develop and articulate standardized procedures, checklists and protocols that are based on current research based evidence Medicare Decision effective October 2008 Beginning with hospital discharges on or after October 1, 2008, the Centers for Medicare and Medicaid Services (CMS) will no longer pay the extra costs of treating patients who develop eleven serious, preventable conditions after they have been hospitalized.44 That is, CMS will not pay more than it would have if the complication did not occur or was not present on admission. There are different definitions for these events, but in general, they are events or conditions that should not occur in hospitals. These conditions include: Foreign object retained after surgery Air embolism Blood incompatibility reaction Catheter associated urinary tract infection Pressure ulcer (stages III &IV) Vascular catheter associated blood stream infection Surgical site infection-mediastinitis after coronary artery bypass graft surgery Hospital acquired injuries including intracranial injury, crushing injury, burn, dislocations and other unspecified effects of external causes Manifestations of poor glycemic control Surgical site infections following certain orthopedic procedures and bariatric surgery for obesity Deep vein thrombosis/pulmonary embolism after total knee and hip replacement Conclusion Medical error continues to be a very serious and complex national concern. What we have learned is that error reduction strategies need to focus on system redesign rather than individual chastisement. We have also learned the importance of building a culture of safety in which people are not afraid to identify errors and learn from each other's mistakes. In this new culture of safety, there should be no retribution for reporting errors or near misses. Healthcare professionals have been identified as essential participants in the team approach to error reduction and remain central to the varied efforts promoting resolution. Through additional study of best practices, organizational guidelines and technical support strategies, our nation hopes to build a healthcare system that can offer the safest patient care possible. PLEASE PROCEED TO TEST AND EVALUATION References 1. Institute of Medicine Division of Healthcare Services Committee on Quality of Healthcare in America. To Err Is Human: Building A Safer Health System. 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Interim Report to the Senate Committee on Appropriations. AHRQ Publication No. 04-RG005. http://www.ahrq.gov/qual/pscongrpt/. Accessed 11/3/08. 22. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Report of the Quality Interagency Coordination Task Force (QuIC) to the President. Washington DC: Quality Interagency Coordination Task Force; February 2000. http://www.quic.gov/report/toc.htm. Accessed 12/14/08. 23. Reason J. Human Error. Cambridge, England: Cambridge University Press, 1990. 24. Elder NC, Dovey SM. Classification of medical errors and preventable adverse events in primary care: A synthesis of the literature. J Fam Pract. 2002;51(11):927-32. 25. National Coordinating Council for Medication Error Reporting and Prevention http://www.nccmerp.org/aboutNCCMERP.html?USP. Accessed 11/03/08. 26. Statement on Medical Errors. John M Eisenberg, M.D., Director, Agency for Healthcare Research and Quality, before the Senate Appropriations Subcommittee on Labor, Health and human Services, and Education, December 13, 1999, Washington DC;. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/stat1213.htm. Accessed 11/12/08. 27. Serafini MW. First, do no harm. Washington: National Journal, Feb. 19, 2000. 28.AHRQ. Mission Statement: Center for Quality Improvement and Patient Safety. February 2004. http://www.ahrq.gov/about/cquips,cquipsmiss.htm. Accessed 11/12/08. 29. IOM. Identifying and preventing medication errors. http://www.iom.edu/?id=35942. Accessed: 11/12/08. 30. Aspden P, Wolcott J, Bootman J, Cronenwett L, editors. Preventing Medication Errors: Quality Chasm Series. The National Academies Press; Washington, DC. 2007. 31. Root Cause Analysis: Common Barriers to Conducting Effective Root Cause Analyses. Joint Commission Perspectives on Patient Safety. 2001;1(1):4-5. 32. Wallace D, Hirsch K. Failure Mode and Effects Analysis (FMEA):Proactive - Root Cause Analysis (RCA):Reactive. Medical Risk Management Associates 2004. http://www.sentinel-event.com/process_optimization.htm. Accessed 11/3/08. 33. AHRQ''s Patient Safety Initiative: Building Foundations, Reducing Risk. Rockville, MD: Agency for Healthcare Research and Quality; December, 2003. Interim Report to the Senate Committee on Appropriations. AHRQ Publication No. 04-RG005. http://www.ahrq.gov/qual/pscongrpt/ Accessed 12/14/08 34. Sentinel event policy changed, but it's still a lawsuit kit for attorneys. Health Risk Management, July 1998. 35. Look alike, sound-alike drug names. Sentinel Event ALERT. 2001;19. 36. ISMP's list of Error-Prone Abbreviations, Symbols, and Dose Designations. http://www.ismp.org/Tools/errorproneabbreviations.pdf. Accessed 12/2/08. 37. ISMP's list of high-alert medications, Institute of Safe Medication Practices Preventing Medication Errors http://www.ismp.org/Tools/highalertmedications.pdf. Accessed 11/18/08. 38. Making Healthcare Safer: A Critical Analysis of Patient Safety Practices. Rockville, MD: Agency for Healthcare Quality and Research; July, 2001. Evidence Report/Technology Assessment No. 43. AHRQ Publication No. 01-E058. July 2001. 39. Reducing Errors in Healthcare. Translating Research Into Practice. Rockville, MD: Agency for Healthcare Quality and Research; April 2000. AHRQ Publication No. 00-PO58. Rockville, MD. http://www.ahrq.gov/qual/errors.htm . Accessed 11/3/08. 40. Medical Errors: The Scope of the Problem. Fact sheet, Publication NO. AHRQ 00-P037. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/qual/errback.htm . Accessed 12/14/08. 41. Morris AH. Protocol Management of Adult Respiratory Distress. New Horizons. 1993;1(4):593-602. 42. Agency for Healthcare Research and Quality. Rockville, MD. 20 Tips to Help Prevent Medical Errors. Patient Fact Sheet. AHRQ Publication No. 00-P038 February 2000. http://www.ahrq.gov/consumer/20tips.htm Accessed 11/12/08 43. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Washington DC: Quality Interagency Coordination Task Force; February, 2000. Report of the Quality Interagency Coordination Task Force (QuIC) to the President. http://www.quic.gov/report/toc.htm. Accessed 12/14/08. 44. Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions. http://www.cms.hhs.gov/HospitalAcqCond/06_Hospital-Acquired_Conditions.asp. Accessed 12/14/08.

HIV/AIDS 1 Hour Update for Florida Health Professionals 2009-2011

2009-01-01T13:00:00Z

Instructor: Jonathan S. Holman, B.S., Pharm. D., CCMEP; Virginia McCarty, RN, CIC, LHRM

HIV/AIDS 1 Hour Update for Florida Health Professionals 2009-2011 To download this course as a .pdf document click here! NEEDS STATEMENT Licensure requirement. New antiviral agents and use and clinical trial data are continually reshaping the therapeutic management of this infection. COURSE GOALS This 1 hour is course designed for home study by healthcare clinicians. Successful completion of this course satisfies the 1 hour HIV/AIDS continuing education requirement for Florida health professionals prior to their initial re-licensure. Information regarding the prevention, transmission, control, diagnosis and treatment of Human Immunodeficiency Virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS) is provided. The legal aspects for Florida healthcare professionals are also discussed. COURSE OBJECTIVES Upon completion of this course, the learner should be able to: Describe the epidemiology, immunopathogenesis, and diagnosis of AIDS. Identify methods of HIV transmission and reduction/prevention techniques. Explain the current clinical management of HIV/AIDS. Discuss current medications and therapeutic strategies used to treat HIV/AIDS. Describe laboratory tests utilized in the diagnosis and management of HIV/AIDS. Outline Florida Law as it relates to HIV testing. INTENDED AUDIENCE This course is designed to meet the 1 hour HIV/AIDS continuing education requirement for health professionals licensed in the state of Florida. FACULTY Jonathan S. Holman, B.S., Pharm. D., CCMEP is co-owner and continuing education administrator at AKH Inc. Dr. Holman has extensive experience as a clinical pharmacist in adult intensive care. He holds a Bachelor of Science degree from the University of Colorado and a Doctor of Pharmacy degree from the Medical University of South Carolina. Dr. Holman has no relevant financial relationships to disclose. Virginia McCarty, RN, CIC, LHRM is a diploma graduate nurse with certification in infection control and a licensed healthcare risk manager is employed by AKH Inc. as an Educational Consultant. She is a member of the Association for Professionals in Infection Control and Epidemiology (APIC) and Florida Risk Managers Association. Ms. McCarty has extensive background in teaching healthcare professionals the principles of infection control, OSHA bloodborne pathogens, hazardous waste management, risk management and documentation. Ms. McCarty has no relevant financial relationships to disclose. CONFLICT OF INTEREST STATEMENT It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this activity. Identified conflict of interest is resolved by AKH prior to certification of the activity. AKH planners and reviewers have no relevant financial relationships to disclose. This continuing education activity is not supported through educational grants from pharmaceutical or manufacturing companies. DISCLAIMER AKH Inc.'s courses are designed solely to provide healthcare professionals with information to assist in their practice and professional development. The courses are researched thoroughly, utilizing current literature and including practical experiences. AKH's courses are not to be considered a diagnostic tool to replace professional advice or treatment. The courses serve as a general guide to the healthcare professional, and therefore, they cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH's educational courses do not endorse commercial products. The author(s) and the publisher specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the courses. AKH further disclaims any responsibility for undetected error, or from the reader's misunderstanding of the course. Copyright © 2009, AKH Inc. No part of this publication may be produced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical photocopying, recording, or otherwise, without the prior permission of the publisher. TABLE OF CONTENTS INTRODUCTION EPIDEMIOLOGY Summary of US HIV/AIDS Data THE HUMAN IMMUNODEFICIENCY VIRUS HIV Life Cycle HIV/AIDS DISEASE PROCESS ROUTES OF TRANSMISSION HIGH RISK GROUPS DIAGNOSIS HIV TESTING - FLORIDA LEGAL CONSIDERATIONS PREVENTION Preventing Sexual Transmission Preventing Injection Drug Transmission Preventing Perinatal Transmission Prevention - HealthCare Personnel Prevention Non-occupational Exposure CLINICAL MANAGEMENT ANTIRETROVIRAL THERAPY When to Initiate Antiretroviral Agents Regimen Revision Due to Treatment Failure Therapeutic Drug Monitoring Treatment Interruption or Discontinuation Opportunistic Infection Prophylaxis FUTURE TRENDS IN MANAGEMENT/TREATMENT SUMMARY RESOURCES REFERENCES INTRODUCTION Acquired Immune Deficiency Syndrome, more commonly known by its acronym AIDS, is caused by the human immunodeficiency virus (HIV). A person is considered infected at the time HIV is acquired. Major medical symptoms are unlikely to develop until viral proliferation progresses and results in significant deterioration of the immune system and acquisition of opportunistic infections. Disease progression has no standard rate or pace. It is directly related to the destruction of crucial immune cells, the CD4+ T-lymphocytes, and can be dramatically delayed by antiretroviral therapies. More US citizens are living with HIV than ever before due in part to the efficacy of available therapies, but also from the occurrence of new cases, a sign that current preventive measures are not as effective as need be. EPIDEMIOLOGY Globally, an estimated 33 million people, half of which are women and 2.1 million children under 15 years of age, were living with HIV in 2007.1 There were approximately 2.7 million new infections that same year, including 370,000 children. Deaths due to AIDS totaled 2 million and included 270,000 children. Sub-Saharan Africa continues to be heavily affected, and accounts for 67% of those living with HIV infection and 72% of the deaths from AIDS. Financially, there continues to be a major difference in available resources and need, particularly in the middle- to low-income nations. While spending increased to $10 billion in 2007, the projected need was more than $18 billion. Consequently, many people living with HIV or at risk for infection do not have access to prevention, care and treatment.2 Within the United States, AIDS cases are reported to the CDC via local health departments. Epidemic trends are currently derived from data obtained from states and US dependent areas with confidential name-based HIV infection reporting. In 2008 HIV incidence estimates were further refined through the use of a serologic testing algorithm for recent HIV seroconversion (STARHS) which differentiates recent from long-standing HIV infections.3 Summary of US HIV/AIDS Data4 The cumulative number of US AIDS cases reported to the CDC through 2006 was 1,014,797. Of these, 565,927 (56%) have died. Adult and adolescent AIDS cases totaled 1,005,641 with 783,786 (78%) cases in males. Through the same time period, 9,156 AIDS cases were reported in children (< 13 years of age). Half of the total cases are from only four states, New York, California, Florida and Texas. The annual incidence of new AIDS cases has decreased slightly from 2002 (39,250) through 2006 (37,852). Cases among children decreased by approximately 64% during this time period, but increased for those 13-29 years and those 45 and older. In 2006 the highest occurrence (approximately 20%) was in those 40-44 (7,298) years of age. New HIV infections for 2006 are estimated at 56,300, a relatively stable rate since 1999. As many as 21% of those infected are unaware of their status.5,6 More than 1.1 million people are living with HIV/AIDS and 73% of adults and adolescents are male, 47% black, 34% white, and 17% Hispanic. Minorities are disproportionately affected considering that blacks compose only 12% of the US population and Hispanics 15%. THE HUMAN IMMUNODEFICIENCY VIRUS HIV is the infectious agent that causes AIDS. It consists of genetic information in the form of two single strands of ribonucleic acid (RNA) enclosed within an envelope.7 HIV is classified as a retrovirus since its method of replication involves reverse transcription of its genetic information into double-stranded deoxyribonucleic acid (DNA). Based on biologic features, HIV is further classified as a lentivirus - a virus associated with a long interval between infection and the onset of symptoms. The DNA containing HIV's genetic information eventually becomes part of the host cell's genetic information (DNA provirus). Consequently, retroviruses exist in two forms, a DNA provirus and an infectious RNA virion (RNA-containing envelope). Two forms of HIV have been identified, HIV-1 and a serologic variant HIV-2. While their structure, transmission and resulting opportunistic infections are similar, HIV-1 is responsible for the majority of infections worldwide while HIV-2 is found mostly in western Africa. HIV has several characteristics that contribute to its survival.7 It has great genetic diversity, allowing it to survive biological attack by simply adopting a new genetic characteristic. This virus also has the quality of latency, with its genetic information residing in the host chromosomal DNA as DNA provirus. This enables the virus to lie dormant for a long time, thus resisting recognition and treatment. Finally, HIV specifically affects CD4+ T-cells and macrophages thus reducing` the host's defense mechanisms. HIV Life Cycle Understanding HIV's life cycle8 helps one appreciate many of the developments in the quest to control and hopefully one day eradicate its infection. Novel treatment strategies that target the processes required for successful viral infection and proliferation have been developed. Two phases compose HIV's life cycle. The first phase (figure; steps 1-5) involves viral attachment, entry, reverse transcription, entry into the nucleus, and integration of the double-stranded DNA (provirus). The second phase (figure; steps 6-10) involves the remainder of the infected cells' life and the production of viral proteins plus new infectious virions as directed by the viral and cellular proteins. HIV must invade a host cell to replicate. Examples of drug category and process interrupted by currently available antiretroviral drug therapies are: fusion inhibitor and CCR5 coreceptor antagonist (Step 2), nucleotide-, nucleoside-, and non-nucleoside reverse transcriptase inhibitors (Step 4), integrase inhibitor (Step 5), and protease inhibitors (Step 10). HIV/AIDS DISEASE PROCESS Once in the body, HIV interacts with CD4 receptors on macrophages and T lymphocytes and coreceptors, CCR5 or CXCR4, to invade and rapidly replicate. As new viruses are released the CD4+ T cells are disabled and ultimately killed. The virus spreads to various organs and tissues. Lymphoid organs, such as the tonsils, adenoids, lymph nodes and spleen, are primary targets. During this period, 2-4 weeks after infection, roughly 70 percent of infected individuals experience an acute flu-like syndrome characterized by fever, malaise, lymphadenopathy, pharyngitis, headache, myalgia, and occasionally rash.8 A period absent of signs or symptoms follows. Carriers of HIV, regardless of manifestations, are capable of spreading the virus. A population of long-living latently infected T cells provides sites where the virus may hide and survive in a dormant state for an extended period of time.7 These cells are partially responsible for the failure of currently available therapies to eradicate the virus in an infected individual. Immune damage and extent of disease is indicated by the CD4+ T cell count. Significant reduction in these cells leads to susceptibility for opportunistic infections (OIs), malignancies, and neurologic dysfunction. Progression of HIV infection to actual AIDS has been greatly impacted by the introduction of highly active antiretroviral therapies (ART). Effective ART can suppress viral replication and restore CD4+ T cell counts in patients with AIDS and eliminate the need for OI prophylaxis. ART, when available, has been credited with extending life expectancy by more than 24 years.9 Despite successes with ART, OIs continue to occur. Treatments may fail for a variety of reasons including development of viral resistance, inadequate drug levels (due to drug interactions, inappropriate agent selection, etc.), or patient noncompliance. Some, for a variety of reasons, simply fail to receive ART. Sometimes care is provided by those who lack current knowledge of HIV infection and recommended therapies. Other times the infected individuals lack access to optimal care. Once HIV infection has reduced the number of CD4+ T cells to approximately 200/mm3 of blood, an infected individual enters an early symptomatic phase that may last months to several years. The most common signs and symptoms associated with active HIV infection are not life-threatening but may be debilitating and are typically persistent and are not due to other common illnesses. These symptoms include severe and chronic fatigue, anorexia, weight loss, fever with night sweats and/or chills, persistent or repeat yeast infections (oral, vaginal), lingering skin rashes or flaky skin, pelvic inflammatory disease in women that is refractory to treatment, and short-term memory impairment.8 The late symptomatic phase of HIV infection develops when the CD4+ T cells drop below 200 cells/mm3 of blood. At this stage of disease progression, any of 26 OIs and rare cancers may appear.8 The duration of this phase may last for months to years, but the cumulative effects usually result in death. ROUTES OF TRANSMISSION HIV is not transmitted from person to person through casual contact. It is spread primarily through unprotected sexual contact or by sharing needles and syringes with an infected person. The virus can enter the body through the membranes of the vagina, vulva, penis, rectum or mouth during sex. Studies suggest that the likelihood of both contracting and spreading HIV is 2-5 times higher in persons with other sexually transmitted diseases.10 Sharing of drug paraphernalia among IV drug users exposes participating persons to others' blood, and can spread the virus if one of the persons using it is infected with HIV. HIV-infected mothers may transmit the virus to their babies before or during birth, or from breast-feeding.11 Once a significant source of HIV infection, blood or blood products are rarely the cause due to current blood and donor screening. Current refinements in screening and collecting donor blood have reduced the risk to 1 in 2 million transfusions.12 In the healthcare setting exposure to contaminated materials from spills, sticks, splashes, or other means may potentially infect workers and or patients. The CDC has identified semen, vaginal secretions, and cerebrospinal, synovial, pericardial, pleural, amniotic and peritoneal fluids as capable of transmission of HIV. The virus has been found in saliva, sputum, tears, urine, stool, and vomitus, but scientific proof of transmission from these materials is lacking. HIGH RISK GROUPS The highest transmission categories and groups in the US for adults and adolescents with HIV/AIDS diagnosed during 2006 are listed in descending order: 1) male-to-male (MSM) sexual contact, 2) high-risk heterosexual contact for women, 3) high-risk heterosexual contact for men, 4) injection drug use (IDU) for men, followed by 5) female IDU.13 MSM continue to be disproportionately affected by HIV/AIDS and represent 50% of all new diagnoses.13 In the US, high-risk heterosexual transmission represents approximately 33% of those diagnosed in 2006. Categorized by gender, heterosexual transmission accounted for nearly 16% of cases in males and 80% in females.13 Injection drug users, a group considered high risk for HIV/AIDS, has seen a significant decline in cases over time with only 12% of new infections attributed to them in 2006. Race/ethnicity has risk implications in the US. Blacks accounted for 49% of all new HIV/AIDS diagnoses in 2006 and Hispanics 18%. Yet, they represent only 13% and 15% of the population respectively. Among women, black women represent approximately two-thirds of new HIV/AIDS diagnoses. DIAGNOSIS The diagnosis of AIDS is made, when in the presence of HIV infection, laboratory values indicate immunosuppression or actual opportunistic infections or cancers are present. For adults and adolescents it applies to those who are HIV positive and have a: CD4+ T-lymphocyte cell count less than 200 cells/mm3; or CD4+ T-lymphocyte percentage of total lymphocytes less than 14%; or any AIDS-defining condition (Table 1).14 Table 1. AIDS-Defining Conditions - Candidiasis - Cervical cancer (invasive) - Coccidioidomycosis, Cryptococcosis, Cryptosporidiosis - Cytomegalovirus disease - Encephalopathy (HIV-related) - Herpes simplex (severe infection) - Histoplasmosis - Isosporiasis - Kaposi's Sarcoma - Lymphoma, Burkitt's (or equiv.), immunoblastic (or equiv.) - Mycobacterium avium complex - Pneumocystis (carinii) jiroveci pneumonia - Pneumonia (recurrent) - Progressive multifocal leukoencephalopathy - Salmonella septicemia (recurrent) - Toxoplasmosis of brain - Tuberculosis - Wasting syndrome due to HIV Testing for HIV can be initiated at home through the use of a collection device, done through private physician offices or in public clinics. The most compelling reason to be tested is the existence of drug therapy that when appropriately initiated and managed can dramatically extend and improve the quality of an infected individual's life. Also, the person who tests positive has the opportunity to know and practice precautions to prevent the spread of HIV. CDC 2006 revised guidelines for testing recommends HIV screening for patients in all healthcare settings and specifies annual screening for persons at high risk for HIV infection.15 HIV testing should be included in routine prenatal screening tests for all pregnant women. Repeat screening is recommended during the third trimester for those in areas with elevated rates of HIV infection. The guidelines also state that one's general consent for medical care should encompass consent for HIV testing and that separate written consent for HIV testing should not be required. The usual laboratory method for detecting and diagnosing HIV infection in the US is through the use of enzyme immunoassay (EIA) screening, and confirmation with a more specific test such as the Western blot test. The EIA tests detect antibodies produced by the body's immune response to the infection, rather than the virus itself and are greater than 99% accurate. False positive results are possible in individuals with collagen-vascular diseases, chronic hepatitis, malaria, or certain HLA phenotypes. For Individuals whose infections are too recent for antibody production; a period of a few weeks to as long as 6 months may test false negative. A positive result should be re-tested. Currently, the standard confirmatory blood test is the Western blot test. An equivalent but seldom used test is the indirect immunofluorescent assay (IFA). The Western blot allows measurement of nine different antibodies that are likely to occur in the blood of people infected with HIV. Four rapid HIV tests, capable of results in less than 30 minutes, have been approved by the FDA. Their use is particularly relevant for women in labor who have not been tested during pregnancy, healthcare or emergency workers who are accidentally exposed to potentially infectious substances, and for the estimated 9,000 people who test positive at public testing sites each year and do not return for their results.16 Other tests used in the diagnosis, monitoring or investigation of HIV infection are: PCR (Polymerase Chain Reaction) -a sensitive technique used to detect and quantify HIV nucleic acids in a person's blood or lymph nodes. It is an FDA-approved test to measure viral load. NAT qualitative HIV-1 nucleic acid test used in the diagnosis of acute and primary HIV-1 infection; another method to confirm HIV-1 infection in those with tests repeatedly positive for HIV-1 antibodies. Viral culture - test utilized in diagnosing HIV infection in infants and in clinical research. P24-antigen - test detects a protein located in the viral core of HIV. It can be used in the diagnosis in infants and to routinely screen blood and plasma at collection centers. Orasure (saliva) and Home Access HIV-1 Test System: anonymous home collection systems for specimens that are mailed to laboratories to determine the presence of HIV antibodies. Note that many non-FDA approved home HIV tests are available for purchase through magazines and the internet. Their accuracy cannot be guaranteed. Specific tests for infants and children, as well as the classification of AIDS disease process are different from that for adults. Briefly summarized, the HIV antibody tests (standard EIA and Western Blot) are not reliable indicators of infection because of the presence of maternal antibodies in infants up to 15-18 months of age. The recommended test for exposed infants under the age of 18 months is the virus culture, PCR test, or p24 antigen assays. Diagnosis in a child over 18 months of age is usually determined by a positive EIA test confirmed by Western blot or IFA.17 HIV TESTING - FLORIDA LEGAL CONSIDERATIONS FLORIDA STATUTES TITLE XXIX CHAPTER 381.00418 specifies legal requirements relating to informed consent, counseling and confidentiality. Except in specific situations (Table 2), Florida state law requires that informed consent be obtained by an individual, or when necessary by their legal guardian or other person authorized by law, prior to HIV testing. Essentials included in this informed consent are the right to confidentiality, the availability of anonymous testing, and notification that positive HIV test results are reported to the county health department. Table 2. Florida Exceptions That Don't Require Informed Consent18 · testing for sexually transmissible diseases: -convicted prostitute -inmates prior to release -medical examiner investigation of cause and manner of death -pregnant women (required with prenatal care but woman may decline test via signed written objection) · blood, organ or tissue donation · medical emergencies when care depends on results · where consent is detrimental to the patient · licensed medical personnel for diagnosis of acute illness and results are necessary for care of the person · as part of an autopsy with general consent · exposure of medical personnel if specific guidelines are followed · defendant upon a victim's request in prosecution of sexual battery where a blood sample is taken from the defendant voluntarily or pursuant to court order · mandated by court order · epidemiological research Florida law allows individual medical practices to handle communication of test results to an infected individual as they deem appropriate, but strict confidentiality provisions and penalties for violation apply. Alternatively, county health departments and registered testing sites are required to provide face-to-face counseling about the meaning of the test results, the possible need for additional testing, measures for the immunodeficiency virus infection, the availability in the geographic area of appropriate healthcare services, and the benefits of locating and counseling any individual that exposed the individual or may have been exposed by the infected individual. Healthcare professionals attending pregnant women are required to counsel them to be tested, and if positive discuss available treatment. If refused by the woman, reasonable steps should be taken to have a signed written statement of the objection placed in her medical record. If HIV testing is offered and refused, the provider of the service is immune from liability if a child contracts HIV/AIDS from the mother (s. 384.31). Florida law provides for confidentiality. It states that no person who has obtained or has knowledge of a test result may disclose or be compelled to disclose the identity of any person upon whom a test is performed, or the results of the test except to the person tested, those with a legally effective release, medical personnel with a need to know, those with a court order, employees of child-placing or caring agencies, and medical personnel who have experienced a significant exposure during work. The Florida department of health has established voluntary HIV testing programs in every county to provide counseling and testing on an anonymous or confidential basis, as desired by the patient. Test results obtained under HRS auspices shall not be used to determine insurability for disability, health or life insurance or to screen or determine suitability for or to discharge a person from employment. Any person who maliciously, or for monetary gain, breaches the confidentiality of sexually transmitted disease information commits a felony of the third degree. The state of Florida recognizes the importance of preventive education, early testing, and aggressive treatment. Floridians have access to a state-wide hotline 1-800-FLA-AIDS (1-800-352-2437), and the state honors the US National Testing Day, June 27th, each year. PREVENTION The most effective means of HIV/AIDS prevention is avoidance of behaviors that place a person at risk for the disease. Behaviors to be avoided are primarily unprotected sexual activity and sharing needles and/or syringes for injecting drugs. Preventing Sexual Transmission Avoiding unprotected sex is also termed safer sex and includes knowledge of sex partners, their sex practices, their possible drug experiences, and the consistent use of latex or polyurethane condoms and lubricant. While abstinence is the ultimate protection from sexual transmission of HIV, monogamy in sexual relationships is a safer precautionary measure.19 Preventing Injection Drug Transmission For injecting drug users who can't or won't stop injecting drugs, using sterile equipment is the safest means of preventing HIV transmission. For those who persist in sharing injection paraphernalia, the use of bleach to cleanse and disinfect the needles and syringes or boiling these items in water has been suggested as a potential, but less reliable, method to prevent viral transmission.20 Preventing Perinatal Transmission Identification of HIV positive pregnant women, their treatment, and perinatal prophylaxis efforts have dramatically reduced this type of transmission in the US. Women who do not use anti-HIV therapies transmit the disease to their infants at a higher rate (22.6%)21 compared to those who do (1.2-1.5%, with combination antiretroviral therapy).22 Cesarean delivery, perinatal combination antiretroviral agents, and ART regimens that reduce maternal HIV RNA to < 1,000 copies/mL have been associated with reduced perinatal transmission of HIV. Management information evolves rapidly. For the most recent related information the participant is referred to the AIDS info Web site (http://AIDSinfo.nih.gov). Prevention - HealthCare Personnel In a work related setting, the use of measures to prevent exposure by healthcare personnel (HCP) to blood and body fluids is the primary method for preventing occupationally acquired HIV. When these measures are breached, post-exposure prophylaxis (PEP) with antiretroviral medications can be considered. Current recommendations are derived from two factors 1) the risk for HIV infection based on type of exposure, and 2) what is known of efficacy and toxicity for various antiretroviral agents. Recommendations address evaluation of the infectious source, exposure type, monitoring, and management for possible and actual exposure to these viruses. The risk of HIV transmission after a percutaneous exposure to HIV-infected blood is relatively small (0.3%) and lower with mucous membrane exposure (0.09%).23 In an early retrospective case-control study of healthcare personnel, ZDV PEP was associated with a reduction in the risk of HIV infection of approximately 81%. Decisions regarding PEP should begin with the evaluation and classification of the exposure followed by the selection of a regimen suitable for the exposure. Currently, regimens of two or more ART agents are recommended on the basis of the level of risk for HIV transmission presented by the exposure. If HIV PEP is initiated, it should be done as soon as possible (within hours). Since most occupational exposures do not result in transmission of the virus and PEP is potentially toxic, reevaluation of the exposure and source is encouraged within 72 hours. If the source is determined to be HIV-negative PEP should be discontinued. Table 3 lists resources to assist with PEP. Table 3. PEP Information Resources · PEPline at http://www.nccc.ucsf.edu/; telephone 888-448-4911; · HIV Antiretroviral Pregnancy Registry at http://www.apregistry.com/index.htm; Address: Research Park, 1011 Ashes Drive, Wilmington, NC 28405. Telephone: 800-258-4263; Fax: 800-800-1052; E-mail: registries@Kendle.com; · FDA (for reporting unusual or severe toxicity to antiretroviral agents) at http://www.fda.gov/medwatch; telephone: 800-463-6332; address: MedWatch, HF-2, Food and Drug Administration, 5600 Fishers Lane, Room 12B05,Rockville, MD 20857; · CDC (for reporting HIV infections in HCP and failures of PEP) at telephone 800-893-0485; · HIV/AIDS Treatment Information Service at http://aidsinfo.nih.gov. Prevention Non-occupational Exposure Based on the efficacy of PEP demonstrated in HCPs and other observational studies where non-occupational postexposure prophylaxis (nPEP) was utilized in situations of high-risk for HIV transmission, DHHS has offered recommendations for nPEP.24 Generally, treatment in these instances is determined by the risk of transmission from their exposure (Table 4), and the elapsed time since exposure. Persons deemed to have negligible exposure risk or those occurring more than 72 hours prior to seeking help should not receive nPEP. Individuals with substantial exposure risk occurring within 72 hours should receive nPEP if the source is known to be HIV positive. If the source is of unknown HIV status and the exposure risk is substantial, the benefits and risks of nPEP should be evaluated on a case by case basis. Where appropriate, risk-reduction counseling and other intervention services should be provided in an attempt to decrease the risk for subsequent exposures. Therapy for nPEP consists of a 4 week course of combination antiretroviral therapy. Table 4. Non-occupational HIV Exposure Risk24 Substantial Exposure of: vagina, rectum, eye, mouth, or other mucous membrane, non-intact skin, or percutaneous contact With: blood, semen, vaginal secretions, rectal secretions, breast milk, or any body fluid that is visibly contaminated with blood When: the source is known to be HIV-infected Negligible Exposure of: vagina, rectum, eye, mouth, or other mucous membrane, non-intact skin, or percutaneous contact With: urine, nasal secretions, saliva, sweat, or tears if not visibly contaminated with blood Regardless of: known or suspected HIV status of the source CLINICAL MANAGEMENT The clinical management of individuals who are HIV positive can be defined as the care, treatment, and services required indefinitely from the time of diagnosis. Due to differences in immune system development at the time of infection and changes in organ function, unique considerations are needed for HIV-infected infants and children. Refer to Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection at http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf for the most current treatment information for this patient population. A baseline medical evaluation to establish a reference point for recognizing early changes and signs of opportunistic infections and formulate a treatment strategy to delay disease progression is essential. A complete history and physical should be performed to assess for additional sexually transmitted diseases, tuberculosis, hepatitis B or C, mental health status, current nutritional needs, and any other appropriate referrals. Assessment and consideration of comorbid conditions must be factored into the long-term treatment plan. Education about HIV infection and the disease process enables the individual to be more knowledgeable about self-care. The patient should also be made aware of the importance of support groups and stress management methods. Education on viral transmission is essential. Clinical management is influenced by the signs and symptoms the patient exhibits and to an increasing extent, is based on laboratory values. A complete blood count, chemistry profile (including serum transaminases and lipid profile), CD4+ T cell count, and plasma HIV RNA measurement is recommended.25 CD4+ levels provide information about the disease progression and the status of the immune system. This information is useful in determining the need for OI prophylaxis. Plasma HIV RNA measures the quantity of the virus in the blood and indicates the rate of its replication. It is a strong prognostic indicator in HIV infection. Reductions achieved with antiretroviral therapy correlate with clinical improvements. Since up to 16% of HIV infected patients naive to ART demonstrate drug resistance, genotypic drug resistance testing is recommended to assist with ART selection for both treatment-naive and experienced patients. Other tests for patient evaluation may include those: pertinent to the prevention of OIs: RPR or VDRL, tuberculin skin test, toxoplasma IgG serology, hepatitis virus B and C serology , and gynecologic exam with Pap smear, etc. clinically indicated: chest X-ray, cytomegalovirus (CMV) serology, ophthalmologic exam, etc. ANTIRETROVIRAL THERAPY The cornerstone of clinical management is the eventual use of ART. Goals for treatment are to reduce HIV-related morbidity and prolong survival; improve quality of life; restore and preserve immunologic function; maximally and durably suppress viral load; and, prevent vertical HIV transmission.25 At this time, treatment is the most dynamic aspect of disease management, but detailed presentation is beyond the scope and intent of this educational activity. Additionally, development of new treatments and strategies, and the accumulation of clinical trial and experience data continually reshape treatment recommendations. For complete information on treatment and related topics the participant is referred to the most current source of information, the AIDS info Web site (http://AIDSinfo.nih.gov). Appropriate ART selection, maximal adherence to the regimen, rational sequencing of drugs, preservation of future treatment options, and resistance testing are tools to accomplish the goals of therapy. ART selection must be effective, accommodate patient lifestyle and comorbidities, and avoid significant drug interactions. Patient involvement and education is a start to encourage regimen adherence but some may need additional support for issues with substance abuse or depression. Drug sequencing is necessary to preserve treatment options for salvage therapy when previous combinations fail and to minimize certain class-specific side effects. Efficacy of antiretroviral treatment is determined through plasma HIV RNA measurements which are expected to show a rapid decrease after 1-4 months treatment and no detectable virus at 3-4 months after treatment initiation. These numbers are not absolute as baseline viral load, CD4 count, and other patient factors will impact the degree of response. To date there are more than 20 FDA approved antiretroviral drugs, involving six different mechanisms of action, from which combination ART can be formulated. These include, in order of FDA approval, the nucleoside reverse transcriptase inhibitors (NRTIs), protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), fusion inhibitors, integrase inhibitors, and most recently a CCR5 antagonist. Fusion and CCR5 inhibitors prevent HIV from entering healthy T-cells while all other drugs within these categories target actively HIV infected T-cells.25 ART has transformed a predictably fatal disease into one that is chronic and manageable for those in whom it is accessible.26 When to Initiate Antiretroviral Agents The trend is for earlier initiation of ART based on data from clinical trials using newer effective and more tolerable therapies in infected individuals. Still antiretroviral therapies are complex, have major side effects and can be detrimental if adherence to therapy is incomplete due to the likely development of viral resistance. For these reasons initiation of ART is recommended for patients with history of AIDS-defining illness or CD4 T-cell count < 350 cells/mm3; pregnant women; patients with HIV-associated nephropathy; and patients co-infected with hepatitis B virus (HBV) and requiring treatment for hepatitis B. The necessity for patient adherence to long-term therapy has to be emphasized and potential barriers identified and addressed prior to starting ART. Patients not in a previously mentioned category with a CD4 T-cell count >or= 350 cells/mm3 may be considered for ART (Table 5) depending on the risks and benefits. Table 5. Considerations For Early ART in Asymptomatic Patients with >or= 350 cells/mm3 CD4 T-Cell Count 25 Potential Benefits: · Maintenance of higher CD4 count; prevent potentially irreversible immune system damage · Decreased risk for HIV-associated complications that may occur at higher CD4 T-cell counts · Decreased risk of nonopportunistic conditions, such as CV, renal, and liver disease, and non-AIDS-associated malignancies and infections · Decreased risk of HIV transmission to others Potential Risks: · Treatment-related side effects and toxicities · Drug resistance due to inadequate viral suppression and loss of future treatment options · Insufficient time to learn about the condition and prepare for adherence to therapy · Increased treatment time and possible treatment fatigue · Incurring treatment before new drugs or combinations determined to be more effective and less toxic are available · Transmission of drug-resistant virus by patients not maintaining full virologic suppression The expert panel for DHHS has identified antiretroviral drugs that are acceptable for treatment-naive patients. The recommendations, which stem from amassed clinical experience, are for 2NRTI agents with either a NNRTI or a PI (with or without ritonavir boosting).25 Which among the preferred or alternate agents to use is determined by factors such as comorbid conditions, adverse drug effects, drug-drug interactions, pregnancy or its potential, drug resistance, gender and pretreatment CD4 T-cell count if considering nevirapine (increased serious hepatic events), HLA-B*5701 testing if abacavir to be used (genetic variation associated with hypersensitivity), and likelihood of patient compliance. Side effects are common with the antiretrovirals and depending on the agent may include gastro-intestinal intolerance, hematological alterations, neuropathies, rash, elevated blood sugar, elevated serum lipids, fat redistribution, hepatitis, kidney stones, and others. Side effects can be exaggerated with combination drug therapies possessing overlapping effects and toxicities. Side effects are most manageable with the NRTI class. They increase with the NNRTIs and are most frequent and bothersome with the PIs. Toxic effects may result from ART and therapies used to manage other medical conditions (e.g. additive hepatotoxicity from select antihyperlipidemics, antihyperglycemics, antifungals, with antiretrovirals). Drug interactions are an increasingly significant issue. As new drugs and combinations are used, new interactions are discovered. Some are beneficial and can be utilized to optimize drug therapy. Such is the case with some combination protease inhibitors where pharmacokinetics are altered and plasma drug concentrations of one or both are increased, allowing for reduced frequency of administration and/or total daily dose (e.g. low dose ritonavir added to a PI such as amprenavir, atazanavir, indinavir, lopinavir, or saquinavir). Others can create toxicities or cause treatment failures from decreased serum levels. Practitioners must continually monitor for drug interactions and utilize contemporary resources to investigate the evolving issue of drug interactions. Antibiotic, antifungal, and other antiviral drugs are used for prophylaxis or treatment of opportunistic infections. Multiple other agents, such as anti-diarrheal drugs, analgesics, and appetite stimulants, are used to treat symptoms. Blood modifiers may be required to counter adverse effects of other necessary medications. Medications for children with AIDS do not include all of those approved for adults. Physicians may legally prescribe these drugs, but many have not been widely tested in children and pediatric data is lacking. Regimen Revision Due to Treatment Failure Failure rates for first-line antiretroviral therapy have been identified to be in the range of 10% to 60%.27 Consequently, eventual changes in ones antiretroviral regimen might be necessary. Treatment failure may be manifest by virologic failure, immunologic failure or by clinical progression. A sub-optimal reduction in plasma viremia (HIV RNA > 400 copies/mL after 24 weeks, >50 copies/mL after 48 weeks) or re-appearance of viremia after successful suppression is indicative of virologic failure.25 Immunologic failure occurs if treatment and viral suppression fails to increase CD4+ T cell count. Various measures are used but a threshold level of 350 or 500 cells/mm3 may be preferred.25 Clinical progression is defined as the occurrence or recurrence of HIV-related events after at least 3 months on an antiretroviral regimen. An HIV RNA and CD4+ cell count should be obtained every 3 to 6 months in patients on antiretroviral therapy. Causes for failure include noncompliance, pharmacokinetic factors, intolerability, virologic impotence, and resistance and the potential for each must be carefully evaluated. Resistance testing, while taking the failing regimen or within 4 weeks of discontinuation, is recommended for new regimen selection. Guidelines advise on appropriate regimen revision strategies depending on previous drug use and resistance. Referral to a clinician experienced in the care of HIV infected patients is strongly recommended. Therapeutic Drug Monitoring Antiretroviral therapeutic drug monitoring (TDM) is a possible strategy to navigate through concentration associated toxicities and treatment failures. Currently there is data supporting TDM for the NNRTI and PI antiretroviral drugs. These drugs exhibit concentration related responses (efficacy, toxicity) and also may have significant inter-patient variability among those taking the same dose. TDM may be a useful tool in evaluating toxicities or drug failure due to drug-drug or drug-food interactions, physiologic changes or pathophysiologic states, alternative unproven dosing regimens, or unexpected response, but are not recommended for routine use. Treatment Interruption or Discontinuation ART may be temporarily discontinued because of acute illness, drug toxicity, or surgery. Generally, if any antiretroviral is stopped, all agents should be discontinued simultaneously so as to decrease the emergence of resistant viral strains. Such patient's clinical and laboratory status should be followed closely and prophylaxis for OIs offered if CD4 cell counts warrant. Structured or supervised treatment interruptions (STI) have been evaluated for salvage therapy, auto-immunization to heighten ones immune control of HIV, and to decrease the total time on antiretroviral therapy. Data supporting STI is limited and doing so is not recommended in current published guidelines. The most compelling evidence discouraging this practice to date are the results from a randomized trial where episodic ART resulted in significantly increased risk of OI or death compared with continuous therapy.28 Additionally, no reduction in the risk of adverse events associated with ART was observed in the episodic therapy group. Opportunistic Infection Prophylaxis HIV-infected adults and adolescents, including pregnant women and those on ART, should receive chemoprophylaxis against opportunistic infections when the disease has impaired one's immune status as demonstrated by their CD4+ cell count and/or clinical presentation. Types of OI prophylaxis with strong evidence for efficacy and substantial clinical benefit which should always be offered include: Cotrimoxazole to prevent Pneumocystis (carinii) jiroveci pneumonia (start when CD4+ < 200 or with occurrence of oropharyngeal Candidiasis). Cotrimoxazole for primary Toxoplasma gondii (start if positive Toxoplasma IgG antibody and CD4+ < 100). Azithromycin or clarithromycin are the agents of choice as prophylaxis for mycobacterium avium complex (CD4+ count < 50). Alternative agents can be considered should these be contraindicated or not tolerated. FUTURE TRENDS IN MANAGEMENT/TREATMENT ART, for those able to access it, has dramatically changed the face of AIDS and transformed it to that of a chronic, long-term illness. Treatment is not cheap. A recent estimate in US dollars of the cost for the lifetime HIV care of an individual is $618,900.30 Despite the advances with ART, several problems resulting in treatment failure, such as viral resistance and drug toxicities, persist. Research continues the quest for the development of an effective vaccine and novel therapies and mechanisms to suppress viral replication. Currently no vaccine is FDA approved and available for use, but more than 30 vaccines have been investigated.31 Possibilities continue to grow with the recent report of discovery of over 250 proteins that, if blocked, interfere with the undesirable effects of HIV.32 Multiple agents that interfere with the various stages of HIV's life-cycle as well as better tolerated and simpler therapies for existing treatment mechanisms continue to be developed thus broadening treatment options. Other research activities include a continued attempt to define the most appropriate time to start ART, and the impact of herpes simplex, hepatitis B, and hepatitis C co-infections on HIV management. SUMMARY The continued presence of HIV/AIDS in our society presents ongoing challenges. If we have learned anything in public health, it is the unfortunate reality that the dissemination of information alone does not change human behaviors. Social struggles against drug use, alcoholism, tobacco use, mental illness, and several other health conditions including HIV/AIDS seek to educate and inform, but that is merely the tip of the iceberg in any effort to change one's behavior. The need to achieve increased awareness must take place on a number of levels and on an ongoing basis. Ironically, some believe advances in drug therapy (such as ART) may contribute to the occurrence of new cases. Effective medication regimens that suppress recognizable symptoms may give rise to a degree of complacency where preventative behaviors are concerned; some may tend to forget that transmission of the disease is still a very real danger. As treatment for HIV infection improves, people are living longer and associated care has transformed to that of a chronic, long-term illness. Researchers seek the development of an effective vaccine and other therapies to suppress viral replication, but the physical characteristics of this resilient virus have not made this an easy task. Healthcare professionals routinely encounter persons infected with HIV. This has great significance when considering our aging US population and their associated co-morbid health conditions. For optimal care of infected individuals, healthcare professionals should remain current with information on the disease process and basic clinical management. RESOURCES There are many national, regional, and state resources available to communities. A few of them are listed below. Departments of Public Health may be contacted for additional resources and the Internet offers a vast resource for HIV/AIDS related readings and concerned organizations. NATIONAL RESOURCES AIDSinfo (treatment, prevention & research) 1-800-448-0440 www.aidsinfo.nih.gov CDC INFO 888-232-6348 (TTY) 888-232-4636; mailto:cdcinfo@cdc.gov http://www.cdc.gov/hiv/contact.htm CDC National Prevention Information Network 800-243-7012 (TTY) 800-458-5231; info@cdcnpin.org http://www.cdcnpin.org/scripts/index.asp US National Library of Medicine HIV/AIDS Information http://sis.nlm.nih.gov/hiv.html MedlinePlus AIDS page: http://www.nlm.nih.gov/medlineplus/aids.html National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) http://www.niaid.nih.gov/daids/ HIV-Drug interactions, University of Liverpool www.hiv-druginteractions.org University of California, San Francisco HIV InSite http://hivinsite.ucsf.edu Johns Hopkins HIV GUIDE www.hopkins-aids.edu HIV Resource for Health Professionals www.thebodypro.com FLORIDA RESOURCES Florida AIDS Hotline English: 800-352-2437 Creole: 800-243-7101 Spanish: 800-545-7432 TTY: 800-503-7118 Web www.211bigbend.org/hotlines/hiv/index.htm Florida Alcohol and Drug Abuse Association: 904-878-2196 Department of Health: HIV/AIDS community assistance- www.myflorida.com Bureau of HIV/AIDS-www.doh.state.fl.us/disease_ctrl/aids/index.html Project Inform - Florida Statewide Resources- http://www.projinf.org/org/Regionrsrc/FL.html REFERENCES 1. UNAIDS, 2008 Report on the Global AIDS Epidemic-Executive summary;2008. 2. UNAIDS, Financing Resources Required to Achieve Universal Access to HIV Prevention, Treatment, Care and Support; September 2007. 3. Centers for Disease Control and Prevention. HIV/AIDS Surveillance CDC HIV/AIDS Facts, July 2008. 4. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report 2006. Vol. 18. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention. 2008;7-13. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ (Accessed 11/10/2008) 5. Hall HI, Song R, Rhodes P, et al. Estimation of HIV incidence in the United States. JAMA. 2008;300:520-529. 6. Kaiser Family Foundation HIV/AIDS Policy Fact Sheet (#3029-09). The HIV/AIDS Epidemic in the United States, October 2008. 7. Streicher H, Reitz M & Gallo R. (2000) Human Immunodeficiency Viruses. In Principles and Practice of Infectious Diseases (Mandell, Douglas, & Bennett, Eds.), p. 1874. Philadelphia, PA: Churchill Livingstone. 8. DHHS/NIAID. How HIV causes AIDS. http://www.niaid.nih.gov/factsheets/howhiv.htm. (Accessed October 12, 2008). 9. Schackman BR, Gebo KA, Walensky RP, et al. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006;44:990-7. 10. Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999;75:3-17. 11. CDC. HIV and Its Transmission. http://www.cdc.gov/hiv/resources/factsheets/transmission.htm (Accessed 11/12/2008). 12. Alter HJ, Klein HG. The hazards of blood transfusion in historical perspective. Blood 2008;112:2617-2626. 13. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report 2006. Vol. 18. Atlanta: US Department of Health and Human Services, Centers for Disease Control and Prevention. 2008;11. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ (Accessed 11/10/2008) 14. CDC. Guidelines for national human immunodeficiency virus case surveillance, including monitoring for human immunodeficiency virus infection and acquired immunodeficiency syndrome. MMWR 1999;48 (RR13):1-28. 15. CDC. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. 2006;55(RR14);1-17. 16. Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Current Infectious Disease Reports. 2006;8:125-131. 17. Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected children. Guidelines for the use of antiretroviral agents in pediatric HIV infection. July 29,2008. 18. Florida Statutes, Title XXIX Chapter 381.001 HIV testing. http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=Ch0381/Sec004.HTM (Accessed 11/13/2008). 19. CDC. HIV/AIDS Basic Information Preventing Transmission. http://www.cdc.gov/hiv/topics/basic/index.htm#prevention (Accessed 11/13/2008) 20. CDC. HIV/AIDS Basic Information How can injection drug users reduce their risk for HIV infection? http://www.cdc.gov/hiv/resources/qa/qa26.htm (Accessed 11/13/2008) 21. Cooper ER, Charurat M, Mofenson L, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1 infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr Hum Retrovirol. 2002:29;484-94. 22. Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States July 8, 2008 23. CDC. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR 2005;54(No.RR-09):1-17]] 24. CDC. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR 2005;54(No.RR-2):1-16. 25. Department of Health and Human Services (DHHS), Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents, November 3, 2008. 26. Wainberg MA. Twenty-five years of AIDs: where are we now? Medscape General Medicine. 2006;8:21. 27. Lee, K. Gulick, R. HIV therapeutic options in the treatment-experienced patient: Recent trials and future directions. Infections in Medicine. 2001;18(3):139-152. 28. CD4+ count-guided interruption of antiretroviral treatment. The Strategies for Management of Antiretroviral Therapy [SMART] Study Group. NEJM. 2006:355:2283-2296. 29. USPHS and IDSA recommendations. Guidelines for preventing opportunistic infections among HIV-infected persons 2002. MMWR. 51(RR-08);1-46. 30. Schackman BR, Gebo KA, Walensky RP, et al. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006;44:990-7. 31. International AIDS Vaccine Initiative. Progress toward and AIDS vaccine since 2000. http://www.iavi.org/viewpage.cfm?aid=13 (Accessed 11/30/06). 32. DeNoon DJ. 272 new possible targets for HIV drugs. WebMD Medical News. January 10, 2008. Please Proceed To The Post Test And Evaluation

HIV/AIDS 1 Hour Update for Florida Health Professionals 2009-2011

2009-01-01T13:00:00Z

Instructor: Jonathan S. Holman, B.S., Pharm. D., CCMEP; Virginia McCarty, RN, CIC, LHRM

HIV/AIDS 1 Hour Update for Florida Health Professionals 2009-2011 To download this course as a .pdf document click here! NEEDS STATEMENT Licensure requirement. New antiviral agents and use and clinical trial data are continually reshaping the therapeutic management of this infection. COURSE GOALS This 1 hour is course designed for home study by healthcare clinicians. Successful completion of this course satisfies the 1 hour HIV/AIDS continuing education requirement for Florida health professionals prior to their initial re-licensure. Information regarding the prevention, transmission, control, diagnosis and treatment of Human Immunodeficiency Virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS) is provided. The legal aspects for Florida healthcare professionals are also discussed. COURSE OBJECTIVES Upon completion of this course, the learner should be able to: Describe the epidemiology, immunopathogenesis, and diagnosis of AIDS. Identify methods of HIV transmission and reduction/prevention techniques. Explain the current clinical management of HIV/AIDS. Discuss current medications and therapeutic strategies used to treat HIV/AIDS. Describe laboratory tests utilized in the diagnosis and management of HIV/AIDS. Outline Florida Law as it relates to HIV testing. INTENDED AUDIENCE This course is designed to meet the 1 hour HIV/AIDS continuing education requirement for health professionals licensed in the state of Florida. FACULTY Jonathan S. Holman, B.S., Pharm. D., CCMEP is co-owner and continuing education administrator at AKH Inc. Dr. Holman has extensive experience as a clinical pharmacist in adult intensive care. He holds a Bachelor of Science degree from the University of Colorado and a Doctor of Pharmacy degree from the Medical University of South Carolina. Dr. Holman has no relevant financial relationships to disclose. Virginia McCarty, RN, CIC, LHRM is a diploma graduate nurse with certification in infection control and a licensed healthcare risk manager is employed by AKH Inc. as an Educational Consultant. She is a member of the Association for Professionals in Infection Control and Epidemiology (APIC) and Florida Risk Managers Association. Ms. McCarty has extensive background in teaching healthcare professionals the principles of infection control, OSHA bloodborne pathogens, hazardous waste management, risk management and documentation. Ms. McCarty has no relevant financial relationships to disclose. CONFLICT OF INTEREST STATEMENT It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The faculty must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this activity. Identified conflict of interest is resolved by AKH prior to certification of the activity. This continuing education activity is not supported through educational grants from pharmaceutical or manufacturing companies. DISCLAIMER AKH Inc.'s courses are designed solely to provide healthcare professionals with information to assist in their practice and professional development. The courses are researched thoroughly, utilizing current literature and including practical experiences. AKH's courses are not to be considered a diagnostic tool to replace professional advice or treatment. The courses serve as a general guide to the healthcare professional, and therefore, they cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH's educational courses do not endorse commercial products. The author(s) and the publisher specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the courses. AKH further disclaims any responsibility for undetected error, or from the reader's misunderstanding of the course. Copyright © 2009, AKH Inc. No part of this publication may be produced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical photocopying, recording, or otherwise, without the prior permission of the publisher. TABLE OF CONTENTS INTRODUCTION EPIDEMIOLOGY Summary of US HIV/AIDS Data THE HUMAN IMMUNODEFICIENCY VIRUS HIV Life Cycle HIV/AIDS DISEASE PROCESS ROUTES OF TRANSMISSION HIGH RISK GROUPS DIAGNOSIS HIV TESTING - FLORIDA LEGAL CONSIDERATIONS PREVENTION Preventing Sexual Transmission Preventing Injection Drug Transmission Preventing Perinatal Transmission Prevention - HealthCare Personnel Prevention Non-occupational Exposure CLINICAL MANAGEMENT ANTIRETROVIRAL THERAPY When to Initiate Antiretroviral Agents Regimen Revision Due to Treatment Failure Therapeutic Drug Monitoring Treatment Interruption or Discontinuation Opportunistic Infection Prophylaxis FUTURE TRENDS IN MANAGEMENT/TREATMENT SUMMARY RESOURCES REFERENCES INTRODUCTION Acquired Immune Deficiency Syndrome, more commonly known by its acronym AIDS, is caused by the human immunodeficiency virus (HIV). A person is considered infected at the time HIV is acquired. Major medical symptoms are unlikely to develop until viral proliferation progresses and results in significant deterioration of the immune system and acquisition of opportunistic infections. Disease progression has no standard rate or pace. It is directly related to the destruction of crucial immune cells, the CD4+ T-lymphocytes, and can be dramatically delayed by antiretroviral therapies. More US citizens are living with HIV than ever before due in part to the efficacy of available therapies, but also from the occurrence of new cases, a sign that current preventive measures are not as effective as need be. EPIDEMIOLOGY Globally, an estimated 33 million people, half of which are women and 2.1 million children under 15 years of age, were living with HIV in 2007.1 There were approximately 2.7 million new infections that same year, including 370,000 children. Deaths due to AIDS totaled 2 million and included 270,000 children. Sub-Saharan Africa continues to be heavily affected, and accounts for 67% of those living with HIV infection and 72% of the deaths from AIDS. Financially, there continues to be a major difference in available resources and need, particularly in the middle- to low-income nations. While spending increased to $10 billion in 2007, the projected need was more than $18 billion. Consequently, many people living with HIV or at risk for infection do not have access to prevention, care and treatment.2 Within the United States, AIDS cases are reported to the CDC via local health departments. Epidemic trends are currently derived from data obtained from states and US dependent areas with confidential name-based HIV infection reporting. In 2008 HIV incidence estimates were further refined through the use of a serologic testing algorithm for recent HIV seroconversion (STARHS) which differentiates recent from long-standing HIV infections.3 Summary of US HIV/AIDS Data4 The cumulative number of US AIDS cases reported to the CDC through 2006 was 1,014,797. Of these, 565,927 (56%) have died. Adult and adolescent AIDS cases totaled 1,005,641 with 783,786 (78%) cases in males. Through the same time period, 9,156 AIDS cases were reported in children (< 13 years of age). Half of the total cases are from only four states, New York, California, Florida and Texas. The annual incidence of new AIDS cases has decreased slightly from 2002 (39,250) through 2006 (37,852). Cases among children decreased by approximately 64% during this time period, but increased for those 13-29 years and those 45 and older. In 2006 the highest occurrence (approximately 20%) was in those 40-44 (7,298) years of age. New HIV infections for 2006 are estimated at 56,300, a relatively stable rate since 1999. As many as 21% of those infected are unaware of their status.5,6 More than 1.1 million people are living with HIV/AIDS and 73% of adults and adolescents are male, 47% black, 34% white, and 17% Hispanic. Minorities are disproportionately affected considering that blacks compose only 12% of the US population and Hispanics 15%. THE HUMAN IMMUNODEFICIENCY VIRUS HIV is the infectious agent that causes AIDS. It consists of genetic information in the form of two single strands of ribonucleic acid (RNA) enclosed within an envelope.7 HIV is classified as a retrovirus since its method of replication involves reverse transcription of its genetic information into double-stranded deoxyribonucleic acid (DNA). Based on biologic features, HIV is further classified as a lentivirus - a virus associated with a long interval between infection and the onset of symptoms. The DNA containing HIV's genetic information eventually becomes part of the host cell's genetic information (DNA provirus). Consequently, retroviruses exist in two forms, a DNA provirus and an infectious RNA virion (RNA-containing envelope). Two forms of HIV have been identified, HIV-1 and a serologic variant HIV-2. While their structure, transmission and resulting opportunistic infections are similar, HIV-1 is responsible for the majority of infections worldwide while HIV-2 is found mostly in western Africa. HIV has several characteristics that contribute to its survival.7 It has great genetic diversity, allowing it to survive biological attack by simply adopting a new genetic characteristic. This virus also has the quality of latency, with its genetic information residing in the host chromosomal DNA as DNA provirus. This enables the virus to lie dormant for a long time, thus resisting recognition and treatment. Finally, HIV specifically affects CD4+ T-cells and macrophages thus reducing` the host's defense mechanisms. HIV Life Cycle Understanding HIV's life cycle8 helps one appreciate many of the developments in the quest to control and hopefully one day eradicate its infection. Novel treatment strategies that target the processes required for successful viral infection and proliferation have been developed. Two phases compose HIV's life cycle. The first phase (figure; steps 1-5) involves viral attachment, entry, reverse transcription, entry into the nucleus, and integration of the double-stranded DNA (provirus). The second phase (figure; steps 6-10) involves the remainder of the infected cells' life and the production of viral proteins plus new infectious virions as directed by the viral and cellular proteins. HIV must invade a host cell to replicate. Examples of drug category and process interrupted by currently available antiretroviral drug therapies are: fusion inhibitor and CCR5 coreceptor antagonist (Step 2), nucleotide-, nucleoside-, and non-nucleoside reverse transcriptase inhibitors (Step 4), integrase inhibitor (Step 5), and protease inhibitors (Step 10). HIV/AIDS DISEASE PROCESS Once in the body, HIV interacts with CD4 receptors on macrophages and T lymphocytes and coreceptors, CCR5 or CXCR4, to invade and rapidly replicate. As new viruses are released the CD4+ T cells are disabled and ultimately killed. The virus spreads to various organs and tissues. Lymphoid organs, such as the tonsils, adenoids, lymph nodes and spleen, are primary targets. During this period, 2-4 weeks after infection, roughly 70 percent of infected individuals experience an acute flu-like syndrome characterized by fever, malaise, lymphadenopathy, pharyngitis, headache, myalgia, and occasionally rash.8 A period absent of signs or symptoms follows. Carriers of HIV, regardless of manifestations, are capable of spreading the virus. A population of long-living latently infected T cells provides sites where the virus may hide and survive in a dormant state for an extended period of time.7 These cells are partially responsible for the failure of currently available therapies to eradicate the virus in an infected individual. Immune damage and extent of disease is indicated by the CD4+ T cell count. Significant reduction in these cells leads to susceptibility for opportunistic infections (OIs), malignancies, and neurologic dysfunction. Progression of HIV infection to actual AIDS has been greatly impacted by the introduction of highly active antiretroviral therapies (ART). Effective ART can suppress viral replication and restore CD4+ T cell counts in patients with AIDS and eliminate the need for OI prophylaxis. ART, when available, has been credited with extending life expectancy by more than 24 years.9 Despite successes with ART, OIs continue to occur. Treatments may fail for a variety of reasons including development of viral resistance, inadequate drug levels (due to drug interactions, inappropriate agent selection, etc.), or patient noncompliance. Some, for a variety of reasons, simply fail to receive ART. Sometimes care is provided by those who lack current knowledge of HIV infection and recommended therapies. Other times the infected individuals lack access to optimal care. Once HIV infection has reduced the number of CD4+ T cells to approximately 200/mm3 of blood, an infected individual enters an early symptomatic phase that may last months to several years. The most common signs and symptoms associated with active HIV infection are not life-threatening but may be debilitating and are typically persistent and are not due to other common illnesses. These symptoms include severe and chronic fatigue, anorexia, weight loss, fever with night sweats and/or chills, persistent or repeat yeast infections (oral, vaginal), lingering skin rashes or flaky skin, pelvic inflammatory disease in women that is refractory to treatment, and short-term memory impairment.8 The late symptomatic phase of HIV infection develops when the CD4+ T cells drop below 200 cells/mm3 of blood. At this stage of disease progression, any of 26 OIs and rare cancers may appear.8 The duration of this phase may last for months to years, but the cumulative effects usually result in death. ROUTES OF TRANSMISSION HIV is not transmitted from person to person through casual contact. It is spread primarily through unprotected sexual contact or by sharing needles and syringes with an infected person. The virus can enter the body through the membranes of the vagina, vulva, penis, rectum or mouth during sex. Studies suggest that the likelihood of both contracting and spreading HIV is 2-5 times higher in persons with other sexually transmitted diseases.10 Sharing of drug paraphernalia among IV drug users exposes participating persons to others' blood, and can spread the virus if one of the persons using it is infected with HIV. HIV-infected mothers may transmit the virus to their babies before or during birth, or from breast-feeding.11 Once a significant source of HIV infection, blood or blood products are rarely the cause due to current blood and donor screening. Current refinements in screening and collecting donor blood have reduced the risk to 1 in 2 million transfusions.12 In the healthcare setting exposure to contaminated materials from spills, sticks, splashes, or other means may potentially infect workers and or patients. The CDC has identified semen, vaginal secretions, and cerebrospinal, synovial, pericardial, pleural, amniotic and peritoneal fluids as capable of transmission of HIV. The virus has been found in saliva, sputum, tears, urine, stool, and vomitus, but scientific proof of transmission from these materials is lacking. HIGH RISK GROUPS The highest transmission categories and groups in the US for adults and adolescents with HIV/AIDS diagnosed during 2006 are listed in descending order: 1) male-to-male (MSM) sexual contact, 2) high-risk heterosexual contact for women, 3) high-risk heterosexual contact for men, 4) injection drug use (IDU) for men, followed by 5) female IDU.13 MSM continue to be disproportionately affected by HIV/AIDS and represent 50% of all new diagnoses.13 In the US, high-risk heterosexual transmission represents approximately 33% of those diagnosed in 2006. Categorized by gender, heterosexual transmission accounted for nearly 16% of cases in males and 80% in females.13 Injection drug users, a group considered high risk for HIV/AIDS, has seen a significant decline in cases over time with only 12% of new infections attributed to them in 2006. Race/ethnicity has risk implications in the US. Blacks accounted for 49% of all new HIV/AIDS diagnoses in 2006 and Hispanics 18%. Yet, they represent only 13% and 15% of the population respectively. Among women, black women represent approximately two-thirds of new HIV/AIDS diagnoses. DIAGNOSIS The diagnosis of AIDS is made, when in the presence of HIV infection, laboratory values indicate immunosuppression or actual opportunistic infections or cancers are present. For adults and adolescents it applies to those who are HIV positive and have a: CD4+ T-lymphocyte cell count less than 200 cells/mm3; or CD4+ T-lymphocyte percentage of total lymphocytes less than 14%; or any AIDS-defining condition (Table 1).14 Table 1. AIDS-Defining Conditions - Candidiasis - Cervical cancer (invasive) - Coccidioidomycosis, Cryptococcosis, Cryptosporidiosis - Cytomegalovirus disease - Encephalopathy (HIV-related) - Herpes simplex (severe infection) - Histoplasmosis - Isosporiasis - Kaposi's Sarcoma - Lymphoma, Burkitt's (or equiv.), immunoblastic (or equiv.) - Mycobacterium avium complex - Pneumocystis (carinii) jiroveci pneumonia - Pneumonia (recurrent) - Progressive multifocal leukoencephalopathy - Salmonella septicemia (recurrent) - Toxoplasmosis of brain - Tuberculosis - Wasting syndrome due to HIV Testing for HIV can be initiated at home through the use of a collection device, done through private physician offices or in public clinics. The most compelling reason to be tested is the existence of drug therapy that when appropriately initiated and managed can dramatically extend and improve the quality of an infected individual's life. Also, the person who tests positive has the opportunity to know and practice precautions to prevent the spread of HIV. CDC 2006 revised guidelines for testing recommends HIV screening for patients in all healthcare settings and specifies annual screening for persons at high risk for HIV infection.15 HIV testing should be included in routine prenatal screening tests for all pregnant women. Repeat screening is recommended during the third trimester for those in areas with elevated rates of HIV infection. The guidelines also state that one's general consent for medical care should encompass consent for HIV testing and that separate written consent for HIV testing should not be required. The usual laboratory method for detecting and diagnosing HIV infection in the US is through the use of enzyme immunoassay (EIA) screening, and confirmation with a more specific test such as the Western blot test. The EIA tests detect antibodies produced by the body's immune response to the infection, rather than the virus itself and are greater than 99% accurate. False positive results are possible in individuals with collagen-vascular diseases, chronic hepatitis, malaria, or certain HLA phenotypes. For Individuals whose infections are too recent for antibody production; a period of a few weeks to as long as 6 months may test false negative. A positive result should be re-tested. Currently, the standard confirmatory blood test is the Western blot test. An equivalent but seldom used test is the indirect immunofluorescent assay (IFA). The Western blot allows measurement of nine different antibodies that are likely to occur in the blood of people infected with HIV. Four rapid HIV tests, capable of results in less than 30 minutes, have been approved by the FDA. Their use is particularly relevant for women in labor who have not been tested during pregnancy, healthcare or emergency workers who are accidentally exposed to potentially infectious substances, and for the estimated 9,000 people who test positive at public testing sites each year and do not return for their results.16 Other tests used in the diagnosis, monitoring or investigation of HIV infection are: PCR (Polymerase Chain Reaction) -a sensitive technique used to detect and quantify HIV nucleic acids in a person's blood or lymph nodes. It is an FDA-approved test to measure viral load. NAT qualitative HIV-1 nucleic acid test used in the diagnosis of acute and primary HIV-1 infection; another method to confirm HIV-1 infection in those with tests repeatedly positive for HIV-1 antibodies. Viral culture - test utilized in diagnosing HIV infection in infants and in clinical research. P24-antigen - test detects a protein located in the viral core of HIV. It can be used in the diagnosis in infants and to routinely screen blood and plasma at collection centers. Orasure (saliva) and Home Access HIV-1 Test System: anonymous home collection systems for specimens that are mailed to laboratories to determine the presence of HIV antibodies. Note that many non-FDA approved home HIV tests are available for purchase through magazines and the internet. Their accuracy cannot be guaranteed. Specific tests for infants and children, as well as the classification of AIDS disease process are different from that for adults. Briefly summarized, the HIV antibody tests (standard EIA and Western Blot) are not reliable indicators of infection because of the presence of maternal antibodies in infants up to 15-18 months of age. The recommended test for exposed infants under the age of 18 months is the virus culture, PCR test, or p24 antigen assays. Diagnosis in a child over 18 months of age is usually determined by a positive EIA test confirmed by Western blot or IFA.17 HIV TESTING - FLORIDA LEGAL CONSIDERATIONS FLORIDA STATUTES TITLE XXIX CHAPTER 381.00418 specifies legal requirements relating to informed consent, counseling and confidentiality. Except in specific situations (Table 2), Florida state law requires that informed consent be obtained by an individual, or when necessary by their legal guardian or other person authorized by law, prior to HIV testing. Essentials included in this informed consent are the right to confidentiality, the availability of anonymous testing, and notification that positive HIV test results are reported to the county health department. Table 2. Florida Exceptions That Don't Require Informed Consent18 · testing for sexually transmissible diseases: -convicted prostitute -inmates prior to release -medical examiner investigation of cause and manner of death -pregnant women (required with prenatal care but woman may decline test via signed written objection) · blood, organ or tissue donation · medical emergencies when care depends on results · where consent is detrimental to the patient · licensed medical personnel for diagnosis of acute illness and results are necessary for care of the person · as part of an autopsy with general consent · exposure of medical personnel if specific guidelines are followed · defendant upon a victim's request in prosecution of sexual battery where a blood sample is taken from the defendant voluntarily or pursuant to court order · mandated by court order · epidemiological research Florida law allows individual medical practices to handle communication of test results to an infected individual as they deem appropriate, but strict confidentiality provisions and penalties for violation apply. Alternatively, county health departments and registered testing sites are required to provide face-to-face counseling about the meaning of the test results, the possible need for additional testing, measures for the immunodeficiency virus infection, the availability in the geographic area of appropriate healthcare services, and the benefits of locating and counseling any individual that exposed the individual or may have been exposed by the infected individual. Healthcare professionals attending pregnant women are required to counsel them to be tested, and if positive discuss available treatment. If refused by the woman, reasonable steps should be taken to have a signed written statement of the objection placed in her medical record. If HIV testing is offered and refused, the provider of the service is immune from liability if a child contracts HIV/AIDS from the mother (s. 384.31). Florida law provides for confidentiality. It states that no person who has obtained or has knowledge of a test result may disclose or be compelled to disclose the identity of any person upon whom a test is performed, or the results of the test except to the person tested, those with a legally effective release, medical personnel with a need to know, those with a court order, employees of child-placing or caring agencies, and medical personnel who have experienced a significant exposure during work. The Florida department of health has established voluntary HIV testing programs in every county to provide counseling and testing on an anonymous or confidential basis, as desired by the patient. Test results obtained under HRS auspices shall not be used to determine insurability for disability, health or life insurance or to screen or determine suitability for or to discharge a person from employment. Any person who maliciously, or for monetary gain, breaches the confidentiality of sexually transmitted disease information commits a felony of the third degree. The state of Florida recognizes the importance of preventive education, early testing, and aggressive treatment. Floridians have access to a state-wide hotline 1-800-FLA-AIDS (1-800-352-2437), and the state honors the US National Testing Day, June 27th, each year. PREVENTION The most effective means of HIV/AIDS prevention is avoidance of behaviors that place a person at risk for the disease. Behaviors to be avoided are primarily unprotected sexual activity and sharing needles and/or syringes for injecting drugs. Preventing Sexual Transmission Avoiding unprotected sex is also termed safer sex and includes knowledge of sex partners, their sex practices, their possible drug experiences, and the consistent use of latex or polyurethane condoms and lubricant. While abstinence is the ultimate protection from sexual transmission of HIV, monogamy in sexual relationships is a safer precautionary measure.19 Preventing Injection Drug Transmission For injecting drug users who can't or won't stop injecting drugs, using sterile equipment is the safest means of preventing HIV transmission. For those who persist in sharing injection paraphernalia, the use of bleach to cleanse and disinfect the needles and syringes or boiling these items in water has been suggested as a potential, but less reliable, method to prevent viral transmission.20 Preventing Perinatal Transmission Identification of HIV positive pregnant women, their treatment, and perinatal prophylaxis efforts have dramatically reduced this type of transmission in the US. Women who do not use anti-HIV therapies transmit the disease to their infants at a higher rate (22.6%)21 compared to those who do (1.2-1.5%, with combination antiretroviral therapy).22 Cesarean delivery, perinatal combination antiretroviral agents, and ART regimens that reduce maternal HIV RNA to < 1,000 copies/mL have been associated with reduced perinatal transmission of HIV. Management information evolves rapidly. For the most recent related information the participant is referred to the AIDS info Web site (http://AIDSinfo.nih.gov). Prevention - HealthCare Personnel In a work related setting, the use of measures to prevent exposure by healthcare personnel (HCP) to blood and body fluids is the primary method for preventing occupationally acquired HIV. When these measures are breached, post-exposure prophylaxis (PEP) with antiretroviral medications can be considered. Current recommendations are derived from two factors 1) the risk for HIV infection based on type of exposure, and 2) what is known of efficacy and toxicity for various antiretroviral agents. Recommendations address evaluation of the infectious source, exposure type, monitoring, and management for possible and actual exposure to these viruses. The risk of HIV transmission after a percutaneous exposure to HIV-infected blood is relatively small (0.3%) and lower with mucous membrane exposure (0.09%).23 In an early retrospective case-control study of healthcare personnel, ZDV PEP was associated with a reduction in the risk of HIV infection of approximately 81%. Decisions regarding PEP should begin with the evaluation and classification of the exposure followed by the selection of a regimen suitable for the exposure. Currently, regimens of two or more ART agents are recommended on the basis of the level of risk for HIV transmission presented by the exposure. If HIV PEP is initiated, it should be done as soon as possible (within hours). Since most occupational exposures do not result in transmission of the virus and PEP is potentially toxic, reevaluation of the exposure and source is encouraged within 72 hours. If the source is determined to be HIV-negative PEP should be discontinued. Table 3 lists resources to assist with PEP. Table 3. PEP Information Resources · PEPline at http://www.nccc.ucsf.edu/; telephone 888-448-4911; · HIV Antiretroviral Pregnancy Registry at http://www.apregistry.com/index.htm; Address: Research Park, 1011 Ashes Drive, Wilmington, NC 28405. Telephone: 800-258-4263; Fax: 800-800-1052; E-mail: registries@Kendle.com; · FDA (for reporting unusual or severe toxicity to antiretroviral agents) at http://www.fda.gov/medwatch; telephone: 800-463-6332; address: MedWatch, HF-2, Food and Drug Administration, 5600 Fishers Lane, Room 12B05,Rockville, MD 20857; · CDC (for reporting HIV infections in HCP and failures of PEP) at telephone 800-893-0485; · HIV/AIDS Treatment Information Service at http://aidsinfo.nih.gov. Prevention Non-occupational Exposure Based on the efficacy of PEP demonstrated in HCPs and other observational studies where non-occupational postexposure prophylaxis (nPEP) was utilized in situations of high-risk for HIV transmission, DHHS has offered recommendations for nPEP.24 Generally, treatment in these instances is determined by the risk of transmission from their exposure (Table 4), and the elapsed time since exposure. Persons deemed to have negligible exposure risk or those occurring more than 72 hours prior to seeking help should not receive nPEP. Individuals with substantial exposure risk occurring within 72 hours should receive nPEP if the source is known to be HIV positive. If the source is of unknown HIV status and the exposure risk is substantial, the benefits and risks of nPEP should be evaluated on a case by case basis. Where appropriate, risk-reduction counseling and other intervention services should be provided in an attempt to decrease the risk for subsequent exposures. Therapy for nPEP consists of a 4 week course of combination antiretroviral therapy. Table 4. Non-occupational HIV Exposure Risk24 Substantial Exposure of: vagina, rectum, eye, mouth, or other mucous membrane, non-intact skin, or percutaneous contact With: blood, semen, vaginal secretions, rectal secretions, breast milk, or any body fluid that is visibly contaminated with blood When: the source is known to be HIV-infected Negligible Exposure of: vagina, rectum, eye, mouth, or other mucous membrane, non-intact skin, or percutaneous contact With: urine, nasal secretions, saliva, sweat, or tears if not visibly contaminated with blood Regardless of: known or suspected HIV status of the source CLINICAL MANAGEMENT The clinical management of individuals who are HIV positive can be defined as the care, treatment, and services required indefinitely from the time of diagnosis. Due to differences in immune system development at the time of infection and changes in organ function, unique considerations are needed for HIV-infected infants and children. Refer to Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection at http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf for the most current treatment information for this patient population. A baseline medical evaluation to establish a reference point for recognizing early changes and signs of opportunistic infections and formulate a treatment strategy to delay disease progression is essential. A complete history and physical should be performed to assess for additional sexually transmitted diseases, tuberculosis, hepatitis B or C, mental health status, current nutritional needs, and any other appropriate referrals. Assessment and consideration of comorbid conditions must be factored into the long-term treatment plan. Education about HIV infection and the disease process enables the individual to be more knowledgeable about self-care. The patient should also be made aware of the importance of support groups and stress management methods. Education on viral transmission is essential. Clinical management is influenced by the signs and symptoms the patient exhibits and to an increasing extent, is based on laboratory values. A complete blood count, chemistry profile (including serum transaminases and lipid profile), CD4+ T cell count, and plasma HIV RNA measurement is recommended.25 CD4+ levels provide information about the disease progression and the status of the immune system. This information is useful in determining the need for OI prophylaxis. Plasma HIV RNA measures the quantity of the virus in the blood and indicates the rate of its replication. It is a strong prognostic indicator in HIV infection. Reductions achieved with antiretroviral therapy correlate with clinical improvements. Since up to 16% of HIV infected patients naive to ART demonstrate drug resistance, genotypic drug resistance testing is recommended to assist with ART selection for both treatment-naive and experienced patients. Other tests for patient evaluation may include those: pertinent to the prevention of OIs: RPR or VDRL, tuberculin skin test, toxoplasma IgG serology, hepatitis virus B and C serology , and gynecologic exam with Pap smear, etc. clinically indicated: chest X-ray, cytomegalovirus (CMV) serology, ophthalmologic exam, etc. ANTIRETROVIRAL THERAPY The cornerstone of clinical management is the eventual use of ART. Goals for treatment are to reduce HIV-related morbidity and prolong survival; improve quality of life; restore and preserve immunologic function; maximally and durably suppress viral load; and, prevent vertical HIV transmission.25 At this time, treatment is the most dynamic aspect of disease management, but detailed presentation is beyond the scope and intent of this educational activity. Additionally, development of new treatments and strategies, and the accumulation of clinical trial and experience data continually reshape treatment recommendations. For complete information on treatment and related topics the participant is referred to the most current source of information, the AIDS info Web site (http://AIDSinfo.nih.gov). Appropriate ART selection, maximal adherence to the regimen, rational sequencing of drugs, preservation of future treatment options, and resistance testing are tools to accomplish the goals of therapy. ART selection must be effective, accommodate patient lifestyle and comorbidities, and avoid significant drug interactions. Patient involvement and education is a start to encourage regimen adherence but some may need additional support for issues with substance abuse or depression. Drug sequencing is necessary to preserve treatment options for salvage therapy when previous combinations fail and to minimize certain class-specific side effects. Efficacy of antiretroviral treatment is determined through plasma HIV RNA measurements which are expected to show a rapid decrease after 1-4 months treatment and no detectable virus at 3-4 months after treatment initiation. These numbers are not absolute as baseline viral load, CD4 count, and other patient factors will impact the degree of response. To date there are more than 20 FDA approved antiretroviral drugs, involving six different mechanisms of action, from which combination ART can be formulated. These include, in order of FDA approval, the nucleoside reverse transcriptase inhibitors (NRTIs), protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), fusion inhibitors, integrase inhibitors, and most recently a CCR5 antagonist. Fusion and CCR5 inhibitors prevent HIV from entering healthy T-cells while all other drugs within these categories target actively HIV infected T-cells.25 ART has transformed a predictably fatal disease into one that is chronic and manageable for those in whom it is accessible.26 When to Initiate Antiretroviral Agents The trend is for earlier initiation of ART based on data from clinical trials using newer effective and more tolerable therapies in infected individuals. Still antiretroviral therapies are complex, have major side effects and can be detrimental if adherence to therapy is incomplete due to the likely development of viral resistance. For these reasons initiation of ART is recommended for patients with history of AIDS-defining illness or CD4 T-cell count < 350 cells/mm3; pregnant women; patients with HIV-associated nephropathy; and patients co-infected with hepatitis B virus (HBV) and requiring treatment for hepatitis B. The necessity for patient adherence to long-term therapy has to be emphasized and potential barriers identified and addressed prior to starting ART. Patients not in a previously mentioned category with a CD4 T-cell count >or= 350 cells/mm3 may be considered for ART (Table 5) depending on the risks and benefits. Table 5. Considerations For Early ART in Asymptomatic Patients with >or= 350 cells/mm3 CD4 T-Cell Count 25 Potential Benefits: · Maintenance of higher CD4 count; prevent potentially irreversible immune system damage · Decreased risk for HIV-associated complications that may occur at higher CD4 T-cell counts · Decreased risk of nonopportunistic conditions, such as CV, renal, and liver disease, and non-AIDS-associated malignancies and infections · Decreased risk of HIV transmission to others Potential Risks: · Treatment-related side effects and toxicities · Drug resistance due to inadequate viral suppression and loss of future treatment options · Insufficient time to learn about the condition and prepare for adherence to therapy · Increased treatment time and possible treatment fatigue · Incurring treatment before new drugs or combinations determined to be more effective and less toxic are available · Transmission of drug-resistant virus by patients not maintaining full virologic suppression The expert panel for DHHS has identified antiretroviral drugs that are acceptable for treatment-naive patients. The recommendations, which stem from amassed clinical experience, are for 2NRTI agents with either a NNRTI or a PI (with or without ritonavir boosting).25 Which among the preferred or alternate agents to use is determined by factors such as comorbid conditions, adverse drug effects, drug-drug interactions, pregnancy or its potential, drug resistance, gender and pretreatment CD4 T-cell count if considering nevirapine (increased serious hepatic events), HLA-B*5701 testing if abacavir to be used (genetic variation associated with hypersensitivity), and likelihood of patient compliance. Side effects are common with the antiretrovirals and depending on the agent may include gastro-intestinal intolerance, hematological alterations, neuropathies, rash, elevated blood sugar, elevated serum lipids, fat redistribution, hepatitis, kidney stones, and others. Side effects can be exaggerated with combination drug therapies possessing overlapping effects and toxicities. Side effects are most manageable with the NRTI class. They increase with the NNRTIs and are most frequent and bothersome with the PIs. Toxic effects may result from ART and therapies used to manage other medical conditions (e.g. additive hepatotoxicity from select antihyperlipidemics, antihyperglycemics, antifungals, with antiretrovirals). Drug interactions are an increasingly significant issue. As new drugs and combinations are used, new interactions are discovered. Some are beneficial and can be utilized to optimize drug therapy. Such is the case with some combination protease inhibitors where pharmacokinetics are altered and plasma drug concentrations of one or both are increased, allowing for reduced frequency of administration and/or total daily dose (e.g. low dose ritonavir added to a PI such as amprenavir, atazanavir, indinavir, lopinavir, or saquinavir). Others can create toxicities or cause treatment failures from decreased serum levels. Practitioners must continually monitor for drug interactions and utilize contemporary resources to investigate the evolving issue of drug interactions. Antibiotic, antifungal, and other antiviral drugs are used for prophylaxis or treatment of opportunistic infections. Multiple other agents, such as anti-diarrheal drugs, analgesics, and appetite stimulants, are used to treat symptoms. Blood modifiers may be required to counter adverse effects of other necessary medications. Medications for children with AIDS do not include all of those approved for adults. Physicians may legally prescribe these drugs, but many have not been widely tested in children and pediatric data is lacking. Regimen Revision Due to Treatment Failure Failure rates for first-line antiretroviral therapy have been identified to be in the range of 10% to 60%.27 Consequently, eventual changes in ones antiretroviral regimen might be necessary. Treatment failure may be manifest by virologic failure, immunologic failure or by clinical progression. A sub-optimal reduction in plasma viremia (HIV RNA > 400 copies/mL after 24 weeks, >50 copies/mL after 48 weeks) or re-appearance of viremia after successful suppression is indicative of virologic failure.25 Immunologic failure occurs if treatment and viral suppression fails to increase CD4+ T cell count. Various measures are used but a threshold level of 350 or 500 cells/mm3 may be preferred.25 Clinical progression is defined as the occurrence or recurrence of HIV-related events after at least 3 months on an antiretroviral regimen. An HIV RNA and CD4+ cell count should be obtained every 3 to 6 months in patients on antiretroviral therapy. Causes for failure include noncompliance, pharmacokinetic factors, intolerability, virologic impotence, and resistance and the potential for each must be carefully evaluated. Resistance testing, while taking the failing regimen or within 4 weeks of discontinuation, is recommended for new regimen selection. Guidelines advise on appropriate regimen revision strategies depending on previous drug use and resistance. Referral to a clinician experienced in the care of HIV infected patients is strongly recommended. Therapeutic Drug Monitoring Antiretroviral therapeutic drug monitoring (TDM) is a possible strategy to navigate through concentration associated toxicities and treatment failures. Currently there is data supporting TDM for the NNRTI and PI antiretroviral drugs. These drugs exhibit concentration related responses (efficacy, toxicity) and also may have significant inter-patient variability among those taking the same dose. TDM may be a useful tool in evaluating toxicities or drug failure due to drug-drug or drug-food interactions, physiologic changes or pathophysiologic states, alternative unproven dosing regimens, or unexpected response, but are not recommended for routine use. Treatment Interruption or Discontinuation ART may be temporarily discontinued because of acute illness, drug toxicity, or surgery. Generally, if any antiretroviral is stopped, all agents should be discontinued simultaneously so as to decrease the emergence of resistant viral strains. Such patient's clinical and laboratory status should be followed closely and prophylaxis for OIs offered if CD4 cell counts warrant. Structured or supervised treatment interruptions (STI) have been evaluated for salvage therapy, auto-immunization to heighten ones immune control of HIV, and to decrease the total time on antiretroviral therapy. Data supporting STI is limited and doing so is not recommended in current published guidelines. The most compelling evidence discouraging this practice to date are the results from a randomized trial where episodic ART resulted in significantly increased risk of OI or death compared with continuous therapy.28 Additionally, no reduction in the risk of adverse events associated with ART was observed in the episodic therapy group. Opportunistic Infection Prophylaxis HIV-infected adults and adolescents, including pregnant women and those on ART, should receive chemoprophylaxis against opportunistic infections when the disease has impaired one's immune status as demonstrated by their CD4+ cell count and/or clinical presentation. Types of OI prophylaxis with strong evidence for efficacy and substantial clinical benefit which should always be offered include: Cotrimoxazole to prevent Pneumocystis (carinii) jiroveci pneumonia (start when CD4+ < 200 or with occurrence of oropharyngeal Candidiasis). Cotrimoxazole for primary Toxoplasma gondii (start if positive Toxoplasma IgG antibody and CD4+ < 100). Azithromycin or clarithromycin are the agents of choice as prophylaxis for mycobacterium avium complex (CD4+ count < 50). Alternative agents can be considered should these be contraindicated or not tolerated. FUTURE TRENDS IN MANAGEMENT/TREATMENT ART, for those able to access it, has dramatically changed the face of AIDS and transformed it to that of a chronic, long-term illness. Treatment is not cheap. A recent estimate in US dollars of the cost for the lifetime HIV care of an individual is $618,900.30 Despite the advances with ART, several problems resulting in treatment failure, such as viral resistance and drug toxicities, persist. Research continues the quest for the development of an effective vaccine and novel therapies and mechanisms to suppress viral replication. Currently no vaccine is FDA approved and available for use, but more than 30 vaccines have been investigated.31 Possibilities continue to grow with the recent report of discovery of over 250 proteins that, if blocked, interfere with the undesirable effects of HIV.32 Multiple agents that interfere with the various stages of HIV's life-cycle as well as better tolerated and simpler therapies for existing treatment mechanisms continue to be developed thus broadening treatment options. Other research activities include a continued attempt to define the most appropriate time to start ART, and the impact of herpes simplex, hepatitis B, and hepatitis C co-infections on HIV management. SUMMARY The continued presence of HIV/AIDS in our society presents ongoing challenges. If we have learned anything in public health, it is the unfortunate reality that the dissemination of information alone does not change human behaviors. Social struggles against drug use, alcoholism, tobacco use, mental illness, and several other health conditions including HIV/AIDS seek to educate and inform, but that is merely the tip of the iceberg in any effort to change one's behavior. The need to achieve increased awareness must take place on a number of levels and on an ongoing basis. Ironically, some believe advances in drug therapy (such as ART) may contribute to the occurrence of new cases. Effective medication regimens that suppress recognizable symptoms may give rise to a degree of complacency where preventative behaviors are concerned; some may tend to forget that transmission of the disease is still a very real danger. As treatment for HIV infection improves, people are living longer and associated care has transformed to that of a chronic, long-term illness. Researchers seek the development of an effective vaccine and other therapies to suppress viral replication, but the physical characteristics of this resilient virus have not made this an easy task. Healthcare professionals routinely encounter persons infected with HIV. This has great significance when considering our aging US population and their associated co-morbid health conditions. For optimal care of infected individuals, healthcare professionals should remain current with information on the disease process and basic clinical management. RESOURCES There are many national, regional, and state resources available to communities. A few of them are listed below. Departments of Public Health may be contacted for additional resources and the Internet offers a vast resource for HIV/AIDS related readings and concerned organizations. NATIONAL RESOURCES AIDSinfo (treatment, prevention & research) 1-800-448-0440 www.aidsinfo.nih.gov CDC INFO 888-232-6348 (TTY) 888-232-4636; mailto:cdcinfo@cdc.gov http://www.cdc.gov/hiv/contact.htm CDC National Prevention Information Network 800-243-7012 (TTY) 800-458-5231; info@cdcnpin.org http://www.cdcnpin.org/scripts/index.asp US National Library of Medicine HIV/AIDS Information http://sis.nlm.nih.gov/hiv.html MedlinePlus AIDS page: http://www.nlm.nih.gov/medlineplus/aids.html National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) http://www.niaid.nih.gov/daids/ HIV-Drug interactions, University of Liverpool www.hiv-druginteractions.org University of California, San Francisco HIV InSite http://hivinsite.ucsf.edu Johns Hopkins HIV GUIDE www.hopkins-aids.edu HIV Resource for Health Professionals www.thebodypro.com FLORIDA RESOURCES Florida AIDS Hotline English: 800-352-2437 Creole: 800-243-7101 Spanish: 800-545-7432 TTY: 800-503-7118 Web www.211bigbend.org/hotlines/hiv/index.htm Florida Alcohol and Drug Abuse Association: 904-878-2196 Department of Health: HIV/AIDS community assistance- www.myflorida.com Bureau of HIV/AIDS-www.doh.state.fl.us/disease_ctrl/aids/index.html Project Inform - Florida Statewide Resources- http://www.projinf.org/org/Regionrsrc/FL.html REFERENCES 1. 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Philadelphia, PA: Churchill Livingstone. 8. DHHS/NIAID. How HIV causes AIDS. http://www.niaid.nih.gov/factsheets/howhiv.htm. (Accessed October 12, 2008). 9. Schackman BR, Gebo KA, Walensky RP, et al. The lifetime cost of current human immunodeficiency virus care in the United States. Med Care. 2006;44:990-7. 10. Fleming DT, Wasserheit JN. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999;75:3-17. 11. CDC. HIV and Its Transmission. http://www.cdc.gov/hiv/resources/factsheets/transmission.htm (Accessed 11/12/2008). 12. Alter HJ, Klein HG. The hazards of blood transfusion in historical perspective. Blood 2008;112:2617-2626. 13. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report 2006. Vol. 18. 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