Scott Holmberg MD, MPH

Transcription

1 1 CDC UPDATED RECOMMENDATIONS FOR MANAGEMENT OF HEPATITIS B VIRUS (HBV) IN HEALTH CARE WORKERS AND STUDENTS Scott Holmberg, MD, MPH Chief, Epidemiology and Surveillance Branch, Division of Viral Hepatitis, CDC (sdh1@cdc.gov) Updated Recommendations for HBV-infected Healthcare Workers (HCWs) and Students Why do we need updated recommendations? Background and data sources Trends in regards HCWs/students with HBV Prevention strategies Technical issues in providing guidelines Recommendations Process Why do we need recommendations? About ¼ of entering medical and dental students are of Asian descent; many others from or born to mothers from highly endemic countries (>2%) for HBV Numerous instances of confusion how to handle HBV-infected surgeons, students, dentists Examples from : Several med, osteopathic and dental students accepted, then denied matricula-tion or, if enrolled, evaluated for dismissal Surgeon required to be tested weekly and demonstrate no viral load BACKGROUND In 1991, CDC provided recommendations for preventing transmission of HIV and HBV to patients during exposure-prone invasive procedures. At the time, these went through considerable internal debate, in large part related to HIV 6 The 1991 Recommendations No restriction on anyone not performing exposure prone procedures (EPPs) OSAP 2013 SYMPOSIUM 1

2 EPPs to be defined by institution HCWs performing EPPs need to work under guidance of an expert panel (not defined) HCWs doing EPPs need to inform prospective patients (both HBV and HIV) Attempt in to update guidelines Clear that adjuration to inform prospective patients was unworkable Attempt to update recommendations for HIV, HBV and HCV (HIV still main focus) Definition of EPPs attempted Nonetheless, updated recs eventually nixed at CDC Director s office Society for Healthcare Epidemiology of America (SHEA) Guidelines 2010 Addressed HIV, HBV, and HCV Suggested composition of expert panels to review work of those performing exposure prone procedures Importantly, SHEA guidelines attempted to define and list such procedures But these recommendations have not been viewed as definitive as federal guidelines Important trends in the 20 years since CDC s 1991 Guidelines Rates of HCW/student transmission to patients Nat l trends in HBV incidence and prevalence Treatments for chronic HBV Other recent guidelines Rates of health care worker/student transmission to patients Standard precautions incl double gloving have almost eliminated risk Several instances of patient-to-patient transmission detected, but Since 1992, only one instance in the US of transmission from an HBV-infected surgeon to 2-8 patients in (unaware of his infection; had very high VL > 17m IU/ml) Rates of health care worker/student transmission to patients (critical to our thinking) No transmission from dentists or dental surgeons since 1987 Never any documented (or suspected) transmission from a medical, dental or osteopathic student National trends in acute hepatitis B incidence Vaccine based elimination strategy (1991) High infant, child vaccine coverage 3,371 reported/ 37,000 est. acute infections in 2009; 95% among at-risk adults National trends in acute hepatitis B incidence The converse situation patient-to-hcw transmission-- has also improved; Occupational (needlestick) exposure cited by acute HBV cases: > 10,000 in 1983 ~ 400 in 2002 < 100 since 2006 (40 in 2010) Treatments for chronic HBV (as could be used for HCWs and students) Continually improving: OSAP 2013 SYMPOSIUM 2

3 5 nuceloside analogues Recent two, entecavir and tenofovir, highly efficacious Rx can now reduce HBV DNA levels ( viral load ) to undetectable or near undetectable levels Other Guidelines: consistency? Prevention issues and strategies Standard Precautions Work practice/engineering controls Testing and vaccination of HCWs and students 17 Standard Precautions [many engendered by HIV/AIDS epidemic] Attention to universal (standard) infection control practices (eg double-gloving) Work practice controls (eg, no recapping of needles) Adherence to standards of cleaning and reusing patient care equipment Work practice and engineering controls, for example: Puncture-resistant needle and sharp object disposal containers; Use of ports and other needleless vascular access when possible; and No unnecessary intravenous catheters (protected needle infusion systems) Testing and vaccination of HCWs 2011 Am. Council on Immunization Practices (ACIP)/CDC recommended testing of HCWs and vaccination of all those found to be susceptible Already by , est. 75% of HCWs had rec d the 3-dose vaccination series Technical issues Monitoring HBeAg vrs HBV DNA Assessing a safe level of HBV DNA Specifying exposure prone procedures Notification of patients of HBV-infection in HCWs Ethical considerations Guidance for Expert Panels Monitoring hepatitis B e-antigen (HBeAg) vrs HBV DNA (viral load) Used to be only assay for infectiousness of HBV-infected person Several transmissions (before 1994) from HBeAg-negative surgeons (UK) Several studies have shown high levels of HBV DNA despite HBeAg-negativity Thus, recommendations now use HBV DNA monitoring Assessing a safe level of HBV DNA in a person performing EPPs Only a handful of surgeons who have transmitted have had an assessment of their viral load OSAP 2013 SYMPOSIUM 3

4 Note: these have been, with one exception, studies of non-us surgeons Brief overview of surgeons who transmitted HBV: What is a safe level of HBV? Specifying exposure prone procedures (EPPs): the most difficult issue Most transmissions have occurred during (ob/gyn) surgery, usually in non-visualized, closed space, with puncture of surgeons gloves SHEA made an extensive list of possible EPPs CDC attempt specified: Digital palpation of a needle tip in a body cavity; and/or The simultaneous presence of a provider s fingers and a needle or other sharp object (eg bony spicule) in a poorly visualized or highly confined anatomic site. Notification of patients of a provider s HBV status Impractical; To our knowledge, never done; Viewed as an insurmountable barrier to medical or dental practice; and Not recommended in any guideline since 1991 Ethical Considerations: Balancing patient vrs. provider rights The abortive attempt at CDC Guidelines in enlisted 17 ethicists (in one room!) to assess recommendations (incl. for HIV) In 2011, we requested CDC Public Health Ethics Committee to review Opinion from 3 external professional medical ethicists..guidelines that allow HCWs with HBV to practice while requiring those with exposureprone procedures to be monitored strikes the right balance between patients rights and HCWs rights. This Committee also concluded that:..that infected providers inform patients of their HBV status is discriminatory and not warranted; and In regards medical and dental education: [T]here is no scientific or ethical basis for restrictions that medical and dental schools are placing on students, and these practices are detrimental to the professions as well as the individual students. Guidance for (institutional) expert panels for HCWs performing EPPs Appropriate members of an expert panel may include persons from: Practitioner s specialty Inf dis/hosp epidemiology dept Liver disease specialty The infected provider s own physician OSAP 2013 SYMPOSIUM 4

5 Ethical/legal counsel Hosp/school administration Publication in Morbidity and Mortality Weekly Report (Recommendations) ACTUAL RECOMMENDATIONS Chronic HBV infection should not preclude practice or study of medicine, surgery, or dentistry All HCWs and students should receive vaccination per current CDC/ACIP recs Persons doing EPPs should receive pre-vaccination testing Actual Recommendations (continued) Exposure of any patient to blood of HBV-infected HCW/student should be handled analogously to the opposite situation (HCW exposed to HBV-infected blood): testing, prophylaxis, etc Those who do not perform EPPs Should not be subject to any restriction on activities or study Specifically, med/dental students: Do not need expert panel oversight Do not need to maintain low or undetectable viral load Should be treated as a matter of student/occupational health Those who do perform EPPs Strict adherence to standard precautions Need guidance/oversight by expert panel Need to maintain low viral load: CDC recommends HBV DNA < 1000 IU/ml (< 5000* GE/ml) Regular monitoring every 6 mos Refraining from EPP if > 1000 IU/ml (? spontaneous fluctuation vrs rx failure) * more than 1 log lower than lowest level in a transmitting surgeon CDC does not recommend: Too frequent demonstration of persistently undetectable viral load; Pre-notification of patients; Mandatory antiviral therapy; or Conformation to any restriction that essentially prevents practice or study CDC does recommend that: Hospitals, medical, osteopathic, and dental schools, and other institutions be aware of these guidelines and have written policies in place for the HCW or student found to be HBV-infected Experts/Organizations Consulted CDC: Office of Director, several Centers, NIOSH, External Ethics, etc Other Gov: NIH, US Dept of Justice Professional orgs: IDSA, AASLD, CSTE, OSAP, ACOEM, ADA CBOs: Hep B Fdn, Wang Ctr (NYC), Asian Liver Ctr OSAP 2013 SYMPOSIUM 5

6 Professional Education Organizations AAMC (Gabriel Garcia) AACOM (Stephen Shannon) ADEA (Anne Wells) Letter to schools of medicine and dentistry from Thomas Perez, US Asst Attorney General We write on behalf of the Department of Justice, the Department of Health and Human Services, and the Department of Education to inform you of the latest recommendations from the Centers for Disease Control and Prevention (CDC) regarding the participation of students who have hepatitis B in medical, dental, and other health-related programs. We also take this opportunity to emphasize the importance of these recommendations Although federal civil rights laws broadly prohibit discrimination on the basis of disability, those laws do not require schools of higher education to permit an individual with a disability to participate in particular activities if doing so would pose a direct threat to the health or safety of others. In determining whether an individual poses a direct threat to the health or safety of others, schools make an individualized assessment, based on a reasonable judgment that relies on current medical knowledge or on the best available objective evidence, to ascertain (1) the nature, duration, and severity of the risk, (2) the probability that the potential injury will actually occur, and (3) whether reasonable modifications of policies, practices, or procedures will mitigate the risk. The Departments of Justice, Health and Human Services, and Education share responsibility for protecting the rights of students and applicants with disabilities, including those who have hepatitis B. The Department of Justice is responsible for enforcing and implementing Title III of the Americans with Disabilities Act of 1990 (ADA), which covers private schools and other public accommodations. Moreover, the Departments of Justice and Health and Human Services both have enforcement authority under Title II of the ADA, which covers state and local government programs and services, including healthrelated public schools. In addition, the Departments of Education and Health and Human Services enforce Section 504 of the Rehabilitation Act of 1973 (Section 504) and Title VI of the Civil Rights Act of 1964 (Title VI) with respect to public and private schools that receive federal financial assistance from these agencies. In its updated recommendations, the CDC also noted several recent instances in which persons with hepatitis B have been threatened with dismissal or actually dismissed from surgical practice on the basis of their [hepatitis B virus] infection, and others have had their acceptances to medical or dental schools rescinded or deferred because of their infection. Some of these instances have involved the imposition of requirements on health-care providers, applicants or students with hepatitis B that are inconsistent with the CDC s current recommendations. Moreover, the Department of Justice and the Department of Health and Human Services have received, and are currently investigating, complaints against medical and dental schools around the country for allegedly discriminating against students and applicants with hepatitis B in violation of the ADA. OSAP 2013 SYMPOSIUM 6

7 The CDC s updated recommendations provide current medical information about managing students who have hepatitis B. The Supreme Court as well as the Departments of Justice, Education, and Health and Human Services places considerable weight on such guidance when analyzing whether there has been a violation of the ADA, Section 504, or Title VI. We strongly urge you to review your policies, practices, and procedures regarding students and applicants with hepatitis B in light of the CDC s updated recommendations and ensure that your institution is complying with its nondiscrimination obligations under the ADA and Section Actions by the US Department of Justice Two accepted students who were denied matriculation have been reinstated. The school has paid $75,000 in restitution to the 2 students At least one other student has been allowed to matriculate (w/o DoJ action) Thank you A difficult issue and I welcome your feedback, thoughts and questions. OSAP 2013 SYMPOSIUM 7