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-----------------------------------------------------------------------------------------------------------------REPORT OF THE MONTH, Volume V, Number 4 – July - August 2001 - - - - from the North Carolina Statewide Program for Infection Control and Epidemiology -----------------------------------------------------------------------------------------------------------------CONTENTS: NEWS/REGULATORY Management of Occupational Exposures to Hepatitis B, Hepatitis C, and HIV REGULATORY/QUESTION OF THE MONTH Small Hospitals Complying with New CDC Occupational Exposure Guidelines NEWS AND ANNOUNCEMENTS COURSES FOR THE INFECTION CONTROL PROFESSIONAL -----------------------------------------------------------------------------------------------------------------NEWS FEATURES Management of Occupational Exposures to Hepatitis B, Hepatitis C, and HIV The following memorandum is from Kelly T. McKee, Jr., M.D., M.P.H., General Communicable Disease Control Branch, Epidemiology Section, North Carolina Division of Public Health. Summary: Management of Occupational Exposures to Hepatitis B, Hepatitis C, and HIV NC Division of Public Health, Epidemiology Section July 18, 2001 Recently, the Centers for Disease Control and Prevention (CDC) issued updated guidelines for the management of occupational exposures to bloodborne pathogens (MMWR 50/RR-11, 29 June 2001 Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis). These guidelines represent a synthesis of recommendations published by CDC (and OSHA) over the past several years in a variety of forums, and reflect the current state of knowledge regarding risks of contracting Hepatitis B, Hepatitis C, and HIV following percutaneous or mucous membrane exposure to blood and body fluids. Additionally, these guidelines summarize current information on, and recommendations for, post-exposure prophylaxis (PEP) for each of these pathogens. Below is a comparison of the changes from previous recommendations. Note that this summary is NOT intended to substitute for a careful review and analysis of the complete CDC document by responsible individuals at the local level. The complete CDC document can be found at: http://www.cdc.gov/mmwr//preview/mmwrhtml/rr5011a1.htm Each local health department should ensure that a plan is in place for management of occupational exposures to blood and body fluids. Emphasis must be placed on prompt assessment of incidents by individuals experienced in the management of HIV, familiar with anti-retroviral therapy, and knowledgeable about drug resistance and its impact on choice of post-exposure prophylaxis regimens. It is incumbent on each health department to identify local and/or regional resources capable of responding knowledgeably and in a timely fashion. Telephone consultation on these matters is available through the Statewide Program for Infection Control and Epidemiology (SPICE) at 919-966-3242; however, this should not substitute for local response capability. _____________________________________________________________________ UPDATES NEW TO 29 JUNE 01 PHS GUIDELINES _____________________________________________________________________ HIV: Last guidelines 1998 (15 May 98; MMWR 47/RR-7). Better definition of “less severe” and “more severe” exposure types driving 2 vs. 3 drug PEP regimens. New anti-retroviral agents approved by FDA; modified PEP recommendations. More info about the use and safety of PEP. For all drugs, much more info on tolerability, toxicities, advantages/disadvantages. OLD: Basic: 4 weeks (28 days) AZT (600 mg qd-divided doses) PLUS lamivudine (3TC) (150 mg bid); Expanded: Basic regimen PLUS indinavir (800 mg tid) OR nelfinavir (750 mg tid) NEW: Basic: 4 weeks (28 days) AZT (600 mg qd-divided doses) PLUS lamivudine (3TC) (150 mg bid) OR lamivudine (150 mg bid) PLUS stavudine (d4T)(40 mg bid) OR didanosine (ddI)(400 mg qd) PLUS stavudine (40 mg bid); Expanded: Basic regimen PLUS indinavir (800 mg tid) OR Nelvinavir (750 mg tid or 1250 mg bid) OR efavirenz (600 mg qd) OR abacavir (300 mg bid) OR ritonavir OR saquinavir OR amprenavir OR delavirdine OR lopinavir/ritonavir. Recommended NOT TO USE nevirapine. HBV: Last comprehensive CDC guidelines 1997 (26 December 1997; MMWR 46/RR-18); included as part of supplement on vaccination of Health Care Professionals (HCPs). OLD: No significant differences in management of PEP between OLD and NEW. NEW: Consolidates and packages information previously provided into single document. More elaboration of factors to consider in assessing need for PEP and evaluation of exposure source. Emphasis on follow-up and counseling. HCV: Last guidelines 1998 (MMWR 1998 47/RR-17). At the present time, the State Laboratory for Public Health is not resourced to support Hepatitis C diagnostic testing; individual arrangements must be made by local health departments for this activity. Recently, the General Communicable Disease Control Branch in Raleigh contracted with the Office of Continuing Education at the University of North Carolina-Chapel Hill School of Medicine to provide a series of CME presentations across the state on Hepatitis C Awareness. The schedule for these presentations is under development, and will be distributed soon. OLD: Post-exposure follow-up of health-care, emergency medical, and public safety workers for hepatitis C virus (HCV) infection. For the source, baseline testing for anti-HCV. For the person exposed to an HCV-positive source, baseline and follow-up testing including baseline testing for anti-HCV and ALT activity; and follow-up testing for antiHCV (e.g., at 4-6 months) and ALT activity. (If earlier diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 4-6 weeks). Confirmation by supplemental anti-HCV testing of all anti-HCV results reported as positive by enzyme immunoassay. NEW: Post-exposure follow-up for HCV For the source, perform testing for anti-HCV. For the person exposed to an HCV-infected source: perform baseline testing for antiHCV and ALT activity; and perform follow-up testing (e.g., at 4-6 months) for anti-HCV and ALT activity (if earlier diagnosis of HCV is desired, testing for HCV RNA may be performed at 4-6 weeks). Confirm all anti-HCV results reported positive by enzyme immunoassay using supplemental anti-HCV testing (e.g., recombinant immunoblot assay [RIBA]). Health care personnel who provide care to persons exposed to HCV in the occupational setting should be knowledgeable regarding risks for HCV infection and appropriate counseling, testing, and medical follow-up. IG and antiviral agents not recommended. No guidelines exist for administration of therapy during the acute phase of HCV infection. When HCV identified, prompt referral is appropriate (because antiviral therapy might be beneficial when started early in course of HCV infection). BOTH HBV and HCV: No modifications to an exposed person’s patient-care responsibilities are necessary to prevent transmission to patients based solely on exposure to HBV or HCV-positive blood. If an exposed person becomes acutely infected with HBV, the person should be evaluated according to published recommendations. No recommendations exist regarding restriction of activities of HCPs with HCV infection. All chronically-infected HCPs (with HBV or HCV) should follow recommended infection control practices (published). ____________________________________________________________________ For additional information contact: General Communicable Disease Control Epidemiology Section NC Division of Public Health 1902 Mail Service Center 225 N. McDowell Street Raleigh, NC 27699-1902 Phone: (919)733-3419 Fax: (919)733-0490 REGULATORY/LEGISLATIVE QUESTION OF THE MONTH Small Hospitals Complying with New CDC Occupational Exposure Guidelines Q: How can a community hospital without an infectious disease or occupational health specialist determine which regimen of drugs to give for each individual bloodborne pathogen exposure? A: Acknowledging the increasing complex factors involved in post-exposure prophylaxis for HIV, the CDC is advising confused clinicians to call for expert consultations before administering the potentially toxic drugs. In addition, the June 29, 2001 edition of the MMWR Recommendations and Reports outlines several special circumstances (e.g., delayed exposure report, unknown source person, pregnancy in the exposed person, resistance of the source virus to antiretroviral agents, or toxicity of the PEP regimen) when consultation with local experts and/or the National Clinicians' Post-Exposure Prophylaxis Hotline ([PEPline] 1-888-448-4911) is advised. A second means of obtaining expert advice regarding the new PEP regimens is a website. The following press release issued by the CDC announced a UCLA Emergency Interactive Website to help healthcare workers exposed to patient bodily fluids. One of the most frightening experiences for healthcare workers is sustaining an accidental needlestick or bodily fluid splash and thus facing the possibility of exposure to HIV, hepatitis or other diseases patients carry. To help doctors, nurses and other healthcare professionals make decisions about how to manage such occupational exposures, the UCLA Department of Emergency Medicine has developed an interactive Website. The Website, named "Needlestick," was funded by the Centers for Disease Control and Prevention (CDC). It is based upon new guidelines that CDC released June 29 for managing and documenting occupational exposures to blood and other body fluids. The original research leading to the website's development was sponsored by the Agency for Healthcare Research and Quality (AHRQ). With AHRQ funding, researchers studied real-time access to clinical guidelines by emergency room healthcare workers exposed to body fluids. The site (www.needlestick.mednet.ucla.edu) functions as a smart electronic medical record. It guides the healthcare provider in acquiring relevant data and selecting appropriate laboratory tests and treatments. Once the case is complete, the healthcare provider may print case-specific aftercare instructions to be given to the exposed healthcare worker and included in the medical record. Each case is managed anonymously, because the site does not collect identifying information about the exposed healthcare worker or the source of the body fluid. Another advantage of this method of healthcare delivery is that when the CDC updates the occupational exposure guidelines again, modification of a single computer should change practices much more rapidly than traditional methods of information dissemination. from CDC Press Release NEWS AND ANNOUNCEMENTS Correction: In the Report of the Month, Volume V, Number 3, May-June 2001, article on "Prevention and Control of Program Downsizing" the first author of the abstract referenced is Calfee. "List of Sterilants and High Level Disinfectants Cleared by Food and Drug Administration in a 510(k) as of June 29, 2001 - Updated" is online at http://www.fda.gov/cdrh/ode/germlab.html "Control and Prevention of Rubella: Evaluation and Management of Suspected Outbreaks, Rubella in Pregnant Women, and Surveillance for Congenital Rubella Syndrome" was published by the Centers for Disease Control and Prevention (CDC) in the July 13, 2001 issue of MMWR Recommendations and Reports. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5012a1.htm "Vaccinia (Smallpox) Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001," which include bioterrorism responses, was published by the Center for Disease Control and Prevention (CDC) in the June 22, 2001, issue of MMWR Recommendations and Reports. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5010a1.htm A Guide to the Clinical Care of Women With HIV: 2001 -- First Edition has been published by the HIV/AIDS Bureau, Health Resources and Services Administration. It is the first guide specifically addressing medical treatment of women with HIV. Information about ordering free copies and downloading online is available at http://hab.hrsa.gov/womencare.htm CDC's Division of Global Migration and Quarantine (DQ), National Center for Infectious Diseases has released the 2001--2002 edition of Health Information for International Travel (The Yellow Book). The new edition contains updated vaccination information; updated information on malaria risk and prophylaxis (by country); updated and revised disease-specific text and tables; new sections on altitude sickness and international adoption; updated country listings; and improved maps and indexing. The Yellow Book can be purchased from the Public Health Foundation, telephone (877) 252-1200 or at http://bookstore.phf.org. specific web site: http://bookstore.phf.org/prod159.htm download from CDC for free at http://www.cdc.gov/travel/reference.htm In July ican, INC. announced that it is ceasing operations of its web site, icanPREVENT, because the company has been unsuccessful in reaching a break-even point in time to continue. COURSES FOR THE INFECTION CONTROL PROFESSIONAL "Infection Control Part II: The ICP as an Environmentalist" will be held September 10-14, 2001 at the Holiday Inn in Chapel Hill. "Infection Control in Home Health and Hospice" will be held October 8, 2001 at The Friday Center in Chapel Hill. -----------------------------------------------------------------------------------------------------------------Contributors to Report of the Month: Karen K. Hoffmann, RN, MS, CIC; William A. Rutala, PhD, MPH; David J. Weber, MD, MPH; Eva P. Clontz, MEd. -----------------------------------------------------------------------------------------------------------------To subscribe to the Report of the Month, send email to [email protected] Report of the Month is also available on the home page of the Statewide Program for Infection Control and Epidemiology at http://www.unc.edu/depts/spice/ The Statewide Program for Infection Control and Epidemiology (SPICE) is funded by the General Assembly of North Carolina to serve the State. SPICE is not a regulatory agency but provides education and consultation to North Carolina healthcare facilities. Copyright 2001 Statewide Program for Infection Control and Epidemiology