Careful planning critical to developing postexposure policies
Careful planning critical to developing postexposure policies
HEH readers share policies, warn of potential trouble spots
Emerging information about HIV antiretroviral drugs and concerns about the risk of transmission of hepatitis C to health care workers have complicated policies on follow-up of exposures to bloodborne pathogens.
Employee health practitioners have largely relied upon the neutral 1990 statement from the federal Centers for Disease Control and Prevention in Atlanta regarding the use of zidovudine (AZT, Retrovir) as chemoprophylaxis after exposure to HIV.1 Now, however, a recent study on postexposure use of the drug and information on newer drugs used to treat HIV have spurred the CDC to consider revising those guidelines. And many hospitals already are moving ahead with new policies for workers potentially exposed to bloodborne pathogens.
A working group comprising representatives from various federal public health agencies, including the CDC, met earlier this year for preliminary discussions on updating recommendations for postexposure chemoprophylaxis. The consensus was that prophylaxis should be offered in certain situations, says David M. Bell, MD, chief of the HIV infections branch of the CDC's hospital infections program.
"There's a feeling that for some types of exposures, prophylaxis should be recommended, for some types it should be offered, for some types it should be discouraged, and for some types it should not be offered," Bell tells Hospital Employee Health, adding that the group has not yet established the nature of those exposures, which drugs will be included, and in what doses.
New drugs considered
"We are looking at a variety of new drugs for HIV that have become available recently, and we're considering all of them," he says. Drugs being considered include lamivudine (3TC, Epivir) and the newly approved protease inhibitors. All of those drugs, including AZT, are licensed for HIV treatment, but not prophylaxis.
"Six years ago, there was much less known [about AZT], and there was only one drug, so the recommendations were strictly neutral," Bell says. "Now there is more of a feeling that prophylaxis ought to be offered in some situations."
One recent finding suggests AZT might be effective as postexposure prophylaxis, Bell notes. In a study of HIV seroconversion in HCWs after percutaneous exposure to HIV-infected blood, CDC researchers found that postexposure use of AZT may be protective. They caution, however, that the retrospective case-control study design used is not optimal for assessing the drug's efficacy.2 (See related stories in HEH, April 1996, pp. 47-48, and June 1995, pp. 79-81.)
The CDC's current guidelines, written in 1989, essentially state that exposed workers should be informed that no data exist to support the efficacy of AZT as postexposure prophylaxis; therefore, the CDC cannot recommend for or against its use. As a result, some employee health practitioners do not offer AZT, while others routinely offer the drug for certain types of exposures after explaining the risks and possible benefits.
Presently, if AZT prophylaxis is being considered, the CDC recommends that HCWs be counseled regarding:
* the theoretical rationale for postexposure prophylaxis;
* the risk of occupationally acquired HIV infection due to the exposure;
* the limitations of current knowledge regarding efficacy;
* current knowledge of AZT's toxicity;
* the need for postexposure follow-up, including HIV serologic testing, regardless of whether AZT is taken.
Protocol ranks exposures by severity
San Francisco General Hospital researchers have devised a protocol for AZT prophylactic treatment. The drug currently is "recommended" for massive exposures, "endorsed" for definite parenteral exposures, "available" for probable parenteral exposures, and "discouraged" or "not provided" for nonparenteral exposures.3
The hospital's protocol for AZT treatment is 200 mg every four hours (6X day) for the first three days following the exposure, then 100 mg to 200 mg every four hours (5X day) for the next 25 days.
Postexposure follow-up should continue for at least six months, whether or not AZT is taken. If the source individual has AIDS, is HIV-positive, or refuses testing, the CDC recommends baseline testing and, if seronegative, retesting at six weeks, 12 weeks, and six months after exposure.
New data and the federal agencies' move toward revising postexposure recommendations have prompted some EHPs and other experts to begin rethinking their own policies.
Bruce Agins, MD, MPH, acting medical director for the AIDS Institute of the New York State Department of Health in New York City, says his agency's guidelines are in a state of flux.
"There are no new formal recommendations presently, but we seem to be heading toward new recommendations based upon the determination of the degree of risk of the exposure. For those exposures that are of high risk, [there is] a move toward recommending treatment with combination therapy," Agins says.
Present guidelines include offering AZT monotherapy postexposure, "not recommending it, so that's a shift," he adds.
Task force recommends two-drug prophylaxis
At Children's Hospital and Medical Center in Seattle, an affiliate of the University of Washington (UW), AZT has been offered to workers exposed to blood known to be HIV-positive. A task force comprising representatives from UW and its hospital affiliates has recommended a combination AZT-3TC postexposure prophylaxis protocol, says Diane Riggert, RN, MPH, employee health services manager. The decision is based on the CDC's recent AZT findings as well as the data from various studies on 3TC.
Within the next two months, plans are for the two-drug regime to be offered prophylactically "to low- and high-risk groups based on what we consider high-risk, low-risk, and no-risk groups," Riggert says. A "loading dose" will be offered initially within four hours after exposure, and the worker will be provided with a five-day supply of the drugs.
"Our assumption is that the CDC recommendations will be made shortly, so we're going ahead with it. Based on what they come out with, we may have to make some changes," she says.
In addition to imminent changes in guidelines for chemoprophylaxis after HIV exposures, the CDC also has issued recommendations for follow-up after occupational exposure to hepatitis C virus (HCV).4
Concerns in recent years for the safety of HCWs exposed to HCV -- for which there is no effective postexposure prophylaxis, no vaccination, and little epidemiological data -- erupted at a recent meeting of the CDC's Hospital Infection Control Practices Advisory Committee (HICPAC).
Some HICPAC members charged that the CDC, in a draft document scheduled for publication as a Hepatitis Surveillance Report, was remiss in not recommending any follow-up for HCWs occupationally exposed to hepatitis C.
Miriam J. Alter, PhD, chief of the epidemiology section of the CDC's hepatitis branch, says the preliminary document was drafted after both the CDC and HICPAC agreed HCV follow-up recommendations were not warranted at this time.
"When we went back to HICPAC [with the draft], several individuals indicated they thought we should say something more definitive, so that's what we did, although we really have nothing to offer," Alter says. "It's not as if we came up with postexposure prophylaxis to offer or definitive counseling recommendations. Those issues still prevail. Instead we came up with some wording that HICPAC felt was more helpful to the institutions that might be confronting this issue."
The amended report explains that the lack of postexposure prophylaxis means that "multiple issues need to be considered in deciding if there should be a defined protocol" for HCW follow-up after occupational HCV exposure. Those issues include: limited data on transmission risk; limitations of serologic testing for infection and infectivity; poorly defined risk of transmission by sexual, household, and perinatal exposures; limited benefits of therapy for chronic disease; follow-up costs; and medical/legal implications.
Nevertheless, hospitals should consider implementing follow-up policies and procedures after occupational exposures to anti-HCV-positive blood "to address individual workers' concerns about their risk and outcome," the report states.
Summary recommendations are as follows:
* No postexposure prophylaxis is available for HCV; immune globulin is not recommended.
* Institutions should provide HCWs with up-to-date, accurate information on the risk and prevention of all bloodborne pathogens, including hepatitis C.
* Institutions should consider implementing follow-up policies and procedures for HCWs after percutaneous or permucosal exposure to anti-HCV-positive blood. Such policies might include baseline testing of the source for anti-HCV, and baseline and six-month follow-up testing of the person exposed for anti-HCV and alanine aminotransferase (ALT) activity. All anti-HCV results reported as repeatedly reactive by enzyme immunoassay should be confirmed by supplemental anti-HCV testing.
* There currently are no recommendations regarding restriction of HCWs with HCV. Transmission risk from worker to patient appears to be very low. Furthermore, there are no serologic assays that can determine infectivity, nor are there data to determine the threshold concentration of virus required for transmission. As recommended for all HCWs, those who are anti-HCV-positive should follow strict aseptic technique and standard (universal) precautions, including appropriate use of handwashing, protective barriers, and care in the use and disposal of needles and other sharps.
HBV recommendations change little
CDC guidelines on hepatitis B postexposure follow-up have remained virtually the same as the agency's 1991 recommendations.5 One change, to be published sometime this year, is included in the table on p. 52, which summarizes prophylaxis for percutaneous or permucosal exposure to blood according to the HBsAg status of the source of exposure and the vaccination status and vaccination response of the exposed HCW.
In 1991, when a source was found to be HBsAg-positive and the exposed HCW was previously vaccinated and a known responder, the recommendation was to test the worker for anti-HBs. If anti-HBs was adequate, no treatment was necessary; if inadequate, a hepatitis B vaccine booster dose was recommended. The new recommendation specifies that treatment is unnecessary for previously vaccinated known responders.
With current recommendations still in place for postexposure follow-up of blood exposures, a number of EHPs have shared their follow-up policies and forms with Hospital Employee Health. (See forms inserted in the center of this month's issue.) Riggert notes she uses three basic packets for exposure reporting. One is placed in the emergency room with instructions and a flow chart to be used when an employee incurs a blood exposure after EHS hours. Another is in the operating room, with instructions to help personnel obtain blood from the source patient for testing.
The third packet is for use in the EHS when an exposed employee reports there. (See pp. 1-5 of the forms insert for selected forms from the package Riggert uses.) Forms in the EHS packet are: the needlestick blood exposure worksheet, the employee blood exposure report form, the employee blood postexposure evaluation form (a checklist), the virology form, the uniform needlestick and sharp object injury report form from EPINet, and the consent form for patient blood testing following an employee exposure.
"Having packets of forms helps to initiate follow-up immediately and provides consistency in how information is communicated," Riggert says.
To obtain source blood, EHS staff talk directly to the patient or the patient's parents. "It's our job to do that. We don't involve the physicians; we've found they don't want to be involved," she explains. "It works very well, but success depends upon us knowing about [the exposure] immediately so patients aren't dismissed before we are able to approach them to get blood. It's very difficult to get parents to bring a child back in."
Needlestick hot line boosts follow-up
Another intervention Riggert finds useful is the hospital's needlestick hot line, a confidential phone line employees are instructed to call when they have a blood exposure. Employees leave specific information regarding the exposure, and calls automatically notify a pager carried by EHS staff.
"This way, the exposed employee can be contacted and follow-up can begin immediately," she explains.
Exposed employees are baseline-tested for HIV, HBV, and HCV, and are tested again at six weeks, three months, and six months postexposure for HIV testing.
Because children are her patient population, Riggert has not encountered a case in which a source patient was HCV-infected. If it should happen, she says she would follow up with the exposed worker for at least six months. If seroconversion occurred, she would refer the HCW to a virologist who specialized in hepatitis C infections.
An area that has been problematic at her facility is getting surgeons to follow the postexposure protocol, Riggert notes.
"They are not as cooperative with reporting blood exposures," she says. "In the OR, the nurses know there's been an exposure, so they'll make sure that the patient's blood is drawn. They're better at letting employee health know there was an exposure, but it's really not their job to report somebody else's exposure. Surgeons are probably our biggest reporting problem, and they don't use the needlestick hotline. That's one area we're working on."
At University Medical Center in Tucson, AZ, one of the main postexposure follow-up problems is after-EHS-hours reporting, says Joyce Kraft, RN, employee health coordinator.
Employees complete accident forms, "but they don't tell anybody. The accident form sits in the patient care manager's box for three days and then the patient has been discharged and I'm not able to get the patient tested for HIV," she says.
Kraft has discussed the problem with patient care managers, emphasizing the importance of more immediate exposure reporting. She also reviews all protocols at new-hire orientations, safety fairs, and annual educational seminars.
AZT has been offered through an infectious disease physician to workers exposed to HIV-positive patients, she says. (For Kraft's complete blood and body fluid exposure protocol and selected forms used by her staff, see pp. 6-7 of the forms insert.)
For hepatitis C follow-up, "if a patient is known to be hepatitis C-positive or high-risk, we would automatically do a baseline on the employee, and then test again at six months and a year," Kraft notes.
Algorithm increases compliance
Continuity of follow-up has increased to 95% at Providence Hospital and Medical Center in Medford, OR, since a new protocol was put in place two years ago, says Ruth DeVee, RN, employee health nurse. Designed in conjunction with an infection control nurse and an emergency room nurse, the protocol includes a follow-up algorithm. (See p. 8 of the forms insert.)
"[Follow-up] packets are placed in the emergency room, in human resources, and with nursing supervisors," DeVee notes. Exposures incurred during employee health department hours are reported there; after-hours exposures are reported through the emergency room. The same packet of forms is used in both locations.
At Providence, AZT has been offered for high-risk exposures through a standing order, so employees can obtain the drug directly from the hospital pharmacy. The EHS gives employees an AZT information sheet.
"When someone gets a needlestick, often they are too shaken up at first to remember what you said after you've talked to them about it," DeVee explains. "We felt if we gave them a packet, they could read it later when they've calmed down."
The EHS obtains source patient blood for testing after getting permission from the patient and attending physician, she says.
For hepatitis C follow-up, if the source is positive, DeVee gets a baseline on the employee and follows up at six months. An employee who tests positive at that time would be sent to an endocrinologist, she says.
Only two needlesticks have been reported this year, which DeVee credits in part to the hospital's adoption of a needleless intravenous system. She finds that the number of needlesticks employees report in a periodic anonymous needlestick survey coincides closely with the number reported to the EHS. She is confident that most employees are compliant with exposure reporting policies.
References
1. Centers for Disease Control and Prevention. Public Health Service statement on management of occupational exposure to human immunodeficiency virus, including considerations regarding zidovudine postexposure use. MMWR 1990; 39(No. RR-1):1-14.
2. Centers for Disease Control and Prevention. Case-control study of HIV seroconversion in health-care workers after percutaneous exposure to HIV-infected blood -- France, United Kingdom, and United States, January 1988-August 1994. JAMA 1996; 275:274-275.
3. Gerberding JL. Management of occupational exposures to blood-borne viruses. N Engl J Med 1995; 332:444-451.
4. Centers for Disease Control and Prevention. Hepatitis Surveillance Report No. 56. Atlanta; 1995.
5. Centers for Disease Control and Prevention. Hepatitis B virus: A comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991; 40(No. RR-13):1-25. *
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