Limit liability: Document decisions on new CDC guidelines for HIV exposure

Federal measures not mandated, but set new standard of care

To limit hospital liability, infection control committees should carefully weigh new voluntary federal guidelines for health care workers occupationally exposed to HIV and document any decision not to adopt the recommendations, a legal/medical expert advises.

Recently issued by the Centers for Disease Control and Prevention in Atlanta, the guidelines end the CDC's 1990 neutral stance on the use of zidovudine (ZDV), also known as AZT, following needlesticks and other exposures to HIV-infected blood.1,2 For the most serious exposures, the CDC is now recommending ZDV in conjunction with two additional drugs, lamivudine (3TC) and indinavir (IDV) (See chart, recommendations, pp. 82, 83.)

Deemed "provisional" because they were based on limited data regarding efficacy and toxicity, the latest guidelines were announced in June at the annual conference of the Washington, DC- based Association for Professionals in Infection Control and Epidemiology (APIC) held in Atlanta.

While some hospitals have not been routinely offering ZDV, even those that had such programs must now decide whether to add the two additional drugs.

Though CDC guidelines are not regulatory standards, infection control professionals would be wise to take the new recommendations before their infection control committees, formally consider the options, and particularly document any decision not to adopt the recommendations, says Larry Gostin, JD, LLD, professor of law at Georgetown University Law Center in Washington, DC,and director of the Law and Public Health program at Georgetown and Johns Hopkins University in Baltimore.

"My advice for hospitals would be that if they decided not to adopt the CDC guidelines, they should do so only on the basis of very careful review by their infection control people," he tells Hospital Infection Control. "Also, they should follow that up and document it with the best scientific evidence they have. If they were not adopted it would be entirely possible and likely that a litigant would raise failure to follow the guidelines in any tort litigation."

Indeed, though there is no requirement for hospitals to adopt CDC guidelines, the new HIV post-exposure recommendations "contribute" to a standard of care that would no doubt be invoked should an exposed health care worker subsequently develop HIV infection, he adds.

"That does not mean that the court would immediately find liability," Gostin says. "The court would obviously use CDC guidelines as one very important factor among many."

The CDC's previous stance of neither endorsing nor discouraging ZDV was based on a lack of data, a situation that changed last year with publication of a new CDC study suggesting some protective efficacy among health care workers.3 Likewise, studies in HIV-infected patients point to the benefits of 3TC, which has greater activity than ZDV alone and does not significantly increase toxicity. Adding a protease inhibitor provides an even greater increase in anti-retroviral activity, the CDC noted in rounding out the drug regimen with IDV.

"The mind-set has changed," said Martin Favero, PhD, acting director of the CDC Hospital Infections Program, in announcing the action at APIC. "The mind-set now is when an individual [is exposed] to an HIV-infected patient, they are going to be actively encouraged not only to receive ZDV for a high risk exposure, but also other antiviral agents."

ICPs plan committee review

Several ICPs contacted by Hospital Infection Control after the announcement were already planning to take the CDC recommendations before their infection control committees and consider policy development.

"We have already been offering [ZDV] free to all employees with known HIV positive exposures," says Patsie Crosson, RN, infection control practitioner at Phoebe Putney Memorial Hospital in Albany, GA. "We really haven't made a decision on the [additional drugs]. It will have to go before our infection control committee. I do know that probably psychologically it will be much more comforting to [workers] to know there is more available if they should have some type of exposure."

On the other hand, hospitals where needlesticks or other exposures involving HIV-infected blood have been very rare may not have an official policy to routinely offer ZDV.

"We are not offering it at this time," says Ellie Mabry, RN, nurse epidemiologist at Mary Black Memorial Hospital in Spartanburg, SC, adding that the hospital has only had one incident -- a mucosal splash -- involving known HIV-infected blood in the last four years.

Though there is no formal policy, workers are made aware that ZDV is available, she says. Now, however, the CDC advisory to recommend prophylaxis will be taken under consideration by the infection control committee.

"We are getting more and more HIV-positive and AIDS patients," she says. "I'm sure it's probably something we need to look into."

Still, as a practical matter, the CDC recommendation to administer post-exposure prophylaxis within the first one-to-two hours may pose problems, as the HIV-status of the source patient may not be known, Mabry says.

"Sometimes you don't always know that until you have tested people and of course it takes a while to get the report back," Mabry explains. "You certainly wouldn't want to give it to somebody without knowing if the source was HIV positive, because there are so many side effects."

According to the CDC guidelines, if the source patient's or the patient's HIV status is unknown, initiating post-exposure prophylaxis should be decided on a case-by-case basis, based on the exposure risk and likelihood of HIV infection in known or possible source patients. The CDC reported that animal studies suggest that prophylaxis probably is not effective when started later than 24-36 hours following exposure, but the interval after which there is no benefit to humans is undefined. Thus initiating therapy as late as two weeks after the exposure may be considered for the highest risk incidents.

Due, in part, to perceived low HIV risk in the patient population and reports of other workers feeling sick after taking ZDV, exposed workers may opt to forego the drugs even if they are offered.

"We have ZDV, but we have hardly had any employees take it," says Beverly Young, RN, clinical facilitator at Memorial Hospital of Carbon County in Rawlins, WY. "They don't want to take it. I don't know anything about these new drugs as far as side effects and whether or not the hospital would want to invest in having those medications in pharmacy. We only have about eight needlesticks a year. I don't know if we will jump on the bandwagon real quick."

Concerning the issue of cost, general drug pricing estimates provided to Hospital Infection Control by the HIV/AIDS Treatment Information Service in Bethesda, MD, may assist ICPs preparing to discuss the issue among hospital committees. The regimens recommended by the CDC for a four-week prophylaxis following occupational exposures were ZDV, 200 mg three times a day; 3TC, 150 mg two times a day; and IDV, 800 mg three times a day. According to the treatment service, ZDV currently costs about $1.55 for a 100 mg tablet; 3TC, $3.11 per 150 mg tablet; and IDV $2 per 400 mg capsule. The drug costs for adopting the full three-drug regimen -- recommended for only the most serious exposures -- would be approximately $770.56 for the four-week period per exposed worker.

Troubling toxicity

There are issues of toxicity and side effects for all three drugs. There is little known about possible delayed or long-term effects from use of the drugs by people not infected with HIV.

ZDV, in recommended doses, usually is tolerated well. Short-term toxicity associated with higher doses includes gastrointestinal symptoms, fatigue, pain and headache, the CDC reported. In HIV-infected adults, 3TC has caused gastrointestinal symptoms and, in rare instances, pancreatitis. IDV toxicity includes gastrointestinal symptoms and, usually after prolonged use, mild hyperbilirubinemia and kidney stones.

"Because most occupational exposures to HIV do not result in infection transmission, potential toxicity must be carefully considered when prescribing post-exposure prophylaxis," the CDC recommended. "When possible, these recommendations should be implemented in consultation with persons having expertise in anti-retroviral therapy and HIV transmission. Changes in drug regimens may be appropriate, based on factors such as the probable anti-retroviral drug resistance profile of HIV from the source patient; local availability of drugs; and the medical conditions, concurrent drug therapy, and drug toxicity in the exposed worker."

The CDC noted that beginning July 15, 1996, health-care workers undergoing the HIV chemoprophylaxis can be enrolled in an anonymous registry developed by CDC and drug manufacturing companies by calling (888) 737-4448 (PEP-4HIV). Unusual or severe toxicity from anti-retroviral drugs should be reported to the manufacturer and the Food and Drug Administration in Bethesda MD at (800) 332-1088.

Reference

1. Centers for Disease Control and Prevention. Update: Provisional public health service recommendations for chemoprophylaxis after occupational exposure to HIV. MMWR 1996: 45: 468-472.

2. 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.

3. 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. MMWR 1995; 44:929-933. *