Frontline PEP: Policies, protocol, and problems
July 1, 1999 8 minutes read
Frontline PEP: Policies, protocol, and problems
How practitioners manage HIV PEP programs
[Editor’s note: Most employee health professionals regard the Centers for Disease Control and Prevention’s (CDC) revised HIV postexposure prophylaxis (PEP) guidelines as an improvement over the earlier version, but many agree that "gray areas" leave room for interpretation of certain practical concerns in establishing and implementing policies.
Discussions with the practitioners interviewed for this article reveal that concerns frequently center around whether two drugs or three drugs are the appropriate PEP prescription for exposures that fall somewhere between the highest-risk and lowest-risk exposures. In its updated 1998 guidelines, the CDC outlined two prophylactic drug regimens depending upon HIV transmission risk and possible drug-resistant virus. The agency formulated a two-page algorithm to help establish an "exposure code" and an "HIV status code" to guide PEP decision making.1 (See Hospital Employee Health, July 1998, pp. 81-86.)
Within the CDC-outlined protocol for prophylactic drug therapy aimed at preventing occupational HIV transmission to health care workers, employee health practitioners are finding that the realities of providing this therapy require tailoring their programs to their institution’s needs.
At Marshfield Clinic, a 40-facility clinical system with 4,500 employees in northern Wisconsin, infectious disease physicians are on call 24 hours a day to evaluate exposures and provide PEP. Employees also can call an 800 number for exposure evaluation.
Out of 740 exposures reported since 1994, with more than 99% of source patients tracked, only one exposure involved an HIV-positive source patient. The patient’s HIV status was previously known; the HCW completed PEP and did not seroconvert.
"We try to emphasize the low risk of seroconversion, even for significant exposures," says Bruce E. Cunha, RN, MS, COHN-S, director of health and safety.
Rural sites pose problems
Difficulties arise from the fact that many of the health system’s facilities are located in remote rural areas, some without pharmacies. This complicated the availability of PEP medications at each clinic site, but now the main clinic pharmacy has the three medications bubble-packed into a one-day supply and kept at each facility.
A second problem is having the rapid HIV test available throughout the system.
"We are finding that very few hospitals in our area run enough tests to be proficient in this test," he explains. "From our laboratory study, we have found that the rate of false positives goes up the less the lab does the test."
Cunha says a common dilemma at health care facilities is whether HIV-negative source patients and employees exposed to their blood should be followed up.
"Some facilities routinely test exposed employees out to six months or a year. Some try to do a second test on the source patient at a later date, typically three to six months. We determined that the risk of a patient being in a window period is so low that [the exposure] presents a very low risk," he says.
A better practice is to evaluate the exposure using CDC guidelines, Cunha suggests. He follows up any exposure in the high-risk category regardless of the source patient’s HIV test results.
Diverse sites also present a problem for Community Hospitals of Indianapolis, a system of four hospitals, a half-dozen occupational health clinics and urgent care centers, and 7,000 employees.
"Assuring that protocols are followed has proven very difficult," says employee health physician Daymon Evans, MD, MPH. "Emerg ency departments and urgent care centers often don’t seem to know what to do or to follow guidelines, despite the packets of consents and information sheets distributed to managers to be readily available and my presenting data at emergency department section meetings. Often, part-time moonlighting doctors are used."
A case in point was a high-risk exposure victim from an outside home health agency who presented to one of the system’s urgent care centers late at night. The staff didn’t know what to do, so the exposed worker had to make her own arrangements by phone, returning to her work site to take antiretroviral medications offered by her source patient, Evans says.
"I had many calls the next days wanting to know why we did not have a program or never told them how to handle HIV exposures," he adds. "Apparently, the information had been thrown out."
Like Cunha, Evans says multisite health care systems, especially those with rural facilities, must develop means of accessing PEP drugs quickly. His organization keeps five-day starter doses in each emergency department’s "robo-pharmacist" unit, available 24 hours a day at the turn of a key.
Evans advocates arranging with local AIDS practitioners to follow up workers on PEP if occupational health, urgent care, or emergency physicians are not comfortable doing so. An experienced emergency medicine physician, Evans also is pushing for HIV PEP to be included in that specialty’s core curriculum.
Counselors must be knowledgeable
Tampa (FL) General Healthcare exposure nurse Jeanne Forsman, RN, also is concerned about the knowledge of health care providers who are counseling HCWs about PEP.
While the CDC guidelines are helpful for discussing PEP decisions with exposed workers, the opinions of practitioners counseling HCWs often can sway the decision, so those counselors must be knowledgeable about appropriate evaluation and treatment, she says.
"Counseling of the exposed health care worker needs to be done with knowledge of types of exposures, known risk factors of the source patient, and familiarity with PEP medications," Forsman says.
She advises all workers to weigh the risk of their exposure against the risk of taking PEP drugs, which often produce side effects and have largely unknown toxicity and efficacy for healthy people.
Infectious disease MDs help manage exposure
When the employee health service is closed, infectious disease physicians are contacted to manage exposures. They can give four days’ worth of PEP medications, and HCWs follow up with the EHS for refills.
While most exposed HCWs at Tampa General rely on the information presented in counseling to guide their PEP decisions, physicians and residents nearly always already know they want the three-drug regimen, Forsman observes.
In 1998, of 182 HCWs reporting blood exposures, 34 opted for two-drug PEP treatment, and 25 for three drugs. Forsman says less than 20% of those completed therapy due either to side effects, self-re-evaluation of their exposures after initial fears subsided, or the source patient’s negative HIV test.
Counseling exposed workers at Driscoll Children’s Hospital in Corpus Christi, TX, has been facilitated by the CDC’s 1998 guidelines, says employee health nurse Raye Nell Hanna, RN.
Approximately 60 blood exposures occur there each year. During the past five years, only four exposures have been to sources known or highly suspected to be HIV-positive. One nurse started three-drug prophylaxis but stopped within 24 hours after getting a severe migraine, Hanna says. The nurse had incurred a low-risk exposure and had been advised that three drugs weren’t recommended.
Hanna says in some of the rare cases in which she does recommend three drugs, exposed workers tend to refuse the regimen because they assume a child is at low risk of being HIV-positive. But Hanna points out that some patients are teenagers who could be sexually active and counsels HCWs appropriately.
"We can’t assume they’re negative just because they’re children," she states. "That’s not a good mindset."
Employees who choose to start PEP are given 24 hours’ worth of medications, available from the pharmacy on a standing prescription arranged with the infection control physician. Within that time, results of the patient’s HIV test are available. Hanna and another staff member take turns on call after hours.
"With all the changes in the PEP and counseling that have occurred, our hospital decided to have us on call for all exposures," she says. "The infection control nurse and I rotate call. This helps ensure that employees receive adequate care."
Mary Wampler, MD, MPH, medical director for clinical services at the 8,000-employee University of Nebraska Medical Center and Nebraska Health Systems in Omaha, has instituted a 24-hour pager for blood and body fluid exposures — 888-OUCH — carried by a nurse practitioner, a physician assistant, or a physician. In the past year, about 50 to 100 blood exposures have been reported, with five to 10 HCWs choosing PEP as a result of the risk assessment.
Four HCWs have opted for the three-drug regimen since 1996, but only one completed the protocol, despite side effects that included vomiting so severe as to require intravenous fluids in the emergency department. The nurse’s motivation to persevere was a very high-risk needlestick. She did not seroconvert.
"Her exposure was to a patient dying of AIDS, and it was a deep stick with a large hollow-bore needle that had just been removed from a central vein," Wampler says. "Other than having his blood transfused into her, it was about as bad as it could get. She was terrified."
Short staffing restricts counseling
Risk assessments generally are done in the EHS, with backup from the infectious disease doctor who runs the system’s AIDS clinic. Wampler says being short-staffed does not allow for as comprehensive a postexposure counseling program as she would prefer.
"We have a real need for formal training in this area," she says. "All the providers do it as we see fit, having a checklist of the basics we need to cover. However, we have no process to do follow-up phone calls or have routine visits after an exposure beyond the follow-up lab tests that need to be done."
Certain counseling-related questions remain unanswered, she adds, such as whether exposed workers should be advised to have "no sex" instead of "safe sex" until final test results, and whether nurses are comfortable counseling physicians, whom nurses might assume know more than they do.
Wampler says she would discourage from taking three drugs any worker exposed to a source not previously known to be HIV-positive.
"The rationale is that the third drug is needed because of resistant virus, and someone not known to be HIV-positive is not going to be on antivirals," she explains.
If follow-up testing cannot be done on a source but previous medical records show no evidence of HIV-positive status, she would recommend two-drug therapy instead of three. However, three-drug treatment would not be denied any worker requesting it.
The question of three drugs vs. two is more of a gray area than it might appear, says Charlene M. Gliniecki, RN, MS, COHN-S, director of employee health and safety at 2,500-employee El Camino Hospital in Mountain View, CA.
"Are three drugs better than two, or is [the choice of three-drug therapy] based on the possibility of having a resistant strain?" asks Gliniecki, who maintains that the CDC’s algorithm makes the decision seem "more clear-cut than it actually is." She suggests that EHPs study all the supporting information in the guidelines carefully and not rely solely on the algorithm.
"These are tough calls, especially having to do with the unknown HIV status of the source," she says. "The biggest challenge is to be able to balance two things: not to have people take medication unnecessarily, and wanting to do everything you can for them on the front end."
Think about PEP before you have to
This is further complicated by the understandable tendency of many exposed workers to panic initially. Therefore, counseling is done "at a time when they can’t hear what you’re saying very well, yet an important decision has to be made," says Gliniecki.
She encourages employees to think about PEP issues before they might need to, but even so, decisions are easier when exposures are either very high-risk or very low-risk, she points out. "There is so much unknown in between. There’s no real answer."
Reference
1. Centers for Disease Control and Prevention. Public Health Service guidelines for the management of health-care worker exposures to HIV and recommendations for postexposure prophylaxis. MMWR 1998; 47(No. RR-7):1-33.
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