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Lack of state policy puts those exposed to HIV at greater risk

By |2009-12-10T09:00:00-05:00December 10th, 2009|News|

It was a mistake, Trevor Hoppe admits. He made a poor choice in a sexual encounter which may have exposed him to HIV.
But being a candidate for a masters degree in public health and for a Ph.D in women’s studies at the University of Michigan, Hoppe knew that if he were prescribed a 28-day course of the medicines used to treat HIV for those infected, that could actually prevent him from contracting the virus. The treatment is called nonoccupational postexposure prophylaxis (nPEP) by the U.S. Centers for Disease Control and Prevention, and is modeled on more than 15 years of similar prevention methods for health care workers.
However, getting access to the medications, he said, led to a confrontation with a nurse practitioner with UM’s University Health Service, where he was denied access to the medications twice. Not only did the staff continue to refer to the antiretroviral medications as “antibiotics,” he said the nurse practitioner was more concerned about judging his behavior than in treating his medical situation.
Hoppe’s experience may not be uncommon in Michigan hospitals, health clinics and health departments, a Michigan Messenger investigation has found, and some of that confusion might rest in the state’s failure to have any written policies, procedures or protocols relating to the use of antiretroviral medications in preventing HIV infections.

History of postexposure prophylaxis use

PEP was first put into a policy and guideline form following the release of protease inhibitors and other classes of anti-retroviral medications. The combination is called Highly Active Antiretroviral Treatment. This was a natural outgrowth of the move in the late 1980s and early ’90s to prescribe health care workers the drug AZT following exposure to infected body fluids in medical settings. Such exposures almost exclusively involved the health care worker sticking themselves with a needle which had infected blood in it.
Those guidelines were released in a June, 1996 memo from the CDC that said “postexposure prophylaxis may reduce the risk for HIV transmission after occupational exposure to HIV-infected blood” and noted a 79-percent decrease in the risk of HIV infection after its use.
Later that year, the U.S. Food and Drug Administration approved new medications to add to medical treatment of HIV. Those new classes of drugs were added to CDC recommendations for PEP in May of 1998.
In June of 2001, the CDC again updated its recommendations for PEP, and expanding the medications recommended for use in prevention of infection not only with HIV, but with Hepatitis B or C. The new guidelines also addressed the possibility of viral resistance to a variety of medications in the PEP protocol.

A lack of knowledge

While most medical professionals, and the state of Michigan’s HIV/AIDS Prevention and Intervention Section, are aware of the occupational exposure PEP guidelines, the growing body of literature featuring the effectiveness of nPEP has gone largely unnoticed. A nonoccupational exposure includes sexual assault, unprotected sexual behavior and the use of unclean needles in drug use.
The body of literature includes Jan. 21, 2005, CDC guidelines which highlighted the effectiveness of nPEP. That document outlines the case for, as well as some reservations about, nPEP. But it specifically notes:
“Certain clinicians and exposed patients are unaware of the availability of nPEP or unconvinced of its efficacy and safety. … access to knowledgeable clinicians or a means of paying for nPEP might constrain its use. … Surveys of clinicians and facilities indicate a need for more widespread implementation of guidelines and protocols for nPEP use.”
The study cites the potential side effects of the medicines – which, in extreme cases, can include liver failure – as well the cost of the medications, which can run as high as $3,000 for a 28-day supply, as additional reasons that clinicians might be avoiding the nPEP guidelines altogether.
In addition to the CDC guidelines, the World Health Organization in 2007 released a protocol which outlines the use of PEP and nPEP.

Hoppe’s Philadelphia hope

It was 1 a.m. and Hoppe was in a city far from Ann Arbor, but he knew he needed access to postexposure prophylaxis.
He called the Mazzoni Center in Philadelphia. The LGBT health center provided him a reference to a local doctor who concurred with Hoppe’s assessment of his situation. He needed to start PEP, and the sooner the better. For the medication to work in preventing an infection, it has to be started no later than 72 hours after exposure, with better outcomes the sooner the protocol is started. But the doctor was uncomfortable writing a prescription because Hoppe was not an area resident or a patient of Mazzoni, which would make the necessary follow-up and monitoring of PEP adherence and possible side effects impossible.
The doctor, Hoppe said, recommended he call the University of Michigan to see if doctors there would prescribe the medications.
Hoppe called the University Health Service’s hotline, designed to help patients triage health events which do not have an immediate need to be treated in a hospital emergency department.
He was greeted by a nurse practitioner and explained his situation. “She didn’t understand what I was talking about when I talked about postexposure prophylaxis … I had to explain to her what these drugs were; what these anti-retrovirals were that she had never heard of,” Hoppe said. “She referred to them … at one point as antibiotics, which signaled to me she didn’t know what I was talking about.”
The exchange with the nurse practitioner continued.
“She said, ‘Well you had your chance to protect to yourself and you didn’t, so…’ and she sort trailed off,” Hoppe recalled. “At that point, and I sort of interrupted her and said ‘Excuse me it’s not your job to moralize this situation, tell me that I have some sort of price to pay for the situation I am in. There are drugs available that can lessen my chances of seroconverting from this potential exposure to HIV and that’s the end of the story as far as you’re concerned.'”
The nurse backed off at this point, Hoppe said, and agreed to consult with the doctor on duty.
In the meantime, Hoppe spoke again with the Mazzoni Center doctor and explained the situation to her. The doctor, Hoppe said, had seen similar responses from health care providers all the time. She then assisted Hoppe in gaining access to the medications, including hunting down a 24-hour pharmacy in Philadelphia which had both medications in stock.
As he was preparing to get the medications, the nurse practitioner from Michigan called back. “She said the doctor on duty didn’t know about these drugs and she said she was sorry, was not going to help me with this matter,” he said. “I was sort of on my own.”
Rick Fitzgerald, a spokesman for the University of Michigan, declined to comment on Hoppe’s case, saying he was “unfamiliar with the situation.”
He said, however, that the health service typically refers weekend callers with concerns about HIV exposure to the emergency room, and that doctors “typically don’t prescribe medication over the phone.”

Location, location, location

A review of county health clinics and hospitals in Michigan found wildly varying adherence to the January 2005 CDC memo and guidelines for nPEP.
In Kent County, officials refer patients with exposures to HIV through nonoccupational events to the area infectious disease specialist, said Denise Bryan, STD and HIV supervisor for the county’s health department. “We don’t have specific guidelines,” Bryan said. “It’s outside the scope of what we do. It would have to be a referral (to an infectious disease specialist). It would not be good medicine to just write a (prescription).”
Bryan pointed to potential toxicities and noted that many people put on PEP from occupational exposures do not complete the course of medications because of side effects.
She also said the clinic has not had any clients seeking the treatment.
But in Ingham County, the health department does provide the medication and support for nPEP, said Marcus Cheatham, a department spokesman.
The difference between Kent and Ingham counties could be the fact that Ingham has an infectious disease clinic specializing in HIV care embedded in its adult health clinic. This puts those knowledgeable about HIV, infection, HIV medications and other issues related to nPEP together under one roof. In Kent, to get that amount of expertise, one has to leave the health department to find it from private care providers.
Erica Phillipich of the Michigan State University Olin Health Center’s Center for Sexual Health Promotion said doctors at the clinic located on the East Lansing campus are encouraged to discuss HIV exposure concerns with patients. “If a student presents with concerns about HIV exposure, they have the opportunity to meet with a provider to discuss what option would be best for them,” she explained. “The provider would refer to the CDC’s PEP recommendation and help the student decide what course of action to take.”
The CDC PEP recommendations she’s referring to are those contained in the January 2005 memo. She said Olin does not have a written policy on implementing the nPEP recommendations.
Fitzgerald said UM’s Univeristy Health Service staff directs patients to the emergency room for evaluation.
“Health Services is not open on weekends,” Fitzgerald said. “So referring people to the emergency room is the best way to get them help quickly.”
But the actions of hospital emergency rooms vary, too.
At the University of Michigan Health Systems, an emergency room physician confronted with an HIV exposure case will call in an infectious disease specialist to consult. If one is not available, the doctor will write a two-week prescription of the nPEP drugs and arrange an appointment with the patient to follow up with a specialist, according to a health system representative.
At Detroit Receiving Hospital, Rose Fernadez, the director of the emergency department, said the hospital utilizes the CDC’s nPEP protocols.

Failure of state policies

Part of the explanation for such a range of disparate policies by health care providers may lie in the fact that the Michigan Department of Community Health has no written policies, procedures, recommendations or memos relating to the nPEP.
MDCH spokesman James McCurtis said the absence of such written documents does not mean the department is not discussing nPEP with providers across the state.
“It’s not mandated. We provide referrals,” McCurtis said. Those referrals are to the CDC’s PEP hotline, or local health departments, which may or may not provide the medication.
“I don’t believe there is a solid, written-in-stone policy that talks about nonoccupational post exposure prophylaxis,” McCurtis said. “But just because there isn’t a policy, doesn’t mean we’re not talking about it.”
Also on the phone with McCurtis was Robert Berri, a public health consultant in quality assurance for the MDCH HIV/AIDS Prevention and Intervention Section which coordinates all HIV response for the state.
“There is a policy. We really push the prevention,” Berri said. “We ask people to take precautions, universal precautions, or to use condoms. We have great prevention programs.”
Those programs are run under the mandate of the state’s three-year prevention strategy, which is developed with stakeholders such as HIV-positive people, doctors, prevention workers and public health officials. That document is shared with the CDC for granting purposes. But both Berri and McCurtis acknowledge nPEP is not included in the strategy, which is currently being rewritten for the new three-year cycle, which begins in January of 2010.
In addition, Berri said nPEP was not that big of an issue, if he were to judge by phone calls. He said he has had three calls in five years from people seeking information about PEP. He was uncertain if those were people seeking information because of an occupation exposure or from a nonoccupational exposure. All were referred to the national PEP hotline.

Prevention vs. treatment

Concerns about the effects of post-exposure treatment on the psychology of prevention were mentioned in the CDC’s January, 2005 memo, which addressed the “possible decrease in risk-reduction behaviors resulting from a perception that postexposure treatment is available,” but the document refers to several studies that minimized that risk.
While Hoppe himself has taken nPEP, he is not a fan of pushing it loudly as a prevention measure.
“To suggest that PEP is a strategy we should sort of rev up to the level of condom use is not an ideal goal,” said Hoppe. “It should be something we keep in mind; it shouldn’t be something you intentionally take time and time again.”
Regardless of whether the use of nPEP is promoted to patients, Hoppe said he believes health care providers need to be educated on the subject and every doctor who deals with patients facing non-occupational exposure must be ready and willing to follow the CDC guidelines and prescribe the appropriate medications.
“I certainly think there needs to be more awareness that these drugs exist,” he said. “They need to be made readily available to anyone who needs them.”

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