Structured PharmD involvement crucial
An adherence intervention created at the University of Buffalo (NY), School of Pharmacy and Pharmaceutical Sciences provides individualized care that appears to be a better way to keep HIV-infected patients on track with their medication regimens. In one study that followed 25 patients who received the adherence intervention, investigators found that this group, when compared with 38 patients who didn’t go through the program, had significantly better viral outcomes, says Lori Esch, PharmD, clinical assistant professor at the University of Buffalo.
Both groups were similar at baseline, but the intervention group’s 48-week data from the 16-week study showed viral loads that were undetectable in 84% of the participants. The comparison group had undetectable viral loads in 37% of patients, she says. "So obviously there was a huge difference in the patients and how well they did once they were in the program," Esch says.
"A couple of reasons for the big differences, however, might have been that the standard care group included patients who didn’t want their medications, but were put on medications anyway," she adds. "But if the intervention patients didn’t want medications, they weren’t put on the medications, and so that’s one reason our numbers were better."
Also, the initial antiretroviral regimens were not standardized between the intervention and comparison groups, and that also may have given the intervention group an advantage, Esch explains. "A couple of things that make our program so unique are that patients aren’t automatically started on medications if they don’t feel they are ready, and if they are ready, they’re questioned about which medications they’d like to take," she says. "Those are two factors that make our outcomes better."
Esch describes how the program works:
• Specially trained pharmacists meet with patients to discuss their disease.
The first step in the program is patient education, and no patients are put on a drug regimen until they receive one-on-one education, she says. "Often, they come into the clinic after being newly diagnosed or referred, and they see the nurse for the first time to have their blood drawn. Then are they given their first referral to the pharmacy program to receive education."
Pharmacists, pharmacy residents, and nurse educators collaborate with physicians in treating HIV-infected patients, and pharmacists will educate patients about their disease before they have been prescribed antiretroviral medications, Esch says. Physicians encourage patients to discuss medication questions with pharmacists. Educators assess each patient’s level of commitment and interest in his or her health. They help patients understand HIV terminology and the basic issues involved in being treated with antiretroviral medications, she explains.
Through this patient-provider dialogue, pharmacists learn more about the patient’s lifestyle, concerns, and potential adherence barriers, such as issues with confidentiality, pill burden, pill time commitments, etc., Esch says. "Maybe the patient only wants to take pills once a day and that’s all he can handle, or maybe he can handle any side effect except diarrhea," she says. "So we figure out what medications the patient would be willing to commit to and how these medications would fit into the patient’s life."
• Patients make repeated visits until they’re ready to begin with a medication program.
A patient’s second visit might occur the next day, in a week, or in a month, depending on whether the patient is ready to make a commitment to medications, Esch says. The second visit might last 30 minutes after the patient has seen the physician, who has made the assessment that the patient probably would benefit from starting an antiretroviral regimen, based on the clinical picture. When patients decide they are ready to start medications, the team works with them on selecting a time to start the drugs, because some patients might want to put off their drug regimen until after a vacation or a job change or some other life event, she says.
• The team of providers comes up with a plan for the patient’s treatment regimen.
"This is somewhat a unique step where we’re individualizing care rather than suggesting that all patients go on the same medications," Esch says. "We believe a high level of commitment is required to make these work and to not encourage the development of resistance through low drug levels."
Patients are included in the planning, and pharmacists work with physicians to select an optimal antiretroviral regimen for each patient. Physicians have been very open to the pharmacists’ suggestions on which HIV medications might be best for a particular patient, she notes. "Then we bring patients back to the clinic and go over the actual medications with them, showing them what the pills look like, how they should be stored, and what each side effect could be," Esch says.
Pharmacists also discuss how patients should handle side effects and give patients tools, such as beepers, charts with stickers, and alarm watches, to help them remember to take their medications and to fit the regimen into their daily activities, she says. "We talk about what medications to avoid when taking these drugs, and we talk about medication interactions with alcohol, drugs, and herbal remedies, and side effects," Esch says. "We tell them what would be unusual or severe and should be reported immediately, and we make it very clear to them that they can make that differentiation very clearly on their own at home."
• Ongoing support is provided by the team.
Generally, within three days of the patients’ last visit with the pharmacist, the pharmacist will call the patients to see how they’re doing with the regimen. "Usually that’s when the patient has the most trouble remembering to take the pills and has difficulty getting the medication regimen into a daily routine," she notes. "We see if the patient has missed any doses or is experiencing any acute side effects."
Then patients are brought back in for a visit with the pharmacist two weeks into the new drug regimen. "We just go through the medications and make sure they’re taking the ones they are supposed to be taking and talk with them about adherence, and make sure they can handle any problems," Esch says. "We provide intensive support over the first couple of weeks." Patients typically will see the physician again four weeks after starting the drug regimen.
As part of the ongoing support, patients are given emergency telephone numbers to call whenever they need help. Also, nurse educators may visit patients, and social workers will be involved in assisting patients with any potential barriers, such as substance abuse issues, domestic violence problems, child care concerns, financial issues, and others, she says.
Although the University of Buffalo program is comprehensive and provider intensive, it can be duplicated in other settings, Esch says. "It’s not an all or nothing approach," she says. "Every amount of education and individualization and support that’s given to a patient is going to be useful."
While it’s important to have a pharmacist involved, the pharmacy involvement could be on a consulting basis, and nurses could be used for the medication education component, and social workers could be more involved with adherence support, she says. "So I think any clinic can use their own resources to at least incorporate parts of this program, and even if they can’t do 30-minute visits, they could at least get patients to make a commitment and provide ongoing support," Esch says.
(Editor’s note: For more information about the adherence program, visit the university’s web site at: www.hiv.buffalo.edu.)