FAME: Pharmacy-Care Program Improves Medication Adherence, as Well as BP and LDL-Cholesterol Levels

November 14, 2006

November 14, 2006 (Chicago, IL) - If patients don't take their medication, the drugs can't work. Despite such an axiomatic truth, getting some patients to take their medications can be difficult for clinicians. With that in mind, a new study investigating the efficacy of a pharmacy-care program, with an emphasis on patient education, has shown that the comprehensive program improves adherence to drug therapy in a cohort of elderly patients taking at least four chronic medications [ 1].

"We spend a lot of money on trials figuring out if drugs work, but in the end we have to get patients to take them," said lead investigator Dr Allen Taylor (Walter Reed Army Medical Center, Washington, DC).

The study, known as the Federal Study of Adherence to Medications in the Elderly (FAME) and presented today during the late-breaking clinical-trials session at the American Heart Association 2006 Scientific Sessions (and published online in the November 13, 2006 issue of the Journal of the American Medical Association), also showed that enrollment in the clinical pharmacy-care program is linked to reductions in cardiovascular risk factors, with decreases in blood pressure and LDL cholesterol.

Dr Harlan Krumholz (Yale University School of Medical, New Haven, CT), who commented on the FAME study immediately following the presentation, said the findings were "remarkable," noting that adherence increased to 97% after the initial six-month intervention. He added that patient adherence is a critically important but underappreciated issue, and one where researchers should focus attention.

"This is the kind of thing we should be talking about today," said Krumholz. "How are we going to improve care for patients? How are we going to bring about better alignment with what patients are doing and the recommendations they are getting?"

America's other drug problem

During a briefing for the media, Taylor said that medication nonadherence is pervasive and results in increased patient morbidity. On the other hand, taking prescribed medications has been shown to result in 50% lower event rates and is also known to decrease healthcare costs. Typically, barriers to medication adherence include the prescription of complex medication regimens and convenience issues, as well as the treatment of asymptomatic disease, such as hypertension or hyperlipidemia. Taylor noted that medication nonadherence is often referred to as "America's other drug problem."

With this in mind, Taylor and colleagues Drs Jeannie Lee and Karen Grace, both clinical pharmacists at Walter Reed Army Medical Center, sought to test the efficacy of a comprehensive pharmacy-care program designed to improve medication adherence and its associated effects on blood pressure and LDL cholesterol. Taylor explained that the program consisted of three components: individualized patient education, customized packaging, and regular follow-up with the pharmacist.

After a two-month run-in phase, in which baseline adherence, blood pressure, and lipid levels were measured, 200 patients were enrolled in a six-month intervention phase. During this phase, patients met with clinical pharmacists to learn drug names, strengths, adverse effects, and usage instructions. The first visit lasted one hour, and subsequent visits, scheduled every two months to assess adherence, refills, and education as necessary, lasted 30 minutes. Instead of using pill bottles, all medications were provided to patients in customized blister packs labeled to meet the standards of the prescriptions.

After six months of the intervention, adherence rates increased significantly, with 97% of patients adherent to their treatment. This was associated with significant improvements in blood pressure and LDL-cholesterol levels, report the FAME investigators.

FAME: Changes in adherence, blood pressure, and LDL cholesterol after enrollment in program

Measurement

Baseline

At 6 mo

p

Adherence (%)

61.2

96.9

<0.001

Blood pressure (mm Hg)

133.2

129.9

0.02

LDL cholesterol (mg/dL)

91.7

86.8

0.001


Following the intervention phase, patients were randomized to one of two treatments. In the first arm, patients continued in the pharmacy-care program, which included continuation of follow-up with the pharmacists and the use of the blister packs. Patients in the second arm were randomized to usual care.

Six months after randomization, the persistence of adherence declined significantly in those who returned to usual care, decreasing to 69.1%. Those randomized to the pharmacy-care program sustained their adherence to medical therapy, with investigators reporting an adherence rate of 95.5%. This was associated with a significant reduction in blood pressure, compared with usual care, but no significant difference in LDL-cholesterol levels between the two treatment arms.

Taylor said there was no formal economic analysis associated with the study, but that the raw materials are cheap. The blister pack, he said, costs 14 cents and "is a simple and small investment for improving adherence." The major cost of the program, he said, is the personnel needed to administer the program and to educate patients. He estimates that one pharmacist is needed for every 200 patients.

"I think we have to invest in this a little bit, like we invest in paying for the pills," he said. "Why don't we invest in how we get patients to take them?" he asked.

Because of these positive results, emphasis should be placed on the development of programs that promote greater adherence to medications, particularly in at-risk patient populations, said Taylor. He stressed, however, that the study is not about the delivery of medications at the pharmacy level, but part of a broader view to alter the clinical delivery of care.

Older, real-world patients

During the late-breaking clinical-trials session, Krumholz said the findings are clinically relevant because those studied included elderly patients taking a minimum of four chronic medications. He pointed out that the trial was relatively small and was conducted in a single-center military hospital, where the approach to pharmacy might differ from that in retail pharmacies and other healthcare systems. In addition to the unknown cost factor, generalizing the results to larger populations is difficult because "whenever you're talking about an education intervention, I always wonder, especially at a single center, how much of the results depend on a talented educator to get that done."

In addition, Krumholz noted that the study looked only at surrogate outcomes; most clinicians will want to be reassured that patients improve clinically when given the intervention. "My question is, What in the heck happens when all of our patients actually start taking all of their medications? We've never seen that before." he said.

Dr Ross Simpson (University of North Carolina, Chapel Hill), who wrote an editorial to coincide with publication of the study in JAMA [ 2], writes that the "study supports the view that a multilayered intervention can improve medication adherence and underscores the value of pharmacists as key providers of patient counseling in correcting poor patient adherence."

Like Krumholz, Simpson wonders whether such results can be generalized to other populations. He also notes that the researchers were unable to untangle the relative value of education and the individualized blister packs on improving outcomes, something Taylor does not see as necessary given that any program should include both components. In the intervention arm, Simpson notes that observation bias might have affected the results because those in the pharmacy-care program were observed more often. To offset this, patients in the usual-care arm could have met with other health practitioners to help control for the frequency and intensity of observation in the trial.

  1. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol. JAMA 2006; DOI:10.1001/jama.296.21.joc60162. Available at: http://www.jama.com.

  2. Simpson RJ. Challenges for improving medication adherence. JAMA 2006;DOI:10.1001/jama.296.21.jed60074. Available at: http://www.jama.com.

 

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