Federal Study of Adherence to Medications - FAME – Presented at AHA 2006
The goal of the trial was to evaluate the effect of a pharmacy intervention program compared with usual care on medication adherence among elderly patients treated with ≥4 chronic medications.
Patients Screened: 208
Patients Enrolled: 200
Mean Follow Up: 14 months
Mean Patient Age: Mean age 78 years
Age ≥65 years, taking ≥4 chronic medications daily
Not living independently (i.e., assisted living or nursing home residents), or presence of any serious medical condition with expected survival <1 year
Observation phase: Change in pills taken versus baseline
Randomization phase: Medication use after 6 months
Changes in blood pressure and LDL-C during observation phase
Following a 2-month run-in phase, all patients were entered a 6-month intervention phase that included medication education, pharmacist follow-up, and medications dispensed in time-specific packets (observation phase). After the 6 months, patients were randomized to either continuation of the intervention (n = 83) or usual care (n = 76) for an additional 6 months (randomization phase). The trial was conducted at the Walter Reed Army Medical Center.
Mean number of chronic medications taken at baseline was 8.7. Medications included treatment for hypertension (91.5%) and hyperlipidemia (80.6%). Mean medication adherence at baseline was 61.2%. Medications included statins (80%), angiotensin-converting enzyme inhibitors (50.2%), beta-blockers (47.3%), calcium channel blockers (36.8%), and thiazide diuretic (25.9%).
Following the observation intervention phase, the primary endpoint of medication adherence increased significantly from baseline (96.9%, p < 0.001). An adherence rate of taking 80% of all medications increased from 5.0% at baseline to 98.7% after intervention (p < 0.001). Among patients with treated hypertension, systolic blood pressure (SBP) was reduced from 133.2 mm Hg at baseline to 129.9 mm Hg at 6 months (p = 0.02). Low-density lipoprotein cholesterol (LDL-C) was also reduced from baseline (91.7 mg/dl to 86.8 mg/dl, p = 0.001) among patients with treated hyperlipidemia.
During the randomization phase, medication adherence decreased to 69.1% in the usual care group but was maintained at 95.5% in the intervention group (p < 0.001). Adherence rate of at least 80% of all medications was higher in the intervention group compared with the usual care group (97.4% vs. 21.7%, p < 0.001). The reduction in SBP among treated hypertensives was greater in the intervention group compared with the usual care group (-6.9 mm Hg vs. -1.0 mm Hg, p = 0.04). Among treated hyperlipidemics, reduction in LDL-C did not differ between the intervention and usual care group (-2.8 mg/dl vs. -5.8 mg/dl, p = 0.85).
Among patients age ≥65 years treated with multiple chronic medications, use of a pharmacy intervention program was associated with better medication use adherence compared with usual care. In addition to demonstrating an association between the intervention program and medication compliance, the trial also demonstrated clinical effects on blood pressure, with a reduction in SBP in treated hypertensive patients in the intervention group compared with the usual care group.
Patients taking multiple chronic medications are at high risk for medication nonadherence. The risk can be even higher for asymptomatic conditions, including hypertension and hyperlipidemia. Nonadherence can lead to worsening health problems, increased hospitalizations, and subsequently higher overall health costs. While the present trial showed the intervention program was effective, the time necessary for pharmacists to provide patient education may be a barrier to widespread use of the program.
Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA 2006;296:2563-71.
Presented by Dr. Allen Taylor at the American Heart Association Annual Scientific Sessions, Chicago, IL, November 2006.
Keywords: Behavior Therapy, Follow-Up Studies, Hyperlipidemias, Cholesterol, LDL, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Coronary Disease, Health Care Costs, Calcium Channel Blockers, Lipoproteins, LDL, Pharmacists, Medication Adherence, Hypertension, Sodium Chloride Symporter Inhibitors
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