The FAME Trial shows that specific supports for elderly people such as pre-packaging medications and involving pharmacists in patient education can significantly improve compliance with complicated medication schedules, according to a presentation at a Late-Breaking Clinical Trials session at the American Heart Association meeting. The study is being simultaneously published in the Journal of the American Medical Association.

The US Federal study of Adherence to Medications in the Elderly (FAME) is the first trial to examine how to improve elderly patients’ adherence to prescribed medication regimes.

“This comprehensive pharmacy program led to substantial improvements in medical adherence among elderly patients receiving complex medical regimes, and medication adherence can result in meaningful improvements in health outcomes,” said Allen J. Taylor, MD, senior author of the clinical trial and chief of cardiology at Walter Reed Army Medical Center in Washington, D.C.

In phase one, researchers recruited 200 patients (average age, 78 years) who were taking four or more daily medications for multiple chronic conditions. Those enrolled took an average of nine different daily medications. They received educational material and oral instructions from pharmacists and individualized blister packs of their medications. Patients met every two months with a pharmacist in this phase of the study. Adherence rates increased from 61 percent to 97 percent after six months.

“That’s a previously unseen increase in the degree of medical adherence,” Taylor said.

Increased adherence also resulted in significant improvements in systolic blood pressure and low-density lipoprotein cholesterol. For example, systolic blood pressure dropped on average 3.3 millimeters of mercury (mm Hg), from 133.2 mm Hg to 129.9 mm Hg. Low-density cholesterol levels decreased 4.9 milligrams per deciliter of blood (mg/dL), from 91.7 mg/dL to 86.8 mg/dL.

In phase two, researchers randomized the same patients to either continue receiving the education and blister-packed pills or to return to usual care ? getting their pills in bottles and sorting them themselves.

Those continuing with prepared packaging plus education continued to take 96 percent of their prescribed pills and their blood pressure continued to decrease, falling by another 5 mm Hg on average at the one-year mark (to 124.4 mm Hg). In comparison, the usual care group’s adherence fell to 69 percent and their blood pressure increased to baseline level.

Researchers hand-packaged each patient’s blister pack for morning, noon, evening and bedtime delivery, aiming to keep their regimen as simple as possible, said Jeannie Lee, PharmD, a clinical pharmacist at Walter Reed and lead author of the report.

For example, a patient taking medicine three times a day would receive a morning pack containing a one-month supply of medications counted out, grouped, labeled and packaged into each daily morning dose of all appropriate pills, as well as similar packs for noon and evening. That way they could get all their pills at once and could tell at a glance if they had taken their medications ? particularly helpful to patients with memory problems.

“Medication non-adherence among older adults is a widespread and costly problem,” Taylor said. “Studies indicate that about 65 percent of people who are past retirement age have two or more chronic conditions, and their typical adherence rates are 60 percent or less.”

Because studies also show that up to 50 percent of cardiovascular admissions may be due to non-adherence, any measure that improves patient compliance is likely to have significant personal benefits and coast effectiveness at the national level.