Compliance Study with Diabetes Patients Gets Underway

Compliance Study with Diabetes Patients Gets Underway

Although research has pointed to the value of unit-of-use and unit-dose packaging and of blister formats in supporting patient adherence, industry has sought more studies. Head-to-head studies comparing blisters and bottles promise to shed insights on which packaging works best for different treatments and patient groups. Yet new studies have been slow to emerge in recent years after a spate of research in the 1980s and 1990s.

The Centers for Education and Research on Therapeutics (CERT), University of Texas, MD Anderson Cancer Center, is embarking on a comprehensive study to evaluate the impact of blister packaging on compliance in diabetes patients. The research is supported by the Healthcare Compliance Packaging Council (HCPC) and companies providing materials, package formats, and packaging services.

The project has started enrolling 160 patients with Type 2 diabetes for a six-month study, reported Eduardo Pollono, post doctoral fellow, Dept. of General Internal Medicine, University of Texas, MD Anderson Cancer Center. He spoke at the HCPC symposium in Valley Forge, PA, in May.

Patients have to be taking at least one other medication, to more closely mirror real world conditions, and their medicating behavior will be tracked for all medications, Pollono said.

A control group to which patients are randomly allocated will use containers with electromechanical MEMs caps. The study group will receive electronically enabled compliance blister packages for each drug they use. MWV is providing its Cerepak for Metformin, and Stora Enso is providing the Pharma DDSi package for aspirin. AmerisoureBergen’s Compliance-In-a-Bottle (CIAB) design will package the statin.

Patients will be periodically surveyed on their medicating behavior to help establish how they prioritize the dosing.
Pollono noted the study’s hypothesis is that a visual reminder (calendar package) will help people take their medications. Adherence is measured as the ratio of prescribed doses to doses taken.

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