Does Compliance Packaging Improve Patient Outcomes?

The SlidePack from PCI Services Inc. is being used in a study of the effects of blister packaging on treatment outcomes.

A study to assess the impact of unit-dose packaging on health outcomes has been approved for government funding, and patient enrollment is commencing in January 2002, a researcher reported at the annual membership meeting of the Healthcare Compliance Packaging Council (HCPC; Falls Church, VA), held November 13 in Washington, DC.

If a significant difference can be detected in the treatment outcomes of those who use blisters versus those who use bottles, the study might provide the long-awaited quantitative evidence that unit-dose packaging improves patient compliance and therefore patient health, HCPC members said.

Philip J. Schneider, MS, FASHP, a clinical professor at the College of Pharmacy at Ohio State University (Columbus, OH), one of three sites where the study will be conducted, reported that funding from the Centers for Medicare and Medicaid Services (CMS; formerly the Healthcare Financing Administration) will enable the study to enroll 300 patients for 12 months each over the course of the next 24 months.

Half the patients will receive their hypertension medication, lisinopril, in a standard pharmacy vial, and the other half will receive it in a blister package, a modified version of SlidePack from PCI Services Inc. (Philadelphia). A label with the days of the week will be affixed to the blister package to further help confirm whether a dose was taken on a particular day. Hypertension was picked because only 12% of cases are adequately diagnosed and treated, and compliance problems play a role in that low figure, Schneider said.

Schneider is coordinating the study with researchers at Brigham & Women's Hospital (Boston) and the University of Arizona's College of Pharmacy (Tucson, AZ). He said the group is interested in applying "durable strategies like packaging" to the effort to build a safer healthcare system with fewer adverse events, especially in the likelihood of a prescription drug benefit being added to Medicare. As a result, this study will examine whether compliance packaging can improve adherence to prescribed treatments for chronic diseases. The researchers will assess the packaging's impact on patient compliance, prescription refills, treatment outcomes, morbidity and complications from chronic diseases, and medical services utilization, which can be defined as unforeseen medical events such as unscheduled physician visits and hospitalizations. They will also compare compliance rates based on how many other medications a patient is taking to see if that is a factor.

Patients who enroll must be at least 65 years of age and on a regimen of once-a-day doses of 5, 10, or 20 mg of lisinopril. They cannot have severe concomitant diseases that would make their hypertension a secondary condition. During the course of the study they will be seen quarterly by a physician for blood pressure monitoring and must see a pharmacist every 28 days to pick up a refill of their medication. They must go to a pharmacy at one of the three research sites, and the pharmacists there will assess compliance.

"Safer medication systems are needed, and safety issues can result in costs equal to or greater than the costs of medication and packaging," Schneider said. "There are gaps between the standard of care and practice. We need to look at safe systems in an outpatient setting."

Advocacy partners of the study include U.S. Representative Deborah Pryce (R–Ohio), who has taken an interest in building safe systems for pharmacotherapy and in a Medicare prescription drug benefit; Cardinal Health (Dublin, OH), parent company of PCI, which is providing the packaging; and drug manufacturer Merck & Company, Inc. (Whitehouse Station, NJ), which is providing the medication at no charge.

Erik Swain

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