EDITORIAL Overdosing on Compliance


Getting patients to follow their drug regimens is one of the greatest challenges in healthcare today. The Healthcare Compliance Packaging Council (HCPC) reports that noncompliance drains $100 billion from our economy every year. It is also blamed for the deaths of more than 125,000 Americans annually.

HCPC's broadcast of these numbers is working—more and more drug makers are choosing packaging that encourages compliance, such as blisters. Many are even relying on blisters to simplify complex clinical trial regimens, which often involve three or more tablets several times per day.

To report the latest in clinical blisters, contributing editor Jenevieve Blair Polin spoke to a number of providers of clinical trial packaging for this month's Spotlight feature, "Child-Resistant, Unit-Dose Packaging for Clinical Trials" on page 28. She learned that a few drug companies, in an attempt to encourage compliance through blister use, seem to be forgetting the basics of packaging science.

For instance, Frank Tiano, vice president of U.S. operations, PCI Clinical Services, says that some companies preparing clinical trial packaging are asking for many disparate tablets or capsules in the same blister cavity. "That just drives me nuts," Tiano says bluntly. "I don't have a problem putting two of the same dosage forms in one cavity, but I've had clients who want to put an active of one dosage form, a placebo of another, or even dissimilar dosage forms together. What I find scary there is, do they have stability data? How do they know that this tablet is not going to interact with the other tablet? It may seem convenient for the patient, but I think there are some pharmaceutical aspects that need to be evaluated."

Charles Mastroni, a clinical packaging specialist for drug manufacturer Boehringer Ingelheim, adds that there may be good reasons other than compliance to put multiple tablets into one cavity. "It may help in blinding a double-blind, double-dummy blister study where trial product, comparator product, and related placebos are needed." However, "you have to do the stability studies for the products/package combination, same as required for any other product/package combination by FDA and EU regulations. Whenever new materials are used to repackage a drug, stability has to be determined to establish expiration dating. And process controls for multiple products in a cavity would have to be bulletproof."

There are ways to balance stability concerns with compliance needs, though. A client of Robert Misher, president of BlisTech Corp., insisted on placing multiple products into one cavity. The study required patients to take four capsules three times a day. "The client was very concerned that if we individually packaged the capsules, there might be a time when the patient didn't dispense all four products. Maybe the patient would only take two or three capsules in the morning and then realize that at noon, and now take five or six at noon," Misher explains. BlisTech's solution was to form a single cavity containing four individual pockets for the solid-dosage forms. When the patient pushed the blister, all four fell out into the hand at once. The client performed stability studies on this configuration and found it to be successful.

While statistics on noncompliance during outpatient clinical trials are hard to come by, the number of people failing to comply with marketed regimens suggests that patients in general need guidance. But don't pit the numbers against science. Creative thinking can reduce the complexity of multiple-product clinical regimens without compromising stability. Just ask BlisTech's client.

Daphne Allen, Editor

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