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Safety is FDA’s favorite topic these days. In early February, the agency asked Congress to fund a number of safety initiatives for food, drugs, and medical devices. One week later, FDA announced the formation of the Drug Safety Oversight Board (DSB) to help healthcare professionals and patients monitor drug risks and benefits. Perhaps all the NSAID trouble is spurring FDA to reiterate its focus on patient safety and to improve its ability “to more rapidly survey, identify, and respond to potential safety concerns regarding marketed drugs,” one of its stated goals for the budget increase.

But NSAID concerns show that FDA—or perhaps Congress, since it directs FDA—is falling short in another way. In general, prescription pharmaceuticals are allowed to reach the market with very little information provided directly from the manufacturer. More often than not, patients do not receive the package inserts that manufacturers carefully prepare, instead getting pharmacy-generated materials. These materials may not always convey safety warnings as clearly or powerfully as they could.

Being a patient and a caregiver myself, I know that the pharmacy printouts that accompany prescriptions are brief in content and cumbersome in size. Not worth the space they take up, they eventually get separated from prescriptions. And in the case of drugs used to treat chronic conditions, we patients and caregivers stop reading these materials. As a result, the safety warnings are noticed once and forgotten or never at all.

Labeling shortfalls may be part of the story behind NSAID trouble. CNN reports that negotiations between FDA and Merck over what Vioxx warnings should be issued may have delayed those warnings.

Unit-of-use labeling is needed to successfully convey warnings. Wraparound or extended-text labels on unit-of-use bottles or foldout or fold-over blister cards may do the trick. They would definitely put drug safety information directly into patients’ hands, time after time.

Extending the Drug Facts labeling requirements now required for over-the-counter drugs to prescription drugs would also call attention to safety information.

Could such labeling have prevented some of the problems that are emerging with continued NSAID use? It is hard to say. But in general, if unit-of-use packages with patient-directed labeling are used consistently, patients will be warned with labeling statements each time they reached for a drug. And complete labeling fosters a better awareness of a drug’s risks and benefits, especially for chronic conditions.

For these labeling solutions to be put to wide use, however, unit-of-use packaging, be it bottle or blister, is needed. That may be the sticking point, though, since most pharmaceutical manufacturers leave packaging up to pharmacists.

As FDA looks to expand its post market surveillance, it should also step up its patient labeling requirements. Industry should be left to decide what type of packaging is needed, but manufacturers should be required to warn patients themselves through labeling.