NACDS urges simple, single med document for patients

Margaret Hamburg

ALEXANDRIA, Va. — Simplify, simplify.

That’s the message chain pharmacy lobbyists conveyed to the Food and Drug Administration in November, as the National Association of Chain Drug Stores urged federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients. The message — conveyed in a letter from NACDS VP government affairs and public policy Kevin Nicholson to FDA commissioner Margaret Hamburg — came as the agency mulls new federal guidelines on patient package inserts and other prescription drug information.

Nicholson also asked the FDA to step up its efforts to clear the way for an approval pathway for generic versions of biologically engineered drugs.

NACDS, Nicholson told Hamburg, strongly endorses federal efforts to adopt a simpler, single medication information document for patients. The goal, he said, should be clear: easy-to-understand instructions and warnings about possible side effects of prescription medicines.

Such a document, Nicholson asserted, provides the “final link in the prescription supply chain,” and should be “standardized with respect to format and content.”

“Today, patients receive several different types of written medication information, developed by different sources that may be duplicative, incomplete or difficult to read and understand,” Nicholson pointed out. “This current system is not adequate to ensure that patients receive essential medication information.”

NACDS, he reminded Hamburg, was part of a coalition of pharmacy groups that urged the agency in 2008 to require drug suppliers to provide “a concise, plain-language document for patients” when they fill a prescription.

Among the group’s other priorities with the agency: adoption of “an abbreviated approval pathway for biogenerics.” Nicholson also applauded recent efforts by the FDA’s Center for Drug Evaluation and Research and its director, Janet Woodcock, to address lingering skepticism among “certain sectors of the public” about the therapeutic equivalence of generic drugs.

“We applaud Dr. Woodcock for acknowledging this skepticism and for making its resolution a high priority,” he added.

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