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Pharmacy leaflets help educate patients about drug benefits and risks

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Researchers from University of Maryland School of Pharmacy, Baltimore, discuss how pharmacy leaflets are an "often overlooked means of communicating drug information to patients." Medication guides, patient package inserts, and pharmacy leaflets are the leading sources of written information about individual drugs.

Researchers from University of Maryland School of Pharmacy, Baltimore, discuss how pharmacy leaflets are an "often overlooked means of communicating drug information to patients." Medication guides, patient package inserts, and pharmacy leaflets are the leading sources of written information about individual drugs. The researchers note that while medication guides are required for about 400 prescription drugs at present and patient package inserts are required for even fewer medications, pharmacy leaflets—which are not subject to FDA regulation—are "ubiquitous." In 2009, the FDA Risk Communication Advisory Committee recommended that these three drug information sources be replaced by a single, standardized document that would be distributed with all prescriptions. After several years of research, FDA said earlier this year that it would not require the inclusion of a quantitative summary of the benefits and risks of a specific drug, noting the difficulty of standardizing such a summary for all prescription drugs. The authors of this article suggest that pharmacy leaflets could include these summaries, with the information "based on the results of high-quality systematic reviews as well as data found in the information the FDA uses to approve a medication for marketing." This also offers an opportunity for innovation, they add, "because pharmacy leaflets come from a trusted source, are ubiquitous, and, most important, are not regulated by the FDA and so do not require FDA approval of their use for new approaches to providing drug information."

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http://archinte.jamanetwork.com/article.aspx?articleid=2473632

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