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FDA Planning One-Page Prescription Drug Summaries


  02:46:05 pm, by MedBen5   , 204 words,  
Categories: News, Prescription

FDA Planning One-Page Prescription Drug Summaries

A few months back on this blog, we noted an effort by the U.S. Pharmacopeial Convention, the group that sets drug standards, to make directions on drug labels easier to understand. Now, the federal government is also looking to simplify the instruction sheets that accompany prescriptions.

The Wall Street Journal reports that “[t]he Food and Drug Administration is planning to test single-page consumer information sheets that would replace the multi-page package inserts and medication guides widely used in retail pharmacies.” Currently, patients can receive written usage instructions from multiple sources, including package inserts from the drug manufacturer and consumer medical information from third-party companies. However, the FDA has found that the information offered is not consistently understandable, and may even be contradictory or inaccurate.

Even though the one-page guides may not be implemented for five or six years, there is initial concern that a single-sided summary cannot provide sufficient information. To that end, the nonprofit safety group Institute for Safe Medication Practices is already working on sample two-page, single-paper brochures for medications with the potential to cause the greatest harm.

The National Community Pharmacists Association says that as many as three-quarters of Americans claim that they don’t take prescription drugs as directed.

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