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Clear up patient medication guidelines, independent pharmacy group urges FDA


ALEXANDRIA, Va. The National Community Pharmacists Association wants the government to give patients a clearer, more concise set of guidelines on how to take their medications, the effects those drugs have and the risks and benefits they carry.

The independent pharmacy organization yesterday urged the Food and Drug Administration’s Risk Communication Advisory Committee to push for a change in the current system of overlapping instructions that go to patients along with their prescriptions. In testimony before the committee, NCPA asked the agency to develop criteria for a guidance that would describe “a single, patient-friendly, written prescription information sheet to eventually replace the multiple written documents that patients can currently receive from their pharmacists with a particular prescription.

Under current practices, those documents can include  Medication Guides, Patient Package Inserts [PPIs] and Consumer Medication Information [CMI]. Too often, said NCPA’s director of public policy, Tony Lee, patients discard the CMI and never read it -- sometimes even throwing it away before they leave the pharmacy.

“While we recognize that the FDA has worked hard to try and improve these medication documents, the problem needs to be addressed in a fundamentally different way that combines useful written information with the personal relationships between the pharmacists and patients,” Lee told the FDA advisory panel.

“It is time for a comprehensive solution to this written prescription information issue,” added John Coster, NCPA’s senior VP of government affairs. “Any FDA effort to make CMI more useful for the patient should be accompanied by a broader assessment of the usefulness and purpose of the other information leaflets that pharmacist may be required to provide. We look forward to working with the agency and patient groups to meet this goal.”

Last summer, NCPA joined other pharmacy provider groups to file a “One Document” citizens’ petition with the FDA. The Risk Advisory Committee was convened specifically to address how to make CMI leaflets more useful for the patient, the group noted.

“These leaflets are voluntarily provided by the pharmacist, but the information contained in these leaflets often duplicates information in other written leaflets,” NCPA stated.

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