The Food and Drug Administration drew praise this week from the National Association of Chain Drug Stores for the progress of its effort to improve the usefulness of the information that patients receive with their prescription medications.


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FDA applauded by NACDS for push to simply Rx information

September 29th, 2010

ALEXANDRIA, Va. – The Food and Drug Administration drew praise this week from the National Association of Chain Drug Stores for the progress of its effort to improve the usefulness of the information that patients receive with their prescription medications.

In a presentation at an FDA public hearing, Kevin Nicholson, vice president of government affairs at NACDS and a pharmacy adviser, said the association is "very pleased" that FDA appears to be advancing toward a single prescription information document with a standardized format and content and urged the agency to "continue to move toward this laudable goal with all reasonable haste."

NACDS reported that it and seven other pharmacy and consumer organizations in June 2008 submitted a Citizen Petition to FDA that called for a move to a concise, plain-language document for patients that would consolidate and replace the multiple written communications that pharmacies currently are required to distribute to patients.

Nicholson said at the hearing that, under the existing requirements, "patients may receive several different types of information, developed by different sources that may be duplicative, incomplete, or difficult to read or understand."

He added that "patients want a useful document, designed and written for them, that recognizes their information needs, that focuses concisely on critical information, and that provides them with clear instructions on where to go for further advice and instruction."

The provision of multiple documents that contain redundant or possibly conflicting information creates logistical and financial burdens for pharmacies that compromise effective patient counseling, Nicholson said at the hearing.

"It would be far more convenient, efficient, and ultimately more effective for pharmacists," he noted, "to counsel patients by providing a single document that could easily be understood and facilitate a discussion concerning proper use of medication."

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