Lupin 2023

NACDS asks FDA to raise standards for drug info

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ALEXANDRIA, Va. — The National Association of Chain Drug Stores has called on the Food and Drug Administration to improve the usefulness of medication information that patients get with prescription drugs.

NACDS outlined its views in a recent letter to the agency. The letter supplemented testimony that was delivered by the association at an FDA public hearing in September and represents the trade group’s latest step regarding the issue of patient medication information.

In 2008 NACDS and seven other pharmacy and consumer organizations submitted a citizen petition to the FDA urging 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.

In the letter, NACDS stressed the importance of FDA-approved information “to ensure that all patient medication information meets FDA standards of accuracy and comprehensibility and that the information is properly balanced to communicate risks and benefits” for patients.

NACDS also urged that if FDA approval was not feasible, pilot programs should be conducted by the agency to determine the best way to achieve a “one-document solution” that would provide the most useful and accurate information for patients about the prescription medicines they are using.

“FDA’s limited resources must not serve as a barrier to moving forward with the ‘one-document solution.’ To address concerns about limited resources, we believe the best overall approach would be for FDA to pilot numerous approaches.

The goals of the pilot programs should be to assess whether the patient medication information content and format meet FDA standards as well as whether distribution is adequate — although current distribution of written consumer information is not considered to be problematic,” the NACDS letter states.

“The key to success for patient medication information will be for continued collaboration among the agency, manufacturers, pharmacies, prescribers and consumer groups. Our membership is pleased with FDA’s recognition of this and looks forward to participation in FDA-developed pilot programs.”

The letter, addressed to FDA commissioner Margaret Hamburg, points out that patients want “a useful document, designed and written for them, that recognizes their information needs.”

Such a document should also provide patients with clear instructions on where to go for further advice and instruction, according to NACDS.

“The provision of multiple documents, containing redundant or even conflicting information, creates logistical and financial burdens for pharmacies that compromise effective patient counseling,” the pharmacy association explains in its correspondence.
“It would be far more convenient, efficient and ultimately more effective for pharmacists 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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