Consumer and Healthcare Groups Call for Clear, Concise Single Document Fro...( Patients Need Information to Take...),Health

Patients Need Information to Take Medicines Safely

WASHINGTON, July 29 /PRNewswire-USNewswire/ -- The National Consumers League has asked the Food and Drug Administration to issue a guidance for a combined and simplified document for patients when they receive their prescription drugs. In a petition filed on June 30, NCL was joined by several national healthcare organizations including the National Association of Chain Drug Stores, the National Community Pharmacists Association, the National Alliance for Hispanic Health, the National Alliance for Caregivers, the Food Marketing Institute, Healthcare Distribution Management Association, and Catalina Health Resource.

"It is very important that patients receive clear, useful information in plain language with their prescription drugs. They should be able to talk to their pharmacist about potential interactions, how to take their medicine and what side effects to expect. Patients do not need to receive multiple and lengthy pieces of paper that are often redundant and may even contain conflicting information," said Sally Greenberg, Executive Director of the National Consumers League. "The present jumble of documents ill-serves the patient who simply needs enough information to take a prescription drug safely and effectively."

The multitude of documents delivered to patients in pharmacies arises from different FDA legal requirements or unwritten, informal interpretation of those requirements from offices within FDA. Some of the legal requirements were established long ago, and were intended to regulate communications directed to healthcare professionals and not directly to consumers.

The FDA-mandated documents for patient communications can be just "too much information," said Greenberg. For example, a person refilling a prescription for an anti-depressant could, theoretically receive:

-- Consumer Medication Information (CMI) describing how to take the prescribed drug, its risks, a
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