July 29, 2008
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Washington, DC – 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, and other information including risk information from the Medication Guide.
- A Patient Package Insert from the manufacturer with a Medication Guide.
- A Medication Guide provided by the pharmacy.
- Full professional labeling if the patient receives a sponsored message about the anti-depressant from the drug manufacturer describing, for example, the importance of adhering to the doctors’ orders.
The National Consumers League and other petitioners believe that it makes more sense to provide a single, clear, patient-friendly document with information for the patient that reinforces the communications between the patient, the pharmacist, and the prescribing healthcare professional. This single patient document would consolidate the many documents now in use and replace them with one that is easy to read, in plain language, in a consistent format, with plain instructions informing the patient where he or she can reliably obtain additional information.
“Many of these documents were never designed for nor intended to apply to the unique pharmacy environment,” said Greenberg. “The risks of patient confusion, conflict, redundancy, and pharmacy burden would be eliminated if FDA permitted a ‘single document solution’ for all patient-directed information disseminated in the pharmacy.”
About the National Consumers League
Founded in 1899, the National Consumers League is America’s pioneer consumer organization. Its mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. NCL is a private, nonprofit membership organization. For more information, visit www.nclnet.org.