The National Consumers League haspetitioned the FDA to issue a guidance for a "combined and simplified document" for patients when they receive their prescription drugs. The move was made in response to what the NCL calls a "jumble" of paper in the form of package inserts and medication guides, among other things.
“It is very important that patients receive clear, useful information in plain language with their prescription drugs...Patients do not need to receive multiple and lengthy pieces of paper that are often redundant and may even contain conflicting information,” Sally Greenberg, who heads the NCL, in a statement. “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, NCL complains, adding that some 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,” says Greenberg. For example, a refill for antidepressants may include a Consumer Medication Information describing how to take the drug, its risks, and other info including risks from a med guide; a patient package insert from the manufacturer with a med guide; a med guide provided by the pharmacy; and labeling in the form of a sponsored message from the drugmaker.
“Many of these documents were never designed for nor intended to apply to the unique pharmacy environment,” says 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.”
NCL was joined by several national healthcare organizations in filing the petition, 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.