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Pilot Quality Improvement program will test a one-page version of drug labels for patient comprehension and retention
Following workshops held under the auspices of the Engelberg Center for Health Care Reform at the Brookings Institution in Washington, and with FDA as an observer, Catalina Health will be testing a one-page, simplified version of patient medical information (PMI), to be an alternative to the standard package insert, which is usually written for prescribers rather than patients. The pilot began in early August, and will continue for several months, followed by assessment of the PMI’s ability to raise patient awareness of drug administration, precautions and other necessary information. The pilot will run in a limited number of pharmacies that are part of Catalina’s national network of retail outlets—Catalina customarily provides the patient information printed out and attached to pharmacy bags when prescriptions are filled, and has some 19,000 pharmacies in this network.
According to Claire DeMatteis, EVP at St. Petersburg, FL-based Catalina Health, the company was one of several organizations that had filed a citizen’s petition with FDA to improve patient communications; based on subsequent FDA actions, and this PMI effort, the petition was withdrawn. Initially, three drugs will be part of the pilot, and if successful results are obtained, the program will expand to other drugs. However, at this time the parallel effort going on with developing medication guides under Risk Evaluation and Mitigation Strategies (REMS) programs will not be part of the initial testing—but they could be in the future.
Catalina Health is one of the market leaders in opening up communication channels between manufacturers and patients via the retail pharmacy. The medical information provided at the point of dispensing has become a valued communication channel for providing co-pay coupons, marketing nonprescription products related to chronic conditions and other forms of direct promotion. In a HIPAA-compliant, anonymous manner, Catalina Health is able to provide demographic and other data pertaining to patient practices revolving around the medications they pick up. And those data, in turn, can help manufacturers and healthcare providers to understand patient behaviors, thereby tuning co-pay and other direct-to-patient promotion.