ParagonRx® | Minimize Risk and Optimize Use

By tracking the use and side effects of a medicine, biotechnology companies can help physicians prescribe those medicines more safely and effectively, as proven in a study released today by BIOCOM, the life sciences trade association representing Southern California. Safety First: The Role of Physician Level Data in Supporting Risk Evaluation and Mitigation Strategies (REMS) for Optimal Patient Care—A Case Study documents the use of physician level data by Amylin Pharmaceuticals (a BIOCOM member) in relation to SYMLIN, a life-changing medication for certain people with diabetes.  Use of physician level data for SYMLIN is critical in meeting the Food and Drug Administration's risk mitigation requirement.  The report outlines how Amylin is using physician level data to:

• Negotiate with the FDA to determine which approaches and tactics were feasible
• Identify physicians skilled in the art of prescribing mealtime insulin—22,000 physicians from a universe of more than 400,000 health professionals who treat type 1 and type 2 diabetes
• Disseminate information and provide support for optimal patient care to selected physicians
• Monitor prescribing patterns on an ongoing basis to identify SYMLIN prescribers outside the original list and provide them with information and support
• Create ongoing dialogue with physicians regarding safety and appropriate use

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