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Best Practices for Effective Stakeholder Involvement in Drug Safety Communication

This presentation by Dr. Paul J. Seligman at the PATHS Annual Meeting discusses the critical role of stakeholder involvement in the realm of drug safety. With over 10,000 drug products marketed in the U.S., including branded, generic, and over-the-counter options, understanding safety-related information is vital. The presentation highlights challenges related to health literacy, the diversity of information sources, and the need for clear communication. It also emphasizes the importance of partnerships in reaching healthcare professionals and patients to ensure timely, accessible, and actionable drug safety information.

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Best Practices for Effective Stakeholder Involvement in Drug Safety Communication

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    1. 1 Best Practices in Stakeholder Involvement Paul J. Seligman, M.D., M.P.H. Associate Director, Safety Policy & Communication Center for Drug Evaluation and Research/FDA PATHS Annual Meeting September 2008

    2. 2 Challenges Drug Products 10,000+ products marketed in US Branded Generic Over-the-counter For wide variety of uses and conditions Life saving Preventative Symptomatic Over 900 safety-related label changes/year Warnings, precautions, adverse events

    3. 3 Challenges Drug Products Everyone uses drugs Language Health literacy Information everywhere Professional label Consumer Medication Information Patient Package Inserts Medication Guides FDA Alerts

    4. 4 Reaching the Audience The Role of Partners MedWatch Patient Safety News Meeting the needs of busy healthcare professionals and their patients Providing easy and quick access to timely and actionable information

    5. 5

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