Lecture 2

Lecture 2 - 1 FDA MedWatch and Patient Safety FDA MedWatch...

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Unformatted text preview: 1 FDA MedWatch and Patient Safety FDA MedWatch and Patient Safety 2 FDA MedWatch and Patient Safety Impact of Adverse Events on the Publics Health 400 B.C. Hippocrates 1999 Institute of Medicine [IOM] Report Adverse Drug Events [ADEs] Voluntary Reporting of Serious Unexpected Adverse Events 2 3 FDA MedWatch and Patient Safety MedWatch program goals Reporting IN Educate about importance of reporting Facilitate the reporting Improve the quality of the reports Safety Information OUT Disseminate clinically useful, new safety information to providers and patients 4 FDA MedWatch and Patient Safety Learning Objectives Outline FDAs role in post-marketing safety surveillance for medical products Describe the reporting IN to MedWatch Discuss how reports are used by the FDA Identify ways MedWatch disseminates safety information about medical products to both healthcare professionals and their patients 3 5 FDA MedWatch and Patient Safety Mission and History Protecting the public health by assuring the safety, efficacy, and security of human ... drugs, biological products, medical devices, cosmetics, and products that emit radiation. from FDA Mission Statement [www.fda.gov] Helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The first U.S. consumer protection agency 1906 Pure Food and Drugs Act 1938 Food Drug and Cosmetics Act 1962 Kefauver/Harris amendments 1993 FDA MedWatch Program 6 FDA MedWatch and Patient Safety How FDA Evaluates Medical Product Safety Pre-Market Review and Approval FDA does not develop or routinely test products itself FDA reviews the results of laboratory, animal, and human clinical testing done by companies Post-Market Monitoring for Safety Careful review of adverse experiences with products once they are marketed 4 7 FDA MedWatch and Patient Safety The Benefits and Limitations of Clinical Trials What Clinical Trials Do Well...
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Lecture 2 - 1 FDA MedWatch and Patient Safety FDA MedWatch...

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