Risk Evaluation Mitigation Strategies: The Evolution of Risk Management Policy
| Autor: | Kristen Hollingsworth, Michael Toscani |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Drug
Consumer Product Safety Drug Industry Leadership and Management media_common.quotation_subject Risk Assessment Drug approval Medicine Policy Making health care economics and organizations Risk management Health policy media_common Finance Risk Management Government United States Food and Drug Administration business.industry Health Policy Public Health Environmental and Occupational Health Biological product Risk evaluation & mitigation strategies United States Pharmaceutical Preparations Government Regulation business |
| Zdroj: | Population Health Management. 16:132-137 |
| ISSN: | 1942-7905 1942-7891 |
| DOI: | 10.1089/pop.2012.0021 |
| Popis: | The United States Food and Drug Administration (FDA) has the primary regulatory responsibility to ensure that medications are safe and effective both prior to drug approval and while the medication is being actively marketed by manufacturers. The responsibility for safe medications prior to marketing was signed into law in 1938 under the Federal Food, Drug, and Cosmetic Act; however, a significant risk management evolution has taken place since 1938. Additional federal rules, entitled the Food and Drug Administration Amendments Act, were established in 2007 and extended the government's oversight through the addition of a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs. REMS is a mandated strategy to manage a known or potentially serious risk associated with a medication or biological product. Reasons for this extension of oversight were driven primarily by the FDA's movement to ensure that patients and providers are better informed of drug therapies and their specific benefits and risks prior to initiation. This article provides an historical perspective of the evolution of medication risk management policy and includes a review of REMS programs, an assessment of the positive and negative aspects of REMS, and provides suggestions for planning and measuring outcomes. In particular, this publication presents an overview of the evolution of the REMS program and its implications. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|