Population health management
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Clinicians may face pragmatic, ethical, and legal issues when treating addicted patients. Equal pressures exist for clinicians to always address the health care needs of these patients in addition to their addiction. Although controversial, mainly because of the lack of evidence regarding their long-term efficacy, the use of opioids for the treatment of chronic pain management is widespread. ⋯ The purpose of this article is to summarize recommendations from a recent meeting of experts convened to recommend how primary care physicians should approach treatment of chronic pain for addicted patients when an addiction specialist is not available for a referral. As there is a significant gap in guidelines and recommendations in this specific area of care, this article serves to create a foundation for expanding chronic pain guidelines in the area of treating the addicted population. This summary is designed to be a practical how-to guide for primary care physicians, discussing risk assessment, patient stratification, and recommended therapeutic approaches.
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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. ⋯ 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.