Population health management
-
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.
-
The objective of this study was to compare episode-related and annual costs and work absence days for employees with <3 versus ≥ 3 annual gout attacks. Human Capital Management Services data (2009-2010) from adult employees with gout (International Classification of Diseases, Ninth Revision code 274.x) and ≥ 12 months of medical and pharmacy benefits were studied. Outcomes of interest included medical and drug costs, number of emergency department and urgent care visits, number of inpatient days, short- and long-term disability, sick leave, workers' compensation costs, and work absence days. ⋯ Medical costs both before ($203 higher) and during attacks ($136 higher) were significantly higher for those with ≥ 3 attacks than for those with <3 attacks. Additionally, a quadratic increasing relationship was found between number of attacks and cost. Frequency of acute gout attacks (≥ 3 episodes per year) among employees with gout was associated with greater short-term disability cost, absence days, and emergency department and urgent care visits, and trends toward higher overall costs.