미국의 위해성 평가 및 완화전략 공유시스템의 현황 및 시사점

Current Status and Implications of the Shared System Risk Evaluation and Mitigation Strategy in the United States

In the United States, the Risk Evaluation and Mitigation Strategy (REMS) has been implemented since 2007, and generic products of original drugs under REMS are also subject to REMS. South Korea has adopted a Risk Management Plan (RMP) to ensure drug safety throughout the drug’s product cycle in 2015. This paper reviews the current status of a Shared System (SS) REMS in the United States and the SS REMS of isotretinoin (iPLEDGE program) to understand its implications for Korea's RMP system. In the United States, generic manufacturers can either individually implement REMS or collaborate with original manufacturers. SS REMS benefits the shareholders by reducing the work burden of participating companies, sharing development costs, and maintaining consistency of risk management in clinical settings. The iPLEDGE program is the oldest and most representative SS REMS. It was developed to prevent potential fetal exposure to isotretinoin. A central, systematic risk management website inspects isotretinoin distribution, prescribing, dispensing, and utilization. For example, prescribing isotretinoin is permitted when the results of pregnancy lab tests and contraceptive methods are entered into the website. Since more generic drugs are expected to enter the market in Korea, the SS of RMP can be a systematic approach to maintain a coherent risk mitigation strategy and reduce the operational burden of manufacturers.