Risk Assessment for Drug Safety: Current Status and Policy

국내외 의약품 리스크 측정의 동향과 정책

Risk assessment includes identification, estimation and evaluation of risk as the first step of risk management on drug development and use. Pharmacovigilance and pharmacoepidemiology are linked in respect to their principles and application methods. The coding systems for adverse drug reactions have been developed as COSTART, WHOART, and MedDRA by the United States, WHO, and ICH, respectively. MedDRA becomes globally accepted coding system due to its comprehensiveness and characteristics of continuous evolution. International organizations including WHO and ICH have developed guidance for accomplishing global standardization on risk assessment. Current pharmacovigilance system needs to be developed further for satisfying the increased concern on drug safety. In Korea, effective risk assessment system has not been established yet because of the lack of trained staffs at KFDA and less active collaboration among academia, regulatory and industry. Korean FDA has to establish more effective system for facilitating spontaneous ADR reporting by the patients as well as from physicians and pharmacists. Highly-qualified experts are also needed to conduct adequate risk assessment activities for detecting signals from the database constructed from the spontaneous ADR reports as well as large automated databases at Health Insurance Review Agency. We reviewed the current status and policy on risk management system focusing on the risk assessment including ADR coding system globally as well as domestically.