Abstract: Objective To investigate the safety-related risk factors in clinical management of narcotics and psychotropic substances by means of failure mode and effect analysis (FMEA). Methods A research group on the management of narcotics and psychotropic substances and on prevention strategies for medication errors was established at Beijing Obstetrics and Gynecology Hospital. The failure modes and risk factors were collected via literature retrieval, questionnaire surveys and field investigation. FMEA was used to score the severity (S), frequency of occurrence (O) and discovery index (D) and determine risk priority numbers (RPNs). Management and prevention strategies were formulated for high-risk factors with RPN scores > 100. Results Based on results of FMEA, there were ten high-risk factors (23 in total) with RPN>100 in the whole life cycle of narcotics and psychotropic substances, four of which were found in patient medications, two in drug production, and one in the management system, information system, drug management and drug use respectively. Conclusion The application of FMEA can effectively identify medication error-related risk factors for narcotics and psychotropic substances in clinical practice. By improving management systems, rules and regulations, and quality targets, the prevention and management strategies in medical institutions can be continuously optimized to ensure the medication safety of narcotics and psychotropic substances, thereby reducing negative social impacts.

Key words: failure mode, effect analysis, narcotics and psychotropic substances, medication errors, risk management, safety management