重庆市药品安全风险管理策略研究OA

Objective To provide reference for improving drug risk management capabilities and risk prevention and control capacity.Methods The manufacturers and business entities of drugs,medical devices,and cosmetics in Chongqing were taken as the research subjects.The data on drug safety risk identification,assessment,and resolution reported by the district/county market supervision administrations and directly affiliated inspection bureaus from 2020 to 2024 were collected.Descriptive statistical methods were used to summarize and analyze indicators such as the number of identified risks,the number of recorded risks,the number of resolved risks,risk levels,and domain distribution.Combined with the mechanisms and practical approaches of drug risk management in Chongqing,the main problems in current work were identified.Results From 2020 to 2024,a total of 9 842 potential risks were identified in Chongqing,including 6 554 drug-related risks(66.59%),2 101 medical device-related risks(21.35%),and 1 187 cosmetic-related risks(12.06%).After assessment,1 282 risks were recorded in the database,all of which were resolved.Among the recorded risks,989 were general risks(77.15%),289 were relatively major risks(22.54%),four were major risks(0.31%),and no exceptionally major risks were found.The main risk included the absence of licensed pharmacists,retail pharmacies selling prescription drugs without a prescription,the sale and use of counterfeit or substandard medical devices,and cosmetic labels failing to comply with regulations.Meanwhile,it was identified that some grassroots units had weak risk management awareness,the regulatory workforce was insufficient,risk detection capabilities were insufficient,the quality of risk prevention and control was low,risk working mechanisms were incomplete,the primary responsibility of enterprises was inadequately fulfilled,and inter-departmental coordination was lacking.Conclusion Chongqing's drug regulation achieved full resolution of all recorded risks from 2020 to 2024.Nevertheless,continuous efforts are needed to strengthen risk management awareness,build a professional and specialized team of drug inspectors,improve risk detection capabilities,enhance the efficiency and quality of risk prevention and control through information technology and big data,and establish a long-term mechanism for fulfilling the primary responsibilities of enterprises and achieving multi-departmental coordination,so as to further improve the level of drug safety assurance.