重庆市集中采购药品质量与供应现状及监管建议

Quality,Supply Status and Regulatory Suggestions for Centralized Drug Procurement in Chongqing

目的为完善我国药品集中采购监管工作提供参考。方法梳理国家组织药品集中采购的政策背景和重庆市药品集中采购政策实施情况,通过信息收集、问卷调查、实地走访等方式对中选药品上市许可持有人、生产企业集中采购品种的质量和供应现状进行调研,分析重庆市药品监督管理局集中采购监管及其直属检查局2022年集中采购专项检查情况。结果共调查了重庆市13家企业的40个集中采购中选品种,中选层级包括国家级、省际联盟、省级集中采购,剂型包括注射剂(14种)、片剂(20种)、其他口服制剂(5种)、外用制剂(1种)。产能均可满足集中采购中选的需求;5家企业共发生8家次生产成本变化,包括原料药、辅料、包装材料价格上涨及运输配送费用增加,分别占25.00%,12.50%,6.25%,6.25%;生产过程中,6家企业发生微小变更。13家企业的中选品种质量内控较好,11家企业建立了应急管理或应急预案,10家企业收到了药品不良反应/药品不良事件的反馈。集中采购中选后,6家企业中选产品市场占有率、销售区域和销售份额均增加,9家企业的中选品种能达到盈亏平衡或略有盈利。结论应加大法律法规宣贯力度,提升企业主体意识;强化集中采购专项检查力度,加强质量与供应监管;注重企业变更情况,督促企业整改落实;关注原料药、辅料、包装材料价格变动,保障中选药品正常供应;创新集中采购药品的监管方式,推动企业落实主体责任。

Objective To provide a reference for improving the supervision of centralized drug procurement in China.Methods The policy background of centralized drug procurement in China and the implementation of the policy in Chongqing were sorted out.Research on the quality and supply status of the marketing authorization holders(MAHs)and production enterprises'centralized procurement drug varieties of bid-wining drugs were conducted through information collection,questionnaire survey,on-site visits,and other methods,the supervision of centralized procurement carried out by the Chongqing Medical Products Administration and the special inspection situation of centralized procurement in 2022 carried out by the Affiliated Inspection Bureaus of Chongqing Medical Products Administration were analyzed.Results A total of 40 selected bid-wining drug varieties from 13 enterprises in Chongqing were surveyed for centralized procurement.The bid-wining levels included national,provincial alliance,and provincial centralized procurement.The dosage forms included injections(14 types),tablets(20 types),other oral preparations(five types),and topical preparations(one type).The production capacity could meet the needs of centralized procurement.Eight production cost changes occurred in five enterprises,including an increase in the prices of raw materials(25.00%),excipients(12.50%),packaging materials(6.25%),and transportation and distribution costs(6.25%).During the production process,six enterprises underwent minor changes.A total of 13 enterprises had better quality internal control of the bid-wining drugs,11 enterprises established emergency management or contingency plans,and 10 enterprises received feedback on adverse drug reactions/events.After bid-wining in the centralized drug procurement,the market share,sales area,and sales share of the bid-wining drugs of six enterprises increased,and the bid-wining drugs of nine enterprises were able to achieve breakeven or slightly profitable.Conclusion It is necessary to increase the dissemination and implementation of laws and regulations,and enhance the subject consciousness;strengthen the special inspection of centralized drug procurement,strengthen quality and supply supervision;attach importance to changes in enterprises and supervise the implementation of rectification measures;pay attention to the price changes of raw materials,excipients,and packaging materials to ensure the normal supply of bid-wining drugs;innovate the regulatory methods for purchasing drugs in centralized drug procurement,and promote enterprises to implement their main responsibilities.