2020—2022年医疗机构药品行政处罚案件分析及启示

Analysis and enlightenment of drug-related administrative penalty cases in medical institutions from 2020 to 2022

目的 分析2020-2022年以医疗机构为当事人的药品行政处罚案件的规律和特点,以更好地提高医疗机构药品管理水平。方法 采用回顾性统计分析法对以医疗机构为当事人的药品行政处罚决定书进行汇总,并将其与2019年版《药品管理法》条款进行匹配并统计分析。结果 本研究纳入医疗机构为当事人的完整行政处罚决定书144份。按案由分析,劣药案件行政处罚126起,占87.50%,其中过效期药品占劣药案件比例超过50.00%;从无药品经营资格的企业或个人购进药品案件15起,占10.42%。按案件处罚金额的幅度分析,从轻处罚案件34起,占23.61%;减轻处罚案件81起,占56.25%。结论 因药品管理违法受到行政处罚的医疗机构是极少数,但医疗机构仍应强化守法意识,认识药品管理的“红线”及容易出现的违法行为,以更好地加强药品质量管理。

OBJECTIVE To analyze the patterns and characteristics of drug-related administrative penalty cases with medical institutions as parties from 2020 to 2022 in order to further improve drug management in medical institutions.METHODS A retrospective statistical analysis was used to summarize the drug-related administrative penalty decisions with medical institutions as parties,and to match them with the provisions of the Drug Administration Law(2019 version) for statistical analysis.RESULTS There were 144 complete administrative penalty decisions with medical institutions as parties.Analyzed by cause,126 cases of administrative punishment for inferior drugs accounted for 87.50%,of which expired drugs accounted for more than 50.00% of the inferior drug cases;15 cases(10.42%) were for purchasing drugs from enterprises or individuals not qualified to operate drugs.Analyzed by the range of punishment amount of the cases,34 cases(23.61%) resulted in lighter penalties,while 81 cases(56.25%) resulted in reduced penalties.CONCLUSIONS There are extremely few medical institutions that have received administrative penalties for drug management violations.Medical institutions should strengthen the awareness of law-abiding,and know the red line of drug management and the illegal behavior that is easy to occur,so as to better strengthen drug quality management.