药品零售企业网售处方药风险及对策研究

Study on the risk and countermeasure of prescription drugs sold online by drug retail enterprises

目的分析药品零售企业网售处方药风险,为网售处方药的风险防控提供对策建议。方法采用层次分析法构建药品零售企业网售处方药风险层次结构模型,再进行风险判断矩阵的归一化权重计算和一致性检验;采用德尔菲专家调查法对123对评价指标进行多轮风险研判,开展模糊定量研究。结果药品零售企业网售处方药风险中的处方调剂及审核风险(6.48%)、先药后方风险(5.48%)、合理用药指导风险(4.99%)、非正常用途购买药品风险(4.97%)、“首诊、非慢性病、非常见病”风险(4.43%)、退货药品质量安全风险(4.34%)、监管技术应用风险(4.06%)为高风险点;药品零售企业(连锁)网售处方药的总体风险为38.67%,药品零售企业(单体)网售处方药的总体风险为61.33%,两者之间相差22.66%。结论药品零售企业网售处方药高风险指标有7个,其中处方调剂及审核风险、先药后方风险、合理用药指导风险为排名前3位的高风险点;药品零售企业(单体)网售处方药的风险要高于药品零售企业(连锁)。建议监管部门重点关注并规范药品零售企业(单体)的网售处方药行为,鼓励药品零售企业(连锁)建立系统的处方药网售流程;对于网售处方药的高风险点,建议监管部门和药品零售企业重点关注并采取有效风险防控措施,以保障老百姓网购处方药的安全用药权益。

OBJECTIVE To analyze the risks of prescription drugs sold online by drug retail enterprises,and to provide countermeasures and suggestions for risk prevention and control of prescription drugs sold online.METHODS The risk hierarchy structure model of prescription drugs sold online by drug retail enterprises was constructed by using analytic hierarchy process.Multiple rounds of risk research and judgment were carried out on 123 pairs of evaluation indicators by using Delphi expert survey method.The normalized weight calculation and consistency test of risk judgment matrix were carried out to perform fuzzy quantitative research.RESULTS The risk of prescription dispensing and review(6.48%),the risk of drug first and prescription later(5.48%),the risk of rational drug use guidance(4.99%),the risk of buying drugs by abnormal channel(4.97%),the risk of“first diagnosis,non-chronic disease and non-common disease”(4.43%),and the quality and safety risk of returned drugs(4.34%)and the application risk of regulatory technology(4.06%)were high risks;the overall risk of drug retail enterprises(chain)selling prescription drugs online was 38.67%,and the overall risk of drug retail enterprises(individual)selling prescription drugs online was 61.33%,with a difference of 22.66%between them.CONCLUSIONS There were 7 high-risk indicators for prescription drugs sold online by drug retail enterprises.Among them,the risk of prescription dispensing and review,the risk of drug first and prescription later,and the risk of rational drug use guidance are the top three high-risk points.The risk of prescription drugs sold online by drug retail enterprises(individual)is higher than that of drug retail enterprises(chain).It is recommended that regulatory authorities focus on and regulate the prescription drugs sold online by drug retail enterprises(individual),and encourage drug retail enterprises(chain)to establish a systematic online sales process for prescription drugs;for high-risk points of prescription drugs sold online,it is recommended that regulatory authorities and drug retail enterprises focus on it and take effective risk prevention and control measures to ensure the safe use of prescription drugs by the general public.