某三甲医院西药药品说明书贮藏条件风险分析及防范建议

Risk analysis and precautions related to storage conditions specified in package inserts of western medicines in a hospital

目的梳理医院所有西药药品贮藏条件的风险,为药品正确养护提供参考,降低贮藏相关不良事件的发生,保障患者用药安全。方法参照《中华人民共和国药典》(2020年)凡例中药品贮藏项的相关规定和一些易忽视的特殊贮藏条件,对本院所有西药药品的说明书贮藏条件进行分类,统计贮藏项中各贮藏条件所占的比例和风险点,并针对特殊贮藏条件的药品制定风险防范建议。结果本次调查的946个西药药品说明书,注射剂380种(40.17%)、口服制剂447种(47.25%),外用制剂119种(12.58%)。贮藏条件标准术语描述正确897个(94.82%)。特殊贮藏条件多,尤其是冷处和常温常常有特定的温度限制,且限制温度区间分布广而不统一。需要遮光或避光或凉暗比例最多的是注射剂(248个,65.26%),需要干燥或密封比例最高的是口服制剂(371个,83.00%),需要阴凉或凉暗比例最高的是外用制剂(32个,26.89%),需要冷处贮藏比例最高的是注射剂(73个,19.21%)。42种同一通用名不同厂家的药品的贮藏条件差异大。眼用制剂为多剂量包装(94.87%,37/39),开启后储存的期限多为4周或30 d。结论特殊贮藏条件药品较多,导致药品实际贮藏存在较大的安全风险。建议相关机构、厂家能够关注这个问题,医院相关部门也应重视药品的贮藏与养护条件,规范药品贮藏管理,保证药品质量,保障临床用药安全、有效。

Objective To comb through the risks related to storage conditions of all western medicines in the hospital,provide reference for proper maintenance of drugs,reduce the incidence of storage related adverse events,and ensure medication safety of patients.Methods According to the relevant provisions concerning general storage items in the Pharmacopoeia of 2020,and some of the special storage conditions that were likely to be ignored,the storage conditions specified in package inserts of all western medicines in our hospital were classified,the proportion and risks of each storage condition were statistically analyzed,and precautions were recommended for drugs that needed to be stored under special conditions.Results Among the 946 instructions for western medicines investigated,380 were for injections(40.17%),447 for oral preparations(47.25%)and 119 for topical preparations(12.58%).Standard terms of storage conditions were described correctly in 897 of these inserts,accounting for 94.82%.There were varied special storage conditions,such as specific temperature limits in the cold and at room temperature.248 types of injections(65.26%)needed shading,371 oral preparations(83.00%)needed to be dried or sealed,32 external preparations(26.89%)needed to be dried or sealed,and 73 injections(26.89%)needed to be cold-stored(21%).42 types of drugs with the same general name and by different manufacturers required different storage conditions.94.87%(37/39)of ophthalmic preparations were in multi dose packaging,and the storage period after opening was 4 weeks or 30 days.Conclusion There are many drugs that need to be stored under special conditions,which leads to greater safety risks.It is suggested that institutions and manufacturers concerned should be alert to this problem,and the related departments of a hospital should also pay attention to the conditions of storage and maintenance,standardize drug storage,ensure drug quality,and improve the safety and effectiveness of clinical drug use.