Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (8): 913-918.
DOI: 10.19803/j.1672-8629.2022.08.20

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

ZHANG Qingxia1, JIANG Yongxian2Δ, DONG Yuexin3, XIAN Ying4, YAN Suying1*   

  1. 1Department of Pharmacy, Xuanwu Hospital, Capital Medical University, Beijing 100053, China;
    2Department of Pharmacy, Chengdu Women’s and Children’s Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu Sichuan 611731, China;
    3Department of Pharmacy, Beijing Puren Hospital, Beijing 100062, China;
    4Department of Pharmacy, Beijing Hospital of integrated Traditional Chinese and Western Medicine, Beijing 102200, China
  • Received:2020-10-31 Online:2022-08-15 Published:2022-08-15

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Abstract: 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.

Key words: drug instructions, storage management, risk analysis, risk prevention

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