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注射剂药品说明书与临床用药的冲突之探讨

         

摘要

通过归纳总结我院静脉药物配制中心(PIVAS)常用的注射剂药品说明书,发现存在下列问题:注射剂药品说明书规定用量与药品规格不匹配;对成品输液的配制浓度、贮藏条件及稳定性不明确;中药注射剂说明书内容含糊不清;注射剂药品说明书规定的常用量与临床经验用药有差异。针对存在的问题,尤其是与临床经验用药相冲突的问题,建议医务工作者在工作中对说明书的阐述产生疑问时,应及时查阅权威资料,确保药品的正确使用。同时建议监管部门加强监管力度,规范药品说明书的审核、修订。%  By collecting the package inserts of injections commonly used in PIVAS of our hospital, and summarizing the problems existed in them, finding out that there were differences in the usage amount between the package inserts and clinical experience, the regulated amount and injection specification does not match, there were difference between the route of administration of regulated and clinical experience. Concentrations of the finished infusion, storage conditions and the stability were not confirmative, and the instructions of traditional Chinese medicine injections were ambiguous. Based on the existing problems of package inserts of injections, especially the confliction with clinical experience. It was suggested that medical practioners should timely refer to authoritative materials while having doubts to ensure the drugs are used correctly. Meanwhile, supervisory departments should strengthen the force of supervision, standardize the auditing and revision system of package inserts.

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