目的：探讨药品说明书存在的问题，为药品说明书的修订与完善提供参考。方法：采用随机直抽样法，抽取扬州市第二人民（以下简称“我院”）常用的药品说明书，分析其科学性、完整性和时效性。结果：85份药品说明书中，有6份与2010年版《中华人民共和国药典·临床用药须知》的要求不一致；有3份药品说明书适应证与《国家基本药物临床应用指南》的要求不一致；有5种药品的说明书为同一种药品各厂家之间批准的内容不一致；有3份说明书中药品规格与实际用量不适合；有4份药品说明书中药理作用与适应证不相符；另外，还存在药理作用、适应证、用法与用量等项信息滞后现象，已不能满足临床需要。结论：某些药品说明书质量有待提高，国家食品药品监督管理总局应指定相关部门定期进行药品说明书的修订工作，以保证药品说明书的科学性、完整性和时效性，减少临床在用药时的困惑，促进临床用药的规范与合理。%OBJECTIVE:To analyze the problems existing in drug package inserts for reference of revision of drug package inserts. METHODS:The common package inserts inYangzhou Municipal Second People�s Hospital( hereinafter referred to as “our hospital”) were randomly selected for analysis regarding their scientificity, scientific integrity and chronergy. RESULTS:Of the 85 package inserts, 6 failed to comply with “Pharmacopoeia of the People�s Republic of China⁃Clinical Medication Instruction”(2010 edition) , 3 failed to comply with“Clinical Application Guide of National Essential Drugs” in indications;the labeled contents in 5 package inserts approved by different manufacturers for the same drug were inconsistent; the drug specifications in 3 package inserts dismatch the actual dosage; the pharmacological actions labeled in 4 package inserts were inconformity with the indications; moreover, there was information lag in items such as pharmacological action, indications, dosage and administration etc, failing to meet the clinical requirement. CONCLUSIONS: The quality of some drug package inserts remains to be improved. China Food and Drug Administration( CFDA) should designate the relevant departments to revise drug package inserts regularly to ensure the scientificity, integrity and chronergy of package inserts of drugs, reduce confusion in clinical drug use and promote standard and rational use of drugs.
展开▼
