157份抗肿瘤药物说明书用药信息标注情况的调查分析
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篇名: 157份抗肿瘤药物说明书用药信息标注情况的调查分析
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摘要: 目的:调查、分析抗肿瘤药物说明书用药信息标注情况,为临床合理用药提供参考。方法:收集南京市某3家“三甲”医院药品目录中抗肿瘤药物说明书,根据《药品说明书和标签管理规定》《化学药品和生物制品说明书规范细则》评价药品说明书中存在的常见问题(如主要内容是否相互矛盾、内容表述是否全面等)、具体标注项目(如“不良反应”“禁忌”“注意事项”等或者此类项下的明细内容)是否标注完整、注射剂静脉配置指导是否详细(如溶剂的选择、配制时的注意事项等)、通用名及给药途径相同的药品说明书标注信息是否存在差异。结果:共收集157份抗肿瘤药物说明书,按来源分为国产药(80份)、进口药(77份),按药品剂型分为口服制剂(44份)、注射剂(113份)。抗肿瘤药物说明书存在的常见问题有主要内容相互矛盾、说明书内容表述不全面、汉字错误、项目缺失、药物相互作用描述简单等。与国产或口服抗肿瘤药物相比,进口或注射抗肿瘤药物说明书各标注项的标注率均较高,但具体标注项如“注意事项”项下止吐防治(<20%)、药物对临床检验干扰(<40%)的标注率均较低,“药品过量”项下大剂量或长期用药后严重不良反应的标注率均小于41%(进口药除外)。进口抗肿瘤药物注射制剂说明书中有关的静脉配制指导的标注率均高于国产。56组通用名及给药途径相同的药品说明书中“注意事项”(30/56,53.57%)、“药理毒理学”(29/56,51.79%)、“禁忌”(26/56,46.43%)等标注项信息均存在差异。结论:抗肿瘤药物说明书标注项目需要进一步规范、完善,建议有关部门强制药品生产企业定期补充说明书中的不足之处,促进临床安全、合理用药。
ABSTRACT: OBJECTIVE: To investigate and analyze medication information labeling in package inserts of anticancer drugs, and to provide reference for clinical rational use. METHODS: The package inserts of anticancer drugs were collected from drug catalogues of 3 Third Grade Class A hospitals in Nanjin. Common problems of drug package inserts (whether the main contents arweree contradictory or not and whether the contents were fully expressed, etc.), complete specific labeling items (detailed contents of “ADR” “contraindication” “precautions” and other items), detailed intravenous injection dispensing guidance (solvent selection, precautions during dispensing, etc.), package insert labeling difference of drugs with same general name and route of administration were evaluated according to Drug Package Inserts and Label Management Regulation,Regulations for Chemical Drugs and Biological Products for Treatment. RESULTS: A total of 157 package inserts for anticancer drugs were collected and divided into domestic drugs (80 pieces) and imported drugs (77 pieces) according to the source as well as also divided into oral preparation (44 pieces) and injection (113 pieces). The common problems of package inserts for anticancer drugs contained contradictory main contents, incomplete description, Chinese character errors, missing items and simple description of drug interactions, etc. Compared with domestic or oral anticancer drugs, the labeling rate of each item in the import or injection anticancer drug package inserts was higher, but specific labeling items such as prevention and treatment of vomiting (<20%) under “precautions” and interference of drugs on clinical tests (<40%) were lower. The labeling rate of serious ADR after large dose or long-term use was all less than 41% under the item of “drug overdose” (except for imported drugs). The labeling rate of intravenous dispensing guidance of imported anticancer drug injection package inserts about preparations was higher than that of domestic ones. There were differences in labeling items as “precautions” (30/56,53.57%), “pharmacological toxicology” (29/56,51.79%), “contraindication” (26/56,46.43%) among 56 groups of drug package inserts with same general name and route of administration. CONCLUSIONS: The labeling items for drug package inserts of anticancer drugs need to be further standardized and improved. It is recommended that the relevant departments force pharmaceutical manufacturers to regularly supplement the deficiencies in the package inserts to improve the safety of drug use in clinic.
期刊: 2019年第30卷第7期
作者: 马静,王妍,鹿博,汤守香,袁丽华,周学敏
AUTHORS: MA Jing,WANG Yan,LU Bo,TANG Shouxiang,YUAN Lihua,ZHOU Xuemin
关键字: 抗肿瘤药物;药品说明书;用药信息;标注;调查分析
KEYWORDS: Anticancer drug; Package inserts; Medication information; Label; Investigation and analysis
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