摘要
目的:调查分析我国通过一致性评价药品说明书概况,研究探讨过评口服药品说明书的科学规范性,以更好地为临床用药提供参考依据。方法:收集山东省第二人民医院药品目录中通过一致性评价的口服药品与原研药品的说明书,并对说明书信息进行比较分析。结果:85种通过一致性评价药品与原研药品说明书对比显示,除性状、适应症、用法用量、不良反应、禁忌、注意事项、有效期和储存条件的标注率达到100%以外,其他包括儿童、孕产妇、老年人、药物相互作用、药代动力学、药理毒理、药物过量、临床试验、警告项目在过评药品说明书中的明确标注率均低于原研药品说明书。过评药品与原研药说明书在有效期、注意事项、不良反应和药理毒理等项目内容上均有显著差异,其存在差异的品种数占比分别为76.47%、49.38%、44.71%和43.53%。结论:过评仿制药品说明书项目的完整性和规范性有待提高,相关部门应加强对药品说明书的审查与监管,敦促相关企业重视和加强其修订工作,进一步完善说明书内容,保证药品说明书的科学、严谨、规范,从而保障患者合理安全用药。
Objective: To investigate and analyze the general situation of inserts of drugs that passed consistency evaluation in China, and to study and explore scientific standardization of the inserts of oral drugs that passed consistency evaluation, so as to provide better references for clinical medication. Methods: The inserts of the oral drugs that passed consistency evaluation and original drugs in the drug catalog of Shandong Second Provincial General Hospital were collected, and the information of the instructions was compared and analyzed. Results: The comparison between the instructions of 85 drugs evaluated by consistency and those of the original drugs showed that the labeling rate of characters, indications, usage and dosage, adverse reactions,contraindications, precautions, expiration dates and storage conditions reached 100%. Other items, including children, pregnant women, the elderly, drug interactions, pharmacokinetics, pharmacology and toxicology, drug overdose, clinical trials and warning items, had lower explicit labeling rates in the instructions of drugs evaluated by consistency than those in the instructions of original drugs. There were significant differences in the projects of expiration date, precautions, adverse reactions and pharmacology and toxicology of the drugs that passed consistency evaluation inserts and the original drug inserts, and the number of varieties with differences accounted for 76.47%, 49.38%, 44.71% and 43.53%, respectively. Conclusion: The completeness and standardization of label items of generic drugs evaluated by consistency need to be improved. Departments should strengthen the examination and supervision of drug inserts, and urge relevant companies to emphasize and enhance their revision work. Companies should improve the contents of the inserts, and ensure the scientific, rigorous and standardization of drug inserts, so as to ensure the rational and safe use of drugs for patients.
作者
聂晶
张荻
石晓晨
吴记勇
Nie Jing;Zhang Di;Shi Xiaochen;Wu Jiyong(Department of Pharmacy,Shandong Second Provincial General Hospital,Jinan 250022,China)
出处
《中国药事》
CAS
2021年第6期700-706,共7页
Chinese Pharmaceutical Affairs
关键词
一致性评价
药品说明书
用药信息
调查
分析
consistency evaluation
drug inserts
medication information
investigation
analysis
