集中采购仿制药说明书一致性评价与风险评估

Assessment of Drug Labelling among Centralized Procurement of Generic Drugs in China:from a Drug Safety Perspective

目的评估国家药品集采目录江苏省中选药品与相应原研药说明书的差异,为药品生产企业和药品监督管理部门进一步提高一致性评价工作质量提供参考、为仿制药临床应用的安全合理性提供科学依据。方法对国家药品集采目录江苏省中选药物的原研药和仿制药说明书全部项目进行一致性评价和风险评估,适应证与禁忌项采用SPSS和Medcalc进行统计分析。结果仿制药与原研药说明书的适应证(P=0.782,ccc=0.93,95%CI0.89~0.95)与禁忌项(P=0.935,ccc=0.97,95%CI0.96~0.98)一致性较高,风险评估发现2组(2.25%)说明书内容差异可引起极度风险、高度风险9组(10.11%),GRADE循证证据佐证高度及以上风险的差异或成为患者用药安全的隐患。结论药品监督管理部门应完善、落实仿制药说明书一致性评价的相关法律法规,保证临床安全用药。

OBJECTIVE To assess the disparity of drug labeling in centrally procured drugs in Jiangsu province and original drugs,which may provide reference for drug manufacturing enterprises and regulatory authorities to improve the consistency evaluation and clinical application of generic drugs.METHODS Generic drugs covered in the first to third batches of centralized procurement in Jiangsu province were included for the comparison.we to compare all the items in drug instructions and analyze the difference.SPSS and Medcalc were used for statistical analysis of the indications and contradictions.RESULTS The indications(P=0.782,ccc=0.93,95%CI 0.89-0.95)and contradictions of the generic and the original drug's instructions were well consistent(P=0.935,ccc=0.97,95%CI 0.96-0.98).However,by risk evaluation of the different items,there are 2 groups(2.25%)and 9 groups(10.11%)of differential descriptions reaching extreme and high risk,respectively.GRADE analysis indicate that these differences may become risk factors for drug safety.CONCLUSION Implementation of relevant laws and regulations for standardization of the writing and review of drug labelling conformity are needed to ensure drug safety.