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%CI 0.89~0.95)与禁忌项(P=0.935, ccc=0.97, 95%CI 0.96~0.98)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。
Abstract
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.
关键词
仿制药 /
药品说明书 /
一致性评价 /
集中采购
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Key words
generic drug /
drug instruction /
consistency evaluation /
centralized procurement
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中图分类号：
R952
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参考文献
[1] NMPA. Drug registraion regulation(药品注册管理办法)[EB/OL].[2020-07-01]. https://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20200330180501220.html.
[2] NMPA. Announcement of the state food and drug administration on issuing the principles for the classification of recombinant collagen medical products(国家药监局关于发布化学仿制药参比制剂遴选与确定程序的公告)[EB/OL].[2019-03-28]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190328162401710.html.
[3] NMPA. Opinions of the general office of the state council on reforming and improving the policy for supply guarantee and use of generic drugs(国务院办公厅关于改革完善仿制药供应保障及使用政策的意见)[EB/OL].[2018-04-03]. http://www.gov.cn/zhengce/content/2018-04/03/content_5279546.html.
[4] NMPA. General office of state council printed and issued opinions on carrying out quality and efficacy consistency evaluation for generic drugs(国务院办公厅印发《关于开展仿制药质量和疗效一致性评价的意见》)[EB/OL].[2016-03-05]. https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20160526170401156.html.
[5] NMPA. Issuance of the 13th five-year plan for national drug safety(“十三五”国家药品安全规划)[EB/OL].[2017-03-09]. https://www.nmpa.gov.cn/directory/web/nmpa/zwgk/ghcw/ghjh/20170309170601864.html.
[6] CONG D D, XUE W, LIU Y, et al. Management of safety information in prescription drug labeling in China, Japan and the united states[J]. Chin J Pharmacovigil(中国药物警戒), 2021, 18(3): 245-249,255.
[7] GAO L L, LI M, WANG Y Z, et al. Generic drug labelling management of FDA and EMA[J]. Chin New Drugs J(中国新药杂志), 2017,26(24):2903-2907.
[8] THOENES A, CARIOLATO L, SPIERINGS J, et al. Discrepancies between the labels of originator and generic pharmaceutical products: implications for patient safety[J]. Drugs Real World Outcomes, 2020, 7(2): 131-139.
[9] WANG Q J, CHEN J. Progress and prospect for generic consistency evaluation[J]. Chin J Mod Appl Pharm(中国现代应用药学杂志), 2019, 36(4): 499-502.
[10] NMPA. Provisions on the Administration of Pharmaceutical Directions and Labels(药品说明书和标签管理规定)[EB/OL].[2006-03-16]. http://www.gov.cn/ziliao/flfg/2006-03/16/content_228465.html.
[11] NMPA. Notice on the issuance of the "Rules for the Specification of Chemical Drugs and Biological(化学药品和治疗用生物制品说明书规范细则)[EB/OL].[2006-05-10. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20060510010101566.html.
[12] Merck & Co, Inc.Classification of drug adverse reactions(药物不良反应的分类)[EB/OL].[2018-08-18]. https://www.msdmanuals.cn/professional/clinical-pharmacology/adverse-drug-reactions/adverse-drug-reactions.
[13] ISO. New Risk Management Standard AS/NZS ISO 31000[EB/OL]. (2019-06-04) https://www.iso.org/iso-31000-risk-management.html/
[14] Evidence-based Nursing Center of Beijing University of Chinese Medicine. GRADE classification standard(GRADE 分类标准)[EB/OL].[2019-03-21]. https://ebn.bucm.edu.cn/xzffxzy/zjfjxt/54213.html.
[15] PHUNG O J, SCHWARTZMAN E, ALLEN R W, et al. Sulphonylureas and risk of cardiovascular disease: systematic review and meta-analysis[J]. Diabet Med, 2013, 30(10): 1160-1171.
[16] MATSUBARA N, KIMURA G, UEMURA H, et al. A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study[J]. Int J Clin Oncol, 2020, 25(4): 720-731.
[17] HROMETZ S L, SHIELDS K M. Role of ambrisentan in the management of pulmonary hypertension[J]. Ann Pharmacother, 2008, 42(11): 1653-1659.
[18] MA L, WEN C, CHEN C, et al. Hepatotoxicity associated with donepezil in an individual taking citalopram[J]. J Am Geriatr Soc, 2016, 64(5): 1144-1145.
[19] BUAWANGPONG N, TEEKACHUNHATEAN S, KOONRUNGSESOMBOON N. Adverse pregnancy outcomes associated with first-trimester exposure to angiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers: a systematic review and meta-analysis[J]. Pharmacol Res Perspect, 2020, 8(5): e00644. Doi: 10.1002/prp2.644.
[20] SAMURA M, TAKADA K, HIROSE N, et al. Incidence of elevated creatine phosphokinase between daptomycin alone and concomitant daptomycin and statins: A systematic review and meta-analysis[J]. Br J Clin Pharmacol, 2021, 79(11):1400-1413.
[21] MORRIS A D, CHEN J, LAU E, et al. Domperidone-associated QT interval prolongation in non-oncologic pediatric patients: a review of the literature[J]. Can J Hosp Pharm, 2016, 69(3): 224-230.
[22] MEASE P, CHARLES-SCHOEMAN C, COHEN S, et al. Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data[J]. Ann Rheum Dis, 2020, 79(11): 1400-1413.
[23] ERDINC B, GHANTA S, ANDREEV A, et al. Acute kidney injury caused by levetiracetam in a patient with status epilepticus[J]. Cureus, 2020,12(6):e8814.
[24] NIE J, ZHANG D, SHI X C, et al. Investigation and analysis of 85 oral drug inserts after consistency evaluation[J]. Chin Pharm Aff(中国药事), 2021,35(6):700-706.
[25] WEN J,LUO J. Comparative analysis of the instruction items of 61 kinds of centralized[J]. Chin J Hosp Pharm(中国医院药学杂志), 2021, 41(21): 2244-2249.
[26] DUAN R, LI Z X. Investigation and analysis of cognition of drug instructions in residents of 155 regions in 29 provinces and cities in China[J]. Eval Anal Drug Use Hosp China(中国医院用药评价与分析), 2021, 21(1): 113-116, 120.
[27] NMPA. Good pharmacovigilance practice(药物警戒质量管理规范)[EB/OL].[2021-05-13]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html.
[28] LIN X T, ZHANG Y, HE G R. Investigation of cognition and behavior of family medication among elderly residents in different areas[J]. Nurs J Chin PLA(解放军护理杂志), 2018, 35(10): 20-24.
[29] FU S Y, YANG Y, YU J R. Game and regulatory suggestions in the revision process of drug instructions for domestic pharmaceutical companies[J]. Chin Pharm J(中国药学杂志), 2018, 53(15): 1318-1322.
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脚注
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基金
江苏省科教强卫青年医学重点人才项目资助(QNRC2016811)
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