Developing a safety assessment model for Chinese patent medicines based on real-world data

doi:10.19803/j.1672-8629.2022.01.04

Abstract

Abstract: Objective To develop a safety assessment model for Chinese patent medicines based on real-word data, so as to provide reference for researchers and decision makers to scientifically and rationally produce and use real-world-data-based safety assessment evidence of Chinese patent medicines. Methods We summarized the role of real-world data in the safety assessment of Chinese patent medicines by referring to domestic and foreign literatures, explored and developed the safety assessment model of Chinese patent medicines based on real-world data. Results We proposed, from the perspective of drug regulation, a safety assessment research model for Chinese patent medicines based on routinely collected and actively collected real-world data, and its application was illustrated with an example. Conclusion Real-world data plays an important role in the safety assessment of Chinese patent medicines, but there are still some limitations. There is an urgent need to introduce new study design and statistical analysis methods in this field.

Key words: real-world data, Chinese patent medicine, safety, assessment

CLC Number:

R994.11

LI Ling, LIU Yanmei, TAN Jing, WANG Wen, YAO Minghong, MA Yu, LUO Xiaochao, LIAO Xing, LIU Yan, SONG Haibo, WEN Zehuai, SUN Xin. Developing a safety assessment model for Chinese patent medicines based on real-world data[J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 18-22.

References

[1] The State Council of the People's Republic of China. China issues guideline to promote the preservation and innovative development of traditional Chinese medicine(TCM) [EB/OL]. (2019-10-20)[2021-09-30]. http://english.www.gov.cn/policies/latestreleases/201910/26/content_WS5db44c20c6d0bcf8c4c15d43.html.
[2] The State Council of the People's Republic of China. Notice of the general office of the China state council on the development of a number of policies and measures to accelerate the characteristics of Chinese medicine [EB/OL]. (2021-02-09)[2021-09-30].http://www.gov.cn/zhengce/content/2021-02/09/content_5586278.htm.
[3] YANG ZJ, LIANG YH.Analysis of "missing items" in 1910 drug lables[J]. Nei Mongol Journal of Traditional Chinese Medicine(内蒙古中医药), 2013, 32(3): 99.
[4] HU J, ZHANG H, LI B, et al.Analysis of adverse events and influencing factors in randomized controlled trials of oral Chinese medicine published in English[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2020, 45(8): 1948-1952.
[5] SUN X, TAN J, TANG L, et al.Real world evidence: experience and lessons from China[J]. BMJ, 2018, 360: j5262.
[6] SUN X, TAN J, TANG L, et al.Revisiting real-world study[J]. Chinese Journal of Evidence-based Medicine(中国循证医学杂志), 2017, 17(2): 126-130.
[7] OYINLOLA JO, CAMPBELL J, KOUSOULIS AA.Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances[J]. BMC Health Serv Res, 2016, 16: 299.
[8] WANG W, TAN J, REN Y, et al.Real-world data studies: update and future development[J]. Chinese Journal of Evidence-based Medicine(中国循证医学杂志), 2020, 20(11): 1241-1246.
[9] WANG L.Opportunities and challenges in using medical big data to monitor and evaluate drug safety[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2015, 12(11): 660-664.
[10] SUN X, TAN J, WANG W, et al.Developing technical guidance for real-world data and studies to achieve better production and use of real-world evidence in China[J]. Chinese Journal of Evidence-Based Medicine(中国循证医学杂志), 2019, 19(7): 755-762.
[11] WANG W, GAO P, WU J, et al.Technical guidance for developing research databases using existing health and medical data[J]. Chinese Journal of Evidence-Based Medicine(中国循证医学杂志), 2019, 19(7): 763-770.
[12] TAN J, PENG X, SHU X, et al.Technical guidance for developing patient registry databases[J]. Chinese Journal of Evidence-Based Medicine(中国循证医学杂志), 2019, 19(7): 771-778.
[13] PENG X, SHU X, TAN J, et al.Technical guidance for designing observational studies to assess therapeutic outcomes using real-world data[J]. Chinese Journal of Evidence-Based Medicine(中国循证医学杂志), 2019, 19(7): 779-786.
[14] GAO P, WANG Y, LUO J, et al.Technical guidance for statistical analysis to assess therapeutic outcomes using real-world data[J]. Chinese Journal of Evidence-Based Medicine(中国循证医学杂志), 2019, 19(7): 787-793.
[15] WEN Z, LI L, LIU Y, et al.Technical guidance for pragmatic randomized controlled trials[J]. Chinese Journal of Evidence-Based Medicine(中国循证医学杂志), 2019, 19(7): 794-802.
[16] China Association of Traditional Chinese Medicine. Technical guidance for real-world studies of traditional Chinese medicine[R]. 2021.
[17] SHERMAN RE, ANDERSON SA, DAL PAN GJ, et al.Real-world evidence - what is it and what can it tell us ?[J]. N Engl J Med, 2016, 375(23): 2293-2297.
[18] CORRIGAN-CURAY J, SACKS L, WOODCOCK J.Real-world evidence and real-world data for evaluating drug safety and effectiveness[J]. JAMA, 2018, 320(9): 867-868.
[19] National Administration of Traditional Chinese Medicine. Notice of the issuance of clinical application guidelines for Chinese medicines[EB/OL]. (2010-06-30)[2021-09-30]. http://www.satcm.gov.cn/yizhengsi/gongzuodongtai/2018-03-24/3071.html.
[20] SHANG H, ZHANG B, LI Y.Clinical orientation of post-marketing Chinese patent drugs: an evidence-based practice[J]. Journal of Chinese Integrative Medicine(中西医结合学报), 2008, 6(9): 887-890.
[21] National Healthcare Security Administration. Notice of the ministry of human resources and social security on the national basic medical insurance, work injury insurance and maternity insurance drug catalog (2020) [EB/OL]. (2020-12-28)[2021-09-30]. http://www.nhsa.gov.cn/art/2020/12/28/art_37_4220.html.
[22] Ministry of Commerce of the People's Republic of China. Pharmaceutical distribution industry operation statistics report[R]. 2018.
[23] U.S. Food & Drug Administration. Framework for FDA's realworld evidence progarm[EB/OL]. (2018-12-01)[2021-09-30]. https://www.fda.gov/media/120060/download.
[24] QIAO R, LIU YQ, ZHUO L, et al.Application scope of real-world data in post-marketing drug safety monitoring and evaluation for drug safety[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(7): 620-623, 631.
[25] MENG R, ZHUO L, QIAO R, et al.Application values of real-world evidence in post-marketing surveillances and evaluation for drug safety[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(7): 624-627.
[26] National Medical Products Administration. NMPA issues implementation opinions to promote the inheritance, innovation and development of traditional Chinese medicine [EB/OL]. (2020-12-25)[2021-09-30].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20201225163906151.html?type=pc&m=. China issues guideline to promote the preservation and innovative development of Traditional Chinese Medicine.
[27] SUN X, LI L, LIU Y, et al.Assessing clinical effects of traditional Chinese medicine interventions: moving beyond randomized controlled trials[J]. Front Pharmacol, 2021, 12: 713071.
[28] SUN X, ZHANG J, WANG W, et al.Formulate technical guidance for real-world studies of traditional Chinese medicine in China to promote the transformation of clinical research of Chinese patent medicine into decision evidence[J]. Chinese Journal of Evidence-based Medicine(中国循证医学杂志), 2020, 20(9): 993-999.
[29] CHENG F, XIE Y, WANG L, et al.Effect of Mailuoshutong pills on renal function indexes in the real world based on propensity scores[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(6): 537-541.
[30] LI YN, LIU X, SONG Z.The combinative therapeutic effects of Mailuo Shutong Granules and synthetic medications on patients with superficial thrombophlebitis[J]. Chinese Traditional Patent Medicine(中成药), 2018, 40(6): 1266-1270.
[31] LIANG G, WU C, ZHANG H, et al.Long-term toxicity of the buthus martensii karsch superfine powder[J]. China Pharmaceuticals(中国药业), 2019, 28(20): 5-8.
[32] Teng G.Clinical analysis of herbal medicine causing acute renal failure in the elderly[J]. China's Naturopathy(中国民间疗法), 2015, 23(11): 71-73.