[1] FERNER RE, MCGETTIGAN P.Adverse drug reactions[J]. BMJ, 2018, 363: k4051. [2] MCMAHON AW, DAL PG.Assessing drug safety in children - the role of real-world data[J]. N Engl J Med, 2018, 378(23): 2155-2157. [3] GAO YJ, ZHAO X, BAI TK, et al.Discovery and identification strategy for drug safety risks based on big data monitoring of adverse reactions[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2024, 21(1): 1-5, 14. [4] ALOMAR M, TAWFIQ AM, HASSAN N, et al.Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future[J]. Ther Adv Drug Saf, 2020, 11: 2042098620938595. [5] PLATT R, BROWN JS, ROBB M, et al.The FDA sentinel initiative - an evolving national resource[J]. N Engl J Med, 2018, 379(22): 2091-2093. [6] KANG B, YOON J, KIM HY, et al.Deep-learning-based automated terminology mapping in OMOP-CDM[J]. J Am Med Inform Assoc, 2021, 28(7): 1489-1496. [7] HOU YF, SONG HB, LIU HL, et al.Practice and discussion on active surveillance by China Hospital Pharmacovigilance System[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(4): 212-214. [8] ONG N, LUCIEN A, LONG JC, et al.What do healthcare staff think about the quality and safety of care provided to children and young people with an intellectual disability? A qualitative study using the framework method of analysis[J]. BMJ Open, 2023, 13(7): e071494. [9] BALL R, ROBB M, ANDERSON SA, et al.The FDA’s sentinel initiative-a comprehensive approach to medical product surveillance[J]. Clin Pharmacol Ther, 2016, 99(3): 265-268. [10] SIVESIND TE, RUNION T, BRANDA M, et al.Dermatologic research potential of the Observational Health Data Sciences and Informatics (OHDSI) network[J]. Dermatology, 2022, 238(1): 44-52. [11] REYNOLDS RF, KURZ X, DE GROOT MC, et al.The IMI PROTECT project: purpose, organizational structure, and procedures[J]. Pharmacoepidemiol Drug Saf, 2016, 25(Suppl 1): 5-10. [12] YANG L, TIAN LJ, LUO G.Comparative research and enlightenment on active post-marketing drug safety surveillance systems from the global perspective[J]. Science and Technology Management Research(科技管理研究), 2017, 7: 182-190. [13] GE SY, LIANG Y.Comparative study on active drug safety surveillance practice of China and the United States[J]. Chinese Journal of Medicinal Guid(中国医药导刊), 2023, 4: 355-361. [14] YANG L, WU D.Research on the mode, core mechanism and implementation path of collaborative governance of drug safety in China[J]. Journal of Shenyang Pharmaceutical University(沈阳药科大学学报), 2021, 9: 964-968. [15] SUISSA S, HENRY D, CAETANO P, et al.CNODES: the Canadian network for observational drug effect studies[J]. Open Med, 2012, 6(4): e134-140. [16] COLOMA PM, SCHUEMIE MJ, TRIFIRO G, et al.Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project[J]. Pharmacoepidemiol Drug Saf, 2011, 20(1): 1-11. [17] ANDERSEN M, BERGMAN U, CHOI NK, et al.The Asian Pharmacoepidemiology Network (AsPEN): promoting multi-national collaboration for pharmacoepidemiologic research in Asia[J]. Pharmacoepidemiol Drug Saf, 2013, 22(7): 700-704. [18] VERKERK K, VOEST EE.Generating and using real-world data: a worthwhile uphill battle[J]. Cell, 2024, 187(7): 1636-1650. [19] LIU F, PANAGIOTAKOS D.Real-world data: a brief review of the methods, applications, challenges and opportunities[J]. BMC Med Res Methodol, 2022, 22(1): 287. [20] HENKE E, ZOCH M, PENG Y, et al.Conceptual design of a generic data harmonization process for OMOP common data model[J]. BMC Med Inform Decis Mak, 2024, 24(1): 58. [21] FDA’s Sentinel Initiative. Sentinel Common Data Model v8.1.0[EB/OL]. (2024-02-13)[2024-02-18]. https://sentinelinitiative.org/methods-data-tools/sentinel-common-data-model. [22] Observational Health Data Sciences and Informatics. OMOP Common Data Model v5.4[EB/OL]. (2023-06-13)[2024-02-18]. https://ohdsi.github.io/CommonDataModel/cdm54.html. [23] REISINGER SJ, RYAN PB, O’HARA DJ, et al. Development and evaluation of a common data model enabling active drug safety surveillance using disparate healthcare databases[J]. J Am Med Inform Assoc, 2010, 17(6): 652-662. [24] LAI EC, RYAN P, ZHANG Y, et al.Applying a common data model to Asian databases for multinational pharmacoepidemiologic studies: opportunities and challenges[J]. Clin Epidemiol, 2018, 10: 875-885. [25] PLATT RW, HENRY DA, SUISSA S.The Canadian Network for Observational Drug Effect Studies (CNODES): reflections on the first eight years, and a look to the future[J]. Pharmacoepidemiol Drug Saf, 2020, 29(Suppl 1): 103-107. [26] National Health Commission of the People’s Republic of China. Notice on the further enhancement of medication safety management to improve the rational use of medication[EB/OL]. (2022-07-27)[2023-11-23]. http://www.gov.cn/zhengce/zhengceku/2022-07/30/content_5703604.htm. [27] The State Council of the People’s Republic of China.“The 14th Five-Year Plan”National drug safety and promotion of high-quality development plan[EB/OL]. (2022-01-02)[2023-11-22]. http://www.gov.cn/xinwen/2022-01/02/content_5667258.htm. |