[1] PIERCE PF.Risk management plans[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2009, 6(11): 695-697.
[2] NMPA. Announcement of the State Drug Administration on Matters Relating to the Implementation of the Drug Administration Law of the People’s Republic of China (No. 103 of2019)[EB/OL]. (2019-11-29)[2023-01-04]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20191129194901851.html.
[3] NMPA. Announcement by the State Pharmacovigilance Administration on the Publication of Pharmacovigilance Quality Management Standards (No. 65 of2021)[EB/OL]. (2021-05-07)[2023-01-04]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html.
[4] U.S. Food and Drug Administration. What’s in a REMS?[EB/OL]. (2018-01-26)[2022-05-18]. https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/whats-rems.
[5] MENG Y.Introduction to drug risk minimization tools[J]. Chinese Journal of Pharmacoepidemiology(药物流行病学杂志), 2012, 21(12): 623-626.
[6] ZHAO P, BIAN L, YANG R.FDA’s risk evaluation and mitigation strategy and the inspirations to our country[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2013, 10(3): 140-144.
[7] U.S. Food and Drug Administration. Public Law 110-85. Food and Drug Administration Amendments Act (FDAAA) of2007. Title IX, Subtitle A,Section 505-1. Enhanced Authorities Regarding Post-market Safety of Drugs, Risk Evaluation and Mitigation Strategies[EB/OL].(2007-02-05)[2022-05-18]. https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf.
[8] European Medicines Agency. European Medicines Agency Guideline on good pharmacovigilance practices Module V: Risk Management Systems[EB/OL]. (2012-06-25)[2022-05-18].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf.
[9] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module XVI, risk minimisation measures: selection of tools and effectiveness indicators[EB/OL]. (2014-02-28)[2022-05-18]. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices.
[10] Official Journal of the European Union. Directive2001/84/EU of the European Parliament and of the Council of 15 December 2010[EB/OL].(2010-12-31)[2022-05-18]. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF.
[11] Ministery of Food and Drug Safety. Regulation for Pharmaceutical Approvals, Notifications and Reviews. MFDS Notification No.2017-77, Partially Amended and Enforced on September 29, 2017[EB/OL]. (2017-09-29)[2022-05-18]. https://www.mfds.go.kr/eng/brd/m_18/view.do?seq=71448&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multiitm_seq=0&company_cd=&company_nm=&page=2.
[12] Health Canada. Guidance document for industry: Submission of Risk Management Plans and Follow-up Commitments2015[EB/OL]. (2015-06-28)[2022-05-18]. https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-documentsubmission-risk-management-plans-follow-commitments.html.
[13] MOUCHANTAF R, AUTH D, MORIDE Y, et al.Risk Management for the 21st Century: Current Status and Future Needs[J]. Drug Safety, 2021, 44(4): 409-419.
[14] BAHRI P, DODOO AN, EDWARDS BD, et al.The ISoP commsig for improving medicinal product risk communication: a new special interest group of the international society of pharmacovigilance[J]. Drug Safety, 2015,38(7): 621-627.
[15] Health Canada. Guidance for industry-Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products[EB/OL]. (2018-10-28)[2022-05-18]. https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/submission-targeted-rm-plans-commitments-prescription-opioid-containing-products-guidance-industry.html.
[16] SMITH MY, MORRATO E.Advancing the field of pharmaceutical risk minimization through application of implementation science best practices[J]. Drug Safety, 2014, 37(8): 569-580.
[17] DAMSCHRODER LJ, ARON DC, KEITH RE, et al.Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science[J]. Implementation Science, 2009, 4(1): 50.
[18] THEOBALD S, BRANDES N, GYAPONG M, et al.Implementation research: new imperatives and opportunities in global health[J]. Lancet, 2018, 392(10160): 2214-2228.
[19] DR L. FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety[EB/OL].(2013-04-28)[2022-05-18]. https://oig.hhs.gov/oei/reports/oei-04-11-00510.pdf.
[20] GRIDCHYNA I, CLOUTIER AM, NKENG L, et al.Methodological gaps in the assessment of risk minimization interventions: a systematic review[J]. Pharmacoepidemiol Drug Safety, 2014, 23(6): 572-579.
[21] CIOMS. Practical Approaches to Risk Minimisation for Medicinal Products: Report of CIOMS Working Group IX[M]. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2014.
[22] CARGO M, STANKOV I, THOMAS J, et al.Development, inter-rater reliability and feasibility of a checklist to assess implementation (Ch-IMP) in systematic reviews: the case of provider-based prevention and treatment programs targeting children and youth[J]. BMC Medical Research Methodology, 2015, 15: 73.
[23] KLESGES LM, ESTABROOKS PA, DZEWALTOWSKI DA, et al.Beginning with the application in mind: designing and planning health behavior change interventions to enhance dissemination[J]. Ann Behav Med, 2005, 29: 66-75.
[24] RADAWSKI C, MORRATO E, HORNBUCKLE K, et al.Benefit-risk assessment, communication, and evaluation (brace) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist[J]. Pharmacoepidemiology Drug Safety, 2015, 24(12): 1233-1240.
[25] SMITH MY, RUSSELL A, BAHRI P, et al.The RIMES statement: a checklist to assess the quality of studies evaluating risk minimization programs for medicinal products[J]. Drug Safety, 2018, 41(4): 389-401.
[26] HAWKINS M, CHENG C, ELSWORTH GR, et al.Translation method is validity evidence for construct equivalence: analysis of secondary data routinely collected during translations of the Health Literacy Questionnaire (HLQ)[J]. BMC Medical Research Methodology, 2020, 20(1): 130.
[27] ZISBLATT L, HAYES SM, LAZURE P, et al.Safe and competent opioid prescribing education: Increasing dissemination with a train-the-trainer program[J]. Substance Abuse, 2017, 38(2): 168-176.
[28] RUSSELL AM, MORRATO EH, LOVETT RM, et al.Quality of reporting on the evaluation of risk minimization programs: a systematic review[J]. Drug Safety, 2020, 43(5): 427-446.
[29] European Medicines Agency. Draft Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum II-Methods for effectiveness evaluation (Rev 3)[EB/OL].(2021-03-29)[2022-05-18]. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xvi-addendum-ii-methods-effectiveness_en.pdf. |