疫苗上市后安全性主动监测模式分析

摘要/Abstract

摘要： 疫苗主动监测是20世纪末为弥补传统被动监测的不足而出现的上市后安全性监测新模式。全球范围内，上市后安全性主动监测尚处于初步发展阶段，其含义理解和功能定位不尽一致，具体开展形式也多种多样。目前部分发达国家已构建了较为完善的疫苗上市后安全性主动监测系统并取得了一定成果。主动监测在疫苗安全性监测中的作用得到广泛认可，成为未来上市后安全性监测模式的主要发展趋势。我国现有的疫苗上市后安全性监测模式仍为被动监测，对开展主动监测的需求日益凸显。了解疫苗上市后安全性主动监测的发展，认识其不同的含义和定位，比较不同的开展形式，借鉴现有的主动监测系统的成功经验，将有助于我国今后构建切实可行的疫苗上市后安全性主动监测体系。

关键词: 疫苗, 安全性, 上市后监测, 主动监测, 综述

Abstract: In the late 20 th century, active surveillance occurred as a novel method of post-marketing surveillance for vaccine safety, to recover the deficiency of traditional passive surveillance. Nowadays, active post-marketing surveillance is still in an initial stage of development, with various definitions and performance around the world. There have been active surveillance systems of vaccine safety established in developed countries and their achievements indicate the great advantages of active surveillance method. However, the primary surveillance mode of vaccine safety in China is currently in a passive way, as the most of developing countries. In view of the increasing amountof new vaccines and the enhanced public attention on vaccine safety, there is an insistent demand for conducting active surveillance for vaccine safety in Chinese population. This study will reviewthe development of active post-marketing surveillance for vaccine safety, analyze the different modes of active surveillance and explore the typical surveillance systems, with the aim to accelerate the foundation of active surveillance system for vaccine safety in China.

Key words: vaccine, safety, post-marketing surveillance, active surveillance, review

中图分类号:

蔡婷, 杨羽, 王亚丽, 董铎, 詹思延 . 疫苗上市后安全性主动监测模式分析[J]. 中国药物警戒, 2017, 14(8): 464-469.

CAI Ting, YANG Yu, WANG Ya-li, DONG Duo, ZHAN Si-yan. Review and Analysis of Active Post-marketing Surveillance Modes for Vaccine Safety[J]. Chinese Journal of Pharmacovigilance, 2017, 14(8): 464-469.

参考文献

[1] Crawford N W, Clothier H,Hodgson K, et al. Active surveillance for adverse events following immunization[J]. Expert RevVaccines, 2014,13(2):265-276.
[2] 董铎,田春华,孙利华.我国疫苗不良事件监测体系现状及思考[J].中国药物警戒, 2007,4(5):261-264.
[3] 王丹.药品不良反应主动监测及其发展趋势[J]. 中国药物警戒, 2015,12(10):600-602.
[4] 王胜锋,詹思延.大数据时代的药品安全主动监测：对照选择的挑战与机遇[J].中华流行病学杂志, 2016,37(7):909-916.
[5] 张倩婷,王亚丽,曲毅.我国疫苗上市后主动监测模式的探讨[J].中国药物警戒, 2016,13(11):673-675.
[6] WHO. The WHO Programme for International Drug Monitoring (PIDM)[EB/OL].(2017-03-15)[2017-03-15]. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/National_PV_Centres_Map.
[7] Chen R T, Rastogi S C, Mullen J R, et al.The vaccine adverse event reporting system (VAERS)[J]. Vaccine, 1994,12(6):542-550.
[8] MHRA. Yellow Card Scheme[EB/OL].(2017-03-15)[2017-03-15].https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/.
[9] PHAC.Canadian Adverse Events Following Immunization Surveillance System (CAEFISS)[EB/OL].(2016-12-09)[2017-03-15].http://www.phac-aspc.gc.ca/im/vs-sv/.
[10] International Conference on Harmonisation of Technical Requirements For Registration of Pharmaceuticals For Human Use (ICH). ICH Harmonised Tripartite Guideline. Post-approval safety data management: definitions and standards for expedited reporting[J/OL].(2003-11-12)[2017-03-15]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf.
[11] Fletcher A P. Spontaneous adverse drug reaction reporting vs event monitoring:a comparison[J].JRSoc Med, 1991,84(6):341-344.
[12] Rosenthal S, Chen R T. The report in sensitivities of two passive surveillance systems for vaccine adverse events[J].Am JPublic Health, 1995,85(12):1706-1709.
[13] Isaacs D, Lawrence G, Boyd I, et al. Reporting of adverse events following immunization in Australia[J].J. Paediatr Child Health, 2005,41(4):163-166.
[14] Waldman E A, Luhm K R, Monteiro S A, et al. Surveillance of adverse effects following vaccination and safety of immunization programs[J]. RevSaudePublica, 2011,45(1):173-184.
[15] Donegan K, Beau-Lejdstrom R, King B, et al. Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK[J]. Vaccine, 2013,31(43):4961-4967.
[16] Coloma P M, Schuemie M J, 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 N K, et al. The Asian Pharmacoepid-emiology Network (AsPEN):promoting multi-national collaboration for pharmacoepidemiologic research in Asia[J].Pharmacoepidemiol Drug Saf, 2013,22(7):700-704.
[18] Chen R T, Glasser J W, Rhodes P H., et al. Vaccine Safety Datalinkproject: a new tool for improving vaccine safety monitoring in the United States[J]. Pediatrics, 1997,99(6):765-773.
[19] Nguyen M, Ball R, Midthun K, et al. The Food and Drug Administration's Post-licensure RapidImmunization Safety Monitoring program: strengthening thefederal vaccine safety enterprise[J]. Pharmacoepidemiol Drug Saf, 2012,21(S1):291-297.
[20] Scheifele D W, Halperin S A, Members of the CPS/Health Canada. Immunization Monitoring Program, Active: a model of active surveillance of vaccine safety[J]. SeminPediatr Infect Dis, 2003,14(3):213-219.
[21] Pillsbury A, Cashman P, Leeb A, et al. Real-time safety surveillance of seasonalinfluenza vaccines in children, Australia, 2015[J]. Euro Surveill, 2015,20(43):1-5.
[22] Klein N P, Fireman B, Yih W K, et al. Measles-mumps-rubella-varicella combination vaccine and the riskof febrile seizures[J]. Pediatrics, 2010,126(1):e1-e8.
[23] Yih W K, Lee G M, Lieu T A, et al. Surveillance for adverse events following receipt of pandemic 2009 H1N1vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM)system, 2009-2010[J]. Am J Epidemiol, 2012,175(11):1120-1128.
[24] Saux N L, Barrowman N J, Moore D L, et al. Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT[J]. Pediatrics, 2003,112(5):e348-e353.
[25] Ali M, Canh D G, Clemens J D, et al. The vaccine data link in NhaTrang, Vietnam: a progress report on theimplementation of a database to detect adverse eventsrelated to vaccinations[J]. Vaccine, 2003,21(15):1681-1686.
[26] Aronson J K, Hauben M, Bate A. Defining 'surveillance' in drug safety[J].Drug Saf, 2012,35(5):347.
[27] Petrov A. Complications in the cardiovascular system fromneurol-eptictreatment[J]. Vutr Boles, 1987,26(5):72-76.
[28] Farrington P, Pugh S, Colville A, et al. A new method foractive surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines[J].Lancet, 1995,345 (8949):567-569.
[29] Weaver J, Willy M, Avigan M. Informatic tools and approachesin-postmarketingpharmacovigilance used byFDA[J]. AAPS J, 2008,10(1):35-41.
[30] Council for International Organizations of Medical Sciences (CIOMS). Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII[M]. Geneva: CIOMS,2010.
[31] Huang Y L, Moon J, Segal J B. A comparison of active adverse event surveillance systemsworldwide[J]. Drug Saf, 2014,37:581-596.
[32] Waldman E A, Luhm K R, Monteiro S A, et al. Surveillance of adverse effects following vaccination and safety of immunization programs[J]. Rev SaudePublica, 2011,45(1):1-11.
[33] Cassidy C, MacDonald N E, Steenbeek A, et al. Adverse event following immunization surveillance systems forpregnant women and their infants: a systematic review[J]. PharmacoepidemiolDrug Saf,2015,24(4):361-367.
[34] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH). Harmonised Tripartite Guideline. PharmacovigilancePlanning[J/OL].(2003-11-12)[2017-03-15]. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf.
[35] Baker M A, Nguyen M, Cole D V, et al. Post-licensure rapid immunization safety monitoring program(PRISM) data chara-cterization[J]. Vaccine, 2013,31S(10):K98-K112.
[36] Center of Disease Prevention and Control (CDC). Vaccine Safety Datalink (VSD)[EB/OL].(2016-05-13)[2017-03-15].http://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html.
[37] Baggs J, Gee J, Lewis E, et al. The Vaccine Safety Datalink: a model for monitoring immunization safety[J]. Pediatrics, 2011,127(S1):45-53.
[38] Bettinger J A, Halperin S A, Vaudry W, et al. The Canadian Immunization Monitoring Program, ACTive (IMPACT): active surveillance for vaccine adverse events and vaccine-preventable diseases[J]. CCDR, 2014,40(S3):41-44.
[39] Scheifele D W. IMPACT after 17 years: lessons learned about successful networking[J]. Paediatr Child Health, 2009,14(1):33-35.
[40] Cashman P, Moberley S, Dalton C, et al. Vaxtracker: Active on-line surveillance for adverse events following inactivated influenza vaccine in children[J]. Vaccine, 2014,32(42):5503-5508.
[41] Leeb A, Regan A K, Peters IJ, et al. Using automated text messages to monitor adverse events following immunisation in general practice[J]. Med J Aust, 2014,200(7):416-418.
[42] Curtis L H, Weiner M G，Boudreau D M, et al. Design considerations, architecture, and use of the Mini-Sentinel distributed data system[J].PharmacoepidemiolDrug Saf, 2012,21(S1):23-31.
[43] Lieu T A, Kulldorff M, Davis R L, et al. Real-time vaccine safety surveillance forthe early detection of adverse events[J]. MedCare, 2007,45(S2):89-95.