Page 33 - 《中国药房》2021年第4期

fda.gov/media/71546/download. gov/safety/fdas-sentinel-initiative.
[12] International Council for Harmonisation of Technical Re- [26] ISHIGURO C，TAKEUCHI Y，UYAMA Y，et al. The
quirements for Pharmaceuticals for Human Use. ICH E2D MIHARI project：establishing a new framework for phar-
guideline：post-approval safety data management：defini- macoepidemiological drug safety assessments by the Phar-
tions and standards for expedited reporting [EB/OL]. maceuticals and Medical Devices Agency of Japan[J].
（2003-11-12）[2020-06-23]. https：//database.ich.org/sites/ Pharmacoepidemiol Drug Saf，2016，25（7）：854-859.
default/files/E2D_Guideline.pdf. [27] European Medicines Agency. Guideline on good pharma-
[13] European Medicines Agency. EudraVigilance[EB/OL]. covigilance practices（GVP）module Ⅸ addendum Ⅰ ：
[2020-06-23]. https：//www.ema.europa.eu/en/human-regu- methodological aspects of signal detection from sponta-
latory/research-development/pharmacovigilance/eudravig- neous reports of suspected adverse reactions[EB/OL].（2017-
ilance. 11-22）[2020-06-23]. https：//www.ema.europa.eu/en/docu-
[14] 王涛，王丹，范燕，等.欧盟药物警戒数据库功能升级与思 ments/scientific-guideline/guideline-good-pharmacovig-
考[J].中国药物警戒，2018，15（7）：411-413、418. ilance-practices-gvp-module-ix-addendum-i-methodologi-
[15] 王涛，王丹，董铎，等.美国药物警戒体系浅析及对我国的 cal-aspects-signal_en.pdf.
启示[J].医药导报，2017，36（4）：361-365. [28] DUGGIRALA HJ，TONNING JM，ELLA S，et al. Use of
[16] U.S. Food and Drug Administration. Questions and an- data mining at the Food and Drug Administration[J].J Am
swers on FDA’s adverse event reporting system Med Inform Assoc，2016，23（2）：428-434.
（FAERS）[EB/OL].（2018-06-04）[2020-06-23]. https：// [29] 石黒智恵子，中村悟，松井和浩. 医薬品医療機器総合機
www.fda.gov/drugs/surveillance/questions-and-answers- 構におけるデータマイニング手法導入後の市販後安
fdas-adverse-event-reporting-system-faers. 全対策業務[J].薬剤疫学，2010，15（1）：23-30.
[17] Japan Pharmaceutical Manufacturers Association. Pharma- [30] 独立行政法人医薬品医療機器総合機構.平成20年度デ
centical administration and regulations in Japan[EB/ ータマイニング手法の導入に関する検討概要につい
OL].[2020-06-23]. http：//www.jpma.or.jp/english/parj/pdf/ て [EB/OL].[2020-06-23]. https：//www.pmda.go.jp/files/
2020.pdf. 000147870.pdf.
[18] 厚生労働省.「患者からの医薬品副作用報告」実施要 [31] WELTER NM. An insight into the post-approval safety
領[EB/OL].（2019-03-26）[2020-06-23]. https：//www.pm- surveillance of medicinal products in the three ICH re-
da.go.jp/files/000228627.pdf. gions（EU，Japan and USA）：with particular focus on the
[19] ROSA G，MARTIJN S，JEFFREY B，et al. Data extraction management of safety signals[R]. Bonn：Deutsche Gesell-
and management in networks of observational health care schaft für Regulatory Affairs，2015.
databases for scientific research：a comparison among [32] POTTS J，GENOV G，SEGEC A，et al. Improving the
EU-ADR，OMOP，Mini-Sentinel and MATRICE strate- safety of medicines in the European Union：from signals
gies[J]. Egems，2016. DOI：10.13063/2327-9244.1189. to action[J].Clin Pharmacol Ther，2020，107（3）：521-529.
[20] 周晓枫，刘青，蔡兵，等.全球上市后药品主动监测系统概 [33] European Medicines Agency. Guideline on good pharma-
况[J].药物流行病学杂志，2012，21（7）：30-34. covigilance practices：module ⅩⅥ：risk minimisation mea-
[21] PACURARIU AC，STRAUS SM，TRIFIRÒ G，et al. Use- sures：selection of tools and effectiveness indicators：
ful interplay between spontaneous ADR reports and elec- rev.2[EB/OL].（2017-03-31）[2020-06-23]. https：//www.
tronic healthcare records in signal detection[J]. Drug Saf， ema.europa.eu/documents/scientific-guideline/guideline-
2015，38（12）：1201-1210. good-pharmacovigilance-practices-module-xvi-risk-mini-
[22] PATADIA VK，COLOMA P，SCHUEMIE MJ，et al. Us- misation-measures-selection-tools_en-3.pdf.
ing real-world healthcare data for pharmacovigilance sig- [34] U.S. Food and Drug Administration. Office of Surveil-
nal detection：the experience of the EU-ADR project[J]. lance and Epidemiology（OSE）divisions [EB/OL].（2020-
Expert Rev Clin Pharmacol，2015，8（1）：95-102. 03-23）[2020-06-23]. https：//www.fda.gov/about-fda/cen-
[23] ENCePP. About us[EB/OL].[2020-06-23]. https：//www. ter-drug-evaluation-and-research-cder/office-surveillance-
encepp.eu/structure/index.shtml. and-epidemiology-ose-divisions.
[24] XAVIER K，SUSANA PG. Strengthening standards，trans- [35] U.S. Food and Drug Administration. MAPP 4121.2：track-
parency，and collaboration to support medicine evalua- ing of significant safety issues in marketed drugs：use of
tion：ten years of the European Network of Centres for the darrts tracked safety issues[EB/OL].（2011-12-20）[2020-
Pharmacoepidemiology and Pharmacovigilance（ENCePP） 06-23]. http：//www.fda.gov/files/about fda/published/Track-
[J]. Pharmacoepidemiol Drug Saf，2018，27（3）：245-252. ing-of-Significant-Safety-Issues-in-Marketed-Drugs-Use-
[25] U.S. Food and Drug Administration. FDA’s sentinel initia- of-the-DARRTS-Tracked-Safety-Issue.pdf.
tive[EB/OL].（2019-10-18）[2020-06-23]. https：//www.fda. [36] U.S. Food and Drug Administration. Drug safety informa-

中国药房 2021年第32卷第4期 China Pharmacy 2021 Vol. 32 No. 4 ·411 ·