Comparative study on drug signal detection and evaluation at home and abroad

doi:10.19803/j.1672-8629.20220206

Abstract

Abstract: Objective To analyze the definitions, sources, detection methods and evaluation principles of drug signal management at home and abroad, and to provide reference for standardizing pharmacovigilance of drug marketing authorization holders. Methods The signal management systems of US, EU, Japan and WHO were analyzed, and the methods of signal detection and evaluation were summarized. Results All the countries concerned had clear definitions of drug signals, established relatively standard processes of signal detection and evaluation, and formulated corresponding guidelines according to the supervision intensity and characteristics of each country. Signal detection methods were based on the collection of more related information while signal verification not only highlighted the collection of more related information, but focused on properties of drugs, characteristics of patients and similar cases so as to make a more reliable judgment. In order to improve the efficiency of signal detection, prioritization was emphasized in the process of determining the nature of information in order to put more resources into the study on the potential risks that might affect the risk-benefit ratio. Conclusions ignal detection in pharmacovigilance in China has just started, so there is the pressing need to promote international exchange and cooperation, and steadily improve the competence of professionals of signal detection in China.

Key words: drug, evaluation, signal detection, pharmacovigilance

CLC Number:

R994.1

SUN Xuelin, QIAN Dongfang, TAN Siyuan, ZHANG Zixuan, HU Xin, ZHANG Yatong. Comparative study on drug signal detection and evaluation at home and abroad[J]. Chinese Journal of Pharmacovigilance, 2022, 19(11): 1218-1222.

Add to citation manager EndNote|Ris|BibTeX

URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20220206

https://zgywjj.magtechjournal.com/EN/Y2022/V19/I11/1218

References

[1] NMPA. Announcement of NMPA on the issuance of pharmacovigilance quality management standards (No.65, 2021)[EB/OL]. (2021-05-07)[2022-04-15]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html.
[2] EDWARDS IR, BIRIELL C.Harmonisation in pharmacovigilance[J]. Drug Safety, 1994, 10(2): 93-102.
[3] Council for International Organizations of Medical Sciences. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII[M]. Geneva: CIOMS, 2010.
[4] EMA. Guideline on good pharmacovigilance practices (GVP)-Module IX-signal management (Rev 1)[EB/OL]. (2017-10-12)[2022-03-31]. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf.
[5] EMA. Screening for adverse reactions in EudraVigilance[EB/OL]. (2016-12-19)[2022-03-31]. https://www.ema.europa.eu/en/documents/other/screening-adverse-reactions-eudravigilance_en.pdf.
[6] FDA Center for Drug Evaluation and Research. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment[EB/OL].[2022-02-23]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment.
[7] FDA Center for Drug Evaluation and Research. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)[EB/OL].[2022-03-29]. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event-reporting-system.
[8] FDA CBER. SOPP8420: FDAAA Section 921: posting of potential signals of serious risk[EB/OL]. (2022-02-27)[2022-04-15]. https://www.fda.gov/media/82363/download.
[9] SHI HW, BA L, ZHOU J, et al.Comparative study on pharmacovigilance signal management system among the European Union, the United States and Japan[J]. China Pharmacy(中国药房), 2021, 32(4): 406-412.
[10] PMDA. PMDA Medical Safety Information[EB/OL].(2018-02-16)[2022-03-31]. https://www.pmda.go.jp/english/safety/info-services/safety-information/0001.html.
[11] NMPA. ICH E2D post-marketing safety data management: Definitions and standards for rapid reporting[EB/OL]. (2019-09-27)[2022-03-31]. https://www.cdr-adr.org.cn/drug_1/ICHzd_1/ICH_E2D/201909/t20190927_36891.html.
[12] ZHU L, ZHU Y, LIU LH, et al.Common problems with post-marketing adverse drug reaction reports from literature[J]. Chinese Journal of Pharmacovigilance(中国药物警戒),2021, 18(12): 1155-1158.
[13] HAUBEN M, ZHOU X.Quantitative methods in pharmacovigilance: focus on signal detection[J]. Drug Safety, 2003, 26(3): 159-186.
[14] UPPSALA Monitoring CentrE. How UMC detects signals[EB/OL]. (2022-03-23)[2022-03-30]. https://who-umc.org/signal-work/signal-detection/.
[15] EMA. Signal management[EB/OL]. (2018-09-17)[2022-03-02].https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management.
[16] WISNIEWSKI AFZ, BATE A, BOUSQUET C, et al.Good signal detection practices: evidence from IMI PROTECT[J]. Drug Safety, 2016, 39(6): 469-490.
[17] GOULD AL, LYSTIG TC, LU Y, et al.Methods and issues to consider for detection of safety signals from spontaneous reporting databases: a report of the dia bayesian safety signal detection working group[J]. Therapeutic Innovation & Regulatory Science, 2015, 49(1): 65-75.
[18] ARNAUD M, BÉGAUD B, THURIN N, et al. Methods for safety signal detection in healthcare databases: a literature review[J]. Expert Opinion on Drug Safety, 2017, 16(6): 721-732.
[19] FDA CBER. SOPP8420: FDAAA Section 921: posting of potential signals of serious risk[EB/OL]. (2022-02-27)[2022-03-31]. https://www.fda.gov/media/82363/download.
[20] POTTS J, GENOV G, SEGEC A, et al.Improving the safety of medicines in the European Union: from signals to action[J]. Clinical Pharmacology & Therapeutics, 2020, 107(3): 521-529.
[21] BENINGER P.Signal management in pharmacovigilance: a review of activities and case studies[J]. Clinical Therapeutics, 2020, 42(6): 1110-1129.
[22] WHO UMC. The use of the WHO-UMC system for standardised case causality assessment[EB/OL]. (2014-07-18)[2022-03-31]. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf.