Statistical signal detection methods
Abstract
Modern approaches to solving the problem of detecting signals about the safety of drugs are presented. The basic concept, provided the detection of signals by quantitative methods in databases of spontaneous messages is presented. Approaches to the interpretation of the signal about disproportionality are described.
About the Authors
K. E. Zatolochina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
I. I. Snegireva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. O. Zhuravleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
M. A. Darmostukova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
R. N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. Lepakhin VK, Romanov BK, Toropova IA. The analysis of reports on adverse drug reactions. The bulletin of the scientific centre for expert evaluation of medicinal products/The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2012; 1: 22–25.
2. Guideline on Good pharmacovigilance practices [Internet]. 2017 (cited 20 Mar 2017). Avaible at: https://goo.gl/jciWGe.
3. Good pharmacovigilance practice. [Internet]. 2017 (cited 20 Mar 2017). Avaible at: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/konsultComitet/Documents82.pdf.
4. Bate A, Lindquist M, Edwards IR, Olsson S, Orre R, Lansner A, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998; 54 (4): 315–21.
5. Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001; 10 (6): 483–6.
6. Lindquist M, Stahl M, Bate A, Edwards IR, Meyboom RHB. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Saf. 2000; 23 (6): 533–42.
7. Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Brit J Clin Pharmacol. 2011 Dec; 72 (6): 905–8.
8. Romanov BK, Lepakhin VK, Astakhova AV, Glagolev SV, Polivanov VA. Perfection of management principles by the safety of medicinal products. Safety and Risk of Pharmacotherapy 2016; (1): 13–20.
9. Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiology and drug safety 2009; 18: 427–436.
10. Zorych I, Madigan D, Ryan P, Bate A. Disproportionality methods for pharmacovigilance in longitudinal observational databases. Stat. Methods Med. Res. 2011; 22: 39–56.
11. CIOMS. Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII. Geneva: CIOMS; 2010.
12. Screening for adverse reactions in EudraVigilance [Internet]. 2017 (cited 20 Mar 2017). Avaible at: https://goo.gl/Yb4YUI.
13. Data Mining at FDA — White Paper [Internet]. 2017 (cited 20 Mar 2017). Avaible at: https://goo.gl/3g3m8g.
14. Snegireva II, Zatolochina KE, Ozeretskovsky NA, Romanov BK, Mironov AN. Vaccine pharmacovigilance in Russia, legal and regulatory framework, current stage of development. Scientific Centre for Expert Evaluation of Medicinal Products Bulletin 2014; 4: 27–31.
15. Romanov BK, Glagolev SV, Polivanov VA, Leonova MV. Monitoring of drug safety. Safety and Risk of Pharmacotherapy. 2014; 3(4): 11–14.
16. Merkulov VA, Bunyatyan ND, Sakaeva IV, Lepakhin VK, Romanov BK, Yefremova TA. New legislative initiatives to improve drug safety in the European Union. Scientific Centre for Expert Evaluation of Medicinal Products Bulletin 2013; 3: 45–48.
17. Lepakhin VK, Romanov BK, Nikitina T, Snegireva II. Estimation of correlation between anticipated benefit and possible risk from the use of medicines. The Bulletin of the Scientific Center for Expert Evaluation of Medical Products 2012; 2: 19–21.
18. Kutekhova GV, Lepakhin VK, Romanov BK. Identify the purpose of medicines with violations of the requirements of the regulations (OFF-LABEL) in pediatric practice. The Bulletin of the Scientific center for expert evaluation of medical products 2012; 3: 23–27.
19. Alyautdin RN, Romanov BK, Guseynov MD, Lopatin PV, Zilfikarov IN. Experimental screening evaluation of the stress-protection action of herbal remedies. Russian medical journal 2008; 3: 29–33.
20. Vaskova LB, Lopatin PV, Romanov BK. Pharmacoeconomics in pharmacy. Moscow: Publishing house of the First Moscow state medical. University. I. M. Sechenov Of Ministry Of Healthcare Of Russia; 2012.
21. Romanov BK. Regulation of Myocardial lysosomal enzyme activity by calcium. Biomedical Chem. 2005; 51(6): 634–642.
22. Zatolochina KE, Snegireva II, Ozeretskovsky NA, Romanov BK, Mironov AN. Features methods of identifying adverse reactions to the vaccination. Doctor- graduate student 2013; 61: 96–103.
23. Merkulov VA, Bunyatyan ND, Sakaeva IV, Lepakhin VK, Romanov BK, Richikhina EM, Koshechkin KA. Analysis and synthesis of documents on the safety of medicines when conducting international clinical trials in Russian Federation. The Bulletin of the Scientific center for expert evaluation of medical products 2013; 2: 21–23.
24. Lepakhin VK, Romanov BK, Snegireva II. Methods of detection and evaluation of adverse reactions to medicines. Moscow; 2013.
25. Romanov BK, Toropova IA, Kolesnikova EY. Medication errors. Safety and Risk of Pharmacotherapy 2014; 2(3): 28–30.
26. Merkulov VA, Bunyatyan ND, Sakaeva IV, Richikhina EM, Lepakhin VK, Romanov BK, Komratov AV, Kolesnikova EYu, Koshechkin KA, Kozlovich AV. Improving the system of evaluating information on the safety of medicines in clinical trials. The Bulletin of the Scientific center for expert evaluation of medical products 2014; 1: 20–26.
27. Snegireva II, Zatolochina KE, Darmostukova MA, Alyautdin RN, Romanov BK. Modern approaches to vaccine interchangeability. The Bulletin of the Scientific center for expert evaluation of medical products 2016; 4: 3–8.
Review
For citations:
Zatolochina K.E., Snegireva I.I., Zhuravleva E.O., Darmostukova M.A., Alyautdin R.N. Statistical signal detection methods. Safety and Risk of Pharmacotherapy. 2017;5(2):76-82. (In Russ.)
Views:
1381
Email this article 