Modern approaches to collecting and reporting information on side effects
Abstract
We have prepared this review of the domestic and foreign scientific literature to characterize the different modern approaches to collecting of ADR information. Advent of new technologies in mobile devices and software applications is leading to facilitate information gathering. The importance of medical literature, social media and patient-generated data for pharmacovigilance were highlighted.
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
A. S. Kazakov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. Yu. Kolesnikova
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
T. M. Bukatina
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
References
1. Strom B. L. Pharmacoepidemiology. Oxford: Wiley-Blackwell; 2012.
2. Guidelines for the examination of drugs. V. III. Mjscow: POLYGRAPH PLUS; 2014 (in Russian).
3. Merkulov VA, Bunyatyan ND, Sakaeva IV, Lepakhin VC, Romanov BK. New legislative initiatives for improving the safety of medicines in the European Union. The Bulletin of the Scientific center for expert evaluation of medical products 2013; 3: 45–48 (in Russian).
4. Snegireva II, Zatolochina KE, Ozeretskovsky NA, Romanov BK, Mironov AN. Vaccine pharmacovigilance in Russia, legal and regulatory framework, current stage of development. The Bulletin of the Scientific center for expert evaluation of medical products 2014; 4: 27–31. (in Russian)
5. Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013; 36(2): 75–81. doi: 10.1007/s40264-012-0014-6.
6. Härmark L, Raine J, Leufkens H, Edwards R, et al. Patient-Reported Safety Information: A Renaissance of Pharmacovigilance? Drug Saf. 2016; 39(10): 883–90. doi: 10.1007/s40264-016-0441-x.
7. Directive 2010/84/EU. Offcial Journal of the European Union 2010; L. 348-74-99.
8. Regulation 1235/2010. Offcial Journal of the European Union 2010; L. 348-1-16.
9. van Hunsel F, Talsma A, van Puijenbroek E, de Jong-van den Berg L, van Grootheest K. The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case-control study. Pharmacoepidemiol Drug Saf. 2011; 20:286–91.
10. Hazell L, Cornelius V, Hannaford P, Shakir S, Avery AJ. How do patients contribute to signal detection? A retrospective analysis of spontaneous reporting of dverse drug reactions in the UK’s Yellow Card Scheme. Drug Saf. 2013; 36: 199–206.
11. Blenkinsopp A,Wilkie P,Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007; 63: 148–56.
12. Medawar C, Herxheimer A. A comparision of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behavior with paroxetine. Int J Risk Saf Med. 2004; 16: 5–19.
13. Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, Hazell L, Krska J, Lee AJ, McLernon DJ, et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol. Assess. 2011; 15:1 – iv.
14. Rolfes L, van Hunsel F, Wilkes S, van Grootheest K, van Puijenbroek E. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf. 2015; 24: 152–8.
15. de Langen J, van Hunsel F, Passier A, deJong-van den BergL, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf. 2008; 31: 515–24.
16. Kennedy SH, Rizvi S. Sexual dysfunction, depression, and the impact of antidepressants. J Clin Psychopharmacol. 2009; 29: 157–64.
17. Ekhart CG, van Puijenbroek EP. Does sexual dysfunction persist upon discontinuation of selective serotonin reuptake inhibitors? Tijdschr Psychiatr. 2014; 56: 336–40.
18. Netherlands Pharmacovigilance Centre Lareb. SSRIs and aggression. [Electronic source] 2016 (cited 21 Dec 2017). Avaible at: http://www.lareb.nl/Signalen/kwb_2009_3_ssris.
19. Netherlands Pharmacovigilance Centre Lareb. SSRI’s and aggression an update. [Electronic source] 2014 (cited 21 Dec 2017). Avaible at http://www.lareb.nl/Signalen/KWB_2014_2_SSRI.
20. de Graaf L, van Puijenbroek EP. Serotonin reuptake inhibitors and shocklike paresthesia. J Clin Psychiatry. 2003; 64: 969–71.
21. Frost L, Lal S. Shock-like sensations after discontinuation of selective serotonin reuptake inhibitors. Am J Psychiatry. 1995; 152: 810.
22. Netherlands Pharmacovigilance Centre Lareb. Serotonin re-uptake inhibitors (SSRIs) and Shocklike Paraesthesia. [Electronic source] 2002 (cited 21 Dec 2017). Avaible at http://www.lareb.nl/Signalen/kwb_2002_2_ssris. Accessed 21 Jan 2016.
23. Netherlands Pharmacovigilance Centre Lareb. Duloxetine and Electric Shock Sensations[Electronic source] 2011 (cited 21 Dec 2017). Avaible at http://www.lareb.nl/Signalen/kwb_2011_2_dulox.
24. Van Hunsel F. Examples of the role of patient reports in safety signals. Lareb 2015.
25. Download the Yellow Card mobile app to report suspected adverse drug reactions. [Electronic source] 2002 (cited 21 Dec 2017). Avaible at https://www.gov.uk/drug-safety-update.
26. WEB-RADR. IMI — Innovative Medicines Initiative. [Electronic source] 2002 (cited 21 Dec 2017). Avaible at https://www.imi.europa.eu/content/web-radr.
27. Guideline on good pharmacovigilance practices (GVP) — Module VI (Rev 1) EMA/873138/2011 Rev 1. 2014.
28. Decision of the Council of the Eurasian Economic Commission dated 03.11.2016¹ 87 «On approval of rules of the Good Pharmacovigilance Practice of the Eurasian Economic Union». [Electronic source] 2016 (cited 21 Dec 2017). Avaible at https://docs.eaeunion.org/docs/ru-ru/01411948/cncd_21112016_87.
29. Sarker A, Ginn R, Nikfarjam A, O’Connor K, Smith K, Jayaraman S, Upadhaya T, Gonzalez G. Utilizing social media data for pharmacovigilance: A review. J Biomed Inform. 2015; 54: 202–12. doi: 10.1016/j.jbi.2015.02.004. Epub 2015 Feb 23.
30. Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pirmohamed M. Social media and pharmacovigilance: A review of the opportunities and challenges. Br J Clin Pharmacol. 2015;80 (4): 910–20. doi: 10.1111/bcp. 12717. Epub 2015 Sep 2.
31. Edwards R, Lindquist M. Social media and networks in pharmacovigilance: boon or bane? Drug Saf. 2011; 34(4): 267–71. doi: 10.2165/11590720-000000000-00000.
32. Benton A, Ungar L, Hill S, Hennessy S, Mao J, Chung A, Leonard CE, Holmes JH. Identifying potential adverse effects using the web: a new approach to medical hypothesis generation. J Biomed Inform. 2011; 44(6): 989–96.
33. Statista — The Statistics Portal for Market Data, Market Research and Market Studies. [Electronic source] 2002 (cited 21 Dec 2017). Avaible at https://www.statista.com.
34. Harpaz R, DuMouchel W, Shah NH, Madigan D, Ryan P, Friedman C. Novel data-mining methodologies for adverse drug event discovery and analysis. Clin Pharmacol Ther. 2012; 91(6): 1010–21.
35. Kass-Hout TA, Alhinnawi H. Social media in public health. Br Med Bull. 2013; 108: 5–24.
36. Harpaz R, Callahan A, Tamang S, Low Y, Odgers D, Finlayson S, Jung K, LePendu P, Shah NH. Text mining for adverse drug events: the promise, challenges, and state of the art. Drug Saf. 2014; 37(10): 777–90.
37. Lardon J, Abdellaoui R, Bellet F, Asfari H, Souvignet J, Texier N, Jaulent MC, Beyens MN, Burgun A, Bousquet C. Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review. J Med Internet Res. 2015; 17(7): e171.
Review
For citations:
Zatolochina K.E., Snegireva I.I., Kazakov A.S., Kolesnikova E.Yu., Zhuravleva E.O., Bukatina T.M., Darmostukova M.A. Modern approaches to collecting and reporting information on side effects. Safety and Risk of Pharmacotherapy. 2017;5(1):32-38. (In Russ.)
Views:
1298
Email this article 