Organization of pharmacovigilance in the world -methodological approaches
Abstract
Medications safety is a relevant problem in the world, requiring global action. International system of pharmacovigilance is based on the method of spontaneous adverse drug reaction reporting, which helps to build databases and detect signals of possible new adverse drug reactions using statistical methods. This method is used internationally, however, organizational features may be different. European Union obliges pharmaceutical companies to monitor adverse drug reactions related to each international nonproprietary name, but not each trade name. In the USA, as well as in Russia, quality of single drug batches is monitored, aiming at identification of poor quality products. In order to improve efficiency of pharmacovigilance several measures can be used - teaching interventions, use of healthcare databases etc. Important aspect is support of research centers, doing research in the area of various aspects of drug safety. Specific approach is required for organization of pharmacovigilance in pregnant women, where spontaneous reporting is not that effective. The most widely used methods are registries and prospective non-interventional observation. In order to provide effective functioning of pharmacovigilance all participants of the healthcare system should be equally involved, including patients, doctors, pharmaceutical companies, regulatory organs, research and educational centers.
About the Author
K. A. Zagorodnikova
North-Western State Medical University n.a. I.I. Mechnikov
Russian Federation
Russian Federation
References
1. Загородникова К.А., Бурбелло А.Т., Покладова М.В. Безопасность лекарств и фармаконадзор у беременных - от «талидомидовой трагедии» до наших дней // Ремедиум. 2012. № 8. С. 15-22.
2. Колбин А.С., Загородникова К.А., Бурбелло А.Т. Фармаконадзор в Российской Федерации и в объединенной Европе в свете новой директивы Евросоюза, ждут ли нас изменения? // Ремедиум. 2012. № 8. С. 8-14.
3. Мурашко М.А., Пархоменко Д.В., Асецкая И.Л. [и др.] Роль и практика фармаконадзора в российском здравоохранении // Вестник Росздравнадзора. 2014. № 3. С. 54-61.
4. О совершенствовании деятельности врачей-клинических фармакологов: приказ МЗ РФ № 494 от 22.10.2003 г.
5. Об утверждении порядка оказания медицинской помощи по профилю «клиническая фармакология»: приказ МЗ РФ № 575н от 02.11.2012 г.
6. Основные задачи Центра экспертизы безопасности лекарственных средств. ФГБУ НЦЭСМП Минздрава. URL: http://www.regmed.ru/fnz/Default.aspx (дата обращения: 05.01.2015).
7. Ткачева О.Н., Бевз А.Ю., Ушкалова Е.А., Чухарева Н.А. Первое всероссийское фармакоэпидемиологическое исследование «Эпидемиология использования лекарственных средств у беременных»: основные результаты // Акушерство и гинекология. 2011. № 4. С. 112-117.
8. Berlin C., Blanch C., Lewis D.J. [et al.] Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker // Pharmacoepidemiol. Drug Saf. 2012. Vol. 21, No. 6. P. 622-630.
9. Biswas P Pharmacovigilance in Asia // J. Pharmacol. Pharmaco-ther. 2013. Vol. 4, Suppl. 1. P. S7-S19.
10. Center for Drug Safety Science. URL: https://www.liv.ac.uk/drug-safety (дата обращения: 06.01.2015).
11. Czeizel A.E., Métneki J., Béres J. 50 years of the Hungarian Congenital Abnormality Registry // Congenit. Anom. (Kyoto). 2014. Vol. 54, No. 1. P. 22-29.
12. Dal Pan G.J., Arlett PR. The US Food and Drug Administration -European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges // Drug Saf. 2015. Vol. 38, No. 1. P 13-15.
13. Directive 2012/26/EU of the European parlament and of the council. URL: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2012_26/dir_2012_26_en.pdf (дата обращения: 06.01.2015).
14. Entezari-Maleki T., Taraz M., Javadi M.R. [et al.] A two-year utilization of the pharmacist-operated drug information center in Iran // J. Res. Pharm. Pract. 2014. Vol. 3, No. 4. P. 117-122.
15. Eudravigilance. Pharmacovigilance in the Euroopean economic area. URL: https://eudravigilance.ema.europa.eu/highres.htm (дата обращения: 04.01.2014).
16. Gerritsen R., Faddegon H., Dijkers F. [et al.] Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods // Drug Saf. 2011. Vol. 34, No. 9. P. 755-762.
17. Good pharmacovigilance practices and pharmacoepidemiologic assessment. URL: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071696.pdf (дата обращения: 06.01.2015).
18. Koren G., Bozzo P. Cost effectiveness of teratology counseling -the Motherisk experience // J. Popul. Ther. Clin. Pharmacol. 2014. Vol. 21, No. 2. P. e266-e270.
19. Li D.Q., Kim R., McArthur E. [et al.] Risk of adverse events among older adults following co-prescription of clarithromycin and statins not metabolized by cytochrome P450 3A4 // Can. Med. Assoc. J. 2014. DOI: http://dx.doi.org/10.1016/j.amjcard.2014.12.009.
20. Lopez-Gonzalez E., Herdeiro M.T., Pineiro-Lamas M., Figueiras A. Effect of an educational intervention to improve adverse drug reaction reporting in physicians: A cluster randomized controlled trial // Drug Saf. 2014. PmID: 25537234 [PubMed - as supplied by publisher].
21. Mcbride W.G. Thalidomide and congenital abnormalities // Lancet. 1961. Vol. 278. P 7216-1358.
22. Miguel A., Azevedo L.F., Lopes F. [et al.] Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting // Pharma-coepidemiol. Drug Saf. 2013. Vol. 22, No. 1. P. 98-102.
23. Nordeng H., Ystrøm E., Einarson A. Perception of risk regarding the use of medications and other exposures during pregnancy // Eur. J. Clin. Pharmacol. 2010. Vol. 66, No. 2 P. 207-214.
24. Schaefer C. Drug safety in pregnancy: utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services // Congenit. Anom. (Kyoto). 2011. Vol. 51, No. 1. P. 6-11.
25. Schuemie M.J., Gini R., Coloma PM. Replication of the OMOP experiment in Europe: evaluating methods for risk identification in electronic health record databases // Drug Saf. 2013. Vol. 36, Suppl. 1. P. S159-S169.
26. Stoll S. Paul Martini’s methodology of therapeutic investigation, 1932 // JRSM. 2009. Vol. 102, No. 11. P. 493-495.
27. Sultana J., Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions // J. Pharmacol. Pharmacother. 2013. Vol. 4, Suppl. 1. P S73-S77.
28. The importance of pharmacovigilance. URL: http://whqlibdoc.who.int/hq/2002/a75646.pdf (дата обращения: 28.12.2014).
29. Uppsala Monitoring Centre - who-umc.org. URL: http://www.who-umc.org (дата обращения: 04.01.2015).
30. Venulet J., Helling-Borda M. WHO’s international drug monitoring--the formative years, 1968-1975: preparatory, pilot and early operational phases // Drug Saf. 2010. Vol. 33, No. 7. P e1-e23.
31. Wallerstedt S.M., Brunlöf G., Sundström A. Rates of spontaneous reports of adverse drug reactions for drugs reported in children: a cross-sectional study with data from the Swedish adverse drug reaction database and the Swedish Prescribed Drug Register // Drug Saf. 2011. Vol. 34, No. 8. P 669-682.
32. World Health Assembly 20 WHO pilot research project for international monitoring of adverse reaction to drugs. 1967. URL: http://www.who.int/iris/handle/10665/89523 (дата обращения: 12.12.2014).
Review
For citations:
Zagorodnikova K.A. Organization of pharmacovigilance in the world -methodological approaches. Pacific Medical Journal. 2015;(1):11-15. (In Russ.)
Views:
346
Email this article 