TOPICAL ISSUES OF DRUG SAFETY MONITORING IN THE RUSSIAN FEDERATION


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

The paper deals with the topical issues of pharmacoviligance development worldwide and in the Russian Federation. Particular attention is given to spontaneous communications, a method used to detect adverse reactions in daily medical practice. The role of practitioners in revealing drug safety problems is considered. The practical aspects of how to organize pharmacoviligance in therapeutic-and-prophylactic institutions are detailed.

Full Text

Restricted Access

About the authors

M. A MURASHKO

Russian Federal Service for Health Supervision

MD, Acting Director Moscow 109074, Slavyanskaya sq. 4 bld. 1

D. V PARKHOMENKO

Russian Federal Service for Health Supervision

Doctor of Physical Sciences, deputy head Moscow 109074, Slavyanskaya sq. 4 bld. 1

I. L ASETSKAYA

Russia information and Methodological Center for Examination, Accounting, and Analysis of Medical Product Circulations, Russian Federal Service for Health Supervision

MD, Chief specialist of the Center for the Study of efficacy, safety and rational use of medicines Moscow 109074, Slavyanskaya sq. 4 bld. 1, Russia

V. V KOSENKO

Russian Federal Service for Health Supervision

Ph.D., head of the organization of state control of the quality of medical products Moscow 109074, Slavyanskaya sq. 4 bld. 1

V. A POLIVANOV

Russian Federal Service for Health Supervision

Email: PolivanovVA@fgu.ru
director of the Center for the Study of efficacy, safety and rational use of medicines Moscow 109074, Slavyanskaya sq. 4 bld. 1

S. V GLAGOLEV

Russia information and Methodological Center for Examination, Accounting, and Analysis of Medical Product Circulations, Russian Federal Service for Health Supervision

Deputy for the Head of Department, Head of the Monitoring the effectiveness and safety Moscow 109074, Slavyanskaya sq. 4 bld. 1, Russia

References

  1. Астахова А.В., Лепахин В.К. Лекарства. Неблагоприятные побочные реакции и контроль безопасности. М.: ЭКСМО; 2008. 256 с.
  2. Зырянов С.К., Грацианская А.Н., Белоусов Ю.Б. Фармаконадзор. Учебно-методическое пособие. М.; 2008. 122 с.
  3. Lazarou J., Pomeranz B.H., Corey P.N. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279(15):1200-5.
  4. Classen D.C., Pestotnik S.L., Evans R.S., Lloyd J.F., Burke J.P. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997; 277(4): 301-6.
  5. Zhan C., Arispe I., Kelley E., Ding T., Burt C.W., Shinogle J., Stryer D. Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Jt Comm. J. Qual. Patient Saf. 2005; 31: 372-8.
  6. Pillans P.I. Clinical perspectives in drug safety and adverse drug reactions. Expert Rev. Clin. Pharmacol. 2008; 1(5): 695-705.
  7. World Health Organization. The importance of pharmacovigilance - safety monitoring of medicinal products. Geneva: World Health Organization; 2002.
  8. Routledge P. 150 years of pharmacovigilance. Lancet. 1998; 351(9110): 1200-1.
  9. Burley D.M. The rise and fall of thalidomide. Pharm. Med. 1988; 3: 231-7.
  10. Waller P.C., Coulson R.A., Wood S.M. Regulatory pharmacovigilance in the United Kingdom: current principles and practice. Pharmacoepidemiol. Drug Saf. 1996; 5(6): 363-75.
  11. Белоусов Ю.Б., Грацианская А.Н., Зырянов С.К., Чубарев В.Н. Опыт английской системы оценки безопасности лекарств. Ремедиум-2006; январь: 24-6.
  12. Косенко В.В., Глаголев С.В. Организация системы мониторинга безопасности зарегистрированных лекарственных препаратов в Российской Федерации. Вестник Росздравнадзора. 2011; 6: 31-9.
  13. Глаголев С.В., Поливанов В.А., Чижова Д.А., Горелов К.В. Мониторинг безопасности лекарственных средств: состояние и перспективы. Вестник Росздравнадзора. 2013; 4: 17-20.
  14. Астахова А.В., Лепахин В.К., Стуров Н.В. Сравнительный анализ методов регистрации неблагоприятных побочных реакций лекарственных средств. Клиническая фармакология и терапия. 2008; 5: 49-53.
  15. Sharma M., Gupta S.K. Postmarketing surveillance. In: Gupta S.K., ed. Textbook of pharmacovigilance. New Delhi: Jaypee Brothers; 2011: 75-92.
  16. Овчинникова Е.А. Проблема безопасности применения лекарственных средств. Российские аптеки. 2006; 11(2): 23-6.
  17. Harmark L., van Grootheest A.C. Pharmacovigilance: methods, recent developments and future perspectives. Eur. J. Clin. Pharmacol. 2008; 64: 743-52.
  18. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module VIII - Post-authorisation safety studies (Rev 1). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2012/06/WC500129137.pdf (дата обращения 17.06.2014).
  19. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Module I - Pharmacovigilance systems and their quality systems. Available at: http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2012/06/WC500129132.pdf (дата обращения 17.06.2014).
  20. Pal S.N., 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.
  21. Hazell L., Shakir S.A. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006; 29: 385-96.
  22. Lopez-Gonzalez E., Herdeiro M.T., Figueiras A. Determinants of underreporting of adverse drug reactions: a systematic review. Drug Saf. 2009; 32: 19-31.
  23. Edwards I.R., Aronson J.K. Adverse drug reactions: definitions, diagnosis and management. Lancet. 2000; 356(9237): 1255-65.
  24. Aagaard L., Stranded J., Melskens L., Petersen P.S., Holme Hansen E. Global patterns of adverse drug reactions over a decade - analyses of spontaneous reports to VigiBase™. Drug Saf. 2012; 35(12): 1171-82.
  25. Lundin T., Fors S.-L. VigiBase: Quality in focus. The Uppsala Monitoring Centre. Uppsala Reports 65. Available at: http://www.who-umc.org/graph- ics/28089.pdf (дата обращения 17.06.2014).
  26. Belton K.J. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur. J. Clin. Pharmacol. 1997; 52: 423-7.
  27. Hasford J., Goettler M., Munter K.H., Muller-Oerlinghausen B. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J. Clin. Epidemiol. 2002; 55(9): 945-50.
  28. Nita Y., Batty K.T., Plumridge R.J. Adverse drug reaction reporting: attitudes of Australian hospital pharmacists and doctors. J. Pharm. Pract. Res. 2005; 35(1): 9-14.
  29. Medicines and Healthcare Products Regulatory Agency. Yellow card. Available at: https://yellowcard.mhra.gov.uk/ (дата обращения 17.06.2014).
  30. Lesar T.S., Briceland L., Stein D. Factors related to errors in medication prescribing. JAMA. 1997; 277: 312-7.
  31. Moore N. The role of the clinical pharmacologist in the management of adverse drug reactions. Drug Saf. 2001; 24(1): 1-7.
  32. Костылева М.Н. Оценка безопасности лекарственных средств, применяемых в многопрофильном педиатрическом стационаре: дис.. канд. мед. наук. М.; 2013.116 с.
  33. Lindquist M. Data quality management in pharmacovigilance. Drug Saf. 2004; 27(12): 857-70.
  34. Bergvall T., Noren G.N., Lindquist M. vigiGrade - a tool to identify well- documented individual case reports and highlight systematic data quality issues. Drug Saf. 2014; 37(1): 65-77.
  35. Cox A.R., Marriott J.F, Wilson K.A., Ferner R.E. Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes. J. Clin. Pharm. Ther. 2004; 29: 31-5.
  36. Figueiras A., Herdeiro M.T., Polonia J., Gestal-Otero J.J. An educational intervention to improve physician reporting of adverse drug reactions. JAMA. 2006; 296: 1086-93.
  37. Edwards I.R. Prevention and pharmacovigilance - what should we do, what can we do? Drug Saf. 2012; 35(2): 87-90.

Supplementary files

Supplementary Files
Action
1. JATS XML

Copyright (c) 2015 Bionika Media

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies