Drug safety: pharmacovigilance in the region
https://doi.org/10.34680/2076-8052.2021.1(122).71-75
Abstract
This article shows the importance of post-registration (post-marketing) monitoring of the use of drugs. The periods of the formation of the pharmacovigilance system at the regional level and the complication of tasks at the stages of development of the regional pharmacovigilance system are considered, the frequency and control of adverse reactions associated with the use of drugs in the Novgorod region are studied. Insufficient activity of specialists is a significant problem, therefore, a significant role should be assigned to systematic, explanatory work to form a correct understanding of the tasks to be solved to overcome the negative consequences of drug use and create a modern regional pharmacovigilance system, strengthen the role of clinical pharmacology and pharmacy. It is necessary to continue work on more complete involvement of specialists in the collection of information on adverse reactions to drugs.
About the Authors
G. A. Antropova
Novgorod State University
Russian Federation
Russian Federation
Veliky Novgorod
T. I. Okonenko
Novgorod State University
Russian Federation
Russian Federation
Veliky Novgorod
M. S. Sviridenko
Medical Information and Analytical Center
Russian Federation
Russian Federation
Veliky Novgorod
References
1. Profilaktika neblagopriyatnykh pobochnykh reaktsiy [Prevention of adverse side effects]. Moscow, GEOTARMedia Publ., 2009. 450 p.
2. Astakhova A.V., Lepakhin V.K. Neblagopriyatnyye pobochnyye reaktsii i kontrol' bezopasnosti [Adverse reactions and safety control]. Moscow, Meditsina Publ., 2008. 470 p.
3. OECD Tackling Wasteful Spending on Health. Jan 2017. Available at: https://www.oecd.org/els/health-systems/Tackling-Wasteful-Spending-on-Health-Highlights-revised.pdf (accessed 04.11.2020).
4. WHO. Patient Safety and Risk Management Service Delivery and Safety. September, 2019. Available at: https://www.who.int/features/factfiles/patient_safety/patient-safety-fact-file.pdf?ua=1 (accessed 04.11.2020).
5. ANSM: na upakovkakh s paratsetamolom dolzhna poyavit’sya preduprezhdayushchaya nadpis’ [Warning Label Should Appear on Paracetamol Packages]. Novosti GMP [GMP News. Available at: https://gmpnews.ru/2019/07/ansm-na-upakovkaxs-paracetamolom-dolzhna-poyavitsya-preduprezhdayushhayanadpis/ (accessed 04.11.2020).
6. Krasheninnikov A.Ye. Agregatnyy podkhod k periodizatsii stanovleniya sistemy farmakonadzora [An aggregate approach to the periodization of the formation of the pharmacovigilance system]. Pharmacy and Pharmacology, 2018, no. 6(6), pp. 584-589 DOI:10.19163/2307-9266-20186-6-584-589
7. Kostyleva M.N., Belousov Yu.B., Gratsianskaya A.N. et al. Otsenka bezopasnosti lekarstvennoy terapii v klinicheskoy praktike [Safety assessment of drug therapy in clinical practice]. Farmakoekonomika, 2014, no. 1, pp. 26-30.
8. Glagolev S.V., Gorelov K.V., Chizhova D.A. Razvitiye sistemy farmakonadzora v Rossiyskoy Federatsii [Development of the pharmacovigilance system in the Russian Federation]. Vestnik Roszdravnadzora, 2019, no. 2, pp. 72-77.
9. Resheniye Soveta Yevraziyskoy ekonomicheskoy komissii ot 03.11.2016 g. № 87 «Ob utverzhdenii Pravil nadlezhashchey praktiki farmakonadzora Yevraziyskogo ekonomicheskogo soyuza» [Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 87 ‘On approval of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union’]. Available at: http://docs.cntd.ru/document/456026106 (accessed 04.01.2020).
10. Asetskaya I.L., Zyryanov S.K., Kolbin A.S. et al. Sistema farmakonadzora v Yevraziyskom ekonomicheskom soyuze [Pharmacovigilance system in the Eurasian Economic Union]. Kachestvennaya klinicheskaya praktika, 2018, no. 4, pp. 53-72. doi: 10.24411/2588-0519-2018-10059.
11. Olefir Yu.V., Romanov B.K., Alyautdin R.N. et al. Assessment of pharmacovigilance reporting in Russia. Bezopasnost’ i risk farmakoterapii = Safety and Risk of Pharmacotherapy, 2018, no. 6(4), pp. 150-154. DOI:10.30895/2312-7821-2018-6-4-150-154.
12. UMC | Uppsala Monitoring Centre. Available at: https://www.who-umc.org (accessed 10.05.2020).
13. Mossialos E. Obzor global'nykh tendentsiy v razvitii zdravookhraneniya [Overview of global healthcare trends]. ORGZDRAV: novosti, mneniya, obuchenie. Vestnik VSHOUZ [Healthcare Management: News, Views, Education. Bulletin of VSHOUZ], 2019, 5 (2), pp. 56-79. doi: 10.24411/2411-8621-2019-12005.
14. Baldo P., Francescon S., Fornasier G. Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology. International Journal of Clinical Pharmacy, 2018, vol. 40, pp. 748-753. DOI: 10.1007/s11096-0180711-z.
15. Philip B., Weber R.J. Enhancing Pharmacy Practice Models Through Pharmacists’ Privileging. Hosp Pharm., 2013, no. 48 (2), pp. 160-165.
16. Roytberg G.Ye., Kondratova N.V. Vozmozhnosti povysheniya bezopasnosti lekarstvennoy terapii v mnogoprofil'nom statsionare [Possibilities of increasing the safety of drug therapy in a multidisciplinary hospital]. Farmatsiya, 2016, no. 6 (65), pp. 46-49.
17. Schwartz V., Kravitz M.S. A new joint approach to drug management: clinical pharmacy services and risk management unit. Harefuah. 2015, no. 154(4), pp. 228-232.
Review
For citations:
Antropova G.A., Okonenko T.I., Sviridenko M.S. Drug safety: pharmacovigilance in the region. Title in english. 2021;(1(122)):71-75. (In Russ.) https://doi.org/10.34680/2076-8052.2021.1(122).71-75
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