Improving the Pharmacovigilance System in Medical Organisations as an Opportunity to Enhance the Quality of Pharmacotherapy

INTRODUCTION. It is essential to monitor the efficacy and safety of medicinal products as part of post-marketing surveillance to identify, assess, and prevent adverse drug reactions (ADRs). The effectiveness of pharmacovigilance depends largely on healthcare professionals’ adherence to the requirements and timeframes for reporting information to regulatory authorities.

AIM. This study aimed to identify and systematise the key aspects of pharmacovigilance through an analysis of experience in organising pharmacovigilance in Moscow-based healthcare institutions in 2018–2024 to determine the focus areas for implementing, monitoring, and improving the pharmacovigilance system operating in medical organisations.

DISCUSSION. The significance of pharmacovigilance systems and the need for their continuous improvement are underpinned by experience in establishing pharmacovigilance databases, including the global VigiBase database, the European Union’s EudraVigilance database, and the Eurasian Economic Union’s database. The main pharmacovigilance tools include active surveillance and collection of unsolicited/solicited reports of suspected ADRs. The Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) has developed clear operational criteria for pharmacovigilance in medical organisations. These criteria require that medical organisations should have in-house regulations for collecting, registering, and reporting data on ADRs to Roszdravnadzor, appointing qualified persons responsible for pharmacovigilance, and obtaining access to the Pharmacovigilance database of Roszdravnadzor’s Automated Information System. This article provides a detailed description of tools for establishing an effective pharmacovigilance system in a medical organisation, as well as the focus areas for organising pharmacovigilance in medical organisations, identified by analysing the experience of a territorial entity of the Russian Federation.

CONCLUSIONS. To improve the effectiveness of pharmacovigilance in medical organisations, it is necessary to ensure the quality, integrity, and completeness of data submitted in spontaneous ADR reports. Spontaneous reporting should be supplemented with active surveillance methods, including the Global Trigger Tool. The current pharmacovigilance system in Moscow demonstrates a steady increase in reporting ADRs to Roszdravnadzor.

1. Murashko MA, Parhomenko DV, Asetskaya IL, Kosenko VV, Polivanov VA, Glagolev SV. The role and practice pharmacovigilance in Russian healthcare. Vestnik Roszdravnadzora. 2014;(3):182–90. (In Russ.). EDN: TCWFZL

2. Kuznetsova EV, Zhuravleva MV, Mikhailov IA, Kurnosova TI. Deve­lopment of methodological approaches to the formation of a risk-based model to minimize the prevalence of adverse reactions in drug application in medical organizations of ­Moscow. ­FARMAKO­EKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2023;16(2):248–57 (In Russ.). https://doi.org/10.17749/2070-4909/farmakoekonomika.2023.184

3. Wettermark B, Elseviers M, Almarsdottir AB, Andersen M, Benko R, Bennie M, et al. Introduction to drug utilization research. In: Drug utilization research: Methods and applications. 2016;1–12. https://doi.org/10.1002/9781118949740.ch1

4. Jyndiang A, Shabaraya AR, Chandur VK. A comprehensive review on pharmacovigilance: Enhancing drug safety and surveillance. Int J in Pharm Sci. 2023;1(12):158–65. https://doi.org/10.5281/zenodo.10302560

5. Zagorodnikova KA. Organization of pharmacovigilance in the world — methodological approaches. Pacific Medical Journal. 2015;(1):11–5 (In Russ.). EDN: ULFLFH

6. Kazakov AS, Darmostukova MA, Bukatina TM, Velts NYu, Alyautdin RN. Comparative analysis of international databases of adverse drug reactions. Safety and Risk of Pharmacotherapy. 2020;8(3):134–40 (In Russ.). https://doi.org/10.30895/2312-7821-2020-8-3-134-140

7. Watson S, Chandle RE, Taavola H, Härmark L, Grundmark B, Zekarias A, et al. Safety concerns reported by patients identified in a collaborative signal detection workshop using VigiBase: Results and reflections from Lareb and Uppsala Monitoring Centre. Drug Saf. 2018;41(2):203–12. https://doi.org/10.1007/s40264-017-0594-2

8. Shubnikova EV Postmarketing surveillance: Review of open sources of drug safety data. Safety and Risk of Pharmacotherapy. 2024;12(3):309–30 (In Russ.). https://doi.org/10.30895/2312-7821-2024-12-3-309-330

9. Bihan K, Lebrun-Vignes B, Funck-Brentano C, Salem JE. Uses of pharmacovigilance databases: An overview. Therapie. 2020;75(6):591–98. https://doi.org/10.1016/j.therap.2020.02.022

10. Slusar OI, Kachalov AB, Ryizhkova MV, Slusar IB. Methodologies for assessing drug safety, effectiveness and adverse drug reactions. Health & Education Millennium. 2018;20(3):112–7. https://dx.doi.org/10.26787/nydha-2226-7425-2018-20-3-112-117

11. Gildeeva GN, Belostotsky AV. Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU. FARMAKO­EKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2019;12(2):86–90. https://doi.org/10.17749/2070-4909.2019.12.2.86-90

12. Glagolev SV, Gorelov KV, Chizhova DA. Russian pharmacovigilance in a newly regulated environment: Two-year results and prospects. Remedium. 2019;3:8–14. https://doi.org/10.21518/1561-5936-2019-3-8-14

13. Mouchantaf R, Auth D, Moride Y, Raine J, Han SY, Smith MY. Risk management for the 21st century: Current status and future needs. Drug Saf. 2021;44(4):409–19. https://doi.org/10.1007/s40264-020-01033-z

14. Asetskaya IL, Polivanov VA, Zyryanov SK. Methodological approaches to studying fatal adverse drug reactions. Safety and Risk of Pharmacotherapy. 2022;10(4):381–95 (In Russ.). https://doi.org/10.30895/2312-7821-2022-10-4-381-395

15. Afanasyeva TG, Starodubtseva IO. Assessment of pharmaceutical workers’ awareness of their competence in pharmacovigilance issues. Eurasian Union of Scientists. 2019;(2–2);37–9. (In Russ.). https://doi.org/10.31618/ESU.2413-9335.2019.2.59.37-39

16. Komissarova VA. Risk minimization measures in pharmacovigilance: Review of national and international experience. Good Clinical Practice. 2019;(3):33–43. (In Russ.). https://doi.org/10.24411/2588-0519-2019-10081

17. Hibbert PD, Molloy CJ, Hooper TD, Wiles LK, Runciman WB, Lachman P, et al. The application of the Global Trigger Tool: A systematic review. International Journal for Quality in Health Care. 2016;28(6):640–49. https://doi.org/10.1093/intqhc/mzw115

18. Vlasova AV, Smirnova EV, Gorev VV, Sychev DA. Adverse reactions in children to antimicrobials: Limitations of the spontaneous reporting method and the possibilities of the global trigger method for drug–induced conditions. Pharmateca. 2023;30(1-2):18–31. (In Russ.). https://dx.doi.org/10.18565/pharmateca.2023.1-2.18-31

19. Comfort S, Dorrell D, Meireis S, Fine J. MOdified NARanjo Causality Scale for ICSRs (MONARCSi): A decision support tool for safety scientists. Drug Saf. 2018;41:1073–85. https://doi.org/10.1007/s40264-018-0690-y

20. Danan G, Teschke R. RUCAM in drug and herb induced liver injury: The update. Int J Mol Sci. 2015;17(1):14. https://doi.org/10.3390/ijms17010014

21. Kuznetsova EV, Zhuravleva MV. Assessment of the functioning of the system for monitoring the effectiveness and safety of pharmacotherapy in medical organisations of the state healthcare system of the city of Moscow. In: Works of graduate students of the Research Institute of Healthcare Organization and Medical Management: Collection of scientific works of graduate students. Moscow; 2023. P. 124-34 (In Russ.). EDN: LUHENM