Analysis of pharmacy organisation staff awareness of pharmacovigilance

The aim of the study was to investigate the awareness of pharmacists’ knowledge of the pharmacovigilance basics in pharmacy organisations (PhOs) of the Russian Federation and to identify the factors influencing their participation in the drug safety monitoring system.

Materials and methods. A single-point survey study was conducted in the form of a single solid group online questionnaire survey of 513 pharmaceutical specialists from different regions of Russia. A specially designed 14-item questionnaire aimed was used to assess their knowledge of the pharmacovigilance system. Retrospective, comparative, statistical, and logical analysis methods were applied.

Results. A comprehensive assessment of the level of pharmaceutical specialists’ pharmacovigilance knowledge in Russia was carried out. The factors influencing the specialists’ awareness were determined. The necessity of educational activities to increase the involvement of PhOs employees in the drug safety monitoring system was justified. The insufficient level of pharmaceutical specialists’ knowledge about the basic concepts and procedures of pharmacovigilance was revealed. Specialists with secondary specialized education and less work experience demonstrated a lower level of awareness. Only 13% of the participants had received training on pharmacovigilance, while the majority (about 80%) considered it necessary to increase the number of training programmes. The influence of education, work experience and job position on the awareness of professionals was established. Most respondents recognize the need to report adverse drug reactions (ADRs) occurring when taking a medicine, but in practice the level of reporting remains low.

Conclusion. Insufficient knowledge of the pharmacovigilance basics among pharmacy workers causes a low level of ADRs reporting by them. A comprehensive approach, including educational initiatives and the development of targeted interventions, is required to improve specialists’ engagement in the drug safety monitoring system. Further research is necessary to develop and evaluate the effectiveness of educational programmes and motivational models to increase pharmaceutical specialists’ pharmacovigilance activities.

1. Gildeeva GN, Belostotsky AV. Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU. Modern Pharmacoeconomics and Pharmacoepidemiology. 2019;12(2):86–90 DOI: 10.17749/2070-4909.2019.12.2.86-90

2. Shukil LV, Fominykh SG, Akhmedov VA, Perepichkina TE. Rational Organisation of Adverse Drug Reaction Monitoring. Safety and Risk of Pharmacotherapy. 2022;10(3):251–8. DOI: 10.30895/2312-7821-2022-10-3-251-258

3. Romanov BK, Krasheninnikov AE. Organization of a pharmacovigilance system in the distribution segment of the pharmaceutic market. Pharmacy. 2018;67(7):38–42. DOI: 10.29296/25419218-2018-07-07

4. Egiazarian E.A., Kosova I.V., Gorelov K.V. Need for involving consumers in EAEU countries pharmacovigilance system // Medical & pharmaceutical journal «Pulse». 2023;25(9):61–6. DOI: 10.26787/nydha-2686-6838-2023-25-9-61-66

5. Alekseeva A, Sobolev I, Moiseeva K, Poletov S. Parent assessment of the accessibilityof health care provided to children in ambulatory conditions. Bulletin of Science and Practice. 2018;4(10):47–55. DOI: 10.5281/zenodo.1461847

6. Svintitskaya AV, Yurovskikh KS, Kostrov VI. Assessment of satisfaction of residents of the Tyumen region with the quality and conditions of medical care in primary health care. Ural University Medicine. 2021;7(4(27)):79–81. EDN: FCRHIF. Russian

7. Sitnikova TN. Assessment of patient satisfaction with the quality of medical care at the therapeutic site. University Medicine of the Urals. 2019;5(2(17)):87–9. EDN: GYLOYS. Russian

8. Chupandina EE, Kurolap MS, Ternovaya NA. Research of the role and place of pharmaceutical worker in the system of regional pharmacovigilance. MODS. 2019;(2):40–2. DOI: 10.30809/solo.2.2019.16

9. Ibragimova GIa, Gaisarov AKh. The development of the functional model of the conducting activities in pharmacies for implementation of pharmacovigilance. Drug development & registration. 2017;(4(21)):288–91. EDN: ZTWVLB

10. Klimenkova AA, Geller LN, Posokhina AA, Skripko AA. The place and role of pharmacy organizations in the pharmacovigilance system. Innovative technologies in pharmacy: Proceedings of the All-Russian Scientific and Practical conference with international participation to the memory of Professor Manyak, Irkutsk, June 13, 2017; EG Goryachkina, editor. Issue No. 4. Irkutsk: IGMU; 2017. Р. 186–90. EDN: ZNWVQR

11. Mishchenko MA, Mineeva NK, Ponomareva AA, Mishchenko ES. Regulatory and legal aspects of the functioning of the pharmacovigilance system at the state level and within the framework of the quality management system of pharmacy organizations. Modern Science. 2020;(2-2):220–6. EDN: PONYLJ. Russian

12. Ryzhova OA. Possibilities of involving pharmacy specialists in monitoring the safety of medicines. Bulletin of the Northern State Medical University. 2010;(1(24)):266–7. EDN: UNNHWJ. Russian

13. Morozova TE, Hoseva EN, Andruschishina TB, Vartanova OA. Safety monitoring of medicines in health facilities: Problems and perspective of development. Consilium Medicum. 2015;17(1):50–53. EDN: TNRGKT

14. Safiullin RS, Krasheninnikov AE. The role of pharmacists in improving the pharmacovigilance system in Russia. Journal of Pharmaceuticals Quality Assurance Issues. 2018;(3(21)):58–62. EDN: YAAZCH

15. Khoseva EN, Morozova TE. Problems of development of a pharmacovigilance in Russia at the present stage (review). Good Clinical Practice. 2013;(3): 40–5. EDN: RWVPGD

16. Fossouo Tagne J, Yakob RA, Dang TH, Mcdonald R, Wickramasinghe N. Reporting, Monitoring, and Handling of Adverse Drug Reactions in Australia: Scoping Review. JMIR public health and surveillance. 2023; 9(e40080):1–9. DOI: 10.2196/40080

17. Hughes ML, Weiss M. Adverse drug reaction reporting by community pharmacists-The barriers and facilitators. Pharmacoepidemiology and Drug Safety. 2019;28(12):1552–9. DOI: 10.1002/pds.4800

18. Kassa Alemu B, Biru TT. Health Care Professionals’ Knowledge, Attitude, and Practice towards Adverse Drug Reaction Reporting and Associated Factors at Selected Public Hospitals in Northeast Ethiopia: A Cross-Sectional Study. BioMed Research International. 2019;2019(8690546):1–11. DOI: 10.1155/2019/8690546

19. Khan Z, Karatas Y, Martins MAP, Jamshed S, Rahman H. Knowledge, attitude, practice and barriers towards pharmacovigilance and adverse drug reactions reporting among healthcare professionals in Turkey: a systematic review. Current Medical Research and Opinion. 2022;38(1):145–54. DOI: 10.1080/03007995.2021.1997287

20. Afifi S, Maharloui N, Peymani P, Namazi S, Gharaei AG, Jahani P, Lankarani KB. Adverse drug reactions reporting: pharmacists’ knowledge, attitude and practice in Shiraz, Iran. The International Journal of Risk & Safety in Medicine. 2014;26(3):139–45. DOI: 10.3233/JRS-140620

21. Farcaș A, Bucșa C, Crișan A, Cazacu I, Leucuța D, Mogoșan C. Knowledge, opinion and attitudes towards adverse drug reactions reporting among pharmacy students in Romania. Farmacia. 2021;69(3):602–608. DOI: 10.31925/farmacia.2021.3.24

22. Yawson AA, Abekah-Nkrumah G, Okai GA, Ofori CG. Awareness, knowledge, and attitude toward adverse drug reaction (ADR) reporting among healthcare professionals in Ghana. Therapeutic Advances in Drug Safety. 2022;13:1–15. DOI: 10.1177/20420986221116468

23. Paudyal V, Al-Hamid A, Bowen M, Hadi MA, Hasan SS, Jalal Z, Stewart D. Interventions to improve spontaneous adverse drug reaction reporting by healthcare professionals and patients: systematic review and meta-analysis. Expert Opinion on Drug Safety. 2020;19(9):1173–91. DOI: 10.1080/14740338.2020.1807003

24. Shmarikhina ES. Application of sampling method in the socio-economic study. Vestnik NGUÈU. 2013;(4):144–52. EDN: RSSVRX

25. Narkevich A, Vinogradov K. Methods for determining the minimum required sample size in medical research. Social aspects of Population Health. 2019;65(6):19.

26. Fomina EE, Zhiganov NK. The methodology of processing of survey results with the use of multivariate and parametric statistics. Bulletin of Udmurt University. Series Philosophy. Psychology. Pedagogy. 2017;27(1):105–10. EDN: YJUWVX