Assessing the knowledge and practice of the Irish Community Pharmacists in reporting Adverse Drug Reactions and Falsified Medicines
Abstract
Background: Pharmacovigilance is a critical aspect of healthcare, enabling the monitoring of adverse drug reactions (ADRs), eradication of falsified medicines (FMs), identification of medication errors, monitoring off-license drug use, addressing abuse and misuse, assessing lack of efficacy, tracking poisoning incidents, managing drug-drug/food interactions, ensuring the destruction of expired stock, and evaluating drug-related mortality. It is essential for healthcare professionals to be aware of their role in Pharmacovigilance.
Objective: This study aims to assess the current knowledge and reporting practices of ADRs and FMs among community pharmacists in Ireland, focusing on two important components of Pharmacovigilance.
Method: The research employed a cross-sectional, observational design, utilizing an online questionnaire survey to gain insights into the pharmacists' knowledge and practices related to Pharmacovigilance programs, ADR reporting, FMs, and their opinions on their role in these areas.
Results: The study found that Irish colleges and universities played a significant role in providing Pharmacovigilance education to pharmacy students. The majority of pharmacists demonstrated a good understanding of Pharmacovigilance, but only a third of them were aware of Irish legislation in this regard. Additionally, only 20.23% of pharmacists believed that Irish patients were aware of ADR reporting, although 92.49% were familiar with the Health Products Regulatory Authority's (HPRA) ADR reporting system. The findings suggest the need for pharmacists to educate their patients about ADR reporting, while recognizing the convenience of the HPRA reporting system.
Conclusion: Overall, the study revealed that most community pharmacists possess a solid understanding of the fundamental aspects of Pharmacovigilance, including ADRs and FMs. However, there are areas for improvement, such as raising awareness among patients about ADR reporting. The findings highlight the importance of continuous education and communication to enhance Pharmacovigilance practices among community pharmacists in Ireland.
Downloads
References
2. Amale PN, Deshpande SA, Nakhate YD, Arsod NA. Pharmacovigilance Process in India: An overview. J Pharmacovigil. 2018;6(2):1-7.
3. Kalaiselvan V, Prasad T, Bisht A, et al. Adverse drug reactions reporting culture in Pharmacovigilance Programme of India. Indian J Med Res. 2014;140(4):563-564.
4. Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: A review of recent observational studies. Drug Saf. 2015; 38:437-453.
5. European Medicines Agency (EMA). Falsified medicines: an overview [Internet]. European Medicines Agency; 2021 Jan 1 [cited 2023 May 5]. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/falsified-medicines-overview
6. World Health Organization (WHO). Definitions of Substandard and Falsified (SF) Medical Products [Internet]. WHO; 2023 [cited 2023 May 5]. Available from:
https://www.who.int/teams/regulation-prequalification/incidents-and-SF/background/definitions
7. Ferrario A, Orubu ESF, Adeyeye MC, et al. The need for comprehensive and multidisciplinary training in substandard and falsified medicines for pharmacists. BMJ Global Health. 2019;4(001681):1-3.
8. World Health Organization (WHO). Pharmacovigilance and Traditional and Complementary Medicine in South-East Asia: A Systematic Review. World Health Organization Regional Office for South-East Asia; 2019:1-26.
9. Uppsala Monitoring Centre (UMC). Members of the WHO Programme for International Drug Monitoring [Internet]. WHO; 2023 Jan 25 [cited 2023 May 5]. Available from:
https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/member-countries/
10. European Medicines Agency (EMA). Pharmacovigilance: Overview [Internet]. European Medicines Agency; 2021 Jan 1 [cited 2023 May 6]. Available from:
https://www.ema.europa.eu/en/human-regulatory/overview/Pharmacovigilance-overview
11. European Medicines Agency (EMA). Implementation of the Pharmacovigilance legislation [Internet]. European Medicines Agency; 2021 Jan 1 [cited 2023 May 6]. Available from:
https://www.ema.europa.eu/en/human-regulatory/overview/Pharmacovigilance/legal-framework/implementation-Pharmacovigilance-legislation
12. Health Products Regulatory Authority (HPRA). Healthcare Professional and Pharmacovigilance [Internet]. HPRA; 2014 [cited 2023 May 7]. Available from:
http://www.hpra.ie/homepage/medicines/safety-information/identifying-and-understanding-risks/healthcare-professional-and-Pharmacovigilance
13. Health Products Regulatory Authority (HPRA). About Pharmacovigilance. [Internet]. HPRA; 2014 [cited 2023 May 7]. Available from:
http://www.hpra.ie/homepage/medicines/safety-information/identifying-and-understanding-risks/about-Pharmacovigilance
14. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2018.p.1-90.
15. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2014.p.1-128.
16. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2015.p.1-124.
17. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2016.p.1-102.
18. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2017.p.1-80.
19. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2019.p.1-90.
20. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2020.p.1-83.
21. Health Products Regulatory Authority (HPRA). Annual Report. Dublin: Health Products Regulatory Authority; 2021.p.1-88.
22. Fornasier G, Francescon S, Leone R, et al. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018;40(4):744-747.
23. European Medicines Agency (EMA). 2018 Annual Report on EudraVigilance for the European Parliament, the Council, and the Commission. European Medicines Agency; 2019.p.1-36.
24. European Medicines Agency (EMA). EudraVigilance [Internet]. European Medicines Agency; 2021 Jan 1 [cited 2023 May 12]. Available from:
https://www.ema.europa.eu/en/human-regulatory/research-development/Pharmacovigilance/eudravigilance
25. Health Products Regulatory Authority (HPRA). EU Pharmacovigilance Legislation. [Internet]. HPRA; 2014 [cited 2023 May 11]. Available from:
http://www.hpra.ie/homepage/medicines/regulatory-information/Pharmacovigilance-and-post-authorisation-safety/eu-Pharmacovigilance-legislation
26. Health Products Regulatory Authority (HPRA). Medicines and Side Effects. Dublin: Health Products Regulatory Authority; n.d.:1-5.
27. Karev N, Raychev D. Serialization of pharmaceutical products: EU delegated Act 2016/161 to protect against falsified medicines (review). J Chem Technol Metall. 2019;54(6):1165-1170.
28. Health Products Regulatory Authority (HPRA). Guide to Reporting and Initial Investigation of Quality Defects in Medicinal Products for Human and Veterinary Use. Dublin: Health Products Regulatory Authority; 2019:1-20.
29. Frontini R. Falsified medicines directive: are we heading in the right direction? MA@PoC. 2017;1(1):55-57.
30. Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use; 2016.
31. Health Products Regulatory Authority (HPRA). Falsified Medicines Legislation [Internet]. HPRA; 2014 [cited 2023 May 18]. Available from:
http://www.hpra.ie/homepage/medicines/special-topics/falsified-medicines-legislation
32. Health Products Regulatory Authority (HPRA). Quality Defects and Recalls. [Internet]. HPRA; 2014 [cited 2023 May 16]. Available from:
http://www.hpra.ie/homepage/medicines/regulatory-information/market-compliance-and-surveillance/quality-defects-and-recalls
33. Rajanand MG, Kumar VP, Yuvashakti S. Roles of Pharmacist in Pharmacovigilance: A Need of the Hour. J Pharmacovigil. 2016;4(6):1-2.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
