Pharmacovigilance and Adverse Drug Reaction Reporting in Primary, Secondary, and Tertiary Healthcare: A Review of Practices, Challenges, and Recommendations

Keywords: pharmacovigilance, adverse drug reactions, healthcare

Abstract


According to the World Health Organization, pharmacovigilance is a science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Since the underreporting of adverse drug reactions (ADRs) remains a significant global issue, reporting ADRs is essential for the success of pharmacovigilance programs. By systematically monitoring and reporting ADRs at the primary, secondary, and tertiary levels of healthcare, pharmacovigilance plays a crucial role in protecting public health. In addition to facilitating the early identification and prevention of negative consequences, reporting also contributes to improving the quality of healthcare services. This article presents a narrative review aimed at synthesizing available literature and regulatory documents related to pharmacovigilance and ADR reporting across various levels of healthcare, with particular emphasis on the national context in Serbia and relevant international comparisons.

 

References

World Health Organization. The Importance of Pharmacovigilance – Safety Monitoring of Medicinal Products. Geneva, 2002.

Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf. 2017;40:855–69. doi: 10.1007/s40264-017-0572-8.

Pharmacovigilance [Internet]. Medicines and Medical Devices Agency of Serbia; 2025 [cited 2025 Jan 2]. Available from: https://www.alims.gov.rs/eng/pharmacovigilance/.

Zhao Z, Shen J, Shen C, Zhu B, Sun J, Yu J, et al. An investigation of pharmacovigilance and reporting of adverse drug reactions in hospitals: a cross-sectional study in China. Curr Med Res Opin. 2021;37(11):2001–06. doi: 10.1080/03007995.2021.1967114.

Kommu S, Carter C, Whitfield P. Adverse Drug Reactions [Internet]. StatPearls. Treasure Island (FL): StatPearls Publishing; 2024 [cited 2025 Jan 10]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK599521/.

Ilić K, Ugrešić N. Farmakovigilanca u kliničkim istraživanjima. Vojnosanit Pregl. 2007;64(4):265–70. doi: 10.2298/VSP0704265I.

Beninger P. Pharmacovigilance: An Overview. Clin Ther. 2018;40(12):1991–2004. doi: 10.1016/j.clinthera.2018.07.012.

Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018;40(4):744–7. doi: 10.1007/s11096-018-0657-1.

ICH E6 Good clinical practice - Scientific guideline [Internet]. Amsterdam: EMA; 2025 [cited 2025 Jan 16]. Available from: https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline.

Radecka A, Loughlin L, Foy M, de Ferraz Guimaraes MV, Sarinic VM, Di Giusti MD, et al. Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action. Drug Saf. 2018;41(12):1285–1302. doi: 10.1007/s40264-018-0708-5.

Cheaib N. Pharmacovigilance in Clinical Trials: Current Practice and Challenges. Account Res. 2015;23(1):23–30. doi: 10.1080/08989621.2014.956868.

Jeetu G, Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. J Young Pharm. 2010;2(3):315–20. doi: 10.4103/0975-1483.66802.

Serious adverse reaction [Internet]. Amsterdam: EMA; 2023 [cited 2025 Jan 16]. Available from: https://www.ema.europa.eu/en/glossary-terms/serious-adverse-reaction.

Pharmacovigilance: ensuring the safe use of medicines [Internet]. WHO; 2022 [cited 2025 Jan 9]. Available from: https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96. doi: 10.2165/00002018-200629050-00003.

Neželjeni efekti ljekova [Internet]. Medical CG; 2013 [cited 2025 Jan 9]. Available from: https://medicalcg.me/nezeljeni-efekti-ljekova/.

Leape LL. Reporting of adverse events. N Engl J Med. 2002;347(20):1633–8. doi: 10.1056/NEJMNEJMhpr011493.

Sienkiewicz K, Burzyńska M, Rydlewska-Liszkowska I, Sienkiewicz J, Gaszyńska E. The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process. Int J Environ Res Public Health. 2021;19(1):413. doi: 10.3390/ijerph19010413.

Hamid AAA, Rahim R, Teo SP. Pharmacovigilance and Its Importance for Primary Health Care Professionals. Korean J Fam Med. 2022;43(5):290–5. doi: 10.4082/kjfm.21.0193.

Aziz AA, Rogers S, Hassanien O, Shalaby L, Nagy M. Knowledge, attitudes and practice regarding pharmacovigilance and adverse drug reaction reporting among physicians and pharmacists in Egypt: a step toward personalized medicine implementation. Per Med. 2022;19(6):495–507. doi: 10.2217/pme-2022-0030.

Sharif MJH, Farrukh MJ, Khan FU, Khan Q, Ahmed SS, Kousar R, et al. Exploring the factors and barriers of healthcare professionals in tertiary care hospitals toward pharmacovigilance: a multicenter study from Khyber Pakhtunkhwa, Pakistan. Curr Med Res Opin. 2022;38(4):595–605. doi: 10.1080/03007995.2022.2042992.

Lavertu A, Vora B, Giacomini KM, Altman R, Rensi S. A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring. Clin Pharmacol Ther. 2021;109(5):1197–202. doi: 10.1002/cpt.2172.

García-Abeijon P, Costa C, Taracido M, Herdeiro MT, Torre C, Figueiras A. Factors Associated with Underreporting of Adverse Drug Reactions by Health Care Professionals: A Systematic Review Update. Drug Saf. 2023;46(7):625–36. doi: 10.1007/s40264-023-01302-7.

Khot A, Dakhale G. Challenges and Possible Solutions of ADR Monitoring (Pharmacovigilance) in Low- and Middle‑Income Countries. In: Badria FA, editor. Pharmacovigilance – Facts, Challenges, Limitations and Opportunities. London: IntechOpen; 2024; pp. 1–12.

Kiguba R, Olsson S, Waitt C. Pharmacovigilance in low- and middle-income countries: A review with particular focus on Africa. Br J Clin Pharmacol. 2023;89(2):491–509. doi: 10.1111/bcp.15193.

Coste A, Wong A, Bokern M, Bate A, Douglas IJ. Methods for drug safety signal detection using routinely collected observational electronic health care data: A systematic review. Pharmacoepidemiol Drug Saf. 2023;32(1):28–43. doi: 10.1002/pds.5548.

Glamočlija U, Tubić B, Kondža M, Zolak A, Grubiša N. Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study. Croat Med J. 2018;59(3):124–31. doi: 10.3325/cmj.2018.59.124.

Živanović D, Mijatović Jovin V, Javorac J, Samojlik I, Rašković A, Jevtić M, et al. Pharmacovigilance in Serbia: a Ten-Year Pharmacoepidemiologic Analysis. Acta Clin Croat. 2023;62(3):486–501. doi: 10.20471/acc.2023.62.03.11.

Putri RA, Ikawati Z, Rahmawati F, Yasin NM. An Awareness of Pharmacovigilance Among Healthcare Professionals Due to an Underreporting of Adverse Drug Reactions Issue: A Systematic Review of the Current State, Obstacles, and Strategy. Curr Drug Saf. 2024;19(3):317–31. doi: 10.2174/0115748863276456231016062628.

Shalviri G, Mohebbi N, Mirbaha F, Majdzadeh R, Yazdizadeh B, Gholami K, et al. Improving adverse drug event reporting by healthcare professionals. Cochrane Database Syst Rev. 2024;10(10):CD012594. doi: 10.1002/14651858.CD012594.pub2.

Published
2025/12/25
Section
Review articles