Pharmacovigilance: Importance and Role of the Clinical Pharmacist in Assessing and Managing Adverse Drug Reactions

  • G. Venkata Nagaraju Assistant Professor, Department of Pharmacy Practice, Hindu College of Pharmacy, Guntur
    drnagaraju.gv@gmail.com
  • Konda Ravi Kumar Professor and Principal, Hetero Institute of Pharmaceutical Sciences, Gangaram, Telangana 507303

Abstract

Pharmacovigilance is a key component of healthcare systems worldwide, focusing on the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs). The rising incidence of ADRs has underscored the necessity for active monitoring to ensure patient safety and rational drug use. Clinical pharmacists play a vital role in pharmacovigilance through the identification, documentation, evaluation, and reporting of ADRs, as well as by educating healthcare professionals and patients. Their involvement in multidisciplinary healthcare teams enhances the early detection and management of ADRs, thereby minimizing morbidity, mortality, and healthcare costs. This review highlights the importance of pharmacovigilance, outlines the essential role of clinical pharmacists in ADR monitoring and management, and discusses the challenges and future perspectives in this domain.

Keywords: Pharmacovigilance, Clinical Pharmacist, Adverse Drug Reactions, Patient Safety, Drug Monitoring, Medication Error

References

1. World Health Organization. The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products. Geneva: WHO; 2002.
2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA. 1998;279(15):1200–5.
3. van Grootheest AC, Olsson S, Couper M, de Jong-van den Berg LTW. Pharmacists’ role in reporting ADRs worldwide. Drug Saf. 2004;27(12):857–70.
4. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255–9.
5. Waller PC, Evans SJ. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf. 2003;12(1):17–29.
6. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. JAMA. 1997;277(4):301–6.
7. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. JAMA. 1995;274(1):29–34.
8. Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance activities in India. Indian J Pharm Pract. 2015;8(1):4–12.
9. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.
10. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of ADRs. Drug Saf. 2009;32(1):19–31.
11. Jose J, Rao PGM. Pattern of adverse drug reactions notified by spontaneous reporting in India. Pharm Pract. 2006;4(4):232–8.
12. Khan LM. Comparative observational study on ADR reporting. Saudi Pharm J. 2013;21(4):375–88.
13. Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of the knowledge, attitude, and practice of pharmacovigilance among clinicians in India. Int J Basic Clin Pharmacol. 2011;1(1):10–4.
14. Aljadhey H, et al. Role of clinical pharmacists in ADR prevention. Am J Health Syst Pharm. 2013;70(1):34–9.
15. Meyboom RH, Egberts AC, Edwards IR, Hekster YA, de Koning FH, Gribnau FW. Principles of signal detection in pharmacovigilance. Drug Saf. 1997;16(6):355–65.
16. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment of ADRs. Am J Hosp Pharm. 1992;49(9):2229–32.
17. Aronson JK. Managing adverse drug reactions. BMJ. 2012;344:e3181.
18. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of underreporting. Drug Saf. 2009;32(1):19–31.
19. Pedrós C, et al. Factors associated with under-reporting of ADRs. Br J Clin Pharmacol. 2009;68(5):848–54.
20. Oshikoya KA, et al. Pharmacovigilance in developing countries: challenges and perspectives. Expert Rev Clin Pharmacol. 2009;2(5):529–40.
21. Harpaz R, et al. Data mining for adverse drug events with electronic health records. Clin Pharmacol Ther. 2012;91(6):1010–21.
22. Sessa M, Mascolo A, Andersen M, et al. Pharmacovigilance in the era of big data. Front Pharmacol. 2020;11:816.
Statistics
159 Views | 103 Downloads
How to Cite
1.
G VN, Konda RK. Pharmacovigilance: Importance and Role of the Clinical Pharmacist in Assessing and Managing Adverse Drug Reactions. Am J Med Nat Sci [Internet]. 2025Oct.30 [cited 2026Jan.15];6(2):12-4. Available from: https://ajmns.com/index.php/journal/article/view/20
Section
Review Articles