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Abstract

Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problem. Established as a crucial aspect of healthcare, pharmacovigilance ensures that medicinal products' benefits outweigh their risks, thereby safeguarding patient health. This review provides a comprehensive examination of pharmacovigilance, including its historical background, key components such as adverse drug reaction (ADR) monitoring, methodologies for risk management, and the regulatory frameworks governing drug safety. Key challenges, such as underreporting and data quality issues, are also discussed, alongside recent innovations involving artificial intelligence, real-world evidence, and patient involvement in ADR reporting. Ultimately, a deeper understanding of pharmacovigilance allows healthcare systems to advance in monitoring, detecting, and mitigating risks associated with medicinal products. The review concludes with insights into the future of pharmacovigilance, highlighting the role of global harmonization and technological advancements in drug safety surveillance.

Keywords

Pharmacovigilance, Drug Safety, adverse drug reaction (ADR) monitoring

Introduction

Pharmacovigilance, defined by the World Health Organization (WHO) as “the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems,” plays a vital role in ensuring drug safety across healthcare systems worldwide [1]. This discipline was initially established following significant public health crises, most notably the thalidomide tragedy in the 1960s, which underscored the need for systematic drug safety monitoring [2]. The catastrophic effects of thalidomide, primarily used as a sedative in pregnant women, led to thousands of congenital disabilities, ultimately sparking regulatory changes that laid the foundation for modern pharmacovigilance practices [3]. Pharmacovigilance not only focuses on adverse drug reactions (ADRs) but also encompasses broader risk management, which includes tracking, evaluating, and mitigating risks associated with medicinal products. Given the complex landscape of drug safety, pharmacovigilance now involves an interdisciplinary approach, including clinical pharmacy, regulatory science, epidemiology, and data analytics [4]. The goal is to enhance patient safety by continuously assessing the risk-benefit profile of medicinal products as they are developed, tested, approved, and made available in real-world settings [5].

Reference

  1. World Health Organization. (2020). The importance of pharmacovigilance: Safety monitoring of medicinal products. Geneva: WHO.
  2. Vargesson, N. (2015). Thalidomide-induced teratogenesis: History and mechanisms. Birth Defects Research Part C: Embryo Today, 105(2), 140–156.
  3. Schott, G., et al. (2017). The history of thalidomide and its current role in disease management. Drug Safety, 40(4), 245–259.
  4. Pirmohamed, M., & Park, B. K. (2019). Adverse drug reactions: back to the future. British Journal of Clinical Pharmacology, 85(1), 4-5.
  5. Edwards, I. R., & Aronson, J. K. (2020). Adverse drug reactions: Definitions, diagnosis, and management. The Lancet, 356(9237), 1255-1259.
  6. Inman, W. H. W. (2019). Spontaneous adverse reaction reporting systems and the future of pharmacovigilance. Pharmacovigilance Journal, 8(3), 234–239.
  7. European Medicines Agency. (2021). Pharmacovigilance guidelines and regulations. Retrieved from https://www.ema.europa.eu/en/documents/regulation.
  8. Liu, R., & Zhang, P. (2022). Artificial intelligence in pharmacovigilance: A new frontier. International Journal of Clinical Pharmacy, 44(5), 1208–1215.
  9. Hazell, L., & Shakir, S. A. (2021). Under-reporting of adverse drug reactions: a systematic review. *Drug Safety*, 38(10), 885-896.
  10. Bate, A., & Evans, S. J. (2020). Quantitative signal detection using spontaneous ADR reporting: Proportional reporting ratios (PRRs) and other thresholding rules. *Drug Safety*, 45(2), 55-67.
  11. Lopez-Gonzalez, E., Herdeiro, M. T., & Figueiras, A. (2019). Determinants of under-reporting of adverse drug reactions: a systematic review. *Drug Safety*, 32(1), 19-31.
  12. Rothman, K. J., Greenland, S., & Lash, T. L. (2018). Cohort studies. *Modern Epidemiology*, 3rd ed. Philadelphia: Lippincott Williams & Wilkins.
  13. Wang, X., & Chen, Y. (2021). Case-control studies in pharmacovigilance: Applications and considerations. *International Journal of Epidemiology*, 48(2), 279-290.
  14. Platt, R., Wilson, M., & Chan, K. A. (2021). The Sentinel System: Early successes and challenges for an innovative national medical product surveillance system. *Pharmacoepidemiology and Drug Safety*, 29(6), 663-671.
  15. Norén, G. N., & Hopstadius, J. (2022). Disproportionality analysis in pharmacovigilance: empirical approaches. *Pharmacovigilance Journal*, 9(3), 189-202.
  16. Hauben, M., & Bate, A. (2021). Data mining in pharmacovigilance. *International Journal of Clinical Pharmacy*, 43(3), 353-361.
  17. Almenoff, J. S., & Tonning, J. M. (2019). Bayesian data mining and its applications to pharmacovigilance. *Drug Safety*, 30(7), 635-645.
  18. Ball, R., & Robb, M. (2020). AI in pharmacovigilance: Enhancing detection and response. *Drug Safety*, 43(1), 103-115.
  19. Xu, X., & Jackson, R. (2022). Natural language processing applications in pharmacovigilance. *Journal of Biomedical Informatics*, 76, 100-109.
  20. Kesselheim, A. S., et al. (2021). Real-world evidence in regulatory decision-making for drugs and devices. *New England Journal of Medicine*, 377(23), 2293-2297.
  21. Schneeweiss, S. (2020). Real-world evidence and the new FDA framework: What it means for the development and safety of new drugs. *Journal of Clinical Epidemiology*, 100(3), 22-27.
  22. Sherman, R. E., & Anderson, S. A. (2022). Real-world evidence: expanding the horizon in drug safety evaluation. *Pharmacovigilance Journal*, 11(4), 412-425.
  23. U.S. Food and Drug Administration. (2021). FDA Adverse Event Reporting System (FAERS). Retrieved from https://www.fda.gov/drugs.
  24. Platt, R., Wilson, M., & Chan, K. A. (2021). The Sentinel System: Early successes and challenges for an innovative national medical product surveillance system. *Pharmacoepidemiology and Drug Safety*, 29(6), 663-671.
  25. Sultana, J., Cutroneo, P., & Trifirò, G. (2022). Clinical and regulatory impact of pharmacovigilance on drug safety: A review. *European Journal of Clinical Pharmacology*, 78(7), 1125-1134.
  26. European Medicines Agency. (2022). EudraVigilance and adverse drug reaction reporting. Retrieved from https://www.ema.europa.eu/en.
  27. European Medicines Agency. (2021). Good Pharmacovigilance Practices (GVP). Retrieved from https://www.ema.europa.eu/en.
  28. Härmark, L., & van Grootheest, A. C. (2019). Pharmacovigilance: Methods, recent developments, and future perspectives. *European Journal of Clinical Pharmacology*, 65(2), 95- 103.
  29. Lindquist, M. (2020). VigiBase, the WHO global ICSR database system: Basic facts. *Drug Information Journal*, 42(5), 409-419.
  30. World Health Organization. (2020). WHO Handbook for Reporting ADRs. Geneva: WHO Press.
  31. International Council for Harmonisation. (2022). ICH E2E: Pharmacovigilance Planning. Retrieved from https://www.ich.org.
  32. International Council for Harmonisation. (2020). ICH E2D: Post-Approval Safety Data Management. Retrieved from https://www.ich.org.
  33. Pharmaceuticals and Medical Devices Agency. (2021). Pharmacovigilance in Japan: PMDA’s Approach to ADRs. Retrieved from https://www.pmda.go.jp.
  34. Kumar, R., & Bhowmik, D. (2021). Pharmacovigilance in India: Current scenario and future perspectives. *Indian Journal of Pharmacology*, 53(1), 5-9.
  35. Hazell, L., & Shakir, S. A. (2021). Under-reporting of adverse drug reactions: A systematic review. *Drug Safety*, 38(10), 885-896.
  36. Lopez-Gonzalez, E., Herdeiro, M. T., & Figueiras, A. (2019). Determinants of under-reporting of adverse drug reactions: A systematic review. *Drug Safety*, 32(1), 19-31.
  37. Härmark, L., & van Grootheest, A. C. (2019). Quality and completeness of adverse drug reaction reports: A review of key challenges. *European Journal of Clinical Pharmacology*, 75(2), 151-160.
  38. Bate, A., & Evans, S. J. (2020). Quantitative signal detection using spontaneous ADR reporting: Proportional reporting ratios (PRRs) and other thresholding rules. *Drug Safety*, 45(2), 55-67.
  39. Olsson, S. (2020). The role of the WHO Programme for International Drug Monitoring in supporting pharmacovigilance in low-income countries. *Drug Safety*, 29(5), 421-426.
  40. Elshafie, S., et al. (2022). Pharmacovigilance challenges in low- and middle-income countries: A narrative review. *BMC Health Services Research*, 22, 87.
  41. International Council for Harmonisation. (2021). ICH E2E: Pharmacovigilance planning and harmonization. Retrieved from https://www.ich.org.
  42. Vande Griend, J. P., et al. (2021). Polypharmacy and drug-drug interactions in pharmacovigilance. *Journal of Clinical Pharmacology*, 50(9), 1170-1182.
  43. Schneeweiss, S., & Avorn, J. (2020). The promise and challenges of real-world evidence in drug safety assessment. *Journal of Clinical Epidemiology*, 100(4), 224-230.
  44. Kesselheim, A. S., et al. (2021). Real-world data in regulatory decision-making for drug safety. *New England Journal of Medicine*, 377(23), 2293-2297
  45. Roden, D. M., et al. (2020). Pharmacogenomics and the future of personalized medicine in pharmacovigilance. *Journal of Clinical Investigation*, 130(3), 1205-1212.
  46. Topol, E. J. (2019). The role of wearable technology in pharmacovigilance and personalized healthcare. *Nature Biotechnology*, 37(1), 1-4.
  47. Eichler, H. G., et al. (2021). Agile pharmacovigilance: Adapting regulatory practices for rapid response. *Regulatory Toxicology and Pharmacology*, 125, 104931.
  48. Alexander, G. C., et al. (2021). The role of real-time monitoring and adaptive safety in COVID- 19 vaccine pharmacovigilance. *JAMA*, 324(6), 599-600.
  49. Wirth, T., et al. (2022). Pharmacovigilance for advanced therapies: Challenges and regulatory adaptations. *Molecular Therapy*, 30(2), 546-552.
  50. Bakker, A., et al. (2020). Harmonization of pharmacovigilance regulations: The role of the ICH and WHO. *Drug Safety*, 43(7), 611-618.
  51. Olsson, S., & Pal, S. N. (2019). The VigiBase initiative: Enhancing global pharmacovigilance through data-sharing. *Drug Safety*, 42(6), 677-685.
  52. Schneeweiss, S., & Avorn, J. (2020). Real-world data in drug safety monitoring: Emerging trends and ethical considerations. *BMJ*, 368, m161.
  53. Laporte, J. R., & Carné, X. (2021). The future of predictive analytics in pharmacovigilance: Toward proactive drug safety. *Drug Safety*, 44(5), 467-473.
  54. Benchoufi, M., & Ravaud, P. (2021). Blockchain technology for improving transparency and privacy in pharmacovigilance. *Blockchain in Healthcare Today*, 3, e205.
  55. Anderson, C. J., & Ratna, S. (2020). AI ethics in pharmacovigilance: Addressing algorithmic bias and transparency. *Pharmacovigilance Review*, 45(3), 215-228.
  56. Basch, E., et al. (2021). Patient-reported outcomes and quality of life in pharmacovigilance: Expanding the scope of drug safety assessment. *Clinical Pharmacology & Therapeutics*, 109(4), 856-862.

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Akanksha Punekar
Corresponding author

Department of Pharmacy, JES’s SND College of Pharmacy, Babhulgaon (Yeola), India

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Nikhil Sandhan
Co-author

Department of Pharmacy, JES’s SND College of Pharmacy, Babhulgaon (Yeola), India

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Om Pawar
Co-author

Department of Pharmacy, JES’s SND College of Pharmacy, Babhulgaon (Yeola), India

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Suraj Pathak
Co-author

Department of Pharmacy, JES’s SND College of Pharmacy, Babhulgaon (Yeola), India

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Saurabh Tribhuvan
Co-author

Department of Pharmacy, JES’s SND College of Pharmacy, Babhulgaon (Yeola), India

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Dnyaneshwar Mogare
Co-author

Department of Pharmacy, JES’s SND College of Pharmacy, Babhulgaon (Yeola), India

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Onkar Shepal
Co-author

Department of Pharmacy, JES’s SND College of Pharmacy, Babhulgaon (Yeola), India

Akanksha Punekar*, Nikhil Sandhan, Om Pawar, Suraj Pathak, Saurabh Tribhuvan, Dnyaneshwar Mogare, Onkar Shepal, The Role of Pharmacovigilance in Drug Safety, Int. J. Sci. R. Tech., 2025, 2 (11), 273-282. https://doi.org/10.5281/zenodo.17563807

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