Published June 2, 2026 | Version v1
Book chapter Open

Pharmacovigilance in Clinical Practice: From Adverse Drug Reaction Detection to Personalized Risk Management

  • 1. Department of Pharmacy Practice, Faculty of Pharmacy, M.S Ramaiah University of Applied Sciences

Description

The science of pharmacovigilance is defined as the activities related to the detection, assessment, understanding, and communication of adverse effects of medicines. Adverse drug reactions (ADRs) are usually of predictable, idiosyncratic, chronic, delayed, withdrawal, failure of treatment, or genetic types. Special populations, including the elderly, pregnant women, and those with organ impairment, are more susceptible. Methods of detecting adverse drug reactions include spontaneous reporting, electronic health records, patient surveys, active surveillance, and analytics using artificial intelligence. These are aided by standardized scales for causality assessment and severity. Clinical scenarios of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-induced gastrointestinal bleeding, clozapine-induced Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and interactions between warfarin and fluoroquinolones highlight the practical application of pharmacovigilance in clinical practice, leading to changes in prescribing patterns. Looking ahead, the focus of pharmacovigilance will be on the use of real-world evidence, pharmacogenomics, artificial intelligence, and global collaboration for better proactive risk management, ensuring safe, personalized medicine, and better patient outcomes.

Files

Chapter-9.pdf

Files (566.8 kB)

Name Size Download all
md5:9b890f77c19a7644013b8f2ec55bda78
566.8 kB Preview Download

Additional details

Dates

Submitted
2025-10-15
Accepted
2026-03-20

References

  • 1. World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: WHO; 2002.
  • 2. De Filippis R, et al. Pharmacovigilance approaches to study rare and very rare side-effects. Expert Opin Drug Saf. 2022;21(12):1477‑1489.
  • 3. World Health Organization. Pharmacovigilance: ensuring the safe use of medicines. Geneva: WHO; 2015.
  • 4. Kharde N. A review on adverse drug reaction and its types with their management. World J Pharm Med Res. 2024;10(3):45‑52.
  • 5. Ghosh S, Biswas P. Pharmacovigilance in India: current status and future prospects. Indian J Pharmacol. 2023;55(2):89‑95.
  • 6. Uppsala Monitoring Centre. VigiBase: global database of individual case safety reports. WHO Collaborating Centre, Sweden; 2023.
  • 7. U.S. Food and Drug Administration. FDA Adverse Event Reporting System (FAERS). Silver Spring (MD): FDA; 2023.
  • 8. European Medicines Agency. EudraVigilance and pharmacovigilance requirements under EU regulation. Amsterdam: EMA; 2024.
  • 9. International Council for Harmonisation. ICH E2E: pharmacovigilance planning. Geneva: ICH; 2004.
  • 10. Pharmacovigilance Programme of India. Annual report. Ghaziabad: Indian Pharmacopoeia Commission; 2024.