European Journal of Biomedical and Pharmaceutical Sciences

ENSURING DRUG SAFETY: A REVIEW OF PHARMACOVIGILANCE PRACTICES

*Dr. Tripuramallu Rajithasree, Vitrouth Akshitha, Thudi Deekshitha Reddy, Aiyesha Ahsan, Dr. Chandrasekhara Rao Baru

ABSTRACT

Pharmacovigilance (PV) is an essential aspect of contemporary healthcare systems that concentrates on identifying, evaluating, comprehending, and preventing adverse drug reactions (ADRs) as well as other issues related to medications. As drug therapies grow more complex and the utilization of medicines becomes widespread, maintaining drug safety during the entire product life cycle has emerged as a significant public health concern. Past incidents involving drug-related harm, such as the toxicity of sulfanilamide and birth defects caused by thalidomide, have underscored the need for organized systems to monitor drug safety. This review highlights the global and Indian progress in pharmacovigilance, pointing out important milestones, regulatory frameworks, and national initiatives like the Pharmacovigilance Programme of India (PvPI). The article examines the scope, significance, and goals of pharmacovigilance, different types of ADRs, mechanisms for reporting ADRs, assessment scales, and the critical role of healthcare professionals, especially pharmacists, in reporting ADRs. It also addresses methods to enhance ADR reporting and the incorporation of digital tools into pharmacovigilance. Ongoing monitoring, efficient reporting systems, and cooperative efforts among healthcare professionals and regulatory bodies are crucial for improving patient safety, reducing drug-related risks, and promoting the rational use of medicines.

Keywords: Pharmacovigilance; Adverse Drug Reactions; Drug Safety; ADR Reporting; PvPI; WHO-UMC; Pharmacist Role; Post-Marketing Surveillance; Risk–Benefit Assessment.