Effect of pharmacovigilance awareness program on adverse drug reaction reporting: A three-year study from a Northern Indian hospital

Title : Effect of pharmacovigilance awareness program on adverse drug reaction reporting: A three-year study from a Northern Indian hospital

Abstract:

Background: Adverse drug reaction (ADR) reporting plays a critical role in ensuring patient safety and improving pharmacovigilance systems.¹ National Pharmacovigilance awareness Week aims to enhance awareness and encourage reporting among healthcare professionals and the public.² This study evaluates the impact of the awareness program on ADR reporting trends over three years (2022–2024) in a northern Indian hospital.

Methods: Data were retrospectively collected from the hospital’s ADR Monitoring Centre, focusing on the total number of ADR cases reported annually and the methods used for reporting. These methods included toll-free helpline no. 1800-180-3024, email submissions, and submissions through ADR forms by Healthcare Professionals. Reporting trends before and after the Pharmacovigilance Awareness Week program were analyzed.

Results: A significant increase in ADR reporting was observed during the campaign across all three years. The total ADR cases reported were 56 in 2022, 151 in 2023, and 371 in 2024. Healthcare professionals accounted for 78.89 % of reports, primarily through ADR forms. Toll-free numbers and email submissions contributed to 13.32 % and 7.78 % of the reports, respectively, reflecting improved public awareness. Additionally, the quality and completeness of ADR reports, including detailed descriptions of drug reactions and patient outcomes, showed marked improvement.

Conclusion: The National Pharmacovigilance awareness Week program significantly improved ADR reporting rates and quality of reporting during the campaign period.³ Healthcare professionals were the primary contributors, and alternative reporting methods also gained importance. To sustain these improvements, continuous training, institutional support, and accessible reporting tools are necessary. This study highlights the program's effectiveness in promoting a culture of pharmacovigilance and provides insights for enhancing ADR reporting systems in India.

Biography:

Mr Anoop Kumar has completed his M.Pharm (Pharmacology). He has more than 12 years diverse experience in Pharmacovigilance (Aggregate Reporting, RMP, Signal Detection, MedDRA Coding, Inspection & Audit, etc.). He was associated with USFDA, EMA and Pharmacovigilance Regulation for health authority of India for various related programme. He has organized and played a cruicial role as a team member under National Health Programme (RNTCP, NACO, AEFI, NVBDCP) and Promotion of PvPI at National Level. He has organized more than 50 training/awareness session. He is looking after all the ADR Monitoring Centres (AMC) at district level.