Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals: A Step towards Patient Safety

Abstract

Introduction: Pharmacovigilance plays an important role in patient safety and rationalizing the use of medicines. It helps in identifying the frequency of adverse drug reactions (ADRs), their causes, and the associated risk factors. Pharmacovigilance activities are facilitated through adverse drug reactions monitoring centers (AMCs) in most of the institutions. Aim: The objective of this paper is to provide an overview to the health care professionals regarding ADRs reported from the associated hospitals of Maulana Azad Medical College (MAMC) and the pharmacovigilance activities undertaken. Observations: Maulana Azad Medical College, Department of Pharmacology was recognized as an AMC in 2014 under the Pharmacovigilance Program of India (PvPI). The AMC established a way for reporting ADRs both by spontaneously and through active monitoring of ADRs from different wards. The causality assessment of all ADR reports collected is done. The program was informed by a college pharmacovigilance committee, emails, and by putting posters in the hospital nursing stations. Fourteen training workshops for doctors and pharmacists and two training workshops exclusively for nurses have been conducted so far on pharmacovigilance. In 2017, a program to sensitize doctors working in the Delhi government hospital was started. A total of 854 healthcare workers have been sensitized. The center has reported a total of 2572 ADRs to the National Coordination Centre (NCC) at Indian Pharmacopoeia Commission until December 2021. ADRs reported were highest in the age group of 20 to 59 years. Most of the reports were from the department of T.B. and Chest (n = 589, 23.8%). The most common class of medicines implicated in causing ADRs was antimicrobials (n = 1100, 44%). Among the ADRs reported, the majority were mild (n = 1451, 81.1%) with 346 (18.8%) reported as serious. Conclusion: A system for reporting ADRs on campus has been established. The pattern of ADRs reported to this ADR monitoring center is comparable to the national and global data. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.