WORLD JOURNAL OF ADVANCE
HEALTHCARE RESEARCH

Mohammed Mudassir, Mohammed Arsalan Khan, Fatima Aiyman, Afiya Muskan, Firdous Begum Ghousia, Syeda Zuleqaunnisa Begum and Mohammed Fareedullah*

ABSTRACT

Background: Pharmacovigilance is an important area of healthcare that focuses on monitoring and evaluating the safety and efficacy of pharmacological drugs. Pharmacovigilance seeks to detect and avoid any possible dangers connected with drugs by collecting, analyzing, and interpreting adverse event data in a systematic manner. Regulatory authorities and organizations are accountable for the effective drug regulation necessary to assure the safety, effectiveness, and quality of pharmaceuticals, as well as the accuracy and appropriateness of drug information provided to the public. Aim: This study aims to evaluate the extent to which ADR monitoring and reporting practices in a tertiary care hospital align with the drug safety alerts issued by regulatory authorities, which can have significant implications for patient safety and healthcare outcomes. Methods: A Prospective and observational study was conducted at a tertiary care hospital over a period of 3 months (April 2023-june 2023). All patients visiting the Hospital over the age of 18 years, experiencing an ADR and willing to give consent, were enrolled in the study. Patients fulfilling the inclusion and exclusion criteria were considered. Results and Discussion: Out of the 120 Patients, 22 ADRs were collected and the total incidence of ADRs is 18.3%. Majority of ADRs were occurred in the Age group of (>58 years) i.e., Group-V. In this group 36.36% ADR were observed. As per causality assessment, 14 ADRs were probable (63.6%). As per the severity assessment Scale 12 ADRs reported were Mild which contributed to 54.5% of total ADRs. Most of the management of the ADRs is done by withdrawing of drug i.e. by 81.8% and majority of patients were recovered. From this study, we found 5 common drugs related ADRs which are already issued as Drug safety alerts by Indian Pharmacopoeia Commission (IPC). Conclusion: Reporting adverse drugs reactions is crucial to protecting patient safety and enhancing overall healthcare quality. Healthcare practitioners, regulatory agencies, and pharmaceutical firms can obtain vital information about the safety profile of medications and make educated decisions about their usage if adverse drug reactions are reported immediately and properly.