THE ROLE OF PHARMACISTS IN MANAGEMENT, MONITORING AND REPORTING OF ADVERSE DRUG REACTIONS

Sara Shreen*, Nadiya Hussain, Umma Ruman and Ume Habeeba

ABSTRACT

Pharmacovigilance is an important area of healthcare focused on managing, monitoring, and evaluating the safety and efficacy of pharmacological drugs. It aims to detect and prevent potential dangers associated with medications through systematic collection, analysis, and interpretation of adverse event data. Regulatory authorities and organizations ensure drug safety, effectiveness, and the accuracy of drug information provided to the public. Aim: This study evaluates the alignment of adverse drug reaction (ADR) monitoring and reporting practices in a tertiary care hospital with drug safety alerts issued by regulatory authorities, aiming to enhance patient safety and healthcare outcomes. Methods: A prospective observational study was conducted at Owaisi Hospital over three months, enrolling patients aged 1-58 years who experienced ADRs and consented to participate. Results and Discussion: Out of 104 patients, 79 ADRs were documented, resulting in an incidence rate of 75.9%. A significant proportion occurred in patients aged 1-18 years (36.7%). Causality assessment classified 49 ADRs as probable (62.0%), and severity assessment indicated 40 ADRs were moderate (50.6%). Withdrawal of the drug was the primary management approach (63.3%), with most patients recovering. The study identified five common ADRs previously flagged by the Indian Pharmacopoeia Commission (IPC). Conclusion: Reporting ADRs is critical for patient safety and healthcare quality improvement, enabling informed decisions by healthcare providers, regulatory agencies, and pharmaceutical firms regarding medication use.
Or
Background: Pharmacovigilance is an important area of healthcare that focuses on management, monitoring and evaluating the safety and efficacy of pharmacological drugs. Pharmacovigilance seeks to detect and avoid any possible dangers connected with drugs by collecting, analysing, 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 Owaisi hospital over a period of 3 months (April 2024-june 2024). All patients visiting the Hospital over the age of 1 - > 58 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 104 Patients, 79 ADRs were collected and the total incidence of ADRs is 75.9%. Majority of ADRs were occurred in the Age group of (1 - 18 years). In this 36.7% ADR were observed. As per causality assessment, 49 ADRs were probable (62.0%). As per the severity assessment Scale 40 ADRs reported were Moderate which contributed to 50.6% of total ADRs. Most of the management of the ADRs is done by withdrawing of drug i.e. by 63.3% 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.

Keywords: Adverse drug reactions, Drug safety alerts, Indian Pharmacopoeia commission, Health care practitioners.