Abstract

Armin Eisa Zaei*

ABSTRACT

Background: Pharmacovigilance monitoring and assessment of medications in hospitals are very important task for prevention of adverse drug reactions and patients harm. Objectives: The aim of the study was to determine the prevalence of adverse drug reactions at a tertiary care hospital in India and to determine the most common Therapeutic Class of Drugs causing ADR and to determine the most common organ system affected by ADRs. Materials and Methods: The Prospective, observational study was conducted at a tertiary care hospital in India, between September 2016 and February 2017. All In-patients admitted in medicine wards were monitored for ADRs. Results and Discussion: Over the study period of 6 months, a total of 97 ADRs were reported in 140 patients. The ADRs observed were higher in male patients [52 (53.60%)]. Based on the reported ADRs, gastro-intestinal adverse drug reactions [28 (28.86%)] were among the highest number of ADRs. The most common therapeutic classes of drugs which were involved with ADRs were antibiotics [24 (24.74%)] followed by antihypertensive agents [19 (19.58%)] and antidiabetics [5 (5.15%)]. Most of the adverse drug reactions [72 (74.22%)] were managed by discontinuing the suspected drug. The causality assessment of the ADRs were carried out using the Naranjo’s Scale algorithm and the majority of the ADRs were found to be definite [31 (32%)]. Conclusion: Presence of clinical pharmacists for regular monitoring and assessment for adverse drug reactions in hospitals is a crucial task which will reduce the adverse drug reactions occurrence and harm to patients and consequently improve the patient safety.