Analysis of the pattern of ADR’s reported to an ADR monitoring center in South India: a prospective study.

Abstract

Background: All medicines with an ability to produce a desired therapeutic effect will also have the potential to cause unwanted adverse effects. It has been established that ~ 2.9%-5.6% of all hospital admissions are caused by Adverse drug reactions (ADRs) & as many as 35% of the hospitalized patients experience an ADR during their hospital stay. An incidence of fatal ADRs is 0.23%-0.41%. In some countries, ADRs rank among the top 10 leading causes of mortality. In order to increase awareness, observe the pattern of ADRs and communicate scientific data to prevent ADRs, this study was undertaken. Methods: It was a prospective observational study conducted at a tertiary hospital in Kochi. All the spontaneously reported ADRs were assessed and analyzed for type, severity and causality. Results: A total of 120 ADRs were reported during the study period. Most of the ADRs were seen in females in the age group of 61-70 years. Skin and appendage disorders were the most common manifestation of different type of ADRs (49.2%). Antineoplastic and immunomodulating agents (30.8%), followed by anti-infectives for systemic use (29.2%) were mostly implicated in the causation of ADRs. Majority of the ADRs were of mild to moderate in severity (89.2%). Conclusions: Although small, but significant number of patients had severe ADRs. Hence, we require a robust system for monitoring the medication use process. So that we can prevent and reduce the morbidity and mortality due to therapeutic agents.