Adverse drug reactions in a cohort of Sri Lankan patients with non-communicable chronic diseases

Abstract

INTRODUCTION AND OBJECTIVES: Adverse drug reactions (ADRs) are a major problem in drug utilization. The study aimed to describe the incidence and nature of ADRs in a cohort of Sri Lankan patients with non-communicable chronic diseases (NCCDs). METHOD: This prospective observational study conducted in a tertiary-care hospital recruited in-ward patients with NCCDs. All ADRs that occurred during the index hospital admission and in the 6-month period following discharge were detected by active surveillance. Details were recorded using the ADR reporting form, developed based on the publication of the Clinical Center, Pharmacy Department, National Institutes of Health. RESULTS: 715 patients were studied (females-50.3%, mean age–57.6 years). The mean number of medicines given per patient was 6.11±2.97. The most prevalent NCCDs were hypertension (48.4%; 346/715), diabetes (45.3%; 324/715) and ischemic heart disease (29.4%; 210/715). 112 patients (15.7%) experienced at least one ADR. In the 112 patients, 154 ADRs (33 during index hospital admission; 121 during 6-month period following discharge) were detected. 51.9% (80/154) of them were potentially avoidable. 47% (73/154) of ADR swere Serious Adverse Events (SAEs); 13 were life threatening, 46 caused hospitalization and 14 caused disability. The most common causes for re-hospitalization due to ADRs were hypoglycemia due to anti-diabetic drugs (17/46), bleeding due to warfarin (14/46) and hypotension due to anti-hypertensives (6/46). CONCLUSIONS: Incidence of ADRs was high in the study population. A large proportion of them were SAEs. The majority of ADRs that required re-hospitalization were caused by widely used medicines and were potentially avoidable.