Adverse drug reactions in a cohort of Sri Lankan patients with non-communicable chronic diseases
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Date
2017
Journal Title
Journal ISSN
Volume Title
Publisher
Elsevier
Abstract
BACKGROUND: Adverse drug reactions (ADRs) pose a major problem in medication use. This study was done to describe incidence, nature and associated factors of ADRs in a cohort of Sri Lankan patients with non-communicable chronic diseases (NCCDs). METHODS: The prospective observational data presented here are obtained as a part of a large study conducted in a tertiary-care hospital in Sri Lanka. In-ward patients with NCCDs were recruited systematically using the admission register in the ward as the sampling frame. All ADRs occurred during the index hospital admission and 6-month post-discharge period were detected by active surveillance. RESULTS: 715 patients were studied (females – 50.3%; mean age – 58.3±15.4years). 35.4% were aged ≥65years. Mean number of drugs prescribed per patient was 6.11±2.97. Most prevalent NCCDs were hypertension (48.4%), diabetes (45.3%) and ischemic heart disease (29.4%). 154 ADRs [33 (21.4%) during index hospital admission; 121 (78.6%) during 6-month post-discharge period) were detected involving 112 (15.7%) patients. 51.9%(80/154) of them were potentially avoidable. 47% (73/154) of ADRs were 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 (6/46) and hypotension due to anti-hypertensives (6/46). ADRs were more common in elderly (34% vs 14.7%, p<0.001), in those who were on ≥5 drugs (25.9% vs 12.7%, p<0.001) and among those with diabetes (28.5% vs 15.6%, p<0.001). 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 drugs and were potentially avoidable. Factors associated with a higher incidence of ADRs were age ≥65years, ≥5drugs in the prescription and presence of diabetes. The healthcare system in the study setting needs improvement in order to minimize ADRs.
Description
Oral Presentation Abstract,13th Congress of the European Association for Clinical Pharmacology and Therapeutics(EACPT), June 24-27, 2017, Prague, Czech Republic
Keywords
Noncommunicable Diseases, Noncommunicable Diseases-drug therapy, Chronic Disease, Chronic Disease-drug therapy, Drug-Related Side Effects and Adverse Reactions, Cohort Studies, Sri Lanka
Citation
Clinical Therapeutics. 2017; 39(8) Sup:e80