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Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients

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Sundaran, S, Udayan, A, Hareendranath, K, Eliyas, B, Ganesan, B, Hassan, A, Subash, R, Palakkal, V and Salahudeen, MS ORCID: 0000-0001-9131-7465 2018 , 'Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients' , Pharmacy, vol. 6, no. 4 , pp. 1-9 , doi: 10.3390/pharmacy6040108.

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Abstract

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intendto identify and quantify the risks associated with the use of medicines. To examine the causality,preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneousADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type,severity and preventability were assessed using necessary assessment scales. The study included3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overallincidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most ofthe ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions(n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderateto severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictabilitywas observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associatedwith ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able tohighlight the clinical pharmacist’s role in ADR monitoring service and create awareness about theway it could be done to promote safer medication use. Similar ADR reporting programs are necessaryto educate and to improve awareness among healthcare professionals in some countries.

Item Type: Article
Authors/Creators:Sundaran, S and Udayan, A and Hareendranath, K and Eliyas, B and Ganesan, B and Hassan, A and Subash, R and Palakkal, V and Salahudeen, MS
Keywords: adverse drug reactions, spontaneous reporting, causality, ADR, severity
Journal or Publication Title: Pharmacy
Publisher: MDPI AG
ISSN: 2226-4787
DOI / ID Number: 10.3390/pharmacy6040108
Copyright Information:

Copyright 2018 The AuthorsLicensed under Creative Commons Attribution 4.0 International (CC BY 4.0)https://creativecommons.org/licenses/by/4.0/

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