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Open AccessArticle

Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients

1
Devaki Amma Memorial College of Pharmacy, Kerala University of Health Sciences, Malappuram, Kerala 673634, India
2
PVS Hospital Pvt Ltd., Calicut, Kerala 673002, India
3
Division of Pharmacy, School of Medicine, University of Tasmania, Hobart 7001, Australia
*
Author to whom correspondence should be addressed.
Pharmacy 2018, 6(4), 108; https://doi.org/10.3390/pharmacy6040108
Received: 17 August 2018 / Revised: 20 September 2018 / Accepted: 27 September 2018 / Published: 29 September 2018
(This article belongs to the Special Issue Patient Safety and Adverse Drug Events in Medication Practice)
Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to 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 spontaneous ADR 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 included 3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of the 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 moderate to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the way it could be done to promote safer medication use. Similar ADR reporting programs are necessary to educate and to improve awareness among healthcare professionals in some countries. View Full-Text
Keywords: adverse drug reactions; spontaneous reporting; causality; ADR; severity adverse drug reactions; spontaneous reporting; causality; ADR; severity
MDPI and ACS Style

Sundaran, S.; Udayan, A.; Hareendranath, K.; Eliyas, B.; Ganesan, B.; Hassan, A.; Subash, R.; Palakkal, V.; Salahudeen, M.S. Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients. Pharmacy 2018, 6, 108.

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