Preprint Article Version 1 This version is not peer-reviewed

Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reactions Found in a Tertiary Care Teaching Hospital

Version 1 : Received: 17 August 2018 / Approved: 18 August 2018 / Online: 18 August 2018 (05:17:05 CEST)

A peer-reviewed article of this Preprint also exists.

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. 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.

Journal reference: Pharmacy 2018, 6, 108
DOI: 10.3390/pharmacy6040108

Abstract

Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend to identify and quantify the risks associated with the use of drugs. 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 drugs 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 drug use. Similar ADR reporting programs are necessary to educate and to improve awareness among the healthcare professionals in developing countries.

Subject Areas

adverse drug reactions; spontaneous reporting; causality; ADR; severity

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