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

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...

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Detalles Bibliográficos
Autores principales: Sundaran, Siraj, Udayan, Anjali, Hareendranath, Keerthi, Eliyas, Basil, Ganesan, Babu, Hassan, Ashik, Subash, Rajesh, Palakkal, Vishnu, Salahudeen, Mohammed Saji
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6306913/
https://www.ncbi.nlm.nih.gov/pubmed/30274320
http://dx.doi.org/10.3390/pharmacy6040108
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author Sundaran, Siraj
Udayan, Anjali
Hareendranath, Keerthi
Eliyas, Basil
Ganesan, Babu
Hassan, Ashik
Subash, Rajesh
Palakkal, Vishnu
Salahudeen, Mohammed Saji
author_facet Sundaran, Siraj
Udayan, Anjali
Hareendranath, Keerthi
Eliyas, Basil
Ganesan, Babu
Hassan, Ashik
Subash, Rajesh
Palakkal, Vishnu
Salahudeen, Mohammed Saji
author_sort Sundaran, Siraj
collection PubMed
description 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.
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spelling pubmed-63069132019-01-02 Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients Sundaran, Siraj Udayan, Anjali Hareendranath, Keerthi Eliyas, Basil Ganesan, Babu Hassan, Ashik Subash, Rajesh Palakkal, Vishnu Salahudeen, Mohammed Saji Pharmacy (Basel) Article 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. MDPI 2018-09-29 /pmc/articles/PMC6306913/ /pubmed/30274320 http://dx.doi.org/10.3390/pharmacy6040108 Text en © 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Sundaran, Siraj
Udayan, Anjali
Hareendranath, Keerthi
Eliyas, Basil
Ganesan, Babu
Hassan, Ashik
Subash, Rajesh
Palakkal, Vishnu
Salahudeen, Mohammed Saji
Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients
title Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients
title_full Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients
title_fullStr Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients
title_full_unstemmed Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients
title_short Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients
title_sort study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6306913/
https://www.ncbi.nlm.nih.gov/pubmed/30274320
http://dx.doi.org/10.3390/pharmacy6040108
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