Type B adverse drug reactions reported by an immunoallergology department

Objective: Characterization of the adverse drug reactions (ADR) reported by the immunoallergology department (IAD), Centro Hospitalar de São João (Porto), to the Northern Pharmacovigilance Centre (NPC). Methods: An observational, descriptive and retrospective study was conducted, based in a spontan...

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Main Authors: Costa MJ, Herdeiro MT, Polónia JJ, Ribeiro-Vaz I, Botelho C, Castro E, Cernadas J.
Format: Article
Language:English
Published: Centro de Investigaciones y Publicaciones Farmaceuticas 2018-03-01
Series:Pharmacy Practice
Subjects:
Online Access:https://www.pharmacypractice.org/journal/index.php/pp/article/view/1070/608
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author Costa MJ
Herdeiro MT
Polónia JJ
Ribeiro-Vaz I
Botelho C
Castro E
Cernadas J.
author_facet Costa MJ
Herdeiro MT
Polónia JJ
Ribeiro-Vaz I
Botelho C
Castro E
Cernadas J.
author_sort Costa MJ
collection DOAJ
description Objective: Characterization of the adverse drug reactions (ADR) reported by the immunoallergology department (IAD), Centro Hospitalar de São João (Porto), to the Northern Pharmacovigilance Centre (NPC). Methods: An observational, descriptive and retrospective study was conducted, based in a spontaneous report system. Participants were all the patients from the IAD, with suspected ADR, reported to NPC by specialists after the study was completed. Results: Studied population had a median age of 41 years, with the predominance of the female gender (73.2%). Allergic rhinitis and asthma were the most frequent comorbidities. All studied ADR were type B, 89.6% were serious, 86.4% unexpected and 2.6% associated with drugs that presented less than 2 years in the market. The most represented drug classes were the non-steroidal anti-inflammatory drugs (NSAIDs) (52.6%) and antibiotics (25.2%). Skin symptoms represented 61.2% of the reported complaints. About 52.9% of these ADR occurred in less than one hour after intake. The most frequent ADR treatment at the time of the reaction was drug interruption (86.2%), followed by the prescription of anti-histamines (42.2%). Conclusions: Reported ADR to NPC by the Drug Alert Unit were mainly serious, unexpected, associated with NSAIDs and antibiotics and related with marketing authorization medicines older than two years. These results could be very useful to develop strategies to prevent the clinical and economic consequences of ADR.
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spelling doaj.art-e4de4e15cfaa47efb6799e0133fb08c12022-12-21T18:40:23ZengCentro de Investigaciones y Publicaciones FarmaceuticasPharmacy Practice1885-642X1886-36552018-03-01161107010.18549/PharmPract.2018.01.1070Type B adverse drug reactions reported by an immunoallergology departmentCosta MJHerdeiro MTPolónia JJRibeiro-Vaz IBotelho CCastro ECernadas J. Objective: Characterization of the adverse drug reactions (ADR) reported by the immunoallergology department (IAD), Centro Hospitalar de São João (Porto), to the Northern Pharmacovigilance Centre (NPC). Methods: An observational, descriptive and retrospective study was conducted, based in a spontaneous report system. Participants were all the patients from the IAD, with suspected ADR, reported to NPC by specialists after the study was completed. Results: Studied population had a median age of 41 years, with the predominance of the female gender (73.2%). Allergic rhinitis and asthma were the most frequent comorbidities. All studied ADR were type B, 89.6% were serious, 86.4% unexpected and 2.6% associated with drugs that presented less than 2 years in the market. The most represented drug classes were the non-steroidal anti-inflammatory drugs (NSAIDs) (52.6%) and antibiotics (25.2%). Skin symptoms represented 61.2% of the reported complaints. About 52.9% of these ADR occurred in less than one hour after intake. The most frequent ADR treatment at the time of the reaction was drug interruption (86.2%), followed by the prescription of anti-histamines (42.2%). Conclusions: Reported ADR to NPC by the Drug Alert Unit were mainly serious, unexpected, associated with NSAIDs and antibiotics and related with marketing authorization medicines older than two years. These results could be very useful to develop strategies to prevent the clinical and economic consequences of ADR.https://www.pharmacypractice.org/journal/index.php/pp/article/view/1070/608Drug-Related Side Effects and Adverse ReactionsAdverse Drug Reaction Reporting SystemsInpatientsAnti-Inflammatory Agents Non-SteroidalAnti-Bacterial AgentsPortugal
spellingShingle Costa MJ
Herdeiro MT
Polónia JJ
Ribeiro-Vaz I
Botelho C
Castro E
Cernadas J.
Type B adverse drug reactions reported by an immunoallergology department
Pharmacy Practice
Drug-Related Side Effects and Adverse Reactions
Adverse Drug Reaction Reporting Systems
Inpatients
Anti-Inflammatory Agents Non-Steroidal
Anti-Bacterial Agents
Portugal
title Type B adverse drug reactions reported by an immunoallergology department
title_full Type B adverse drug reactions reported by an immunoallergology department
title_fullStr Type B adverse drug reactions reported by an immunoallergology department
title_full_unstemmed Type B adverse drug reactions reported by an immunoallergology department
title_short Type B adverse drug reactions reported by an immunoallergology department
title_sort type b adverse drug reactions reported by an immunoallergology department
topic Drug-Related Side Effects and Adverse Reactions
Adverse Drug Reaction Reporting Systems
Inpatients
Anti-Inflammatory Agents Non-Steroidal
Anti-Bacterial Agents
Portugal
url https://www.pharmacypractice.org/journal/index.php/pp/article/view/1070/608
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AT ribeirovazi typebadversedrugreactionsreportedbyanimmunoallergologydepartment
AT botelhoc typebadversedrugreactionsreportedbyanimmunoallergologydepartment
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