Type B adverse drug reactions reported by an immunoallergology department

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 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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Main Authors: Costa,Maria J, Herdeiro,Maria T, Polónia,Jorge J, Ribeiro-Vaz,Inês, Botelho,Cármen, Castro,Eunice, Cernadas,Josefina
Format: Digital revista
Language:English
Published: Centro de Investigaciones y Publicaciones Farmacéuticas 2018
Online Access:http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1885-642X2018000100003
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spelling oai:scielo:S1885-642X20180001000032021-04-06Type B adverse drug reactions reported by an immunoallergology departmentCosta,Maria JHerdeiro,Maria TPolónia,Jorge JRibeiro-Vaz,InêsBotelho,CármenCastro,EuniceCernadas,Josefina Drug-Related Side Effects and Adverse Reactions Adverse Drug Reaction Reporting Systems Inpatients Anti-Inflammatory Agents Non-Steroidal Anti-Bacterial Agents Portugal 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.Centro de Investigaciones y Publicaciones FarmacéuticasPharmacy Practice (Granada) v.16 n.1 20182018-03-01journal articletext/htmlhttp://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1885-642X2018000100003en
institution SCIELO
collection OJS
country España
countrycode ES
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access En linea
databasecode rev-scielo-es
tag revista
region Europa del Sur
libraryname SciELO
language English
format Digital
author Costa,Maria J
Herdeiro,Maria T
Polónia,Jorge J
Ribeiro-Vaz,Inês
Botelho,Cármen
Castro,Eunice
Cernadas,Josefina
spellingShingle Costa,Maria J
Herdeiro,Maria T
Polónia,Jorge J
Ribeiro-Vaz,Inês
Botelho,Cármen
Castro,Eunice
Cernadas,Josefina
Type B adverse drug reactions reported by an immunoallergology department
author_facet Costa,Maria J
Herdeiro,Maria T
Polónia,Jorge J
Ribeiro-Vaz,Inês
Botelho,Cármen
Castro,Eunice
Cernadas,Josefina
author_sort Costa,Maria J
title Type B adverse drug reactions reported by an immunoallergology department
title_short 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_sort type b adverse drug reactions reported by an immunoallergology department
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.
publisher Centro de Investigaciones y Publicaciones Farmacéuticas
publishDate 2018
url http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1885-642X2018000100003
work_keys_str_mv AT costamariaj typebadversedrugreactionsreportedbyanimmunoallergologydepartment
AT herdeiromariat typebadversedrugreactionsreportedbyanimmunoallergologydepartment
AT poloniajorgej typebadversedrugreactionsreportedbyanimmunoallergologydepartment
AT ribeirovazines typebadversedrugreactionsreportedbyanimmunoallergologydepartment
AT botelhocarmen typebadversedrugreactionsreportedbyanimmunoallergologydepartment
AT castroeunice typebadversedrugreactionsreportedbyanimmunoallergologydepartment
AT cernadasjosefina typebadversedrugreactionsreportedbyanimmunoallergologydepartment
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