Adverse Drug Reactions And Quality Deviations Monitored By Spontaneous Reports.

dc.creatorVisacri, Marília Berlofa
dc.creatorde Souza, Cinthia Madeira
dc.creatorSato, Catarina Miyako Shibata
dc.creatorGranja, Silvia
dc.creatorde Marialva, Mécia
dc.creatorMazzola, Priscila Gava
dc.creatorMoriel, Patricia
dc.date2015-Apr
dc.date2016-05-23T19:42:50Z
dc.date2016-05-23T19:42:50Z
dc.date.accessioned2018-03-29T01:30:03Z
dc.date.available2018-03-29T01:30:03Z
dc.identifierSaudi Pharmaceutical Journal : Spj : The Official Publication Of The Saudi Pharmaceutical Society. v. 23, n. 2, p. 130-137, 2015-Apr.
dc.identifier1319-0164
dc.identifier10.1016/j.jsps.2014.06.008
dc.identifierhttp://www.ncbi.nlm.nih.gov/pubmed/25972731
dc.identifierhttp://repositorio.unicamp.br/jspui/handle/REPOSIP/235831
dc.identifier25972731
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/1304074
dc.descriptionThe aim of this study was to determine the frequency and profile of spontaneous reports of Adverse Drug Reactions (ADRs) and quality deviations in a Brazilian teaching hospital and propose a consistent classification to study quality deviations. This is a descriptive and retrospective study involving the analysis of spontaneous reports of ADRs and quality deviations in 2010. ADRs were classified according to the reaction mechanism, severity, and causality. The drugs were classified according to their therapeutic classes and symptoms according to the affected organ. The quality deviations were classified according to the type of deviation and type of medicine available in the Brazilian market. A total of 68 forms were examined; ADRs accounted for 39.7% of the notifications, while quality deviations accounted for 60.3%. ADRs occurred more frequently in men (51.9%) and adults (63.0%). The skin (28.0%) was the most affected organ, while anti-infectives (40.7%) were the therapeutic class that caused the most ADRs. The most common ADRs were type B (74.0%), moderates (37.0%), and probables (55.6%). In relation to quality deviations, the most frequent notifications were breaks, splits and leaks (20.9%) and related to generic drugs (43.9%). The classification system to study quality deviations was clear and consistent. This study demonstrated that practices and public policies related to more effective pharmacovigilance need to be implemented so that the number of spontaneous reports increases.
dc.description23
dc.description130-137
dc.languageeng
dc.relationSaudi Pharmaceutical Journal : Spj : The Official Publication Of The Saudi Pharmaceutical Society
dc.relationSaudi Pharm J
dc.rightsembargo
dc.sourcePubMed
dc.subjectAdverse Drug Reaction
dc.subjectPharmacovigilance
dc.subjectQuality Deviation
dc.subjectSpontaneous Report
dc.titleAdverse Drug Reactions And Quality Deviations Monitored By Spontaneous Reports.
dc.typeArtículos de revistas


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