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Regulatory issues on pharmacovigilance in Latin American countries
(Network of Centres for Study of Pharmaceutical Law, 2014)
Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, ...
Analysis of completeness for spontaneous reporting of disease-modifying therapies in multiple sclerosis
(2021-01-01)
Introduction: Considering the need for effective postmarketing surveillance of disease-modifying therapies (DMTs) in multiple sclerosis (MS), we analyzed the potential of the spontaneous reports for safety signal detection, ...
Causes for the underreporting of adverse drug events by health professionals: A systematic review
(2014-01-01)
Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed ...
Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital
(Universidade de São Paulo (USP), Faculdade de Medicina, 2014-03-01)
OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to ...
Confounding Variables and the Performance of Triggers in Detecting Unreported Adverse Drug Reactions
(2017-04-01)
Purpose This study explored the performance of trigger in detecting adverse drug reactions (ADRs), the confounding variables impairing the causal association of the ADRs, and the underreporting rate by hospital health ...
Development of instrument to report and assess causality of adverse events related to herbal medicinesDesarrollo de un instrumento para reportar y evaluar la causalidad de los eventos adversos asociados a plantas medicinales
(2017-01-01)
Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. ...
Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização
(Faculdade de Saúde Pública da Universidade de São Paulo, 2011)
O objetivo da revisão foi analisar aspectos conceituais e operacionais de sistemas de vigilância de eventos adversos pós-vacina. Foram incluídos artigos disponíveis em formato eletrônico, publicados entre 1985 e 2009, ...
Notificações espontâneas de eventos adversos a medicamentos hospitalares: estudo piloto
(2015)
Introduction: Post-marketing surveillance of drugs aims to detect problems related to safety, effectiveness and quality. The identification of adverse drug events (ADE) is made, mainly, by health professionals´ spontaneous ...
Causes for the underreporting of adverse drug events by health professionals: a systematic review
(Univ Sao Paolo, 2014-08-01)
Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed ...
Avaliações farmacoeconômicas em vigilância de medicamentos
(2014)
The study aimed to identify pharmacoeconomic studies in pharmacovigilance and to observe the economic outcomes in post-marketing surveillance. Therefore, a bibliographic survey was performed in databases Lilacs, PubMed/ ...