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O crescente aumento do consumo de psicofármacos, que em Portugal é particularmente elevado para as benzodiazepinas e antidepressivos em geral, conduz à necessidade de monitorização dos dados de segurança relativos ao uso destes fármacos.
O objetivo principal do estudo foi analisar as notificações de potenciais reações adversas aos medicamentos (RAMs) causadas por psicofármacos (ansiolíticos, sedativos e hipnóticos; antipsicóticos; antidepressivos), obtidas por via de notificação espontânea, e rececionadas nas várias unidades regionais de Farmacovigilância em território Português no período compreendido entre 2017 e 2021. Foi realizado um estudo observacional, retrospetivo, cuja fonte dos dados foi o Sistema Nacional de Farmacovigilância – Portal RAM – INFARMED, I.P..
A maioria das notificações era relativa a indivíduos do género feminino (67,78%), 33,82% destes pertenciam à região de Lisboa, sendo as notificações maioritariamente realizadas pela indústria farmacêutica (62,16%). Os antidepressivos foram os fármacos que originaram maior número de notificações (61,90%), sendo a sertralina e a trazodona os que apresentaram maior número de RAMs, correspondendo respetivamente a 11,51% e 10,40%.
Quanto à gravidade, 58,44% das notificações continham pelo menos uma RAM grave, cerca de metade (45,63%) foram consideradas “clinicamente importantes”, e 43,84% das RAMs evoluíram para cura. As reações mais prevalentes foram náuseas (10,92%), tonturas (10,70%) e uso off label (10,30%). Das reações com causalidade imputada, 45,49% apresentava uma relação de causalidade “possível”, 42,25% “provável” e apenas 4,96% “definitiva”.
Esta análise de notificações de RAMs poderá ser útil para a definição prática d
The increasing use of psychotropic drugs, which is particularly high in Portugal for benzodiazepines and antidepressants in general, highlights the need for monitoring safety data related to the use of these drugs. The main objective of the current study was to analyze notifications of potential adverse drug reactions (ADRs) caused by psychotropic drugs (anxiolytics, sedatives, and hypnotics; antidepressants; and antipsychotics), obtained through spontaneous reporting, and received at the regional Pharmacovigilance units in Portugal between 2017 and 2021. An observational, retrospective study was conducted, with data sourced from the National Pharmacovigilance System - RAM Portal - INFARMED, IP. Notifications received were mostly related to female patients (67,78%), 33,82% were from the region of Lisbon, and performed by the pharmaceutical industry (62,16%). Antidepressants were the drugs that generated the highest number of notifications (61,90%), with sertraline and trazodone presenting the highest number of ADRs, corresponding to 11,51% and 10,40%, respectively. Regarding severity, 58,44% of notifications contained at least one serious ADR, about half (45,63%) were considered "clinically important", and 43,84% of ADRs evolved to cure. The most prevalent ADRs identified were nausea (10,92%), dizziness (10,7%), and off-label use (10,30%). For those reactions with imputed causality, 45,49% had a "possible" causal relationship, 42,25% were "probable", and only 4,96% were classified as "definitive". This analysis of ADRs notifications could be useful for the practical definition of measures that contribute to the safe and responsible use of drugs.
The increasing use of psychotropic drugs, which is particularly high in Portugal for benzodiazepines and antidepressants in general, highlights the need for monitoring safety data related to the use of these drugs. The main objective of the current study was to analyze notifications of potential adverse drug reactions (ADRs) caused by psychotropic drugs (anxiolytics, sedatives, and hypnotics; antidepressants; and antipsychotics), obtained through spontaneous reporting, and received at the regional Pharmacovigilance units in Portugal between 2017 and 2021. An observational, retrospective study was conducted, with data sourced from the National Pharmacovigilance System - RAM Portal - INFARMED, IP. Notifications received were mostly related to female patients (67,78%), 33,82% were from the region of Lisbon, and performed by the pharmaceutical industry (62,16%). Antidepressants were the drugs that generated the highest number of notifications (61,90%), with sertraline and trazodone presenting the highest number of ADRs, corresponding to 11,51% and 10,40%, respectively. Regarding severity, 58,44% of notifications contained at least one serious ADR, about half (45,63%) were considered "clinically important", and 43,84% of ADRs evolved to cure. The most prevalent ADRs identified were nausea (10,92%), dizziness (10,7%), and off-label use (10,30%). For those reactions with imputed causality, 45,49% had a "possible" causal relationship, 42,25% were "probable", and only 4,96% were classified as "definitive". This analysis of ADRs notifications could be useful for the practical definition of measures that contribute to the safe and responsible use of drugs.
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Keywords
Farmacovigilância Notificação espontânea Psicofármacos Reações adversas Sistema nacional de farmacovigilância