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Perfil de notificação das reações adversas graves na região sul de Portugal no período 2011 a 2015
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Introdução: A ocorrência de reações adversas graves aos medicamentos – aquelas que resultam em morte, que motivam ou prolongam hospitalização, que provocam incapacidade persistente ou significativa, que constituem perigo de vida, que provocam malformação ou anomalia congénita, ou que são consideradas medicamente importantes – está associada e elevados custos sociais e económicos, podendo comprometer as atividades diárias e o estado geral e mental dos doentes afetados.
Objetivos: Analisar e caracterizar o perfil de notificação espontânea de suspeita de reações adversas graves aos medicamentos, através das notificações dirigidas à Unidade de Farmacovigilância do Sul, no período de 2011 a 2015.
Métodos: Estudo observacional descritivo, de orientação transversal, realizado através da análise da base de dados de notificações espontâneas dirigidas à UFS no período de 2011 a 2015, a análise descritiva dos dados foi efetuada no sistema informático EPI INFO 2007.
Resultados: De um total de 1664 casos de RAM foram analisados 482 (28,96%) casos de RAM grave.
O ano em que houve maior número de notificações de RAM grave foi 2015 (n=168; 41,48%). O distrito de onde provieram mais notificações de RAM graves foi Évora (n=198; 41,60%), e o hospital foi a instituição mais participativa (n=372; 78,15%). O profissional de saúde que mais notificou RAMs graves foi o farmacêutico (n=344; 71,37%).
Os doentes mais afetados foram os idosos do sexo feminino (n=145; 30,21%), seguidos dos adultos do sexo feminino (n=128; 26,67%), sendo que mais de metade dos casos (n=246; 51,25%) ocorreram em idosos.
O critério de gravidade mais frequente foi “medicamente importante” (n=205; 42,53%), seguido do critério “hospitalização” (n=149; 30,91%). Mais de metade dos casos evoluíram para cura (n=280; 58,09%) e 24 casos (4,98%) culminaram em morte.
O SOC 8 (Perturbações gerais e alterações no local de administração), o SOC 23 (Afeções dos tecidos cutâneos e subcutâneos) e o SOC 7 (Doenças gastrointestinais) foram os mais frequentes.
Os sub-grupos terapêuticos, mais frequentemente associados aos casos de RAMs graves (de um total de 70) foram os “agentes antitrombóticos” (12,24%), seguidos pelos “alcaloides e outros produtos naturais” (6,12%) pelos “outros agentes antineoplásicos” (6,12%) (n=572).
Os fármacos mais frequentemente suspeitos de provocarem as RAMs graves (de um total de 241) foram a Varfarina (6,47%), o Docetaxel (5.07%) e a Amoxicilina + Ácido Clavulânico (2,80%). (n=572)
Conclusões: O ano de 2015 foi aquele em que houve maior número de notificações de reações adversas graves, tendo sido o hospital a instituição que mais contribuiu e o farmacêutico o profissional de saúde mais participativo.
Évora foi o distrito que mais RAMs graves notificou e os idosos do sexo feminino foram os mais afetados.
Atendendo ao elevado impacto económico e social das RAMs graves, reforça-se a importância da monitorização contínua do balanço benefício-risco dos medicamentos, para a qual o método da notificação espontânea é fundamental. Para tal, urge uma maior consciencialização desta matéria de saúde pública, e o envolvimento de toda a comunidade.
Introduction: The occurrence of serious adverse drug reactions - those that result in death, motivate or prolong hospitalization, cause significant disability or incapacity, lead to life-threatening situations, cause malformation or congenital anomaly, or are considered medically important - are associated to high social and economic expenses and may compromise daily activities and general and mental condition of the affected patients. Objectives: Analyse and characterize the profile of spontaneous reporting of suspected serious adverse drug reactions (ADR) by the notifications addressed to Pharmacovigilance South Unit (UFS), in the period 2011 to 2015. Methods: Observational descriptive study with transverse orientation, accomplished through spontaneous reporting database analysis, from the UFS in the period 2011 to 2015. Descriptive analysis of the data was performed in the computer system EPI INFO 2007. Results: From 1664 ADR cases, 482 (28.96%) were serious ADR. The higher number of severe ADR reports was observed in 2015, (n = 168; 41.48%). The district of Évora was the one that presented the higher percentage of serious ADR reports (n = 198; 41.60%), and the hospital was the most participatory institution (n = 372; 78.15%). The health care professional that notified ADR more frequently was the pharmacist (n = 344; 71.37%). The most affected patients were elderly women (n = 145; 30.21%), followed by adult females (n = 128; 26.67%), and more than half of the cases (n = 246; 51.25%) occurred in the elderly. The most frequent criterion of gravity was "medically important" (n = 205; 42.53%), followed by the criterion "hospitalization" (n = 149; 30.91%). More than half of the cases were cured (n = 280; 58.09%) and 24 cases (4.98%) resulted in death. SOC 8 (General disorders and administration site conditions), SOC 23 (disorders of the skin and subcutaneous tissue) and SOC 7 (Gastrointestinal disorders), were those most frequent. From 482 serious cases, there was only one suspected drug for 86% (414) of the cases. The therapeutit sub-groups more frequent (from 70 observed) were "antithrombotic agents" (12.24%), followed by "alkaloids and other natural products" (6.12%) and "other antineoplastic agents" (6.12%), (n=572) The main suspect drugs that caused serious ADR (from 241 observed) were Warfarin (6.47%), Docetaxel (05.07%) and Amoxicillin + Clavulanic Acid (2.80%). (n=572) Conclusions: 2015 was the year in which there was a greater number of notifications of serious adverse reactions, having been the hospital the health institution that contributed the most and the pharmacist the more participating amongst the health professionals. Évora was the district with more serious ADR notifications and female elderly were the most affected people. Given the high economic and social impact of serious ADR, it reinforces the importance of continuous monitoring of the benefit-risk balance of medicines available in the therapeutic market, for which the method of spontaneous reporting is key. To this end, it urges greater awareness of this public health issue, and the involvement of the entire community.
Introduction: The occurrence of serious adverse drug reactions - those that result in death, motivate or prolong hospitalization, cause significant disability or incapacity, lead to life-threatening situations, cause malformation or congenital anomaly, or are considered medically important - are associated to high social and economic expenses and may compromise daily activities and general and mental condition of the affected patients. Objectives: Analyse and characterize the profile of spontaneous reporting of suspected serious adverse drug reactions (ADR) by the notifications addressed to Pharmacovigilance South Unit (UFS), in the period 2011 to 2015. Methods: Observational descriptive study with transverse orientation, accomplished through spontaneous reporting database analysis, from the UFS in the period 2011 to 2015. Descriptive analysis of the data was performed in the computer system EPI INFO 2007. Results: From 1664 ADR cases, 482 (28.96%) were serious ADR. The higher number of severe ADR reports was observed in 2015, (n = 168; 41.48%). The district of Évora was the one that presented the higher percentage of serious ADR reports (n = 198; 41.60%), and the hospital was the most participatory institution (n = 372; 78.15%). The health care professional that notified ADR more frequently was the pharmacist (n = 344; 71.37%). The most affected patients were elderly women (n = 145; 30.21%), followed by adult females (n = 128; 26.67%), and more than half of the cases (n = 246; 51.25%) occurred in the elderly. The most frequent criterion of gravity was "medically important" (n = 205; 42.53%), followed by the criterion "hospitalization" (n = 149; 30.91%). More than half of the cases were cured (n = 280; 58.09%) and 24 cases (4.98%) resulted in death. SOC 8 (General disorders and administration site conditions), SOC 23 (disorders of the skin and subcutaneous tissue) and SOC 7 (Gastrointestinal disorders), were those most frequent. From 482 serious cases, there was only one suspected drug for 86% (414) of the cases. The therapeutit sub-groups more frequent (from 70 observed) were "antithrombotic agents" (12.24%), followed by "alkaloids and other natural products" (6.12%) and "other antineoplastic agents" (6.12%), (n=572) The main suspect drugs that caused serious ADR (from 241 observed) were Warfarin (6.47%), Docetaxel (05.07%) and Amoxicillin + Clavulanic Acid (2.80%). (n=572) Conclusions: 2015 was the year in which there was a greater number of notifications of serious adverse reactions, having been the hospital the health institution that contributed the most and the pharmacist the more participating amongst the health professionals. Évora was the district with more serious ADR notifications and female elderly were the most affected people. Given the high economic and social impact of serious ADR, it reinforces the importance of continuous monitoring of the benefit-risk balance of medicines available in the therapeutic market, for which the method of spontaneous reporting is key. To this end, it urges greater awareness of this public health issue, and the involvement of the entire community.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2016
Palavras-chave
Medicamento Reações adversas graves Mestrado Integrado - 2016