Sinais de Segurança analisados pelo Comité de Avaliação do Risco em Farmacovigilância: biológicos vs terapêutica convencional
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Data
2019
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Edições Universitárias Lusófonas
Resumo
O Comité de Avaliação do Risco em Farmacovigilância (PRAC) monitoriza a segurança dos medicamentos na
Europa. Os medicamentos biológicos (MBs) reforçaram o tratamento de doenças graves e crónicas, mas, devido às
suas especificidades, tornaram-se num desafio para a farmacovigilância. Este trabalho avalia os sinais de segurança
gerados pelo PRAC para MBs vs. medicamentos tradicionais (MTs) entre setembro de 2012 e dezembro de 2018
(819 sinais). Considerando o número de moléculas (DCI) em cada classe de medicamentos, obteve-se a proporção
de sinais de segurança por tipo de terapêutica: 4 para MBs vs. 2,5 para MTs . Foram comparadas as Classes
de Sistemas e Órgãos (SOCs) afetadas pelos sinais de segurança gerados por MBs e MTs. As principais SOCs
associadas aos sinais dos MTs são perturbações gerais e condições no local de administração (14%), distúrbios da
pele e dos tecidos subcutâneos (7%) e doenças gastrointestinais (6%). Para os MBs, os sinais estão principalmente
relacionados com doenças do sangue e do sistema linfático (14%), distúrbios da pele e dos tecidos subcutâneos
(13%) e do sistema nervoso (10%). Durante o período do estudo, os sinais de segurança para MBs foram
proporcionalmente 1,6 mais elevados do que os gerados para os MTs.
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for medicines safety monitoring in Europe. Biologic drugs (BDs) have more recently been developed and reinforced the treatment of serious and chronic diseases. Because of their specificities, BDs have become a new challenge for pharmacovigilance. This work evaluates safety signals generated by PRAC for BDs vs. conventional therapy (CT) between September 2012 and December 2018 (819 signals). Normalizing the results by the number of molecules (INN) in each drug class we found the proportion of safety signals by therapy type to be 4 for BDs vs. 2.5 for CT. The System Organ Classes (SOCs) affected by safety signals triggered for BDs and CT were compared. The three most relevant System Organ Classes (SOCs) found to be related to CT signals are general disorders and administration site conditions (14%), skin and subcutaneous tissue disorders (7%) and gastrointestinal disorders (6%). Signals related to BDs are mainly associated with blood and lymphatic system disorders (14%), skin and subcutaneous tissue disorders (13%) and nervous system disorders (10%). During the study period safety signals for BDs were proportionally 1.6 higher than safety signals for CT.
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for medicines safety monitoring in Europe. Biologic drugs (BDs) have more recently been developed and reinforced the treatment of serious and chronic diseases. Because of their specificities, BDs have become a new challenge for pharmacovigilance. This work evaluates safety signals generated by PRAC for BDs vs. conventional therapy (CT) between September 2012 and December 2018 (819 signals). Normalizing the results by the number of molecules (INN) in each drug class we found the proportion of safety signals by therapy type to be 4 for BDs vs. 2.5 for CT. The System Organ Classes (SOCs) affected by safety signals triggered for BDs and CT were compared. The three most relevant System Organ Classes (SOCs) found to be related to CT signals are general disorders and administration site conditions (14%), skin and subcutaneous tissue disorders (7%) and gastrointestinal disorders (6%). Signals related to BDs are mainly associated with blood and lymphatic system disorders (14%), skin and subcutaneous tissue disorders (13%) and nervous system disorders (10%). During the study period safety signals for BDs were proportionally 1.6 higher than safety signals for CT.
Descrição
Biomedical and biopharmaceutical research : jornal de investigação biomédica e biofarmacêutica
Palavras-chave
MEDICINA, MEDICAMENTOS, MEDICAMENTOS BIOLÓGICOS, FARMACOVIGILÂNCIA, MEDICINE, DRUGS, BIOLOGICAL DRUGS, PHARMACOVIGILANCE, COMITÉ DE AVALIAÇÃO DO RISCO EM FARMACOVIGILÂNCIA, PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE