Gestão do sinal e avaliação de risco em medicamentos
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2019
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Todos os medicamentos são suscetíveis de causar efeitos adversos. Desta forma, é crucial a implementação e manutenção de Sistemas de Farmacovigilância, sejam eles a nível nacional ou europeu, das Autoridades ou do titular de AIM. É da responsabilidade de todos, médicos, enfermeiros, farmacêuticos e do próprio utilizador do medicamento a notificação de acontecimentos adversos. Em Portugal subsistem os problemas da subnotificação, sendo que a própria OMS recomenda uma taxa de notificação acima de 10%.
A monitorização da segurança de todos os medicamentos durante todo o ciclo de vida é requisito regulamentar que serve para proteger a saúde pública. A metodologia e a legislação de Farmacovigilância representam um constante desafio pois têm evoluído com novas descobertas científicas. A nível europeu, o Comité de Avaliação do Risco em Farmacovigilância (PRAC) tem assumido esta difícil tarefa, através da realização de análises de segurança, elaborando novos requisitos regulamentares e orientando as empresas para a melhoria das práticas de Farmacovigilância. Adicionalmente a todas as funções do PRAC, outro dos seus papéis é monitorizar os sinais de segurança para medicamentos a nível europeu. Para além dos medicamentos tradicionais, os medicamentos biológicos (e biossimilares) apresentam novos desafios na área farmacêutica, pois permitem a cura ou trazem qualidade de vida aos doentes não tratados por medicamentos tradicionais. No entanto, devido às suas especificidades e diferenças em relação à terapia convencional, eles tornaram-se um novo desafio na Farmacovigilância. Neste sentido, propõe-se fazer uma avaliação dos sinais gerados pelo PRAC para os medicamentos biológicos (e/ou bisossimilares) e compará-los com os sinais gerados para os medicamentos tradicionais, não sem antes ser feita uma perspetiva histórica e um enquadramento legal e do estado da arte da Farmacovigilância.
Tanto as pequenas moléculas como os medicamentos biológicos e/ou biossimilares dão resposta a patologias derivadas de anomalias nos recetores, deficiência na produção de transmissores e de outros mecanismos autoimunes. Desde Setembro de 2012 a Dezembro de 2018 foram discutidos pelo PRAC 842 sinais (819 sinais para medicamentos biológicos e tradicionais).
Foram discutidos 644 sinais para os medicamentos tradicionais (76% do total de sinais) e 175 sinais para os medicamentos biológicos (21% do total de sinais). É possível observar que existem muitos mais sinais analisados pelo PRAC relativamente aos medicamentos tradicionais do que sinais analisados para medicamentos biológicos (e/ou biossimilares) (a média de sinais e desvio padrão para os medicamentos biológicos 25±12; a média de sinais e desvio padrão para os medicamentos tradicionais foi de 92±24).
Quando analisando o número de sinais gerados por DCI /tradicionais vs sinais gerados pelos medicamentos biológicos/DCI conclui-se que não existem diferenças estatisticamente significativas no número de sinais gerados por DCI/medicamentos tradicionais vs DCI medicamentos biológicos.
De toda esta informação tratada, destacou-se a Classificação Farmacoterapêutica (CFT) 16.3 Imunomoduladores com 147 sinais. Seguiu-se a CFT 8.4.2 Outros antidiabéticos com 38 sinais, sendo que destes 38 sinais, 35 sinais foram gerados pelos medicamentos tradicionais ou pequenas moléculas.
A evidência da discrepância entre os sinais discutidos é tão grande que tentou-se procurar a razão do destaque para a CFT 16.3 Imunomodulares. Desta CFT, os sinais mais discutidos no PRAC são os que têm como indicação terapêutica para a artrite reumatóide.
All drug products are likely to cause adverse effects. Following this, the implementation and maintenance of Pharmacovigilance Systems, whether at national level, European level or by the MAH itself, is crucial. It is the responsibility of all: doctors, nurses, pharmacists and the user of the medicine itself to report adverse events. In Portugal, the problems of under-reporting persist, although WHO recommends a notification above 10%. Monitoring the safety of all medicines throughout its lifecycle is a regulatory requirement to protect public health. Pharmacovigilance methodology and regulations represent a constant challenge as they have evolved with new scientific discoveries. At European level, the Pharmacovigilance Risk Assessment Committee (PRAC) has assumed this difficult task by doing safety analysis, developing new regulatory requirements and issuing guidelines to the Industry so that they can improve their pharmacovigilance practices. In addition to all PRAC functions, one of its other role is to monitor the safety signs for medicines at European level. In addition to traditional medicines, biological drugs (and biosimilars) represent new challenges in the pharmaceutical area, as they allow the cure or bring quality of life to patients not treated by traditional medicines. However, because of their specificities and differences from conventional therapy, they have become a new challenge in Pharmacovigilance. For a better assessment of the signs generated by PRAC meetings on biologic signals, it is proposed to make an evaluation of the signs generated by PRAC for biological drugs (and / or biosimilars) and to compare them with the signs generated for traditional medicines. However, firstly it will be given an historical perspective followed by the legislation framework and the correspondent state of the art for Pharmacovigilance. Both small molecules and biological and/or biosimilar drugs are designed to pathologies derived from receptor anomalies, deficiency in the production of transmitters, and other autoimmune mechanisms. From September 2012 to December 2018 were discussed by PRAC 842 signs (819 signs for biological and traditional medicines). 644 signs for traditional medicines (76% of total signs) and 175 signs for biological drugs (21% of total signs) were discussed. It is possible to observe that there are many more signs analyzed by PRAC for traditional medicines than signs analyzed for biological drugs (and/or biosimilars) (average signs and standard deviation for biological drugs 25 ± 12; average signs and standard deviation for traditional medicines was 92 ± 24). When analyzing the number of signals generated by INN/traditional vs signals generated by the biological drugs/INN it is concluded that there are no statistically significant differences in the number of signals generated by INN/traditional drugs vs. INN for biological drugs. Of all this information treated, we highlight the Pharmacotherapeutic Classification (CFT) 16.3 Immunomodulators with 147 signs generated by PRAC. Followed by CFT 8.4.2 Other antidiabetics with 38 signs, of which 38 signs, 35 signs were generated by traditional drugs or small molecules. There was such a discrepancy between the signs discussed at PRAC that it was attempted to look for the reason of this prominence for CFT 16.3 Immunomodulators. From this CFT, the most discussed signs in PRAC are those that have as a therapeutic indication rheumatoid arthritis.
All drug products are likely to cause adverse effects. Following this, the implementation and maintenance of Pharmacovigilance Systems, whether at national level, European level or by the MAH itself, is crucial. It is the responsibility of all: doctors, nurses, pharmacists and the user of the medicine itself to report adverse events. In Portugal, the problems of under-reporting persist, although WHO recommends a notification above 10%. Monitoring the safety of all medicines throughout its lifecycle is a regulatory requirement to protect public health. Pharmacovigilance methodology and regulations represent a constant challenge as they have evolved with new scientific discoveries. At European level, the Pharmacovigilance Risk Assessment Committee (PRAC) has assumed this difficult task by doing safety analysis, developing new regulatory requirements and issuing guidelines to the Industry so that they can improve their pharmacovigilance practices. In addition to all PRAC functions, one of its other role is to monitor the safety signs for medicines at European level. In addition to traditional medicines, biological drugs (and biosimilars) represent new challenges in the pharmaceutical area, as they allow the cure or bring quality of life to patients not treated by traditional medicines. However, because of their specificities and differences from conventional therapy, they have become a new challenge in Pharmacovigilance. For a better assessment of the signs generated by PRAC meetings on biologic signals, it is proposed to make an evaluation of the signs generated by PRAC for biological drugs (and / or biosimilars) and to compare them with the signs generated for traditional medicines. However, firstly it will be given an historical perspective followed by the legislation framework and the correspondent state of the art for Pharmacovigilance. Both small molecules and biological and/or biosimilar drugs are designed to pathologies derived from receptor anomalies, deficiency in the production of transmitters, and other autoimmune mechanisms. From September 2012 to December 2018 were discussed by PRAC 842 signs (819 signs for biological and traditional medicines). 644 signs for traditional medicines (76% of total signs) and 175 signs for biological drugs (21% of total signs) were discussed. It is possible to observe that there are many more signs analyzed by PRAC for traditional medicines than signs analyzed for biological drugs (and/or biosimilars) (average signs and standard deviation for biological drugs 25 ± 12; average signs and standard deviation for traditional medicines was 92 ± 24). When analyzing the number of signals generated by INN/traditional vs signals generated by the biological drugs/INN it is concluded that there are no statistically significant differences in the number of signals generated by INN/traditional drugs vs. INN for biological drugs. Of all this information treated, we highlight the Pharmacotherapeutic Classification (CFT) 16.3 Immunomodulators with 147 signs generated by PRAC. Followed by CFT 8.4.2 Other antidiabetics with 38 signs, of which 38 signs, 35 signs were generated by traditional drugs or small molecules. There was such a discrepancy between the signs discussed at PRAC that it was attempted to look for the reason of this prominence for CFT 16.3 Immunomodulators. From this CFT, the most discussed signs in PRAC are those that have as a therapeutic indication rheumatoid arthritis.
Descrição
Orientação: Margarida Estudante ; co-orientação: Dinah Duarte
Palavras-chave
MESTRADO INTEGRADO EM CIÊNCIAS FARMACÊUTICAS, CIÊNCIAS FARMACÊUTICAS, MEDICAMENTOS, AVALIAÇÃO DO RISCO, FARMACOVIGILÂNCIA, PHARMACEUTICAL SCIENCES, DRUGS, RISK ASSESSMENT, PHARMACOVIGILANCE