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PASS - Post authorisation safety studies: aspetos legais e regulamentares, relevância, estrutura e metodologia.
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Abstract(s)
Esta monografia aborda a componente legislativa e regulamentar, a estrutura, a metodologia e a relevância dos estudos de segurança pós-autorização. Desde os anos 60, a farmacovigilância adquiriu uma nova dimensão devido à tragédia que ocorreu na europa a cerca de dez mil crianças que nasceram com deformações congénitas, nomeadamente a focomelia, que se identifica com o encurtamento ou ausência dos membros num bebé à nascença. Estes eventos adversos estavam associados à talidomida que na altura seria utilizada para reduzir as náuseas nas mulheres grávidas. Após esta tragédia, foi necessário tomar novas medidas e precauções para a indicação de novos medicamentos e para os já comercializados. Foram fundadas entidades nacionais, como o INFARMED, I.P, e internacionais, como a Agência Europeia do Medicamento, que asseguram que os medicamentos de uso humano introduzidos no mercado possuam um determinado nível de qualidade, segurança e eficácia. Os estudos de segurança pós-autorização têm um papel importante na farmacovigilância na medida em que podem esclarecer dúvidas relativamente ao perfil de segurança de um medicamento numa fase de pós-comercialização e porque são tomados por doentes com características diferenciadas, quer seja pela faixa etária, pelas comorbilidades ou por serem mulheres grávidas ou em amamentação. A evidência gerada no mundo real é importantíssima para que o perfil de segurança de um medicamento tenha uma validação externa. Antes de uma companhia farmacêutica iniciar um estudo de segurança pós-autorização é necessário primeiro apresentar um protocolo do estudo ao Comité de Avaliação de Risco de Farmacovigilância e posteriormente um relatório final do estudo deve ser apresentados até 12 meses após a recolha dos dados, tendo ambos os documentos elaborados num formato padrão. Os resultados dos estudos de segurança pós-autorização são então fulcrais para a atribuição, renovação ou revogação da autorização de introdução no mercado. Os estudos de segurança pós-autorização são relevantes na terapia antidepressiva e antipsicótica porque têm muitos riscos potenciais e identificados que devem ser estudados após a sua comercialização para obtermos evidência gerada do mundo real da sua segurança.
This dissertation addresses the legislation, regulation, structure, methodology and relevance of post-authorisation safety studies. Since the 1960s, pharmacovigilance has acquired a new dimension due to the tragedy that occurred in Europe to around ten thousand children who were born with congenital deformities, such as phocomelia, which is identified with the shortening or absence of limbs in a baby at birth. These adverse events were associated with thalidomide which at the time would be used to reduce nausea in pregnant women. After this tragedy, it was necessary to take new measures and precautions for the indication of new drugs and for those already marketed. National entities were founded, such as INFARMED, I.P, and international ones, such as the European Medicines Agency, which today ensure that medicines for human use introduced on the market have a certain level of quality, safety and efficacy. Post-authorisation safety studies have an important role in pharmacovigilance, as they can clarify doubts regarding the safety profile of a drug in a post-marketing phase and because they are taken by patients with different characteristics, whether due to age group or comorbidities or because they are pregnant or nursing women. Real world evidence is critical for a drug's safety profile to have external validation. Before a pharmaceutical company starts a post-authorisation safety study, a study protocol must first be submitted to the Pharmacovigilance Risk Assessment Committee and then a final study report must be submitted within 12 months of data collection, both of which documents produced in a standard format. The results of the post-authorisation safety studies are then pivotal to the assignment, renewal or withdrawal of the marketing authorisation. Post-authorisation safety studies are relevant in antidepressant and antipsychotic therapy because they have many potential and identified risks that should be studied after their marketing to obtain a real-world generated evidence of their safety.
This dissertation addresses the legislation, regulation, structure, methodology and relevance of post-authorisation safety studies. Since the 1960s, pharmacovigilance has acquired a new dimension due to the tragedy that occurred in Europe to around ten thousand children who were born with congenital deformities, such as phocomelia, which is identified with the shortening or absence of limbs in a baby at birth. These adverse events were associated with thalidomide which at the time would be used to reduce nausea in pregnant women. After this tragedy, it was necessary to take new measures and precautions for the indication of new drugs and for those already marketed. National entities were founded, such as INFARMED, I.P, and international ones, such as the European Medicines Agency, which today ensure that medicines for human use introduced on the market have a certain level of quality, safety and efficacy. Post-authorisation safety studies have an important role in pharmacovigilance, as they can clarify doubts regarding the safety profile of a drug in a post-marketing phase and because they are taken by patients with different characteristics, whether due to age group or comorbidities or because they are pregnant or nursing women. Real world evidence is critical for a drug's safety profile to have external validation. Before a pharmaceutical company starts a post-authorisation safety study, a study protocol must first be submitted to the Pharmacovigilance Risk Assessment Committee and then a final study report must be submitted within 12 months of data collection, both of which documents produced in a standard format. The results of the post-authorisation safety studies are then pivotal to the assignment, renewal or withdrawal of the marketing authorisation. Post-authorisation safety studies are relevant in antidepressant and antipsychotic therapy because they have many potential and identified risks that should be studied after their marketing to obtain a real-world generated evidence of their safety.
Description
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2021, Universidade de Lisboa, Faculdade de Farmácia.
Keywords
Pós-autorização Segurança PASS PRAC INFARMED Mestrado integrado - 2021