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A implementação da diretiva dos medicamentos falsificados: alterações, desafios e medidas regulamentares
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Orientador(es)
Resumo(s)
A diretiva 2011/62/UE de 8 de junho de 2011, estabeleceu um código comunitário para
os medicamentos de uso humano de forma a prevenir a introdução de medicamentos
falsificados na cadeia de abastecimento legal. O regulamento delegado 2016/161 de 2
de outubro de 2015, estabeleceu as regras para os dispositivos de segurança que
figuram nas embalagens dos medicamentos para uso humano e que entrou em vigor a
9 de fevereiro de 2019.
Esta foi a resposta da União Europeia ao aumento da circulação de medicamentos
falsificados, que chegam aos doentes não só através de meios ilegais, mas também
através da cadeia legal de abastecimento.
Os medicamentos falsificados podem conter constituintes falsificados, fora das
especificações, quantidades adulteradas de substâncias corretas ou incorretas e são
considerados uma grave ameaça para a saúde pública.
Assim, os medicamentos têm de dispor de dispositivos de segurança na sua embalagem
que consiste num identificador único e num dispositivo anti-adulteração. Esta
implementação exigiu a adaptação de todos os intervenientes (fabricantes,
distribuidores por grosso, farmácias e hospitais) de modo a que fossem colocados os
identificadores únicos e os dispositivos anti-adulteração nas embalagens dos
medicamentos e que fosse efetuada a verificação e desativação dos mesmos conforme
definido na legislação.
Numa primeira parte deste trabalho foi realizado um enquadramento teórico da
problemática da falsificação de medicamentos, da serialização e do impacto que a
mesma iria ter no ciclo de vida do medicamento.
Numa segunda parte foi elaborado um inquérito acerca do tema dirigido a entidades do
circuito do medicamento, às respetivas associações e ao Infarmed, de modo a identificar
quais as alterações que tinham sido implementadas e impacto das mesmas, quais os
desafios enfrentados e de que forma é que consideram esta medida uma mais valia
para a segurança do doente e para o combate ao comércio de medicamentos
falsificados em Portugal.
O objetivo deste trabalho é identificar e analisar as alterações, os desafios e as medidas
regulamentares a implementar de modo a cumprir com a diretiva dos medicamentos
falsificados que entrou em vigor a 9 de fevereiro de 2019.
Verificou-se que os vários agentes do setor do medicamento tiveram de se adaptar de
modo a dar cumprimento à diretiva, alterando os seus processos internos e adquirindo novos equipamentos. Houve um impacto significativo nestas entidades ao nível de
custos, de adaptação de processos e de redução da eficiência das suas atividades. Ao
nível dos sistemas e ao nível logístico o impacto foi elevado, devido à necessidade de
adaptação de sistemas informáticos já existentes e adaptação de fluxos já definidos.
Em relação aos desafios enfrentados de uma forma global são o investimento
necessário, as adaptações aos processos e a necessidade de aquisição de novos
equipamentos.
Verificou-se que esta é uma medida adicional de segurança para o circuito do
medicamento e para o doente, contudo ainda há trabalho a fazer ao nível de outros
canais de distribuição para a segurança e proteção da saúde pública.
The Directive 2011/62/EU of 8 June 2011 established a community code relating to medicinal products for human use in order to prevent the introduction of falsified medicines into the legal supply chain. The delegated regulation 2016/161 of 2 October 2015 established the rules for the safety features appearing on the packaging of medicinal products for human use and it entered into force on 9 February 2019. This was the answer of the European Union to the increased circulation of falsified medicines, which reach patients not only through illegal chain, but also through the legal supply chain. Falsified medicines may contain falsified ingredients, out of specification, adulterated quantities of correct or incorrect substances and are considered a serious threat to public health. Thus, medicines must have safety features in their packaging that are composed of a unique identifier and an anti-tampering device. This implementation required the adaptation of all stakeholders (manufacturers, wholesalers, pharmacies and hospitals) in order to place the unique identifiers and anti-tampering devices on the packaging of the medicines and to verify and decommissioning it as defined by law. In a first phase of this work, a theoretical framework was elaborated on the problem of falsified medicines, serialization and the impact that it would have on the drugs life cycle. In a second phase, a survey was carried out on the topic addressed to stakeholders, their associations and Infarmed, in order to identify the changes that had been implemented and their impact, the challenges faced and if this measure is considered an added value for patient safety and to combat falsified medicines in Portugal. It was found that stakeholders had to adapt to comply with the directive by changing their internal processes and acquiring new equipments. There was a great impact on these entities in terms of costs, process adaptation and the reduction of efficiency of their activities. The objective of this work is to identify and analyse the changes, challenges and regulatory measures to be implemented in order to comply with the falsified medicines directive that came into force on 9 February 2019. It was found that many stakeholders in the pharmaceutical industry had to adapt to comply with the directive by changing their internal processes and acquiring new equipments. There was a significant impact on these entities in terms of costs, adaptation of processes and reduction of the efficiency of their activities. At systems and logistics level, the impact was high, due to the need to adapt existing computer systems and defined flows. In relation to the challenges faced in a global way are the monetary investment that was necessary, the adaptations to the processes and the need to acquire new equipments. This is an additional safety measure for the medicines and patient circuit, however there is still work to be done at the level of other distribution channels for the safety and protection of public health.
The Directive 2011/62/EU of 8 June 2011 established a community code relating to medicinal products for human use in order to prevent the introduction of falsified medicines into the legal supply chain. The delegated regulation 2016/161 of 2 October 2015 established the rules for the safety features appearing on the packaging of medicinal products for human use and it entered into force on 9 February 2019. This was the answer of the European Union to the increased circulation of falsified medicines, which reach patients not only through illegal chain, but also through the legal supply chain. Falsified medicines may contain falsified ingredients, out of specification, adulterated quantities of correct or incorrect substances and are considered a serious threat to public health. Thus, medicines must have safety features in their packaging that are composed of a unique identifier and an anti-tampering device. This implementation required the adaptation of all stakeholders (manufacturers, wholesalers, pharmacies and hospitals) in order to place the unique identifiers and anti-tampering devices on the packaging of the medicines and to verify and decommissioning it as defined by law. In a first phase of this work, a theoretical framework was elaborated on the problem of falsified medicines, serialization and the impact that it would have on the drugs life cycle. In a second phase, a survey was carried out on the topic addressed to stakeholders, their associations and Infarmed, in order to identify the changes that had been implemented and their impact, the challenges faced and if this measure is considered an added value for patient safety and to combat falsified medicines in Portugal. It was found that stakeholders had to adapt to comply with the directive by changing their internal processes and acquiring new equipments. There was a great impact on these entities in terms of costs, process adaptation and the reduction of efficiency of their activities. The objective of this work is to identify and analyse the changes, challenges and regulatory measures to be implemented in order to comply with the falsified medicines directive that came into force on 9 February 2019. It was found that many stakeholders in the pharmaceutical industry had to adapt to comply with the directive by changing their internal processes and acquiring new equipments. There was a significant impact on these entities in terms of costs, adaptation of processes and reduction of the efficiency of their activities. At systems and logistics level, the impact was high, due to the need to adapt existing computer systems and defined flows. In relation to the challenges faced in a global way are the monetary investment that was necessary, the adaptations to the processes and the need to acquire new equipments. This is an additional safety measure for the medicines and patient circuit, however there is still work to be done at the level of other distribution channels for the safety and protection of public health.
Descrição
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2019, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Medicamentos falsificados Dispositivos de segurança Identificador único Dispositivo anti-adulteração Verificação Desativação Teses de mestrado - 2019