Le risque est consubstantiel à la médecine. Dans le système de santé malagasy la médecine est partagée entre plusieurs mondes : le traditionnel et le moderne, le visible et l’invisible puis, le public et le privé. Ainsi, les différents acteurs œuvrant dans ces différents mondes peuvent voir leur responsabilité devant le juge pénal, le juge civil, le juge administratif et le juge disciplinaire en cas de violation des normes de comportement prédéterminées par le Législateur et l’Administration. Effectivement, le sorcier guérisseur, le Tradipraticien, le professionnel de santé et l’Administration peuvent causer des préjudices corporels sur le patient. La pluralité des mondes confrontée à un pluralisme juridique pourrait être à l’origine d’une incohérence dans le traitement des faits relatifs à la relation de soins. Cette confrontation est dédoublée d’une carence textuelle, d’une absence d’uniformisation des systèmes de responsabilité et des systèmes de réparation notamment en matière assurantielle. En effet, il est important de compenser l’insuffisance de support de la réparation des dommages corporels. Une des manières d’harmoniser ne se trouve pas dans la complétude mais dans la réunion de la tradition et du moderne dans le système de santé et dans le système normatif. Il est désormais nécessaire que l’intégration de la médecine traditionnelle soit parfaite dans le système de santé malagasy. Les différents acteurs de droit tel que le Législateur, le juge et l’assureur devraient suivre cette dynamique. / The risk is consubstantial with the medicine. In the malagasy health system the medicine is shared between several worlds: the traditional and the modern, the visible and the invisible then, the public and the private. So, the various actors working in these various worlds could be responsible in front of the penal judge, the civil judge, the administrative judge and the disciplinary judge in case of violation of the standards of behavior predetermined by the Legislator and the Administration. Actually, the wizard quack, Tradipraticien, the healthcare professional and the Administration can cause physical damages on the patient. The plurality of the worlds confronted with a legal pluralism could be at the origin of an incoherence in the treatment of the facts linked with the relation of care. This situation is increased by a textual deficiency, an absence of standardization of the systems of responsibility and of the systems of repair in particular in insurance. Indeed, it is important to fill the space created by the insufficiency of support of the repair of the physical injury. One of the manners to harmonize is in the meeting of the tradition and the modern. It is necessary from now on that the integration of the traditional medicine is completed in the health system malagasy. The various actors of right such as the Legislator, the judge and the insurer should follow this dynamics.

A manipulação de medicamentos pode ser considerada a essência da profissão farmacêutica. Os produtos manipulados são destinados a um indivíduo e, por essa razão, eles são considerados uma importante ferramenta na terapêutica. Entretanto, de acordo com a literatura, a ausência de comprovação científica quanto à segurança e eficácia clínica desses medicamentos faz com que os profissionais de saúde assumam um risco toda vez que um medicamento manipulado é dispensado. Com a finalidade de regular esse setor, a ANVISA aprovou o Regulamento Técnico de Boas Práticas de Manipulação em Farmácia BPMF a RDC 67/2007, a qual tem sido criticada devido aos seus exigentes requisitos para as farmácias comunitárias. Os objetivos desse trabalho foram identificar os riscos sanitários, seus efeitos e impactos na tríade qualidade-segurança-eficácia e as medidas de controle que podem ser aplicadas para reduzir os riscos identificados, a fim de verificar se tais medidas de controle se constituem como requerimentos de BPMF. Este trabalho, considerado teórico-conceitual, foi elaborado com base em uma pesquisa documental, por meio da hermenêutica da RDC 67/2007, do desenvolvimento e aplicação da ferramenta Análise de Perigos, Efeitos e Medidas de Controle e da pesquisa bibliográfica, a qual auxiliou na identificação dos riscos sanitários e das medidas de controle. Os resultados mostraram que os processos envolvidos na manipulação de medicamentos em farmácia apresentam riscos sanitários que podem ser reduzidos por meio de medidas de controle que, em sua maioria, são requisitos regulatórios da RDC 67/2007. Entretanto, existem algumas medidas de controle, tais como validação de software e de limpeza, qualificação de todos os equipamentos utilizados na manipulação e no controle de qualidade que não são cobertos pelas Boas Práticas de Manipulação brasileiras e que alguns dos requisitos das BPMF precisam ser revistos para evitar erros de interpretação e para facilitar a implantação do Sistema de Gestão da Qualidade. Conclui-se, portanto, que para garantir a tríade qualidade-segurança-eficácia dos medicamentos manipulados é mais do que o Saber-Fazer galênico dos farmacêuticos. É necessário conhecer os riscos sanitários envolvidos na manipulação, suas conseqüências, seus impactos e as medidas de controle, a fim de que seja criada uma cultura organizacional de gestão do risco por meio de um sistema de gestão da qualidade implantado e mantido com o propósito de manter os riscos sanitários sob controle. / Pharmaceutical compounding is the essence of pharmaceutical profession. Compounded drug products are addressed to an individual patient and for this reason they are considered an important tool in therapeutics. However, the literature states that the absence of scientific confirmation of clinical safety and efficacy, as required to the manufactured drug products, make the health professionals to assume a sanitary risk each time a compounded drug product is dispensed. In order to regulate this market, ANVISA approved the brazilian Good Compounding Practices RDC 67/2007, which are being criticized due to their hard requirements for community pharmacies. The objectives of this work were to identify the sanitary risks, the impact and effect of them in quality-safety-efficacy triad and the control measures that can be applied to reduce the identified risks, in order to see if these control measures are requirements of Good Compounding Practices. This work, considered theoretical-conceptual, was written based on the documental research and hermeneutics of RDC 67/2007, the development and application of the tool Hazard-Effect Analysis and Control Measures and the bibliographic research, which aided in the identification of sanitary risks and control measures. The results showed that the pharmaceutical compounding process encompass sanitary risks that can be reduced through some control measures that are most related to the regulatory requirements of RDC 67/2007. However, there are some control measures, such as software and cleaning validation, the qualification of all equipments used in compounding/quality control, that are not covered by the brazilian Good Compounding Practices and some requirements of them need to be reviewed in order to avoid misunderstanding errors and facilitate the implementation of the Quality Management System. We conclude that to assure the quality-safety-efficacy triad of compounded drug products is necessary more than the galenic know-how of the pharmacists. Is necessary to know the sanitary risks in pharmaceutical compounding, their impact, effects and control measures, in order to create an organizational culture of risk management though a Quality Management System implemented and monitored designed to keep the sanitary risks under control.

A manipulação de medicamentos pode ser considerada a essência da profissão farmacêutica. Os produtos manipulados são destinados a um indivíduo e, por essa razão, eles são considerados uma importante ferramenta na terapêutica. Entretanto, de acordo com a literatura, a ausência de comprovação científica quanto à segurança e eficácia clínica desses medicamentos faz com que os profissionais de saúde assumam um risco toda vez que um medicamento manipulado é dispensado. Com a finalidade de regular esse setor, a ANVISA aprovou o Regulamento Técnico de Boas Práticas de Manipulação em Farmácia BPMF a RDC 67/2007, a qual tem sido criticada devido aos seus exigentes requisitos para as farmácias comunitárias. Os objetivos desse trabalho foram identificar os riscos sanitários, seus efeitos e impactos na tríade qualidade-segurança-eficácia e as medidas de controle que podem ser aplicadas para reduzir os riscos identificados, a fim de verificar se tais medidas de controle se constituem como requerimentos de BPMF. Este trabalho, considerado teórico-conceitual, foi elaborado com base em uma pesquisa documental, por meio da hermenêutica da RDC 67/2007, do desenvolvimento e aplicação da ferramenta Análise de Perigos, Efeitos e Medidas de Controle e da pesquisa bibliográfica, a qual auxiliou na identificação dos riscos sanitários e das medidas de controle. Os resultados mostraram que os processos envolvidos na manipulação de medicamentos em farmácia apresentam riscos sanitários que podem ser reduzidos por meio de medidas de controle que, em sua maioria, são requisitos regulatórios da RDC 67/2007. Entretanto, existem algumas medidas de controle, tais como validação de software e de limpeza, qualificação de todos os equipamentos utilizados na manipulação e no controle de qualidade que não são cobertos pelas Boas Práticas de Manipulação brasileiras e que alguns dos requisitos das BPMF precisam ser revistos para evitar erros de interpretação e para facilitar a implantação do Sistema de Gestão da Qualidade. Conclui-se, portanto, que para garantir a tríade qualidade-segurança-eficácia dos medicamentos manipulados é mais do que o Saber-Fazer galênico dos farmacêuticos. É necessário conhecer os riscos sanitários envolvidos na manipulação, suas conseqüências, seus impactos e as medidas de controle, a fim de que seja criada uma cultura organizacional de gestão do risco por meio de um sistema de gestão da qualidade implantado e mantido com o propósito de manter os riscos sanitários sob controle. / Pharmaceutical compounding is the essence of pharmaceutical profession. Compounded drug products are addressed to an individual patient and for this reason they are considered an important tool in therapeutics. However, the literature states that the absence of scientific confirmation of clinical safety and efficacy, as required to the manufactured drug products, make the health professionals to assume a sanitary risk each time a compounded drug product is dispensed. In order to regulate this market, ANVISA approved the brazilian Good Compounding Practices RDC 67/2007, which are being criticized due to their hard requirements for community pharmacies. The objectives of this work were to identify the sanitary risks, the impact and effect of them in quality-safety-efficacy triad and the control measures that can be applied to reduce the identified risks, in order to see if these control measures are requirements of Good Compounding Practices. This work, considered theoretical-conceptual, was written based on the documental research and hermeneutics of RDC 67/2007, the development and application of the tool Hazard-Effect Analysis and Control Measures and the bibliographic research, which aided in the identification of sanitary risks and control measures. The results showed that the pharmaceutical compounding process encompass sanitary risks that can be reduced through some control measures that are most related to the regulatory requirements of RDC 67/2007. However, there are some control measures, such as software and cleaning validation, the qualification of all equipments used in compounding/quality control, that are not covered by the brazilian Good Compounding Practices and some requirements of them need to be reviewed in order to avoid misunderstanding errors and facilitate the implementation of the Quality Management System. We conclude that to assure the quality-safety-efficacy triad of compounded drug products is necessary more than the galenic know-how of the pharmacists. Is necessary to know the sanitary risks in pharmaceutical compounding, their impact, effects and control measures, in order to create an organizational culture of risk management though a Quality Management System implemented and monitored designed to keep the sanitary risks under control.

In 2013, Peru initiated a reform process under the premise of recognizing the nature of health as a right that must be protected by the state. This reform aimed to improve health conditions through the elimination or reduction of restrictions preventing the full exercise of this right, and the consequent approach aimed to protect both individual and public health and rights within a framework characterized by strengthened stewardship and governance, which would allow system conduction and effective responses to risks and emergencies. The reform led to an increase in population health insurance coverage from 64% to 73%, with universalization occurring through the SIS affiliation of every newborn with no other protection mechanism. Health financing increased by 75% from 2011, and the SIS budget tripled from 570 to 1,700 million soles. From 2012 to May 2016, 168 health facilities have become operational, 51 establishments are nearing completion, and 265 new projects are currently under technical file and work continuity with an implemented investment of more than 7 billion soles. Additionally, this reform led to the approval of the Ministry of Health intervention for health emergencies and strengthened the health authority of the ministry to implement responses in case of risks or service discontinuity resulting from a lack of regional or local government compliance with public health functions. / In 2013, Peru initiated a reform process under the premise of recognizing the nature of health as a right that must be protected by the state. This reform aimed to improve health conditions through the elimination or reduction of restrictions preventing the full exercise of this right, and the consequent approach aimed to protect both individual and public health and rights within a framework characterized by strengthened stewardship and governance, which would allow system conduction and effective responses to risks and emergencies. The reform led to an increase in population health insurance coverage from 64% to 73%, with universalization occurring through the SIS affiliation of every newborn with no other protection mechanism. Health financing increased by 75% from 2011, and the SIS budget tripled from 570 to 1,700 million soles. From 2012 to May 2016, 168 health facilities have become operational, 51 establishments are nearing completion, and 265 new projects are currently under technical file and work continuity with an implemented investment of more than 7 billion soles. Additionally, this reform led to the approval of the Ministry of Health intervention for health emergencies and strengthened the health authority of the ministry to implement responses in case of risks or service discontinuity resulting from a lack of regional or local government compliance with public health functions.