[Cost/benefit analysis of cancer drugs]. / Bénéfice clinique et coût des traitements anticancéreux.

A detailed analysis of the clinical benefit for 47 approved cancer drugs, using two internationally recognized assessment systems, shows essentially no correlation between clinical benefit and weekly treatment costs. This is true both in the USA and in four European countries, although prices are dramatically lower in Europe.

Ética e assistência farmacêutica na atenção básica: desafios cotidianos / Ethics and pharmaceutical services in primary health care: daily challenges / Ética y servicios farmacéuticos en atención primaria de salud: desafíos cotidianos

Resumo Este estudo buscou identificar e discutir problemas éticos vivenciados por farmacêuticos na atenção básica à saúde. Os dados foram coletados por meio de entrevistas semiestruturadas com 19 farmacêuticos, no município de Florianópolis/SC. O conteúdo das falas foi analisado por abordagem temático-categorial, à luz de referenciais teóricos da bioética. Identificaram-se dez problemas éticos ligados à dimensão política do trabalho e da produção do cuidado, envolvendo questões relativas à estrutura dos serviços, a processos de gestão e à forma de organização da atenção à saúde. Conclui-se que a análise ética comprometida com a resolução dos problemas apontados é importante estratégia para qualificar os serviços farmacêuticos na atenção básica à saúde.

Abstract This study aimed to identify and discuss ethical problems experienced by pharmacists in primary health care. Data were collected through semi-structured interviews conducted with 19 pharmacists in Florianópolis, Santa Catarina, Brazil. The content of interviews was analyzed through thematic-categorical analysis in the light of bioethics references. Ten ethical problems were identified related to the political dimension of the working process and health care, involving issues related to the structure of services and work environment, and management of health services. An ethical analysis to solve these questions is an important strategy to improve pharmaceutical services in primary health care.

Resumen Este estudio tuvo por objetivo identificar y discutir los problemas éticos vivenciados por farmacéuticos en la atención primaria de salud. Los datos fueron recolectados por medio de entrevistas semiestructuradas con 19 farmacéuticos, en el municipio de Florianópolis, Santa Catarina, Brasil. Se hizo un análisis temático-categorial de los relatos recopilados utilizando referenciales teóricos bioéticos. Se identificaron diez diferentes problemas éticos entrelazados con la dimensión política del trabajo y la producción del cuidado, envolviendo cuestiones sobre la estructura de los servicios, los procesos de gestión y las formas de organización de la atención de la salud. Se concluye que el análisis ético comprometido con la resolución de problemas es una importante estrategia para la calificación de los servicios farmacéuticos en la atención primaria de salud.

Tecendo redes de educação construtivista em Deontologia Farmacêutica: formação e dispositivos ativos na arte de ensinar / Building constructivist education networks in Pharmaceutical Deontology: education and active devices in the art of teaching / Cómo tejer redes de educación constructivista en Deontología Farmacéutica: formación y dispositivos activos en el arte de enseñar

As metodologias ativas (MA), apoiadas em abordagens construtivistas de educação, são importantes ferramentas que permitem tecer redes de formação individual e coletiva. O objetivo deste artigo foi relatar a vivência do uso de MA e do webfólio como ferramentas de formação construtivista em saúde, visando contribuir como dispositivo educativo para o ensino da Deontologia Farmacêutica. Trata-se de um relato de experiência entre educador e educandos do curso de Farmácia. As MA foram: Acolhimento: o colar diversidade; Deontocinéfilos: viagem educacional e formação construtivista; "Quero olhar pelo seu olhar": compartilhamento dos significados percebidos; Plenária ética simulada: construção da ética profissional farmacêutica; e Uso de mapas conceituais. A utilização desses dispositivos de aprendizagem permitiu a materialização do conteúdo ministrado, a aquisição de competências e, dessa maneira, tornou mais fácil compreender o sentido das práticas sanitárias e, consequentemente, sua aplicabilidade na vida profissional.(AU)

Active education methodologies supported by constructivist education approaches are important tools that enable to build individual and collective education networks. The objective of this article was to report the experience of using active learning methodologies and a webfolio with constructivist health education tools to assist teaching in Pharmaceutical Deontology. It is a teacher-student experience report of the Pharmacology course. The active methodologies were: Embracement: the diversity necklace; Deontocinephile: educational trip and constructivist education; "I want to look through your eyes": Sharing perceived meanings; Mock ethical plenary: building a professional pharmaceutical ethics; Using conceptual maps. These learning devices helped materialize the content and develop competencies, being easier to understand the sanitary practices' meaning and their applicability in professional life.(AU)

Las metodologías activas (MA), apoyadas en abordajes constructivistas de educación, son importantes herramientas que permiten tejer redes de formación individual y colectiva. El objetivo de este artículo fue relatar la vivencia del uso de MA y del webfólio como herramientas de formación constructivista en salud, buscando contribuir como dispositivo educativo para la enseñanza de la deontología farmacéutica. Se trata de un relato de experiencia entre educador y educandos del curso de farmacia. Las MA fueron: Acogida: el collar diversidad; Deontocinéfilos: Viaje educativo y formación constructivista; "Quiero mirar por su mirada": Compartición de los significados percibidos; Plenaria ética simulada: construcción de la ética profesional farmacéutica; Uso de mapas conceptuales. La utilización de esos dispositivos de aprendizaje permitió la materialización del contenido dictado y la adquisición de competencias y, de tal forma, se hizo más fácil comprender el sentido de las prácticas sanitarias y, por lo tanto, su aplicabilidad en la vida profesional.(AU)

Profissão farmacêutica em São Paulo: prática científica, ensino e gênero, 1895-1917 / Pharmaceutical profession in São Paulo: scientific practice, teaching and gender, 1895-1917

Expõe caminhos, alianças e disputas por meio dos quais farmacêuticos paulistas buscaram criar espaços de fala, atuação e ensino separados da medicinam, a partir de 1895

El delito de ejercicio ilegal de las profesiones de farmácia y medicina en Costa Rica: reflexiones en torno a la prescripción y el despacho de medicamentos / The crime of illegal exercise of the professions of pharmacy and medicine in Costa Rica: reflections on the prescription and delivery of medicines

Objetivo: Analizar el delito de ejercicio ilegal de las profesiones de farmacia y medicina en Costa Rica. Metodología: Se realizó una investigación bibliográfica en libros y artículos del área jurídica, se analizó la legislación promulgada en Costa Rica, Argentina y España, además de las sentencias de tribunales penales, emitidas en Costa Rica desde el año 1980. Resultados: se determinó la legislación que ha regulado el delito de ejercicio ilegal de la profesión, así como los principales aspectos considerados en las sentencias para establecer los elementos que configuran el delito. Conclusión: El profesional en farmacia podría incurrir en el delito de ejercicio ilegal de la medicina en caso de que prescriba medicamentos, así como, el profesional en medicina podría cometer el delito de ejercicio ilegal de la farmacia si despacha medicamentos. El ejercicio de las profesiones médicas o farmacéuticas por personas no autorizadas debe ser analizado en sede penal, sin embargo, se asume el criterio que la sanción debería ser pecuniaria y no privativa de libertad. (AU).

Objective: to analyze the crime of illegal exercise of the professions of pharmacy and medicine in Costa Rica. Methodology: a bibliographic research was carried out in books and articles of the legal area; the legislation promulgated in Costa Rica, Argentina and Spain was analyzed, as well as the sentences of criminal courts, issued in Costa Rica since 1980. Results: creation of a legislation that regulated the crime of illegal exercise of the profession, as well as the main aspects considered in the sentences to establish the elements that make up the offense. Conclusion: the professional in pharmacy could incur in crime of illegal exercise of medicine in case he or she prescribes a medication, as well as, the medical professional could commit the crime of illegal exercise of the pharmacy if it dispenses medication. The exercise of the medical or pharmaceutical professions by unauthorized persons must be analyzed at the criminal court, however, it is assumed that the sanction should be pecuniary and not custodial. (AU).

Objetivo: analisar o crime de exercício ilegal das profissões de farmácia e medicina na Costa Rica. Método: uma pesquisa bibliográfica foi realizada em livros e artigos na área jurídica, a legislação promulgada em Costa Rica, Argentina e Espanha, bem como as sentenças de tribunais criminais, emitido em Costa Rica desde 1980. Resultados: determinou-se a legislação que regulamenta o crime de exercício ilegal da profissão, bem como os principais aspectos considerados nas sentenças para estabelecer os elementos que compõem o delito. Conclusão: o farmacêutico profissional pode incorrer no crime de prática ilegal da medicina se prescrever medicamentos, bem como o profissional médico pode cometer o crime de exercício ilegal da farmácia se despachar medicamentos. O exercício de profissões médicas ou farmacêuticas por pessoas não autorizadas deve ser analisado em um tribunal criminal, no entanto, a pena deve ser de pecuniária. (AU).

Fair, just and compassionate: A pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials.

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or 'preapproval', access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients' best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee (CompAC). Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice.

Sobre as invisibilidades: a mulher cientista em filmes de comédia utilizados no ensino de deontologia e ética farmacêutica / On invisibilities scientist woman in comedy films used in the teaching of ethics and pharmaceutical ethics

A proposição do uso do cinema de comédia em sala de aula emergiu da necessidade de seencontrar uma estratégia motivadora para auxiliar na apreensão dos conteúdos daDeontologia e Ética Farmacêutica, disciplina baseada em normas e leis, campo de poucointeresse dos alunos de graduação em Farmßcia. Essa prßtica pedagógica jß foi utilizadacom sucesso em outros contextos e tomou como base estudos similares conduzidosanteriormente no Programa de Pós-graduação em Ensino em Biociências e Saúde doInstituto Oswaldo Cruz. Os filmes utilizados foram: O inventor da mocidade (1952); Oprofessor aloprado (1963); Júnior (1994); O professor aloprado (1996) e Sem sentido (1998).Dessa forma, o objetivo deste trabalho é discutir a apropriação do cinema de comédia comoestratégia no ensino de Deontologia e Ética Farmacêutica e analisar, consequentemente,como a sétima arte reflete a imagem do profissional que pesquisa medicamentos. Osresultados apurados indicaram que a grande maioria dos discentes apoia o uso do cinemacomo ferramenta facilitadora e aproximadora de campos de estudos considerados tão ßridose distantes de sua realidade e indicaram a comédia como gênero cinematogrßfico de grandeaceitação. No decorrer da anßlise dos filmes selecionados constatou-se que a imagem docientista de medicamentos construída pelo cineasta geralmente é atrelada ao homem,professor de Universidade, médico ou químico...

The proposal of the use of comedies in the classroom arose out of the need to find amotivating strategy to help teach about Pharmaceutical Deontology and Ethics,discipline based on rules and laws, field of scarce interest to undergraduatePharmacy students. This pedagogical practice has been already successfullyemployed in other contexts and was based on similar previous studies carried out at.The selected movies were: ôThe monkey businessõ (1952); ôThe nutty professorÆ(1963); ôJuniorõ (1994); ôThe nutty professorõ (1996) and ôSenselessõ (1998). Thus,the aim of this work is to discuss the appropriation of comedies as pedagogicalstrategies in the teaching of Deontology and Ethics Pharmaceutical and to analyze,therefore, how the seventh art reflects the image of the professional that developstherapeutic substances. The results of this study indicated that most students agreethat the use of comedies is capable of improving the interest in Deontology themes,which are usually so distant from their own reality, and elected comedy as a preferredfilm genre. During the analysis of the selected films the image of the scientist whoresearches therapeutic substances that the filmmaker produced was shown to belinked to that of the male gender, university professor, doctor or chemist. Pharmacistwomen were excluded...

Perfil da assistência farmacêutica na coordenadoria regional de saúde sul do município de São Paulo / Profile of the pharmaceutical care

A qualidade do uso de medicamentos está diretamente relacionada à qualidade do serviço de saúde. Neste contexto, a padronização e a distribuição de fármacos tornam-se fatores primordiais para a boa avaliação destes serviços, visto que a farmácia é o elo final entre o serviço prestado pelo SUS e o usuário. A credibilidade de todo o sistema depende, entre outras coisas, do bom trabalho da farmácia. A distribuição dos serviços de farmácia, de forma regionalizada visa aproximar o usuário da satisfação de suas necessidades, colocando a sua disposição uma série de equipamentos especializados, que enriquecem a atenção básica em saúde.

Perfil da Assistência Farmacêutica na Coordenadoria Regional de Saúde Sul do município de São Paulo

A qualidade do uso de medicamentos está diretamente relacionada à qualidade do serviço de saúde. Neste contexto, a padronização e a distribuição de fármacos tornam-se fatores primordiais para a boa avaliação destes serviços, visto que a farmácia é o elo final entre o serviço prestado pelo SUS e o usuário. A credibilidade de todo o sistema depende, entre outras coisas, do bom trabalho da farmácia. A distribuição dos serviços de farmácia, de forma regionalizada visa aproximar o usuário da satisfação de suas necessidades, colocando a sua disposição uma série de equipamentos especializados, que enriquecem a atenção básica em saúde

A magic bullet for the "African" mother? Neo-Imperial reproductive futurism and the pharmaceutical "solution" to the HIV/AIDS Crisis.

On the basis of a close reading of popular and medical texts which address a debate over the ethics of clinical drug trials funded by the United States and designed mainly for sub-Saharan Africa, I argue that international public health discourse about infant HIV infection in that region reflects and legitimates a neo-imperialist, anti-reproductive justice ideology. Participants share a fetal-centered logic that US-funded biomedicine must shoulder the burden of rescuing sub-Saharan Africa from itself by using the bodies of HIV-positive pregnant women to transmit biomedicine's magic bullet­antiretroviral drugs­to the next generation. The survival of the fetus, disguised as the well-being of the HIV-positive woman and accomplished by the magic of biomedical research, becomes the survival of a region otherwise doomed by its present state of economic, political, and medical incapacity. This version of what queer theorist Lee Edelman (2004, No Future: Queer Theory and the Death Drive) calls "reproductive futurism" redounds to the benefit of the more explicitly women-hating and nationalist ideologies of still-powerful right-wing movements against reproductive and sexual rights.

[The evolution of pharmaceutical practice within the context of changing health territories: How can social sciences contribute to pharmaceutical education?]. / Evolution de la pratique pharmaceutique en contexte de redéfinition des territoires de la santé : ce que les sciences humaines et sociales peuvent apporter à la formation du pharmacien.

Pharmaceutical practice in France is evolving as presented in the legislation reforming hospitals and regarding patients, health and the territories. Hence, the pharmaceutical "territory" has been reconfigured and requires evolving ideas about pharmaceutical training. At the heart of this paper is the following question: What can social sciences bring to pharmaceutical education? Three levels were considered: patients and their social environment, interaction and coordination management among health professionals and political, economical and social drug regulation systems.

Development of a qualitative exploratory case study research method to explore sustained delivery of cognitive services.

OBJECTIVE: To develop, apply and evaluate a new research method to establish relationships between structural and process elements of the provision of cognitive services. In-depth knowledge about how local organisational structural elements of community pharmacies shape the implementation process of cognitive services is needed to develop targeted quality assurance systems to ensure that the services are continuously provided to the patients who need them. The first publicly reimbursed cognitive service in Denmark, the Inhaler Technique Assessment Service (ITAS) is used as the case. SETTING: The research method was developed at the Faculty of Pharmaceutical Sciences at the University of Copenhagen and later applied to seven community pharmacies geographically spread around Denmark. METHODS: A pilot study as well as a subsequent literature review was conducted to determine which structure-process elements to focus on in the research method as well as to select appropriate theories and methods. RESULTS: The developed research method was a qualitative exploratory multi-case study, that was based on method triangulation of field observations, semi-structured interviews, group interviews as well as collection of documentary material. The three main themes of the research method were: the administration of tasks, leadership style and professional values. We integrated the organisational theories of Mintzberg, Bolman and Deal as well as Sørensen to support and clarify the data collection process and analyses. A cross-case analysis and an exploratory contextual analysis relating the leadership style of the pharmacy owner to the ITAS provision were applied to the collected data. CONCLUSION: The developed qualitative exploratory multi-case study research method was satisfactory with regard to achieving nuanced and in-depth results of some relationships between structural and process elements of provision of cognitive services. The research method can be considered an important supplement to the existing literature on the sustainability of cognitive services.

Marco ético y código de conducta, para la regulación farmacéutica / Ethical framework and code of conduct for pharmaceutical regulation

Valores morales y principios éticos. Aplicación al sector farmacéutico público. Aplicación de los valores en el sector farmacéutico. Aplicación en las cinco funciones investigadas en el sector farmacéutico

Etica y medicamentos / Ethics and drugs

Utilizando los principios de la ética médica se analizaron las distintas fases del desarrollo de los medicamentos, encontrándose las siguientes faltas a la ética: uso inadecuado de fármacos en algunos ensayos clínicos en países en desarrollo, suspensión de la producción de medicamentos por falta de rentabilidad, información científica fraudulenta, manipulación de la información para favorecer la venta de ciertos productos farmacéuticos, promoción de medicamentos con folletos fraudulentos y la irresponsable publicidad de medicamentos en medios de información pública. Se proponen algunas alternativas de solución.

Using the principles of the medical ethics the different phases were analyzed from the development of medicines, found the following offenses for ethics: inadequate drug use in some clinical essays in developing countries, suspension of the medicine production for failing of yield, fraudulent scientific information, manipulation of informátion to promote the sale of certain pharmaceutical products, medicine promotion with fraudulent pamphlets and the irresponsible promotion of medicine in means of public information. Suggests some alternative solutions.

Marco ético y código de conducta, para la regulación farmaceútica / Ethics and code of conduct for pharmaceutical regulation

El presente documento ha sido elaborado en dos partes: la primera parte donde presentan los entecedentes y la justificación del estudio, en le capítulo segundo los resultados y sus conclusiones; en el tercer capítulo se presentan los valores morales y principios éticos y su aplicación en el sector farmaceútico.

The ethics of off-label use of drugs: oncology pharmacy in Italy.

The off-label use of drugs is very common in cancer treatment for many reasons. This practice is challenging for pharmacists who practice in oncology, for bureaucratic and medico-legal reasons and for reasons concerning ethics. Several Italian legislative Acts and Laws allow pharmacists to have a voice in the management of off-label use of drugs in oncology and offer instruments to allow reasoning from an ethical perspective. The main aim of this paper was to identify the role of pharmacists within the ethical context in the off-label use of drugs in oncology, taking into account the legislative framework and clinical oncology setting. We consider the existing norms to develop an ethical perspective, through the values underlying the Laws and Acts. From a hermeneutical perspective, we focus on the actual oncology setting to identify the ethical space. The off-label use of drugs in Italy is currently regulated by Law 648/96, Law 94/98 and Decree Law on the therapeutic use of drugs under clinical investigation. From the oncology pharmacist's perspective, the application of the Laws mentioned is often problematic. The disease itself brings forth many ethical issues. In particular, human experience is extremely important in oncology and cannot be separated from other considerations. When faced with the common choice of oncologists to use drugs off-label the late stages of the disease or after many chemotherapy attempts, pharmacists have to take responsibility for the sick person. This usually involves collaboration with the physician, within a process oriented by the 'circumstances of compromise in ethics'. The pharmacist practising in oncology should promote real collaboration especially with the physician for the benefit of the sick person. The pharmacist has to maintain his/her professional integrity, and orient it towards accurate evaluation of the so-called 'circumstances of compromise in ethics'.