Farmacoeconomia ed etica: cure sostenibili e rispetto della persona

The scarcity of economic resources today is a fundamental problem in public healthcare. The importance of making well-founded choices for optimal resources allocation concerns also pharmacological treatments and is justified also on ethical grounds, besides the economic, political and/or medical considerations. In fact, a better management, also in economic sense, of the patient and sickness involves the possibility of offering an efficient treatment to all the sick, or at least to as many of them as possible. However, these considerations should always be subordinated to the ethical centrality of the patient, to the protection of his life, his health and his personal dignity, to the extent that life and health are priceless. The goal of ethics in pharmacoeconomics can be summarised in respect for the person, which must remain the end and reference of every therapeutic choice as well as every healthcare policy. The indispensable instruments for the realisation of the above objectives are, amongst others, those already highlighted but which demand further explanation: a) a suitable standard background/training and a multidisciplinary approach for optimising the evaluation procedures and increasing accuracy and verifiableness of the data; b) measures to contrast and disclose the conflict of interest for more transparency and credibility; c) a coherent evaluation of the ethical quality and humanness of the pharmacoeconomic analysis which requires a correct consideration of quality of life and a real respect for persons

Allogeneic versus Autologous: ethical issues in umbilical cord blood use

OBJECTIVE. To analyse some ethical issues involved in umbilical cord blood (UCB) collection, storage and use. MATERIALS AND METHODS. Ethical issues were addressed in the light of the wellknown fundamental ethical principles for biomedicine: beneficence/non maleficence, respect for autonomy and justice. Specific issues that have been debated concerning the clinical utility of autologous use compared with allogeneic use for transplantation, the validity of informed consent, especially in private UCB banking, and finally the controversial question of private UCB banking for-profit compared to public UCB banking non-profit. RESULTS. Our ethical analysis has highlighted that the allogeneic UCB use for transplantation, compared to autologous UCB use, seems to fulfil the principle of beneficence/non maleficence as it provides “logistic” and clinical benefits and it decreases risks; the acquisition of informed consent requires some counselling, particularly for autologous collection; finally, public UCB banking seems to fulfil the criteria for justice more than private ones. CONCLUSION. Present and future therapeutic UCB possibilities for treating a wide variety of diseases need to increase the number of UCB units available. For this purpose, a “gift” culture and a “solidarity chain” between donors and recipients are requested. Moreover, in recent years, a further and emerging model of bank seems usable, i.e. “hybrid” banking

Allogeneic versus Autologous: ethical issues in umbilical cord blood use

OBJECTIVE. To analyse some ethical issues involved in umbilical cord blood (UCB) collection, storage and use. MATERIALS AND METHODS. Ethical issues were addressed in the light of the wellknown fundamental ethical principles for biomedicine: beneficence/non maleficence, respect for autonomy and justice. Specific issues that have been debated concerning the clinical utility of autologous use compared with allogeneic use for transplantation, the validity of informed consent, especially in private UCB banking, and finally the controversial question of private UCB banking for-profit compared to public UCB banking non-profit. RESULTS. Our ethical analysis has highlighted that the allogeneic UCB use for transplantation, compared to autologous UCB use, seems to fulfil the principle of beneficence/non maleficence as it provides “logistic” and clinical benefits and it decreases risks; the acquisition of informed consent requires some counselling, particularly for autologous collection; finally, public UCB banking seems to fulfil the criteria for justice more than private ones. CONCLUSION. Present and future therapeutic UCB possibilities for treating a wide variety of diseases need to increase the number of UCB units available. For this purpose, a “gift” culture and a “solidarity chain” between donors and recipients are requested. Moreover, in recent years, a further and emerging model of bank seems usable, i.e. “hybrid” banking

Health technology assessment of pathogen reduction technologies applied to plasma for clinical use

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed

Farmacoeconomia ed etica: cure sostenibili e rispetto della persona

The scarcity of economic resources today is a fundamental problem in public healthcare. The importance of making well-founded choices for optimal resources allocation concerns also pharmacological treatments and is justified also on ethical grounds, besides the economic, political and/or medical considerations. In fact, a better management, also in economic sense, of the patient and sickness involves the possibility of offering an efficient treatment to all the sick, or at least to as many of them as possible. However, these considerations should always be subordinated to the ethical centrality of the patient, to the protection of his life, his health and his personal dignity, to the extent that life and health are priceless. The goal of ethics in pharmacoeconomics can be summarised in respect for the person, which must remain the end and reference of every therapeutic choice as well as every healthcare policy. The indispensable instruments for the realisation of the above objectives are, amongst others, those already highlighted but which demand further explanation: a) a suitable standard background/training and a multidisciplinary approach for optimising the evaluation procedures and increasing accuracy and verifiableness of the data; b) measures to contrast and disclose the conflict of interest for more transparency and credibility; c) a coherent evaluation of the ethical quality and humanness of the pharmacoeconomic analysis which requires a correct consideration of quality of life and a real respect for persons

La contracepción de emergencia

The term "emergency contraception" also known as "postcoitus contraception" indicates a series of practices appealed to, after a suspected fertilizing sexual intercourse, with the purpose of hampering initiated pregnancy development. Recent appearance in Italy of pill "Norlevo" boosted an open debate on the international community, since use of this method affects young population and victims of violence. Studies on protocols and products used worldwide to prevent gestation have evidenced, according to authors of this work, that despite inhibition effect on ovulation, the real action mechanism of this products, in 70 to 100% of the cases, is abortion, not contraception. In fact, such pharm products hamper pregnancy development acting on the luteous, the tube and particularly on the endometrius interfering with post fertilization phase, hence hindering embryo development as a result of a fertilized sexual experience. Summing up, authors denote semantic manipulation on both scientific and institutional spheres to gain public acceptance, which calls for the need to provide women facing unexpected pregnancy with clear objective information on the real action of mechanism of these products.Con la expresión "contracepción de emergencia", también llamada "contracepción postcoital", se indica un conjunto de prácticas a las que se recurre luego de una relación sexual presuntamente fecundante, con el fin de impedir el desarrollo de un embarazo cuando ya se ha iniciado. La reciente comercialización en Italia de la píldora "Norlevo" ha suscitado un debate abierto ya en el ámbito internacional, donde se realizan estas estrategias, en las que se ven implicadas adolescentes y víctimas de violencia. Después de haber descrito los diversos protocolos y productos en uso para tal fin, a la luz de los datos encontrados en la literatura internacional, las autoras han puesto en evidencia cómo -no obstante un efecto de inhibición de la ovulación, en realidad en gran parte entre el 70 y el 100% de los casos- el mecanismo de acción de estos productos es abortivo y no contraceptivo. En efecto, tales productos impiden la continuación del embarazo mediante su acción sobre el cuerpo lúteo, la trompa y, en particular, el endometrio: tres efectos que interfieren con la fase postfertilización; por lo tanto, evitan el desarrollo del embrión, ya presente si la relación sexual ha sido fecunda. En suma, las autoras evidencian la manipulación semántica aplicada ya en el ámbito científico o en el institucional, para mejorar la aceptabilidad por parte de la opinión pública, de lo cual surge la necesidad de dar a las mujeres información clara y objetiva sobre el real mecanismo de acción de estos productos, respecto al eventual desarrollo de un embarazo

La contracepción de emergencia

21 páginasThe term "emergency contraception" also known as "postcoitus contraception" indicates a series of practices appealed to, after a suspected fertilizing sexual intercourse, with the purpose of hampering initiated pregnancy development. Recent appearance in Italy of pill "Norlevo" boosted an open debate on the international community, since use of this method affects young population and victims of violence. Studies on protocols and products used worldwide to prevent gestation have evidenced, according to authors of this work, that despite inhibition effect on ovulation, the real action mechanism of this products, in 70 to 100% of the cases, is abortion, not contraception. In fact, such pharm products hamper pregnancy development acting on the luteous, the tube and particularly on the endometrius interfering with post fertilization phase, hence hindering embryo development as a result of a fertilized sexual experience. Summing up, authors denote semantic manipulation on both scientific and institutional spheres to gain public acceptance, which calls for the need to provide women facing unexpected pregnancy with clear objective information on the real action of mechanism of these products.Con la expresión "contracepción de emergencia", también llamada "contracepción postcoital", se indica un conjunto de prácticas a las que se recurre luego de una relación sexual presuntamente fecundante, con el fin de impedir el desarrollo de un embarazo cuando ya se ha iniciado. La reciente comercialización en Italia de la píldora "Norlevo" ha suscitado un debate abierto ya en el ámbito internacional, donde se realizan estas estrategias, en las que se ven implicadas adolescentes y víctimas de violencia. Después de haber descrito los diversos protocolos y productos en uso para tal fin, a la luz de los datos encontrados en la literatura internacional, las autoras han puesto en evidencia cómo -no obstante un efecto de inhibición de la ovulación, en realidad en gran parte entre el 70 y el 100% de los casos- el mecanismo de acción de estos productos es abortivo y no contraceptivo. En efecto, tales productos impiden la continuación del embarazo mediante su acción sobre el cuerpo lúteo, la trompa y, en particular, el endometrio: tres efectos que interfieren con la fase postfertilización; por lo tanto, evitan el desarrollo del embrión, ya presente si la relación sexual ha sido fecunda. En suma, las autoras evidencian la manipulación semántica aplicada ya en el ámbito científico o en el institucional, para mejorar la aceptabilidad por parte de la opinión pública, de lo cual surge la necesidad de dar a las mujeres información clara y objetiva sobre el real mecanismo de acción de estos productos, respecto al eventual desarrollo de un embarazo

L'etica della ricerca biomedica con l'uomo:valore e significato della partecipazione delle persone alle sperimentazioni cliniche

La ricerca biomedica costituisce un ambito del sapere biomedico essenziale per il progresso della medicina e per il bene stesso dell\u2019uomo. Vi sono in effetti ampie convergenze sui contenuti fondamentali dell\u2019etica della sperimentazione clinica. Ma il fatto che ci sia una sorta di consensus su molti aspetti pratici dell\u2019etica della sperimentazione non deve per\uf2 trarre in inganno quanto alla reale condivisione sulle questioni fondamentali: i dissensi emergenti sulle singole questioni, come il confronto versus placebo o gli standard etici per la sperimentazione nei Paesi in via di sviluppo, riflettono spesso radicali divergenze fra i presupposti culturali soggiacenti a questo apparente consenso. Le interpretazioni del significato della ricerca biomedica sono in effetti molteplici e spesso rimangono implicite, poich\ue9 tali posizioni convergono quasi sempre nelle indicazioni operative presenti nelle linee guida e nelle regolamentazioni. Un certo dibattito, seppur confinato, si \ue8 sviluppato intorno al tema della giustificazione etica della sperimentazione, ma soprattutto in relazione alle motivazioni e al significato del coinvolgimento delle persone nelle ricerche cliniche: perch\ue9 una persona dovrebbe partecipare ad una sperimentazione? Che significato dare a questa scelta? Le teorie che giustificano il coinvolgimento delle persone nelle sperimentazioni si basano ora sulla doverosit\ue0 a partecipare, per rispondere ad una chiamata, che \ue8 per tutti, a contribuire al fondamentale progresso scientifico, ora sul concetto di alleanza per la ricerca, all\u2019interno di una tradizione etico-deontologica, rappresentata da una sorta di contratto-partnership tra soggetto e ricercatore, ora su un significato \u2013 ma questo \ue8 l\u2019elemento pi\uf9 difficile da far emergere, come testimoniano i pochi studi sulla materia, \u2013 di prossimit\ue0 e di partecipazione solidale. Partecipare ad una sperimentazione - al di l\ue0 delle attese verso una nuova terapia che il paziente pu\uf2 legittimamente avere e che il medico-ricercatore deve chiarire e definire - \ue8 una scelta che esprime innanzitutto una con-divisione tra soggetto e ricercatore. Condividere in questo caso significa fare insieme (collaborando secondo il proprio ruolo) un nuovo percorso, fatto di atti, di decisioni, di problemi, di speranze, per trovare, nell\u2019ambito dell\u2019obiettivo generale della cura, nuove soluzioni contro la malattia. Il vero senso di tale condivisione del soggetto/paziente non pu\uf2 che essere frutto di un\u2019adesione assolutamente libera e quindi pienamente consapevole, scevra da ogni condizionamento: si tratta non di una generica adesione al progresso della medicina ma a contribuire, in prima persona, a quello specifico obiettivo della sperimentazione. Perci\uf2 la scelta \ue8 della persona e non pu\uf2 essere considerata una obbligazione verso la societ\ue0. Invece \ue8 importante sottolineare ai soggetti, qualora non l\u2019avessero gi\ue0 compreso, il valore della solidariet\ue0 verso altri. Gli obiettivi della ricerca possono cos\uec avere un significato molto pi\uf9 alto del mero risultato scientifico e diventare un segno concreto della speranza non solo di chi partecipa e contribuisce ma anche di altri che percorrono, sconosciuti ed ignari, lo stesso di percorso di sofferenza

“Centralizar-se na prática”: ética clínica de consulta num caso de transplante hepático ortotópico

The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Università Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery.DOI: 10.5294/pebi.2016.20.1.7 El artículo presenta un caso clínico, dirigido en el año 2011 por el equipo de servicio de consulta ética clínica del Instituto de Bioética y Humanidades Médicas de la Facultad “Agostino Gemelli” de Medicina de la Universidad Católica del Sacro Cuore en Roma (Italia). El caso clínico se refiere a los dilemas éticos sobre las perspectivas del paciente para recibir un trasplante hepático ortotópico porque no era residente del país y carecía de un cuidador para asistirlo durante el periodo de seguimiento, así como de un lugar para quedarse después de la cirugía.DOI: 10.5294/pebi.2016.20.1.7  Este artigo apresenta um caso clínico dirigido em 2011 pela equipe de serviço de consulta ética clínica do Instituto de Bioética e Humanidades Médicas da Faculdade de Medicina Agostino Gemelli, da Università Cattolica del Sacro Cuore (Roma, Itália). O caso clínico se refere aos dilemas éticos sobre as perspectivas da paciente para receber um transplante hepático ortotópico porque não era residente do país, carecia de um cuidador para assisti-la durante o período de observação e de um lugar para ficar depois da respectiva cirurgia.DOI: 10.5294/pebi.2016.20.1.7

"CENTRALIZAR-SE NA PRÁTICA": ETICA CLÍNICA DE CONSULTA NUM CASO DE TRANSPLANTE HEPÁTICO ORTOTÓPICO

7 páginasEl artículo presenta un caso clínico, dirigido en el año 2011 por el equipo de servicio de consulta ética clínica del Instituto de Bioética y Humanidades Médicas de la Facultad "Agostino Gemelli" de Medicina de la Universidad Católica del Sacro Cuore en Roma (Italia). El caso clínico se refiere a los dilemas éticos sobre las perspectivas del paciente para recibir un trasplante hepático ortotópico porque no era residente del país y carecía de un cuidador para asistirlo durante el periodo de seguimiento, así como de un lugar para quedarse después de la cirugía.The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the "Agostino Gemelli" School of Medicine of the Università Cattolica del Sacro Cuore, Rome (Italy). The clinical case regards ethical dilemmas about the patient's prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant surgery