Gravity of the non-authorized use of substances not intended for clinical use in invasive aesthetic procedures: the portuguese case

SUMMARY INTRODUCTION: There is a worldwide increase in the number of invasive aesthetic procedures, and there is a general apprehension in medical societies towards the assurance of patient safety, that is dependent on the quality and certification of providers, of the materials and substances used, and where they take place. It is the main objective of this study to determine the perception of the gravity of non-authorized substances for clinical use in invasive aesthetic procedures among Portuguese plastic surgeons and its variation by the clinical sector of practice. METHODS: We proceeded to an inquiry by using a questionnaire, measured in a Linkert scale, and the collected data were statistically treated with a non-parametric Kruskal-Wallis test. RESULTS: We obtained a 41,4% answer rate and a global perception that this is a serious problem - a median of 8,00 and mean of 7,45 points on a 1 to 10 scale. 70% of the plastic surgeons that answered the questionnaire work both in the private and public sector, 19% exclusively in the public sector and 11% only in private practice. The perception of the problem was most serious among those that work exclusively in the private sector (statistically significant difference). CONCLUSION: The causes of the observed difference may reside in various reasons: the higher number of patients submitted to invasive aesthetic procedures exclusively in private practice; the higher perception of regulatory deficits in the private sector; scarce specific health politics for procedures outside the traditional boundaries of medicine; the difficulty for independent regulatory agencies to adopt effective measures.

RESUMO INTRODUÇÃO: Os procedimentos estéticos invasivos estão a aumentar globalmente, e são acompanhados por uma apreensão das sociedades médicas sobre a segurança desses procedimentos, dependentes da qualidade e certificação dos prestadores, dos dispositivos e substâncias utilizados e do local onde são efetuados. O presente estudo procura aferir a percepção dos cirurgiões plásticos portugueses sobre a gravidade da utilização de substâncias não autorizadas para uso clínico em procedimentos estéticos, e a sua variação consoante o setor em que exercem a atividade clínica. MÉTODOS: Foi utilizado um inquérito sob a forma de questionário, medido numa escala de Likert, e os dados foram tratados estatisticamente pelo teste não paramétrico de Kruskal-Wallis. RESULTADOS: Obteve-se uma taxa de resposta de 41,4% e a perceção global é a de que o problema é grave — mediana de 8,00 e média de 7,45 numa escala de 1 a 10. Setenta por cento dos cirurgiões plásticos que responderam ao inquérito trabalham num regime misto, 19% exclusivamente no setor público e 11% apenas no setor privado. A percepção do problema como mais grave (diferença estatisticamente significativa) foi observada na atividade exclusiva no setor privado. CONCLUSÕES: A diferença observada pode dever-se a vários fatores: à maior observação de pacientes submetidos a esses procedimentos exclusivamente no setor privado; à maior percepção de déficits de regulação no setor privado; ao déficit de políticas de saúde específicas a técnicas utilizadas fora do contexto tradicional da medicina; à dificuldade de as agências administrativas reguladoras independentes adotarem práticas efetivas no setor privado da saúde.

Threats to bioethical principles in medical practice in Brazil: new medical ethics code period

We aimed to outline the profile of medical professionals in Brazil who have violated the deontological norms set forth in the ethics code of the profession, and whose cases were judged by the higher tribunal for medical ethics between 2010 and 2016. This survey was conducted using a database formed from professional ethics cases extracted from the plenary of the medical ethics tribunal of the Federal Council of Medicine. These were disciplinary ethics cases that were judged at appeal level between 2010 and 2016. Most of these professionals were male (88.5%) and their mean age was 59.9 years (SD=11.62) on the date of judgment of their appeals, ranging from 28 to 95 years. Most of them were based in the southeastern region of Brazil (50.89%). Articles 1 and 18 of the medical ethics code were the rules most frequently violated. The sentence given most often was the cancellation of their professional license (37.6%) and the acts most often sentenced involved malpractice, imprudence, and negligence (18.49%). It is acknowledged that concern for the principles of bioethics was present in the appeal decisions made by the plenary of the medical ethics tribunal of the Federal Council of Medicine.

new law regarding medical responsibility in the United Arab Emirates

In the United Arab Emirates, medical responsibility was formerly defined and governed by the provisions of Law 7 of 1975 for the practice of medical professions; this had been a part of civil law. The passing of Law 10 of 2008, namely the Law on Medical Responsibility in the UAE ", which was enacted on the 16th of December 2008, created a new framework to deal with this issue. The old master-servant relationship for compensations is replaced by insurance companies, which will pay damages to the plaintiff [patient] injured as a result of a physicians' negligence. This paper provides the first translation of the Arabic text of the new law into English. This is particularly important for expatriate doctors working in UAE; many of whom do not speak Arabic. Where appropriate, a comparison is made between provisions of the old law and new law dealing with similar points. Moreover this paper provides an overview of some contemporary legal and ethical issues in medical practice, i.e. confidentiality, consent, euthanasia, abortion, sterilization, assisted reproduction technology and cloning of humans. Legal and ethical restrictions have been presented and discussed for the benefit of physicians in order to increase their awareness of these matters

O responsável legal é de fato o responsável? Um questionamento ético-legal sobre o termo / Is the legally responsible party indeed responsible?An ethical-legal question on the term

Os autores discutem o significado ético e jurídico da expressão "responsável legal", questionando seus limites. Demonstram que de fato ela não atende satisfatoriamente o que se denomina responsabilidade legal, pois para tanto teria que encontrar amparo nos códigos e normas legais, o que, de fato, não acontece. Assim, a expressão representante legal pode não possibilitar ao profissional, quando de sua utilização respaldo ético e legal normativo a sua atividade profissional.

The authors discuss the legal and ethical meaning of the expression "Third-Party Consent" by questioning its limits. It is indeed shown that it does not satisfactorily meet what is called third-party consent because this would require legal endorsement by legal codes and norms which, in fact does not occur. As such, the expression "third-party consent", whenever used, may not provide the professional with the normative, ethical and legal support needed for professional performance.

Estimación de las capacidades de autocuidado para hipertensión arterial en una comunidad rural / Esteem of self-care capacities for arterial hypertension in countryside

Introducción: Las Capacidades de Autocuidado (CAC) están determinadas conceptualmente por Oremen la teoría del Déficit de Autocuidado. En las personas, es el desarrollo de habilidades especializadas que les permiten cuidar de su salud, estas tienen un profundo significado cultural y pueden ser adquiridas de forma intencional en estados de salud o enfermedad en el individuo. Objetivo: Estimar las capacidades de autocuidado (CAC) para hipertensión arterial en personas de 20 a 69 años de una comunidad rural. Metodología: A través de la visita domiciliaria en una comunidad rural del estado de Morelos, se hizo la selección en dos momentos hasta completar un total de 120 personas, en las que bajo consentimiento informado y previa estandarización de los procedimientos de medición clínica con base en la NOM-030-SSA2-1999, se realizó la medición y registro de la presión arterial. Para la valoración de las CAC se aplicó la versión en español de la Escala Estimativa de Capacidades de Autocuidado. Resultados: Dicha población presenta una edad promedio de 42 años, predominando el sexo femenino; se identificaron cifras de presión arterial por arriba de los estándares estableados en 16.6% de la población estudiada, en la cual se identificó una mejor capacidad de autocuidado que en las personas que presentaron cifras dentro de los rangos estándares de normalidad. Conclusiones: Con la aplicación de la escala estimativa de capacidad de autocuidado se logró identificar que las personas con hipertensión perciben mejor sus capacidades de autocuidado que las que no la presentan.

Introduction: Self-care capacities are conceptually determined by Orem, in the self-care deficit theory. The development of specialized abilities let people to care about their health. They have a deep cultural meaning and it could be acquire by an intentional way in health or illness statements on people. Objective: To estimate the self-care capacities for arterial hypertension on people from 20 to 69 years old in a rural community. Methodology and methods: During a home visit in a rural community at Morelos state in Mexico, a selection to get a total of 120 persons was made with its improvement and previous procedure standardization for clinical measurement done in base with NOM-030-SSA2-1999, measurement and registry of blood pressure were done either. For self-care capacities valuation, the Spanish version of the self-care capacities scale was applied. Results: The community presents an average age of 42 years old, predominating feminine genre, numbers of arterial pressure were identified above from the established standards on 16.6% of the studied population, in which was identified a better self-care capacity than people who presented numbers in the normal standard ranks. Conclusion: Applying the self-care capacities scale it was possible to identify people with hypertension who perceived on a better way their self-care capacities than with the people who does have it.

Uma boa prática médica / Good clinical practice

São abordadas as diretrizes para a condução de um estudo clínico em seres humanos. Esta revisão discute e apresenta as novas orientações internacionais para o desenvolvimento e acompanhamento de um ensaio clínico destacando as funções e responsabilidades de todos os envolvidos no processo

Proyecto de una unidad modelo de farmacología clínica para evaluar medicamentos genéricos intercambiables / Project for a model clinical pharmacology unit to evoluate interchangeable generic drugs

La regulación que en materia de prescripción de medicamentos se ha establecido en la práctica pública y privada para su denominación genérica, hace necesario que los sectores involucrados: instituciones de salud, industria farmacéutica, universidad y comunidad usuaria, den cumplimiento a los procedimientos normativos en torno a este nuevo sistema. Con fundamento en lo anterior, se ha estructurado el Programa gubernamental sobre medicamentos genéricos intercambiables, con un enfoque dirigido a la validación de fármacos, sin soslayar el impacto económico y social que aportará en los aspectos de costo-beneficio, costo-eficacia y costo-calidad. Este proyecto innovador contempla además la elaboración de un catálogo de actualización dinámica de este tipo de medicamentos, la apertura de un mercado nacional y la creación y desarrollo de unidades de farmacología clínica para su evaluación. Ante la creciente demanda de servicios en el área de la farmacología clínica será prioritarios contar en México con suficientes centros de investigación de alta calidad en este campo. El Instituto Mexicano del Seguro Social presenta en este documento el proyecto de una unidad modelo de farmacología clínica, instrumentada con la infraestructura suficiente que le permita la evaluación de medicamentos genéricos que se acreditarán como intercambiables, ya que no existen procedentes en el país de una estructura operativa con estas características. Así mismo, estas unidades especializadas podrán realizar funciones de apoyo en el proceso de enseñanza, e investigación, fungir como centros de información de medicamentos, farmacovigilancia, farmacoepidemiología, farmacoeconomía y de referencia a nivel nacional e internacional