Implications of the concept of the standard of care on self-regulation and medical ethics based on medical regulation

Self-regulation has a long tradition in countries such as Germany. In healthcare, a professional level of quality is known as the standard of care, but the concept is not defined by law. In practice, this concept has developed into physician self-regulation. In addition, a normative judgment about the medical standard can be understood as a concept developed by precedent related to medical malpractice cases. The law functions reactively rather than proactively. However, clinical ethics has a wider scope within the legal field than simply the corrective function of medical liability. This study focuses on a legal approach to self-regulation, the normative concept of medical standards in legal criteria, and its requirement. Regarding civil responsibility, the paper reviews an assessment of autonomy in the determination of the medical standard. In comparison to the disciplinary system of Germany's criminal law, the offenses of doctors under Korean law is considerably below the international standards for self-regulation. In fact, discipline for malpractice is effectively regulated by the state. Therefore, when doctors take an ethical approach, it can help protect patients and at the same time raise a sense of professional responsibility. This plays an important role in the complementary relationship between medical ethics as a preventive function and the standard of care or practice standards as a part of self-regulation. In conclusion, self-regulation can have a much more effective and positive impact on relationships between the patient and the doctor and strengthen preventive measures for the patient's safety within medical regulation.

Current status and plans for development of medical self-regulation in Korea

Following several medical scandals, the issue of medical regulation has come under the spotlight in the Republic of Korea. In this article, the authors examine the administrative measures newly required of doctors in the past five years in order to illustrate the current state of medical regulation and demonstrate the urgent need for self-regulation. The history of the General Medical Council in the United Kingdom and its newly launched system of "revalidation" can provide an instructive example of a self-regulation system, and it suggests several principles for self-regulation in Korea. The recent disarray can be viewed as an opportunity to introduce a new system of self-regulation. The authors present three principles-professionalism, transparency, and fairness-for a successful system of medical regulation.

Clinical and regulatory protocol for the treatment of jaundice in adults and elderly subjects: a support for the health care network and regulatory system / Protocolo clínico e de regulação para o tratamento de icterícia no adulto e idoso: subsídio para as redes assistenciais e o complexo regulador

PURPOSE: Clinical interventions and controlled access to the health care system can be improved by a Regulatory System (RS) and Clinical and Regulatory Protocols (CRPs). The objective of the present paper is to present the methodology used for elaborating the CRPs. METHODS: The process used to elaborate the CPRs involved a scientific co-operation between university and health care system. Workshops were held and attended by primary care practitioners, RS team, and matrix team (university specialists supporting primary care practitioners). RESULTS: The treatment of jaundice in adults and elderly subjects is amongst the themes selected for elaborating the CRPs since jaundice is a medical sign frequently seen in four clinical scenarios involving distinctive diagnostic and therapeutic interventions which can be performed in different health care settings. Evaluation guidelines as well as the clinical and regulatory procedures were established for different health care settings. The most relevant clinical and regulatory interventions were expressed as algorithms in order to facilitate the use of CRPs by health care practitioners. CONCLUSION: It is expected that the implementation of this protocol will minimise the imbalance between the icteric patients' needs and the treatment modalities being offered, thus contributing to a more co-operative health care network.

OBJETIVO: As ações clínicas e de ordenação do acesso à rede de saúde podem ser aperfeiçoadas pelo Complexo Regulador (CR) e pelos Protocolos Clínicos e de Regulação (PCR). Nesse trabalho apresenta-se a metodologia de elaboração dos PCR mediante cooperação entre universidade e sistema de saúde. MÉTODOS: O processo utilizado para a elaboração dos PCR envolve oficinas com a participação de profissionais da atenção básica, do CR e das equipes matriciais (especialistas da universidade que dão suporte às equipes de atenção básica). RESULTADOS: Dentre os temas selecionados para elaboração dos PCR, incluiu-se a icterícia no adulto e no idoso. Trata-se de um sinal clínico que comporta quatro cenários de apresentação com distintos percursos diagnósticos e terapêuticos passíveis de serem executados em diferentes pontos da rede assistencial. As diretrizes de avaliação, bem como as decisões e ações clínicas e reguladoras cabíveis para os diferentes cenários foram estabelecidas desde a atenção básica até o hospital terciário. As ações clínicas e reguladoras mais relevantes foram colocadas em algoritmo para facilitar o emprego do protocolo pelos profissionais de saúde. CONCLUSÃO: Há a expectativa que a implementação desse protocolo possa minimizar o descompasso entre as necessidades dos pacientes ictéricos e a modalidade de serviço oferecida e, assim, contribuir para a configuração de uma rede assistencial mais cooperativa.

The influence of treatment access regulation and technological resources on the mortality profile of acute biliary pancreatitis / A influência da regulação do acesso aos serviços de saúde e da incorporação tecnológica no perfil de mortalidade da pancreatite aguda biliar

PURPOSE: The influence of treatment access regulation and technological resources on the mortality profile of acute biliary pancreatitis (ABP) was evaluated. METHODS: The cases seen in a tertiary hospital were studied during two periods of time: 1995-1999 and 2000-2004, i.e., before and after the implementation of medical regulation. RESULTS: Among the 727 patients with acute pancreatitis, 267 had ABP and were classified according to APACHE II scores. The cases being referred to the tertiary hospital decreased from 441 to 286 (p < 0.001). The patients' profile regarding age, gender, severity, cholestasis incidence and mortality were similar during the first and second periods of study (n = 154 and n = 113, respectively). The number of patients with hematocrit > 44 percent was smaller during the second study period (p<0.002). The use of magnetic resonance cholangiography, videolaparoscopic cholecystectomy, and access to the ICU were found to be more frequent during the second study period. Regarding the deaths occurring within 14 days of hospitalisation, 73.4 percent and 81.3 percent were observed during the first and second study periods, respectively. CONCLUSION: Since the improvement in clinical and technological approach was not enough to modify the mortality profile of ABP, further studies on the treatment of inflammatory responses should be carried out.

OBJETIVO: Avaliou-se a influência do acesso aos recursos assistenciais e tecnológicos sobre a mortalidade na pancreatite aguda biliar (PAB). MÉTODOS: Os casos de PAB tratados num hospital universitário foram estudados em dois períodos: 1995 a 1999 e 2000 a 2004, antes e depois da implantação da Regulação Médica. RESULTADOS: Do total de 727 casos com pancreatite aguda atendidos, 267 apresentavam PAB e tiveram a gravidade avaliada pelo escore de APACHE II. Houve redução dos encaminhamentos de casos entre os períodos, de 441 para 286 (p < 0,001). O perfil dos pacientes com PAB no primeiro período (n = 154) e no segundo (n =113) foi semelhante quanto à idade, sexo, gravidade, incidência de colestase e mortalidade. A incidência de pacientes com hematócrito > 44 foi menor no segundo período (p < 0,002). O emprego de colangiografia por ressonância magnética, da colecistectomia por videolaparoscopia e do acesso à terapia intensiva foi significantemente maior no segundo período. A maioria dos óbitos ocorreu até os 14 dias de admissão, 73,4 por cento no primeiro período e 81,3 por cento no segundo. CONCLUSÃO:A melhora do suporte tecnológico e clínico não foi suficiente para modificar o perfil de mortalidade na PAB, o que indica a necessidade de avaliar terapêuticas para a sua resposta inflamatória.