Analysis and enlightenment of drug-related administrative penalty cases in medical institutions from 2020 to 2022 / 中国药房

OBJECTIVE To analyze the patterns and characteristics of drug-related administrative penalty cases with medical institutions as parties from 2020 to 2022 in order to further improve drug management in medical institutions. METHODS A retrospective statistical analysis was used to summarize the drug-related administrative penalty decisions with medical institutions as parties， and to match them with the provisions of the Drug Administration Law （2019 version） for statistical analysis. RESULTS There were 144 complete administrative penalty decisions with medical institutions as parties. Analyzed by cause， 126 cases of administrative punishment for inferior drugs accounted for 87.50%， of which expired drugs accounted for more than 50.00% of the inferior drug cases； 15 cases （10.42%） were for purchasing drugs from enterprises or individuals not qualified to operate drugs. Analyzed by the range of punishment amount of the cases， 34 cases （23.61%） resulted in lighter penalties， while 81 cases （56.25%） resulted in reduced penalties. CONCLUSIONS There are extremely few medical institutions that have received administrative penalties for drug management violations. Medical institutions should strengthen the awareness of law-abiding， and know the red line of drug management and the illegal behavior that is easy to occur， so as to better strengthen drug quality management.

Analysis of Penalties Imposed on Organisations for Breaching Safety and Health Regulations in the United Kingdom

BACKGROUND: The study analyzes penalties imposed on organizations for breaching safety and health regulations. The research questions are as follows: what are the commonly breached safety and health regulations? How proportional are penalties imposed on organizations for breaching health and safety regulations in the United Kingdom? METHODS: The study employed sequential explanatory mixed research strategies for better understanding of health and safety penalties imposed on organizations. Actual health and safety convictions and penalties data for 10 years (2006 to 2016) were obtained through the United Kingdom Health and Safety Executive (HSE) public register for convictions. Overall, 2,217 health and safety cases were analyzed amounting to total fines of £37,179,916, in addition to other wide-ranging penalties. For thorough understanding, eight interviews were conducted with industry practitioners, lawyers, and HSE officials as part of the study qualitative data. RESULTS: Findings show that the Health and Safety at Work (HSW) Act accounted for 46% of all HSE prosecution cases in the last decade. This is nearly half of the total safety and health at work prosecutions. Moreover, there is widespread desire for organizations to comply with the HSW Act, but route fines are seen as burdensome and inimical to business growth. CONCLUSION: A key deduction from the study reveal significant disproportionality concerning penalties imposed on organizations for breaching safety and health regulations. On aggregate, small companies tend to pay more for health and safety offenses in a ratio of 1:2 compared to large companies. The study also reveals that the HSW Act accounted for nearly half of the total safety and health at work prosecutions in the last decade.

Ethics committee laws, penalty comparison across globe: a mandatory thought before accreditation process in India.

To have a better quality of life and to fight with the diseases evolved the concept of clinical trials. A test of any new or existing drug on human being through different phases to check the efficacy and safety of the molecule is clinical trial. To cope up with the defects in drug system, India introduced Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules in 1945. Objective: To compare and contrast the different GCP guidelines and law suits, penalties, worldwide. We reviewed different internet databases and resources to find out the various penalties. The death occurring during clinical trials shook the pillars of credibility of clinical trials and led the government to make some regulatory provisions. The outcome is that now the ethics committee has to be accredited by a competent authority. This step led many problems for upcoming as well as the existing ethics committee and trial sites. The objective of the review article is to know the roles and responsibilities of different players of clinical trials i.e. the investigator, the sponsor and the ethics committee and to know the laws governing their responsibilities and the penalties affiliated to it. Since now the clinical trials in India are becoming more and more stricter there is a dire need to make aware the ethics committee members, sponsor and the investigator of their rights and duties towards one another and towards the patient/subject, so the tragedies in the clinical trials can be minimized.

Percepción, expectativas y temores frente al regreso a la libertad en una muestra de reclusos colombianos en el año 2011 / Perception, expectations and fears of return to freedom in a sample of Colombian prisoners in 2011 / Percepção, expectativas e temores perante ao retorno à liberdade em uma amostra de reclusos colombianos em 2011

El objetivo fue conocer la percepción frente al regreso a la libertad en una muestra de internos e internas condenados en doce establecimientos carcelarios y penitenciarios del Instituto Nacional Penitenciario y Carcelario (INPEC), y explorar las expectativas y los temores frente al regreso a la libertad. Para ello se aplicó el instrumento denominado "cuestionario de expectativas, percepciones y temores frente al regreso a la libertad" a 202 internos e internas, al igual que se realizaron unas preguntas sociodemográficas. Entre los resultados se encontró que más del 50 % de los internos e internas presentan un nivel alto de expectativas, percepciones y temores frente al regreso a la libertad, lo cual se relaciona con percepciones positivas, elevados niveles de seguridad y altas expectativas, a excepción de los ítems relacionados con las expectativas frente a la consecución de empleo, la formación recibida y su relación con la oferta laboral; los ítems relacionados con la confianza de la comunidad hacia ellos y la solidaridad y apoyo de la misma, y finalmente un ítem referido a la percepción de la ayuda económica por parte de la familia hacia ellos. Con referencia a la escala, presentó un Alfa de Cronbach de 0,77, un índice de confiabilidad alto.

The objective was to know the perception of convicted male and female inmates in a sample examined at twelve prison facilities of the National Penitentiary and Prison Institute (INPEC) with respect to their return to freedom, and explore their expectations and fears in the face of that eventuality. For this purpose, the instrument known as "questionnaire of expectations, perceptions and fears in the face of return to freedom" was applied in the case of 202 male and female inmates. Likewise, some sociodemographic questions were made, and among them it was found that those perceptions, expectations and fears were nurtured by more than 50% of them, this associated in turn with positive perceptions, high security levels, and high expectations with the exception of items relating to their prospects about getting a job, the training or instruction received and its relationship with labor supply, along with doubts having to do with confidence and trust from the community, as well as with its solidarity and support. Finally, an item referring to their perception about help and economic help to be expected from their families was included. Concerning the scale, it showed a Cronbach Alfa of 0.77, a high reliability index.

O objetivo foi conhecer a percepção perante ao retorno à liberdade em uma amostra de presos homens e mulheres condenados em doze prisões e penitenciárias do Instituto Nacional Penitenciário e Carcerário (INPEC), e explorar as expectativas e os temores perante ao retorno à liberdade. Deste modo, o instrumento chamado "questionário das expectativas, percepções e temores perante ao retorno à liberdade" foi aplicado para 202 presos mulheres e homens, e também foram realizadas perguntas sociodemográficas. Entre os resultados achou-se que mais de 50% dos presos homens e mulheres têm um nível alto de expectativas, percepções e temores perante ao retorno à liberdade, que é relacionado às percepções positivas, níveis elevados da segurança e altas expectativas, exceto os itens relacionados às expectativas perante à procura de emprego, treinamento recebido e sua relação com a oferta de trabalho; os itens relacionados à confiança da comunidade e a solidariedade e suporte, e finalmente um item referido à percepção da ajuda econômica por parte da família deles. Com referência à escala, apresentou um Alfa de Cronbach de 0.77, um índice elevado de confiabilidade.

Reflexões a respeito dos processos de judicialização e criminalização no controle da contemporaneidade / Reflections regarding processes judicialization and criminalization in control the contemporary / Reflexiones en relación con los procedimientos judicialización y en el control de penalización contemporáneo

As práticas de recurso ao Judiciário, para lidar com as tensões, têm-se expandido, nas últimas décadas, em um processo de judicialização e criminalização da vida. . Nos dois casos, assinalamos uma relação entre sociedade e o Poder Judiciário pautada na busca de ampliação das leis e tipificações penais como maneiras de governar condutas, no campo de um legalismo securitário. O Poder Judiciário parece converter-se em uma espécie de arena única para a qual converge toda sorte de tensão e desentendimento, e as leis, assim, transformam-se na linguagem dessa mediação. Porém, abordamos igualmente uma descrição e análise histórica que opera pela normalização da lei, nos tribunais da norma. Desse modo, buscamos, nesta breve análise, refletir sobre tais questões, propondo analisar esses dispositivos de controle que se intensificam na atualidade e que provocam novas formas de assujeitamento.

The practical uses of the judiciary to deal with the stress in have expanded in recent years; in a process judicialization and criminalization of life. We note a relationship between society and the Judiciary ruled in search of expanding laws and criminal typification as ways of governing conduct in the field of a security-legalism. The judiciary seems to become a kind of unique arena to which converge all sorts of tension and disagreement, and the laws thus become the language of this mediation. But also a description and analysis approach that operates by historical standards of the law in the courts of the norm. Thus, we seek in this brief analysis, reflect on these issues, proposing analyze these control devices which intensify today, and causing new forms of subjection.

La apelación a las prácticas judiciales para hacer frente a las tensiones, se han ampliado en las últimas décadas, en el proceso de legalización y la criminalización de la vida. Observamos uma relación entre la sociedad y el poder judicial gobernado en la búsqueda de la expansión de las leyes penales y tipificaciones como formas de regir la conducta en el ámbito de la seguridad-legalismo. El poder judicial parece convertirse en una especie de escenario único para que convergen todo tipo de tensión y desacuerdo, y las leyes, por lo tanto, se convierten en el lenguaje de esta mediación. Pero también nos acercamos a una descripción y análisis histórico que opera la normalización de la ley en los tribunales de la norma. De este modo, se busca, en este breve análisis, reflexionar sobre estas cuestiones, proponiendo analizar estos dispositivos de control que intensifican hoy y las nuevas formas de provocación de sujeción.

Qualitative research on the impact of administrative penalties on medical staff in medical disputes / 中国实用护理杂志

Objective To describe the impact of administrative penalties for medical disputes on the medical staff, including their perception on the penalty and its impact on their mind and body, professional behavior, career development, etc, and to provide a theoretical basis for health policy making and hospital management. Methods The phenomenological research method was adopted to conduct in-depth interview to 10 hospital staff in Taian who were involved in medical disputes and got punished, and the Giorgi qualitative data analysis was used in the research. Results The interviewees′perception and impacts of the punishment were concluded into five aspects:physiologically, psychologically, cognitively, behaviorally and professional development. Conclusions It is concluded that the current punishment to individuals has caused quite negative effects, and a new mechanism should be established to systematically reconstruct the procedure and reduce the medical disputes to the minimum.

Las medidas de seguridad en materia penal juvenil / Security measures in juvenile criminal law

En la actualidad exite una ardua discusión sobre las sanciones dentro del derecho penal juvenil, tema que cobra especial relevancia cuando nos enfrentamos a conductas delictivas cometidas por personas menores de edad en las cuales se ha determinado su condiciçon de inimputables o toxicómanos a partir de las conclusiones de las pericias respectivas. El cuestionamiento nos lleva a dos posibles soluciones: una darle un abordaje como un problema de salud y excluirlo del derecho penal y otra, mantener la línea tradicional, en la cual se faculta al derecho penal sancionar la conducta delictiva, imponiendo una medida de seguridad. Si se admite la primera posición, la normativa aplicable lo constituye el Código de la Niñez y la Adolescencia, el cual contempla la posibilidad de imponer medidas de protección para quienes están en una situación de vulnerabilidad, dentro de las que se ubican los casos de inimputables y toxicómanos, esto implica admitir medidas de "seguridad o protección" con una naturaleza jurídica de carácter administrativo. Posición que implicaría no sólo una vulneración de derechos sino que contraviene lo señalado por Sala Constitucional, la cual al desarrollar el alcance del artículo 39 de la Constitución Política, ha señalado que la imposición de las sanciones y por ende de las medidas de seguridad gozan de la garantía de la reserva de ley, destacando su naturaleza jurisdiccional y exclusivamente ante la comisión de delitos. La única solución posible en aras del respeto de esta reserva legal, es aplicar, conforme al artículo 9 de la Ley de Justicia Penal Juvenil la legislación penal de adultos y admitir la imposición de medidas de seguridad en la justicia penal juvenil.

Currently, there has been an arduous discussion about penalties in juvenile criminal law, topic which becomes especially relevant when we are faced to criminal conducts from people who are underage, in which their condition of not guilty or drug addict has been determined from the conclusions of respective expertise. The question leads up to two possible solutions: first, face it like a health problem and exclude it from criminal law; second, keep the traditional line, in which the criminal law can punish the criminal conduct, imposing a security measure. If we admit the first solution, the laws applicable are the Code of Childhood and Adolescence, contemplating the possibility of applying protection measures towards those who are in a vulnerable situation, in which we would put the cases of the not guilty and the drug addicts; this would imply admitting "security or protection" measures with a juridical nature of administrative sort. Position that would imply not only a weakening of rights, but would also violate what the Constitutional Chamber has said, when studying the scope of Article 39 of the Political Constitution, that the imposition of punishments and security measures have the guarantee of law reserve, which makes its nature jurisdictional and exclusive to when a crime is committed. The only possible solution, in order to respect this law reserve, is to apply, according to Article 9 of the Law of Juvenile Criminal Justice, the legislation applicable to adults and to admit the imposition of security measures in juvenile criminal justice.