Lesão Por Pressão Relacionada a Dispositivos Médicos: Frequência E Fatores Associados / Medical Device-related Pressure Injury: Frequency and Associated Factors / Lesión Por Presión Relacionada a Dispositivos Médicos: Frecuencia Y Factores Asociados

Objetivo:analisar a ocorrência de lesões por pressão relacionadas a dispositivos médicos em pacientes internados em unidade de terapia intensiva. Método: estudo quantitativo, de caráter observacional descritivo, do tipo coorte prospectivo, realizado com 171 pacientes, no período de 15 de maio a 31 de agosto de 2018 nas unidades de terapia intensiva de um hospital público do Distrito Federal. Resultados: os principais fatores de risco foram presença de lesões por pressão na admissão, com associação significativa para a formação de lesão por pressão relacionada a dispositivos médicos (p=0,002), e pacientes que evoluíam ao desfecho óbito, com associação para formação de lesão por pressão relacionada a dispositivos médicos (p=0,012); taxa de incidência de lesão por pressão relacionada a dispositivos médicos de 40,35%. Conclusão: o uso de dispositivo médico tem crescido, bem como a apropriação dessas tecnologias no ambiente de cuidados críticos. A equipe multiprofissional deve ficar atenta para a formação das lesões por pressão relacionadas a dispositivos médicos que podem acometer os pacientes internados.

Objective:to analyze the occurrence of pressure injuries related to medical devices in patients admitted to an intensive care unit. Method: quantitative, observational, descriptive, prospective cohort study, carried out with 171 patients, from May 15 to August 31, 2018 in the intensive care units of a public hospital in the Federal District. Results: the main risk factors were the presence of pressure injuries at admission, with a significant association for the formation of pressure injuries related to medical devices (p=0.002), and patients who progressed to death, with an association for the formation of pressure injuries related to medical devices (p=0.012); medical device-related pressure injury incidence rate of 40.35%. Conclusion: the use of medical devices has grown, as well as the appropriation of these technologies in the critical care environment. The multidisciplinary team should be aware of the formation of pressure injuries related to medical devices that can affect hospitalized patients.

Objetivo:analizar la ocurrencia de lesiones por presión relacionadas a dispositivos médicos en pacientes internados en unidad de terapia intensiva. Método: estudio cuantitativo, de carácter observacional descriptivo, del tipo cohorte prospectivo, realizado con 171 pacientes, en el periodo del 15 de mayo al 31 de agosto de 2018 en las unidades de terapia intensiva de un hospital público del Distrito Federal. Resultados: los principales factores de riesgo fueron presencia de lesiones por presión en la admisión, con asociación significativa para la formación de lesión por presión relacionada a dispositivos médicos (p=0,002), y pacientes que evolucionaron al desenlace de muerta, con asociación para la formación de lesión por presión relacionada a dispositivos médicos (p=0,012); tasa de incidencia de lesión por presión relacionada a dispositivos médicos del 40,35 %. Conclusión: el uso de dispositivo médico ha aumentado, así como también la apropiación de esas tecnologías en el ambiente de cuidados críticos. El equipo multiprofesional debe ser consciente de la formación de lesiones por presión relacionadas a dispositivos médicos que pueden afectar a los pacientes internados.

Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law / 中国药房

OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.

Brasil e Espanha: uma análise comparada sobre a concepção das políticas esportivas / Brazil and Spain: a comparative analysis on the design of sports policies

O estudo busca analisar como o esporte é tratado nos ordenamentos legais e dispositivos políticos do Brasil e da Espanha. Para tanto foi realizado um estudo comparado através de levantamento documental e revisão bibliográfica. Observou-se que o esporte aparece como dever do Estado em ambos os países, entretanto, a legislação infraconstitucional e os dispositivos, em quase sua totalidade, caminha no sentido de consolidar as práticas esportivas como mercadorias.

The study seeks to analyze how sport is treated in the legal systems and political provisions of Brazil and Spain. For this purpose, a comparative study was carried out through documentary survey and bibliographic review. It was observed that sport appears as a duty of the State in both countries, however, the infra-constitutional legislation and the devices, in almost their entirety, are moving towards consolidating sports practices as commodities.

Study on Main Changes of Counterfeit and Inferior Drugs ’Relevant Provisions in the Newly Revised Drug Administration Law and Their Impact on Law Enforcement / 中国药房

OBJECTIVE：To provide reference for further clarifying the definition of counterfeit and inferior drugs and law enforcement for revelent departments ，and guaranteeing the safety of drug use and legitimate right for the public. METHODS ： Through comparative research ，literature research and interpretation of the new law ，comprehensive analysis and research was conducted for the relevant provisions of counterfeit and inferior drugs in the newly revised Drug Administration Law in respect of the definition ，penalty rules and identification basis of counterfeit and inferior drugs. The challenges and impacts of these changes on drug law enforcement were put forward from the perspective of drug law enforcement practice. RESULTS & CONCLUSIONS ： In terms of definition ，the newly revised Drug Administration Law redefined the counterfeit and inferior drugs ，which was reduced from 15 cases before the amendment to 11 kinds，but the content was more abundant. It cancelled the concept of punishing counterfeit and inferior drugs ；increased the prohibition of the use of counterfeit and inferior drugs ；punished violation behavior of drug administration order not according to counterfeit and inferior drugs ；removed two items that being punished as counterfeit drugs；adjusted the definition of contaminated drugs from counterfeit drugs to inferior drugs ；clarified the definition of excipients. In terms of penalty provisions ，the provisions of legal liability for counterfeit and inferior drugs in the newly revised Drug Administration Law comprehensively used a variety of punishment measures ，greatly increased the amount of fine ；differentiated the situation of production ，wholesale and retail of inferior drugs ，and set different punishment ranges ；appropriately reduced the punishment range of producing and selling TCM decoction pieces that did not meet the drug standards ；increased the punishment for the violation of drug management order ，and the scope of punishment was similar to that of counterfeit and inferior @qq.com drugs. The “double penalty system ”was implemented for serious illegal acts and punished to individuals. The punishment for drug users who used counterfeit and inferior drugs was clarified. The situation of heavier punishment for producing and selling counterfeit and inferior drugs was increased ，and the first responsibility system and punitive compensation were added to protect the legitimate rights and interests of consumers. In terms of identification basis ，the newly revised Drug Administration Law had deleted the provisions that specific situation of quality inspection conclusion may not be specified ，and only provided the principle provisions. The challenges and impacts of the newly revised Drug Administration Law on law enforcement included how to understand the “ingredients”in the definition of counterfeit drugs；how to distinguish between deteriorated drugs and contaminated drugs ；how to investigate and deal with unauthorized acts ； whether drug inspection reports were required in all cases of counterfeit and inferior drugs ；how to understand the situation that did not affect the safety and effectiveness ，and connecting administrative law enforcement with criminal justice for counterfeit and inferior drugs ，etc. It is suggested to further strengthen the law popularization ，and introduce the interpretation of the newly revised Drug Administration Law as soon as possible ，clarify the legislative intent ，and guide the grassroots law enforcement ；issue Amendment Ⅺ to the Criminal Law of the People ’s Republic of China as soon as possible ，increase the charges of illegal acts against the order of drug administration ，do a good job in connecting administrative law enforcement with criminal justice and crack down on the illegal and criminal acts in the field of drugs ，and further promote the administration according to law.

Supervision System and Legal Applicability of Food and Drug Regulation / 中国药学杂志

OBJECTIVE: To standardize the concept and nature of food and drug regulatory filing behavior. METHODS: According to the provisions of laws, regulations, rules and regulatory documents in the regulation of food and Drug Administration, analyze the existing problems and application defects in the regulation of food and drug regulatory record. RESULTS: To suggest how to design and perfect the food and drug regulatory filing system. CONCLUSION: As a widely applicable administrative act, administrative record is closely related to the administrative organ and the administrative relative person. Administrative filing as an extensive application, and administrative organs and administrative counterparts are closely related to the administrative behavior, more and more play an important role. Therefore, it is necessary to clean up those filing provisions, which are not standardized in the existing laws, regulations, regulations; to regulate the establishment of food and drug regulatory administrative record; to build a sound food and drug regulatory administrative filing procedures.