Evidências do gerenciamento de resíduos dos serviços de saúde na atenção primária / Evidencia de gestión de residuos de servicios de salud en la atención primaria / Evidence of health service waste management in primary care

Objetivo: Descrever o estado das evidências relacionadas ao gerenciamento e educação em serviço da equipe interprofissional sobre Resíduos dos Serviços de Saúde (RSS), especificamente na Atenção Primária à Saúde (APS). Método: Revisão integrativa nas bases LILACS, BDENF, PubMed®, WOS, CINAHL e SciVerse Scopus entre 2010 e 2020 nos idiomas português, inglês e espanhol. Resultados: A amostra foi de 17 artigos de países emergentes e subdesenvolvidos, com carência de conhecimentos e inconformidades no gerenciamento e cumprimento das normativas quanto à saúde ambiental, resvalando em riscos ocupacionais. A interpretação gerou: (1) O gerenciamento e a premência da educação permanente em serviço: entre inadequações e adequações e (2) Propostas de efetivação do gerenciamento correto na Atenção Primária. Conclusão: Sintetizaram-se evidências de nível VI, descrevendo a premência de educação permanente em serviço para mudança de práticas e uma maior atenção ao Plano de Gerenciamento dos Resíduos de Serviços de Saúde na APS.

Objective: To describe the state of evidence related to the management and in-service education of the interprofessional team on Waste from Health Services (WHS), specifically in Primary Health Care (PHC). Method: Integrative review in LILACS, BDENF, PubMed®, WOS, CINAHL and SciVerse Scopus databases between 2010 and 2020 in Portuguese, English and Spanish. Results: The sample consisted of 17 articles from emerging and underdeveloped countries, with a lack of knowledge and nonconformities in the management and compliance with regulations regarding environmental health, slipping into occupational risks. The interpretation generated: (1) The management and urgency of continuing education in service: between inadequacies and adaptations and (2) Proposals for effective management in Primary Care. Conclusion: Level VI evidence was synthesized, describing the need for permanent in-service education to change practices and pay greater attention to the Health Services Waste Management Plan in PHC.

Objetivo: Describir el estado de la evidencia relacionada con la gestión y educación en servicio del equipo interprofesional sobre Residuos de los Servicios de Salud (RSS), específicamente en la Atención Primaria de Salud (APS). Método: Revisión integradora en las bases de datos LILACS, BDENF, PubMed®, WOS, CINAHL y SciVerse Scopus entre 2010 y 2020 en portugués, inglés y español. Resultados: La muestra estuvo conformada por 17 artículos de países emergentes y subdesarrollados, con desconocimiento e inconformidades en la gestión y cumplimiento de las normas en materia de salud ambiental, incursionando en los riesgos laborales. La interpretación generó: (1) La gestión y urgencia de la educación permanente en servicio: entre insuficiencias y adaptaciones y (2) Propuestas para una gestión eficaz en Atención Primaria. Conclusión: Se sintetizó evidencia de nivel VI, describiendo la necesidad de educación permanente en servicio para cambiar prácticas y prestar mayor atención al Plan de Gestión de Residuos de los Servicios de Salud en la APS.

Resíduos de Serviços de Saúde: o que mudou na legislação? / Waste from Health Services: what has changed in the legislation?

Introdução: os Resíduos de Serviços de Saúde (RSS) têm sido uma fonte de preocupação para os gestores hospitalares, pois necessitam atender às exigências legais; nos últimos anos houve mudanças no Brasil com a publicação da atual Resolução de Diretoria Colegiada (RDC) 222/18, que normatiza o gerenciamento interno dos resíduos. Objetivo: comparar a RDC 306/04 com a RDC 222/18 quanto ao gerenciamento de Resíduos de Serviços de Saúde, bem como apresentar as implicações da legislação em vigência. Material e Método: trata-se de uma pesquisa exploratória e descritiva, de abordagem qualitativa do tipo documental; para tal, criou-se um roteiro de análises baseado nas etapas de gerenciamento dos RSS; os resultados foram apresentados em tabelas por grupos (A, B, C, D e E) que foram as categorias documentais para a comparação da legislação RDC 306/04 com a RDC 222/18. Resultados: observou-se importantes mudanças na lei atual, com impacto para os gestores e profissionais que atuam em hospitais, como o descarte de bolsas de sangue e peças anatômicas caracterizadas como A1, liberação de descarte de equipamentos de proteção individual (EPIs) como resíduos do Grupo D comum, seringas e agulhas podem ser desconectadas quando tiverem o dispositivo de segurança, novos critérios para descarte de oito grupos de medicamentos, entre outras. Discussão: as mudanças citadas necessitam ser incorporadas nos planos de gerenciamento, planejamento de novos fluxos de segregação de resíduos e aquisição de novos coletores que em médio prazo podem contribuir na redução de custo financeiro, e diminuição dos impactos ambientais desses resíduos quando descartados de forma segura. Conclusão: ao comparar as duas legislações, o presente estudo contribui para direcionar as adequações necessárias, a fim de atender a atual legislação, com informações diretas para orientar novos critérios de classificação, acondicionamento, tratamento e destinação final para o gerenciamento seguro dos resíduos nos serviços de saúde.

Introduction: Waste from Health Services (RSS) has been a source of concern for hospital managers, as they need to meet legal requirements; in recent years there have been changes in Brazil with the publication of the current Resolution of the Collegiate Board 222/18, which regulates the internal management of waste. Objective: to compare Resolution of the Collegiate Board 306/04 with Resolution of the Collegiate Board 222/18 regarding the management of RSS, as well as present the implications of the legislation in force. Material and Method: this is an exploratory and descriptive research, with a qualitative approach of the documentary type; for this, an analysis script was created based on the steps of managing the RSS; the results were presented in tables by groups (A, B, C, D and E) which were the document categories for the comparison of legislation Resolution of the Collegiate Board 306/04 with Resolution of the Collegiate Board 222/18. Results: important changes were observed in the current law, with an impact on managers and professionals working in hospitals, such as the disposal of blood bags and anatomical parts characterized as A1, release of disposal of Personal Protective Equipment as waste from Group D common, syringes and needles can be disconnected when they have the safety device, new criteria for disposing of eight groups of drugs, among others. Discussion: the aforementioned changes need to be incorporated into management plans, planning new waste segregation flows and acquisition of new collectors that in the medium term can contribute to reducing the financial cost, and reducing the environmental impacts of these wastes when disposed of safely. Conclusion: by comparing the two legislations, this study contributes to direct the necessary adjustments, in order to meet the current legislation, with direct information to guide new classification, packaging, treatment and final disposal criteria for the safe management of waste in the services of health.

The FAIRness of data management plans: an assessment of some European DMPs / FAIRness dos planos de gestão de dados: uma avaliação de alguns PGDs Europeus / FAIRness de los planes de gestión de datos: una evaluación de algunos PGDs Europeos

The FAIR principles have become a data management instrument for the academic and scientific community, since they provide a set of guiding principles to bring findability, accessibility, interoperability and reusability to data and metadata stewardship. Since their official publication in 2016 by Scientific Data ­ Nature, these principles have received worldwide recognition and have been quickly endorsed and adopted as a cornerstone of data stewardship and research policy. However, when put into practice, they occasionally result in organisational, legal and technological challenges that can lead to doubts and uncertainty as to whether the effort of implementing them is worthwhile. Soon after their publication, the European Commission and other funding agencies started to require that project proposals include a Data Management Plan (DMP) based on the FAIR principles. This paper reports on the adherence of DMPs to the FAIR principles, critically evaluating ten European DMP templates. We observed that the current FAIRness of most of these DMPs is only partly satisfactory, in that they address data best practices, findability, accessibility and sometimes preservation, but pay much less attention to metadata and interoperability.

Os princípios FAIR tornaram-se um instrumento de gestão de dados para a comunidade acadêmica e científica, uma vez que fornecem um conjunto de princípios orientadores que facilitam a localização, acessibilidade, interoperabilidade e reutilização de dados e metadados. Desde sua publicação oficial em 2016 pela Scientific Data - Nature, esses princípios receberam reconhecimento mundial e foram rapidamente endossados e adotados como pilares da gestão de dados e das políticas de pesquisa. No entanto, quando postos em prática, apresentam ocasionalmente desafios organizacionais, jurídicos e tecnológicos que podem levar a dúvidas e incertezas quanto ao esforço em implementá-los. Logo após sua publicação, a Comissão Europeia e outras agências de financiamento começaram a exigir nas suas propostas de projetos um Plano de Gestão de Dados (PGD) com base nos princípios da FAIR. Este artigo relata a aderência dos PGDs aos princípios FAIR, avaliando criticamente dez modelos europeus de PGD. Observamos que o nível de FAIRness da maioria dos PGDs analisados ainda é parcialmente satisfatório, uma vez que abordam as melhores práticas de dados, localização, acessibilidade e, às vezes, preservação, mas dão pouca atenção aos metadados e a interoperabilidade.

Los principios FAIR se han convertido en una herramienta de gestión de datos para la comunidad académica y científica, ya que proporcionan un conjunto de principios rectores que facilitan la localización, accesibilidad, interoperabilidad y reutilización de la gestión de datos y metadatos. Desde su publicación oficial en 2016 por Scientific Data - Nature, estos principios han recibido reconocimiento mundial y fueron rápidamente respaldados y adoptados como pilares de la política de investigación y gestión de datos. Sin embargo, cuando se ponen en práctica, ocasionalmente presentan desafíos organizativos, legales y tecnológicos que pueden generar dudas e incertidumbres sobre el esfuerzo para implementarlos. Poco después de su publicación, la Comisión Europea y otras agencias de financiación comenzaron a exigir en sus propuestas de proyectos un Plan de Gestión de Datos (PGD) basado en los principios de FAIR. Este artículo informa sobre la adherencia de los PGD a los principios FAIR, evaluando críticamente diez modelos europeos de PGD. Observamos que el nivel de FAIRness de la mayoría de los PGD analizados sigue siendo parcialmente insatisfactorio, ya que abordan las mejores prácticas de datos, ubicación, accesibilidad y, a veces, preservación, pero prestan poca atención a los metadatos y la interoperabilidad.

Validación del instrumento sobre manejo de las estrategias de conservación ambiental para reducir, reciclar y reutilizar los desechos sólidos / Validation of the tool on management of environmental conservation strategies to reduce, recycle and reuse solid waste

Las actividades humanas producen un fuerte impacto en la degradación del ambiente. Por tanto, es necesario considerar que, si bien es cierto que en general, los residuos que genera no son tóxicos, su volumen es considerable, produciendo contaminación visual y la rápida colmatación de los vertederos. Objetivo: la presente propuesta de estudio tiene como objetivo validar un instrumento de investigación con el fin de obtener los datos necesarios para diseño de un plan de manejo ambiental y la búsqueda de estrategias para clasificar, reducir, y reutilizar los desechos. Y que autoevalúe el sistema de gestión ambiental, teniendo en cuenta aquellos aspectos relacionados con la normatividad de medio ambiente. Materiales y métodos: El instrumento fue sometido a consideración por juicio de expertos en el tema en el que intervinieron 3 PhDs y 2 especialistas del tema y determinó el grado pertinencia, la validez y la confiabilidad, aplicando el método Delphi que permite encontrar el coeficiente de competencia en forma y contenido. Resultados: Se evidencia que tanto los PhD y los especialistas indican que el instrumento está en la categoría de excelente, por tanto, se puede afirmar que es un instrumento pertinente, válido y confiable para ser aplicado en una prueba piloto. Conclusión: El instrumento presenta validez y confiabilidad aceptable para medir el manejo de las estrategias de conservación ambiental con el fin de reducir, reciclar y reutilizar los desechos sólidos(AU)

Human activities produce a strong impact on the degradation of the environment. Therefore, it is necessary to consider that, although it is true that in general, the waste generated is not toxic, its volume is considerable, producing visual pollution and the landfills rapid clogging. Objective: The purpose of this study proposal is to validate a research instrument in order to obtain the necessary data for the design of an environmental management plan and the search for strategies to classify, reduce and reuse waste. In addition, to self-evaluate the environmental management system, taking into account those aspects related to environmental regulations. Materials and methods: The instrument was submitted to the judgment of experts in the subject, in which three PhDs and two specialists in the subject participated and determined the degree of relevance, validity and reliability, applying the Delphi method that allows finding the coefficient of competence in form and content. The results: It is evident that both the PhDs and the specialists indicate that the instrument is in the excellent category; therefore, it can be affirmed that it is a pertinent, valid and reliable instrument to be applied in a pilot test. Conclusion: The instrument presents acceptable validity and reliability to measure the management of environmental conservation strategies to reduce, recycle and reuse solid waste(AU)

Investigation of the Description of Important Identified Risks and Important Potential Risks in Risk Management Plan in Patient Information Materials / 医薬品情報学

Objective: The Risk Minimization Plan is developed in the Risk Management Plan (RMP), patient information materials are sometimes prepared as Additional Risk Minimization Activities (ARMA). On the other hand, there are many patient information materials that are not prepared as RMP materials, but are prepared independently by pharmaceutical companies and are actually used to provide information to patients. However, there is no detailed report on the differences between them. Therefore, in this report, we investigated for description of Important Identified Risks (IIRs) and Important Potential Risks (IPRs) in patient information materials.Methods: The previously published RMP of 588 drugs were obtained on October 1,2020, and used in analysis. We surveyed the description of IIRs and IPRs in patient information materials, and compared patient information materials based on ARMA in the RMP (patient information materials as RMP materials) and patient information materials developed independently by pharmaceutical companies that are not based on ARMA in the RMP (patient information materials as not RMP materials).Results: Of the 588 drugs, 454 drugs had patient information materials. In addition, 241 drugs had patient information materials as RMP materials. One thousand fifteen of the 1,577 IIRs were listed in the patient information materials as RMP materials (64.4%listing rate). One hundred sixty-six of the 724 IPRs were listed in the patient information materials as RMP materials (22.9%). On the other hand, 700 of the 1,131 IIRs were listed in the patient information materials as not RMP materials (61.9% listing rate). Ninty one of the 447 IPRs were listed in the patient information materials as not RMP materials (20.4%).Conclusion: It was found that there was no difference in the description of IIRs and IPRs between patient information materials as RMP materials and patient information materials as not RMP materials.

Concept of Routine Pharmacovigilance, Especially Signal Management in the US and Europe / 薬剤疫学

Monitoring of the safety profile for the approved medical products consists of routine pharmacovigilance activities for all drugs and additional pharmacovigilance activities for product-specific concerns. Signal management is an important part of routine pharmacovigilance activities, so EMA and FDA have published the guidelines for signal management in various documents. The AMED Risk Management Plan （RMP） research group, which started its activities in 2018 to enhance risk management plan in Japan, reviewed the guidelines and related articles and then put together the principles of signal management. The guidelines in EU and US describes the signal detection and evaluation methods including points to consider when conducting them, responsibilities of each action, and the procedures that the regulatory authorities disclose the outcome of their activities, in addition to the principles and procedures of signal management. Through the guidelines, they establish transparency for public including pharmaceutical industry. Our group first created the Japanese definitions of signal-related terms. Based on them, we created high-level concept for a series of activities from signal detection to risk identification and discussed the future vision of signal management in Japan.

Study on Post-marketing Drug Risk Management Plan in Japan and Its Enlightenment to China / 中国药房

OBJECTIVE：To provide reference for i mproving the post-marketing drug risk management in China by refering to the experience of post-marketing drug risk management plan （RMP）in Japan. METHODS ：The process of post-marketing drug regulation in Japan was introduced ，and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use （ICH）guidelines embodied in RMP in Japan were analyzed. The formulation and application of RMP in Japan during the post-marketing safety management were studied. And suggestions were offered for the improvement of post-marketing drug risk management in China. RESULTS & CONCLUSIONS ：The post-marketing regulation of drugs in Japan is characterized with dynamic regulation and social co-governance. ICH principle runs through the RMP management in Japan. Safety specification and risk minimization activities stipulated in RMP in Japan are consistent with ICH guidelines. RMP is defined in Pharmaceutical Affairs Law in Japan ，and is formulated and implemented under the guidance of the Good Vigilance Practice ；the changes are made under the guidance of the Good Post-marketing Study Practice. RMP is a necessary document for the registration and the re-review of new drugs in Japan ，its formulation is responsible by pharmaceutical enterprise ；RMP of new drug is available to the public through the subscription media system of Pharmaceuticals and Medical Devices Agency （PMDA）， which reflects the multi-governance of the government-pharmaceutical enterprises-the public. In China ，RMP supervision is not systematic and is inexperienced，and there is a lack of guidance documents and insufficient application of information and communication technology. It is suggested that China should strengthen post-marketing safety data management ，promote the connection between sentinel hospitals and pharmacovigilance systems of pharmaceutical enterprise ，increase the application of information and communication technology. Relevant normative documents and guidance documents of RMP should be issued by National Medical Products Administration. And the post-marketing supervision system for drugs should be clarified. Taking RMP publicity as an opportunity promote drug risk mamagement co-government ， realize sunshine and scientific supervision .

Reef fishes biodiversity and conservation at the largest Brazilian coastal Marine Protected Area (MPA Costa dos Corais)

Abstract Coral reefs harbor one of the largest fish biodiversity on earth; yet information on reef fishes is still absent for many regions. We analyzed reef fish richness, distribution, and conservation on the largest Brazilian multiple use coastal MPA; which cover a large extent of coral reefs at the SWA. A total of 325 fish species have been listed for MPA Costa dos Corais, including Chondrichthyes (28 species) and Actinopterygii (297). Fish species were represented by 81 families and the most representative families were Carangidae (23 species), Labridae (21) and Gobiidae (15). The MPA fish richness represented 44% of all recorded fish species of the Southwestern Atlantic Ocean (SWA) highlighting the large-scale importance of this MPA. A total of 40 species (12%) are registered at Near Threatened (NT), Vulnerable (VU), Endangered (EN) or Critically Endangered (CR). This study reinforces the importance of MPA Costa dos Corais on reef fish biodiversity and conservation and emphasize the urgent need of conservation strategies.

Resumo Os recifes de coral abrigam uma das maiores biodiversidades de peixes do planeta; no entanto, as informações sobre peixes de recife ainda estão ausentes em muitas regiões. Analisamos a riqueza, distribuição e a conservação de peixes recifais na maior Área de Proteção Ambiental (APA) costeira de uso múltiplo do Brasil; área que possui grande extensão de recifes de corais no SWA. Um total de 325 espécies de peixes foram listadas para APA Costa dos Corais, incluindo Chondrichthyes (28 espécies) e Actinopterygii (297). As espécies de peixes foram representadas por 81 famílias e as famílias mais representativas foram Carangidae (23 espécies), Labridae (21) e Gobiidae (15). A riqueza de peixes da APA representou 44% de todas as espécies de peixes registradas no Oceano Atlântico Sudoeste (SWA), destacando a importância em grande escala desta APA. Um total de 40 espécies (12%) estão registradas como Quase Ameaçada (NT), Vulnerável (VU), Em Perigo (EN) ou Criticamente Em Perigo (CR). Este estudo reforça a importância da APA Costa dos Corais na biodiversidade e conservação dos peixes recifais e enfatiza a necessidade urgente de estratégias de conservação.

Management plan for prevention and control of novel coronavirus pneumonia among children in Xiangya Hospital of Central South University / 中国当代儿科杂志

@#Since December 2019, an epidemic of novel coronavirus pneumonia (NCP) has occurred in China. How to effectively prevent and control NCP among children with limited resources is an urgent issue to be explored. Under the unified arrangement of the Xiangya Hospital of Central South University, the Department of Pediatrics has formulated an action plan with Xiangya unique model to prevent and control NCP among children according to the current epidemic situation and diagnostic and therapeutic program in China.

Survey on Timing Related to Preparation and Publishing of Risk Management Plans / 医薬品情報学

Objective: Risk Management Plan (RMP) is created and submitted by a pharmaceutical company while applying for new drug approval; it is published to be used by healthcare professionals. For example, healthcare professionals utilize RMP when considering whether to adopt a drug. However, there is no stipulation for the release date of RMPs; moreover, surveys regarding this are limited. We conducted a cross-sectional survey on the relationship between RMP-related timing and regulatory affairs-related timing.Methods: The surveyed drugs were those for which the first version of RMP was notified by PMDA Medinavi (mail delivery service) in FY2014 and FY2018. We examined regulatory affairs-related timing (i.e., “manufacturing and marketing approval date,” “drugprice standards listing date,” and “release date”) and RMP-related timing (i.e., “RMP creation date” and “Medinavi delivery date”).Results: For 7 of 43 items in FY2014 and 5 of 41 items in FY2018, the “RMP creation date” occurred later than the “drug-price standards listing date.” For one item in FY2014, the “RMP creation date” occurred later than the “release date.” For 12 items in FY2014 and 13 items in FY2018, the “Medinavi delivery date” occurred later than the “release date.”Conclusion: No considerable difference was confirmed between FY2014 and FY2018 regarding RMP-related timing and regulatory affairs timing. It was confirmed that there were several items for which the RMP creation occurred later than drug-price standard listing and items for which the publishing notice by Medinavi was delayed for drug marketing release. To promote the utilization of RMPs by healthcare professionals, RMPs must be created and published without delay.

Survey of the Description of “Medication Guides for Patients” and “Early Post-Marketing Phase Vigilance” on Additional Risk Minimization Activities of Risk Management Plans / 医薬品情報学

Objective: The risk management plan (RMP) is a useful information source for healthcare professionals, including pharmacists, to ensure drug safety. The “risk minimization activities” (RMA) of the RMP are especially important elements for healthcare professionals. It is known that “Medication Guides for Patients” (MGP) and “Early post-marketing phase vigilance” (EPPV) are items listed as part of the RMA. However, the creation of MGPs and the implementation of EPPVs are not performed for all medicines. In a previous study, it was difficult to evaluate this sufficiently with the safety specifications. The aim of this investigation was to evaluate RMAs, especially MGPs and EPPVs, not in terms of the safety specifications of RMP.Methods: The previously published RMPs of 177 drugs were obtained on February 22,2016, and used in the analysis. The relationship between the creation of the MGP and the description in the RMA and the relationship between the conduct described in the EPPV and the description in RMA was investigated for each medicine.Results: An MGP was created in 151 of the analyzed drugs. Of these, it was not listed in the RMA of 40 drugs. In contrast, EPPV was not listed in RMA in 2 out of 33 drugs when underway. EPPV was described in the RMA of 33 of the EPPV finished drugs. The time lag from the end of EPPV until the revision of the RMP was 4.5 month son average.Conclusion: MGPs and EPPVs are created especially for drugs requiring patient education, information provision, or safety monitoring. Therefore, for drugs for which MGPs or EPPVs are required, they should be listed in the RMA. In this study, the time lag of RMP revision was also highlighted as a problem. In order to promote the utilization of RMP by pharmacists, these issues should be resolved.

Research for Recognition of Pharmaceutical Companies toward the Effective Use of “Drug Guide for Patients” as Package Inserts for Patients / 医薬品情報学

Objective: “Drug Guide for Patients” (DGP) is a drug information tool designated as one of the routine risk minimization activities in risk management plan (RMP) developed by the Ministry of Health, Labour and Welfare. However, patients and their families hardly recognize DGP. Therefore, we administered a questionnaire on drug consultation service of pharmaceutical companies that provide DGP with an aim to collect their views, elucidate problems when they prepare DGPs and examine effective utilization of DGP in the future.Methods: We sent a questionnaire by letter for 127 drug consultation service of pharmaceutical companies, and received questionnaire results using “Questant” that is web questionnaire making software. The results were examined using Fisher’s exact test or Pearson’s chi-squared test.Results: We obtained responses from 84 (66.1%) companies out of 127. As for the question of the published situation of DGP on their website, the most companies responded “Not published” with 47.6% and subsequently 41.7% for “Published for healthcare professionals”. The combined rate of “Published for Patients (3.6%)” and “Published for both healthcare professionals and patients (7.1%)” was only 10.7%. On the other hand, regarding the burden of companies making DGP, we found that more than 60% of pharmaceutical companies (63.5%) felt burdensome, whereas only 36.5% responded “Not burdensome.” Regarding the question on the role of DGP in RMP, pharmaceutical companies answered that the role is “sufficient” 3.6%, 29.8% “not sufficient”, and 66.6% “unknown”.Conclusion: Our results suggested that it is difficult for patients to get DGP from website of pharmaceutical companies and pharmaceutical companies felt burdensome in making DGP, and they recognized that DGP was not very much utilized by patients. Therefore, it would be necessary to improve the creation criteria of DGP. Furthermore, we felt it necessary to have the DGP known and utilized widely by (consumers and) patients.

How to well prepare before the start of medical projects of The National Key Research and Development Program of China / 中华医学科研管理杂志

Objective The management of medical projects of the National Key Research and Development Program of China is difficult.Thus this article aims to analyze the common problems and summarize the preparatory work before the project initiation.Methods Comprehensively adopted the methodologies of literature analysis,survey investigation to analyze the common problems before the project initiation,and then particularly summarize the preparatory works for biomedical research,especially for clinical research,from the perspective of investigators.Results Proposed several aspects that should take into consideration before the initiation of the projects..clarify the organizational management framework,play the role of kick-off meeting,organize tailored training on financial management,prepare research protocol and related documents,seek Institutional Review Board approval and conduct clinical research registration,normalize document managment,formulate project management plan,and prepare research facilities timely.Conclusions Investigators should develop a detailed project management plan before initiation of the project,preparation work should focus on personnel,financial resources,facilities,research progress,quality,data,etc.

O planejamento integrado de bacia hidrográfica e uso do solo na Escócia / Water basin management plan integrated in spatial plans in Scotland

RESUMO A implementação da Diretiva da Água 2000/60/EC demandou a articulação entre a gestão da água e a gestão territorial na comunidade europeia, fomentando a integração entre diferentes níveis de planejamento, como o regional, aplicado na escala da bacia hidrográfica, e o local, aplicado em âmbito municipal. Na Escócia, a integração entre os diferentes setores e escalas de planejamento é conduzida pela aplicação da Avaliação Ambiental Estratégica (AAE). Neste artigo, foram comparados os procedimentos e etapas de elaboração de dois instrumentos de planejamento territorial realizados para a mesma área: o Plano de Bacia Hidrográfica da Escócia para 2009/2015 e sua AAE e o Plano de Desenvolvimento Local de Glasgow para 2010/2015 e sua respectiva AAE. Como resultado, as diferentes características dos instrumentos de planejamento analisados influenciam nos objetivos e no nível de detalhamento utilizado pelas AAEs, cujos resultados conduziram gradativamente à integração dos planos. Como conclusão, o uso da AAE mostrou-se efetivo para propiciar a integração dos diferentes instrumentos de planejamento, atendendo aos requisitos da Diretiva da Água.

ABSTRACT The Water Directive 2000/60/EC regards the water basin management plans integrated in spatial plans in the European community, affecting the regional and local planning. In Scotland, the Strategic Environmental Assessment is used to combine distinct sectors and planning scales. This paper compared the procedures and steps of spatial planning for the same area: Scottish River Basin Management Plan 2009/2015 and Local Development Plan for Glasgow 2010/2015, with their Strategic Environmental Assessment as well. As a result, features of each planning tools affect the aims and details of Strategic Environmental Assessment, which conducts gradually the planning integration. The practice of Strategic Environmental Assessment is useful regarding the Water Directive objectives.

Leitura integrada da gestão dos recursos hídricos com o uso do solo em Caraguatatuba (SP) / Integrated screening of the management of water resources and spatial plan at Caraguatatuba (São Paulo, Brazil)

RESUMO A conservação dos recursos hídricos demanda ações de controle do uso e da ocupação do solo, influenciando instrumentos de gestão territorial nas escalas regional e local. O objetivo deste artigo foi analisar os instrumentos de planejamento territorial aplicados no Brasil, tendo como estudo de caso o litoral norte do Estado de São Paulo. A metodologia é baseada na análise da articulação dos dispositivos legais, notadamente a Política Nacional dos Recursos Hídricos, o Estatuto da Cidade, o Plano de Bacia Hidrográfica, o Zoneamento Ecológico-Econômico e o Plano Diretor Municipal. Como resultados, são apontadas dificuldades relacionadas ao uso de instrumentos normativos de integração, com a ausência de ferramentas de suporte à decisão das distintas competências.

ABSTRACT The conservation of water resources deals with spatial plans, influencing territorial management tools at regional and local scale. This paper aimed to analyze the planning tools applied in Brazil, focusing on the Northern Coast of São Paulo. The methodology was based on the analysis on the articulation of laws: Política Nacional de Recursos Hídricos, Estatuto da Cidade, Plano de Bacia Hidrográfica, Zoneamento Ecológico-Econômico and Plano Diretor Municipal. As results, there are troubles in the laws interaction's, with lack of decision support tools.

ANÁLISIS DE UNIDADES DE PAISAJE Y EVALUACIÓN DE IMPACTO AMBIENTAL COMO HERRAMIENTAS PARA LA GESTIÓN AMBIENTAL MUNICIPAL. CASO DE APLICACIÓN: MUNICIPIO DE TONA, ESPAÑA / ANALYSIS OF LANDSCAPE UNITS AND EVALUATION OF ENVIRONMENTAL IMPACT AS TOOLS FOR MUNICIPAL ENVIRONMENTAL MANAGEMENT. CASE OF APPLICATION: MUNICIPALITY OF TONA, SPAIN

A través de este artículo se presenta una propuesta metodológica para desarrollar la formulación de un plan de gestión ambiental municipal. Para ello se emplean como herramientas de identificación y diagnóstico de los problemas territoriales de escala local, el análisis de unidades del paisaje y la evaluación de impacto ambiental. Precisamente, con el fin de visibilizar su fácil aplicabilidad, se exponen los resultados obtenidos de un ejercicio académico investigativo efectuado en el municipio de Tona, Cataluña-España. Por último, se esbozan una serie de programas y acciones de gestión ambiental para esta localidad, orientados a prevenir, controlar, mitigar y corregir los impactos generados por su urbanización y los diferentes usos del suelo.

Through this article a methodological proposal to develop the formulation of a Municipal Environmental Management Plan is presented. To this end, the analysis of landscape units and environmental impact assessment are used as tools for the identification and diagnosis of the territorial conflicts at the local level. Precisely, to visualize its easy applicability, the results of a research academic exercise carried out in the Municipality of Tona, Catalonia-Spain are exposed. Finally, a series of environmental management programs and actions for this location, designed to prevent, control, mitigate and correct the impacts generated by urbanization and the different land uses are outlined.

1．Evaluation of the Effectiveness of Risk Minimization Activities / 薬剤疫学

Various measures have been taken to minimize risk for individual drug products in the past. It is noteworthy that these measures are now documented and made public as a　“risk minimization plan” with the implementation of the scheme of Risk Management Plan （RMP). Risk minimization activities are conducted with the aim of securing and enhancing patients' safety, and at the same time, it places additional burdens on patients, healthcare practitioners and manufacturers/distributors. In this context, it should be assessed whether the original purpose is achieved. It is the key　for RMP to revise the plan effectively based on the assessment result. Measures to evaluate the effectiveness of risk minimization activities include analysis using medical information databases, questionnaire survey/interview to healthcare practitioner and patients. We may need to conduct prospective/retrospective surveys for some cases. There is no single method to be universally applied to different situations and we have no other way than putting our heads together and moving into action.

<b>1．Evaluation of the Effectiveness of Risk Minimization Activities </b> / 薬剤疫学

<p>Various measures have been taken to minimize risk for individual drug products in the past. It is noteworthy that these measures are now documented and made public as a　“risk minimization plan” with the implementation of the scheme of Risk Management Plan （RMP). Risk minimization activities are conducted with the aim of securing and enhancing patients' safety, and at the same time, it places additional burdens on patients, healthcare practitioners and manufacturers/distributors. In this context, it should be assessed whether the original purpose is achieved. It is the key　for RMP to revise the plan effectively based on the assessment result. Measures to evaluate the effectiveness of risk minimization activities include analysis using medical information databases, questionnaire survey/interview to healthcare practitioner and patients. We may need to conduct prospective/retrospective surveys for some cases. There is no single method to be universally applied to different situations and we have no other way than putting our heads together and moving into action.</p>

Survey of the Description of the Risk Minimization Activities in Pharmaceutical Risk Management Plans / 医薬品情報学

<b>Objective: </b>Currently, the creation of a pharmaceutical risk management plan (RMP) for new drug information is obliged to pharmaceutical companies.  The created RMP is published on the Pharmaceuticals and Medical Devices Agency (PMDA) website.  RMP is a useful information source to ensure drug safety by healthcare professionals, including pharmacists.  “Risk minimization activities” of the RMP are especially important elements for healthcare professionals because they describe measures to minimize risk to patients.  We conducted a cross-sectional survey of the description of the contents of “risk minimization activities” in the RMP.<br><b>Methods: </b>The RMP of 177 drugs that had been published in February 22, 2016 were investigated.<br><b>Results: </b>Total risks enumerated for the study drugs were 1,678.  “Routine risk minimization activities” constituted 92.0% of total risks.  The most listed item on “routine risk minimization activities” was “attention on the product labeling of the drug package insert” (91.3%).  Differences in the expression level on “attention on the product labeling” were observed.  On the other hand, the most listed item of “additional risk minimization activities” was “the creation of documents for healthcare professionals” (38.3%) and “implementation of Early Post-marketing Phase Vigilance” (27.1%).<br><b>Conclusion: </b>A clear understanding of RMP by healthcare professionals is important.  In the RMP, “risk minimization activities” (especially “additional risk minimization activities”) are the most important contents for healthcare professionals, because they include information of documents created by the pharmaceutical company for patient safety.  The level of description of the contents of RMP varies between drugs.  It is essential that these descriptions be uniform the expression level to be easily and accurately utilized by healthcare professionals.

Description of Important Potential Risks of Japanese Risk Management Plan on Each Package Insert / 医薬品情報学

<b>Objective: </b>The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs.  One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts.  In this study, we investigated the description of potential risks on package inserts.<br><b>Design: </b>Document analysis.<br><b>Methods: </b>We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.<br><b>Results: </b>Of 268 important potential risk items in 81 products, 56 items were not described on package insert.  The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.<br><b>Conclusion: </b>About 20% of important potential risks are not described in package inserts.  Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.