The single case format: Proposal for a structured message for the telematic transmission of information on individual case reports in pharmacovigilance

The development of telematic exchange of information in pharmacovigilance has as a consequence the necessary development of the messages used to transmit the information. The first of these messages is the one used to transmit information on individual case reports. Common formats exist on paper, but these have not been applied to electronic transmission. A structured message for the transmission of single case information has been developed within the ENS European research programme, by three National Pharmacovigilance administrations, and reviewed by the relevant European bodies. It has been submitted to the Western European Edifact Board MD9 for admission as an EDIFACT message, so that it will be possible to exchange information concerning these single cases, using standard EDI methodology.     

我国药品不良反应监测工作对开展医疗器械不良事件监测的启示

为探讨我国医疗器械不良事件监测工作开展模式,分析比较影响药品不良反应监测与医疗器械不良事件监测工作发展的关键因素。根据医疗器械不良事件监测工作的特点,从相关法律法规制订、组织机构与人员配备、技术体系建设等方面提出了医疗器械不良事件监测的工作思路。     

中药品种保护制度法规概述

目的探讨《中药品种保护条例》修订的必要性。方法对国家相关部门研究制定的一系列中药品种保护相关法规政策进行探讨分析。结果与结论中药品种保护制度仍是我国中药品种行之有效的行政保护措施,其相关法规在保障和促进该项制度的贯彻实施中起到了积极作用,但同时也存在着较大的局限性。《中药品种保护条例》的修订势在必行。     

从大医院人员编制结构谈人事制度改革

深化人事制度改革，加快制定人员编制的标准，是当前卫生改革中亟待解决的问题之一。本文分析了目前三级综合医院人员编制和结构中存在的问题，主要是编制过大和人员结构组成不合理。例如医生过多，高、低年资的医生比例不理想；护理人员编制的标准不够科学；行政后勤人员中大量使用临时工等。为此，作者提出了医院人事制度改革的一些设想，即学习和贯彻邓小平人才人事理论、明确各级医院的职能与分工、尽早制定新的人员编制标准、创造人员合理流动的机制、职称与工资脱钩、着眼于人才成长与发挥作用，以及同步采取医学教育和分配制度改革措施等。     

A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies

Near-infrared spectroscopy (NIRS) is a fast and non-destructive analytical method. Associated with chemometrics, it becomes a powerful tool for the pharmaceutical industry. Indeed, NIRS is suitable for analysis of solid, liquid and biotechnological pharmaceutical forms. Moreover, NIRS can be implemented during pharmaceutical development, in production for process monitoring or in quality control laboratories.This review focuses on chemometric techniques and pharmaceutical NIRS applications. The following topics are covered: qualitative analyses, quantitative methods and on-line applications. Theoretical and practical aspects are described with pharmaceutical examples of NIRS applications.     

中药在欧美国家注册管理概况

参阅美国食品药品监督管理局（FDA，Food and Drug Administration）；欧盟委员会（EC，European Commission）；欧盟药品审评局（EMEA，The European Agency for the Evaluation of Medicinal Products）及欧盟食品兽医办公室（FVO，Foodand Veterinary Office）有关法律法规文件，就中药在欧美国家申请上市注册的基本要求做简要介绍。     

国内药食同源的产生与应用

中国“药食同源”的思想源远流长,随着国家对中医药产业的日益重视,伴随中医药产业走向世界,药食同源观点必将被世界所接受与认可。综述了药食同源文化来源、应用现状和发展前景,总结了药食同源品种的质量标准、检测方法、企业状况和中药监管法律法规等环节的现状及面临问题,提出“采用多种检测方法、完善质量标准、重视科研创新和加强监督管理”等多方面监管措施,以推进药食同源产业的健康发展。     

A review of suspected cases of driving under the influence of drugs (DUID) involved in traffic accidents in Istanbul (Turkey)

Nowadays traffic accidents, which have high mortality and morbidity, are an important public health problem. The association between the use of alcohol and/or drugs by drivers and the increased risk of traffic accidents with a high risk of death and injury has been well described in the literature.This study aimed to review the incidence of cases of driving under the influence of drugs (DUID) among all cases of driving under the influence (DUI) of alcohol and/or other drugs involved in traffic accidents and to evaluate the type of the psychoactive drugs (with or without alcohol) detected in blood samples in Istanbul and its surrounding area. This study is the first investigation on the subject of DUID cases in Turkey.The reports of the Istanbul Toxicology Department of the Council of Forensic Medicine (Turkey) on suspected DUID cases involved in traffic accidents between 1 July 2010 and 30 June 2011 were retrospectively reviewed for alcohol and/or drug use.Alcohol analysis was requested in 4274 suspected DUI cases, whereas drug along with alcohol analysis was requested in only 91. The rate of suspected DUID cases (n = 91) among the suspected DUI cases (n = 4274) was only 2.1% and in this study, we evaluated only the DUID cases in detail. Alcohol was present in 44% of suspected DUID cases. Psychoactive drugs were present in 15.4% of cases. The incidence among 46 confirmed DUID cases was found to be 17.4% for cannabis, 8.7% for benzodiazepines, 4.3% for barbiturates, 4.3% for antidepressants, 2.2% for cocaine and 2.2% for amphetamines.Although there is a zero-tolerance approach for DUID in the Turkish regulations, it is not well recognised and not inspected by police and legal authorities who are responsible for taking measures in traffic accidents and for routine traffic controls in Turkey. It is concluded that psychoactive drugs should be checked as well as alcohol in all traffic accident cases and roadside controls.     

对一起疫苗流通和预防接种管理案的分析与思考

本文通过对一起疫苗流通和预防接种管理行政处罚案的分析与思考,指出我国卫生法律、法规立法尚存在空白,并提出对策建议。