上海东方肝胆外科医院 2006年第3期（总第11期）药品不良反应监测通讯2006年 9月 埃利斯宣言WHO国际药物监测合作中心等国际组织于1997年9月27日在意大利西西里岛的埃利斯联合召开了由30个国家参加的发展药物监测信息交流国际会议，会议发表了埃利斯宣言（TheEriceDeclaration）。该宣言旨在促进药物安全信息的交流，其内容如下。前言：药物安全性的监测、评价和交流是一项具有深远意义的卫生事业，它依赖于有关方面的公正和集体责任，他们包括消费者、卫生专业人员、研究人员、学术界、宣传媒体、制药工业、药品管理官员、政府部门和国际机构。高度的科学标准、伦理标准、职业标准和道德标准，在这项事业中必须起主导作用。药物利弊的不确定性需要承认并加以解释。基于这种不确定性而采纳的决定和措施应符合科学性临床原则，并考虑到社会现实和环境。药物安全信息在社会各阶层的差距，导致怀疑、误传及误导等危害，甚至形成一种风气：隐藏、压制或忽视药品安全数据。事实必须与推测和假说加以区别，采取的措施应考虑到受害者的需要及他们必须的治疗。对于这种措施还需要在国家和国际上建立制度和法律，以保证全面地、公开地交流信息和有效的评价标准。该标准应保证对药物的利弊能够进行评价、解释和公开地采取措施，以提高普遍的信任和信心。来自30个国家的与会者一致同意下述声明规定的基本要求： 1.药物安全信息必须为公众健康报务。这种信息无论在内容和方法上都必须符合道德规范，并能有效地交流。事实、假说和结论要加以区别，承认不确定性，信息的提供要适合一般性的需要和个别的需要。2.关于药物正确使用的教育，包括对安全信息的解释，对广大公众、病人和医务工作者都是至关重要的。进行这种教育需要特殊的承诺和资源。针对公众的药物信息，无论采用何形式，在药物的风险和利益方面要得到平衡。3.必须使人们容易得到评价及了解风险和利益所需要的一切证据。要认识到压制交流信息将阻碍人们达到既定目标，这种现象应予以克服。4.每个国家需要建立一独立的专家评价系统，保证全面地收集现有药物安全信息，公正地进行评价，并让大家都能得到这种信息。应排除偏见，提供充足的经费支持该系统。要鼓励并支持国与国之间交流数据和作出的评价。5.虽然有时只是对灾难性事件和发生作出反应，但长期以来药物安全监测系统已奠定了基础。当前这个领域的技术革新需要保证在发生意外问题时，对问题能够迅速辨认，并能有效地进行处理，保证有效地交流信息和解决方案。Effective Communications in Pharmacovigilance - The Erice DeclarationThe following declaration was drawn up at the International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily, 24-27 September 1997. It was attended by health professionals, researchers, academics, media writers, representatives of the pharmaceutical industry, drug regulators, patients, lawyers, consumers and international health organisations. Preamble:Monitoring, evaluating and communicating drug safety is a public-health activity with profound implications that depend on the integrity and collective responsibility of all parties - consumers, health professionals, researchers, academia, media, pharmaceutical industry, drug regulators, governments and international organisations - working together. High scientific, ethical and professional standards and a moral code should govern this activity. The inherent uncertainty of the risks and benefits of drugs needs to be acknowledged and explained. Decisions and actions that are based on this uncertainty should be informed by scientific and clinical considerations and should take into account social realities and circumstances. Declaration:Flaws in drug safety communication at all levels of society can lead to mistrust, misinformation and misguided actions resulting in harm and the creation of a climate where drug safety data may be hidden, withheld, or ignored. Fact should be distinguished from speculation and hypothesis, and actions taken should reflect the needs of those affected and the care they require. These actions call for systems and legislation, nationally and internationally, that ensure full and open exchange of information, and effective standards of evaluation. These standards will ensure that risks and benefits can be assessed, explained and acted upon openly and in a spirit that promotes general confidence and trust. The following statements set forth the basic requirements for this to happen, and were agreed upon by all participants from 34 countries at Erice:1. Drug safety information must serve the health of the public. Such information should be ethically and effectively communicated in terms of both content and method. Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged, and information provided in ways that meet both general and individual needs. 2. Education in the appropriate use of drugs, including interpretation of safety information, is essential for the public at large, as well as for patients and health-care providers. Such education requires special commitment and resources. Drug information directed to the public in whatever form should be balanced with respect to risks and benefits. 3. All the evidence needed to assess and understand risks and benefits must be openly available. Constraints on communication parties, which hinder their ability to meet this goal must be recognised and overcome. 4. Every country needs a system with independent expertise to ensure that safety information on all available drugs is adequately collected, impartially evaluated, and made accessible to all. Adequate nonpartisan financing must be available to support the system. Exchange of data and evaluations among countries must be encouraged and supported. 5. A strong basis for drug safety monitoring has been laid over a long period, although sometimes in response to disasters. Innovation in this field now needs to ensure that emergent problems are promptly recognised and efficiently dealt with, and that information and solutions are effectively communicated.2006年5月-8月共收到不良反应报告13例，其中新的一般不良反应3例，严重不良反应1例。临床用药请加强不良反应监测工作，一旦发生不良反应，应及时处理，减轻危害。2006年5-8月药品不良反应报告统计表序号药品名称途径药品不良反应名称例数1甘利欣与阿拓莫兰静滴呕吐112注射用头孢曲松静滴左侧下眼睑水肿1，面部皮疹123复方甘草口服溶液口服面部潮红、心慌114加替沙星注射液静滴恶