摘要
目的循证评价多国超说明书用药相关法律、法规、指南等,为规范我国超说明书用药提供参考。方法计算机检索CBM、CNKI、VIP3个中文数据库,EMbase、PubMed等11个外文数据库以及15国药品管理部门/学术组织官方网站及WHO官方网站,获取各国/组织超说明书用药的法律、法规、指南等文献。运用系统评价方法,自定义指标评价,从文献类型、内容相关性、时效性3个方面,评价纳入文献质量。采用Excel制订资料提取表,由7名研究员独立提取资料,内容包括:文献基本信息,超说明书用药前提,允许超说明书用药的药品范围,超说明书用药规程及法律责任。采用描述性分析法分析结果。结果共获取文献4 735篇,经层层筛选,最终纳入文献104篇,含A级89篇(85.58%),B级15篇(14.42%)。统计分析结果显示,(1)目前,全球有与药品超说明书使用相关立法的国家共7个,它们是美国、德国、意大利、荷兰、新西兰、印度和日本。除印度禁止超说明书用药外,其余6国均允许合理的超说明书用药,但仅英国和爱尔兰明确规定了超说明书处方权。(2)在明确超说明书用药责任的国家中,主要责任仍由医务人员承担。(3)有10个国家的政府部门或学术组织发布了与超说明书用药相关的指南或(和)建议。各国对超说明书用药规程的规范主要涉及以下程序:①获取超说明书用药相关信息与证据支持;②患者知情同意;③经伦理委员会或(和)药事管理委员会批准;④记录超说明用药的原因及疗效;⑤监测超说明书用药的不良反应。除对医疗机构的监管外,对企业的监管涉及:①要求企业培训专门人员处理超说明书用药相关问询;②公布企业医学部的联系方式;③不得鼓吹或广告宣传超说明书用药用法。此外,超说明书用药的保险支付是各国超说明用药政策中有待解决和完善的问题。结论超说明书用药具有其合理性与必要性。为保障患者用药安全,同时规避医疗机构和医务人员的执业风险,我国需尽快出台相应规章,以规范超说明书用药行为。作为发展中国家,我国医疗卫生体制和条件有别于发达国家,制订我国超说明书用药规范时,应在循证评价各国现有超说明用药法律、法规、政策、指南基础上,结合我国国情及专家意见,初拟一套规范制度,经试行后修订完善,再扩大试点并验收合格后,最终推行。
Objective To evaluate the related laws,regulations and guidelines about off-label drug use in several countries,so as to provide evidence for regulating off-label drug use in China.Methods The following 3 Chinese databases as CBM,CNKI and VIP,11 foreign databases including EMbase,PubMed and so on,15 countries＇ official websites of pharmaceutical administration department or academic organization,and WHO website were searched to obtain the related laws,regulations and guidelines about off-label drug use.By adopting the system evaluation method and self-defined index evaluation,the quality of the included literatures was evaluated in three aspects： literatures＇ type,content relevance and timeliness.Seven researchers independently extracted data by Excel which included basic information of literatures,preconditions of off-label drug use,medicines categories that could be off-labelly used,regulations and legal responsibility in off-label drug use.And finally the descriptive analysis was conducted.Results A total of 4 735 literatures were retrieved,104 of which were finally included,including 89 at grade A quality level（85.58%） and 15 was at grade B（14.42%）.The analysis showed that,a） Seven countries had laws related to off-label drug use： America,Germany,Italy,Netherland,New Zealand,India and Japan.Except India,the rational off-label drug use was allowed in the other 6 countries.The right to prescribe off-label drug was defined in Britain and Ireland;b） Medical staff had to take the responsibility of off-label drug use in the country where the duty regulations were formulated;and c） Ten countries published guidelines or statements related to off label drug use by their official departments and academic organizations.And the regulation included the following procedures： firstly,to obtain the relative information and evidence;secondly,to get the informed consent;thirdly,to be approved by the ethics committee and/or pharmacy administration committee;fourthly,to record the reasons and effectiveness of off-label use;fifthly,to monitor the adverse reactions of off-label drug use.Besides monitoring the medical institutes,the pharmaceutical companies had also be monitored which included the following 3 aspects： a） to require companies to train specialized staffs to answer the questions related to off-label drug use;b） to open the contact information of medical departments of companies;and c） to prohibit preaching and advertising the off-label drug use.Conclusion Off-label drug use has its rationality and necessity.To protect the safety of patients,avoid the risk for hospitals and medical staffs,it requires formulating relative regulations soon in order to manage the off-label drug use in China.As a developing country,China is different from the developed countries in health care system.Therefore,when formulating the regulations,it is necessary to perform evidence-based evaluation on each country＇s laws,regulations and guidelines about off-label drug use,with Chinese national conditions and experts＇ opinions in combination.After a regulation is preliminarily drawn up,it needs to be put into pilot practice,and then revised and spread to the whole country.
出处
《中国循证医学杂志》
CSCD
2012年第4期426-435,共10页
Chinese Journal of Evidence-based Medicine
基金
十一五国家科技支撑计划重点项目,“乡镇卫生院药物配置与物流关键技术研究与产品开发”(编号:2008BAI65B22)
关键词
超说明书用药
政策
系统评价
Off-label drug use
Policy
Systematic review
