贵州省三级医疗机构超说明书用药管理的现状调研及其对策

Evaluations of a management system for off-label drug use at tertiary hospitals in Guizhou Province

目的:调查贵州省三级医疗机构超说明书用药(off-label drug use,OLDU)的管理制度,为构建贵州省统一的OLDU管理制度,规范OLDU行为提供基线证据。方法:通过电话结合电子邮件形式收集全省所有三级医疗机构OLDU的管理制度及其医疗机构基本信息。根据《医疗机构药品拓展性临床应用管理规范》(征求意见稿)设计评分表,从OLDU管理的组织架构与备案流程、使用的前提条件、循证证据体系、知情同意和其他管理要求5个方面对收集的制度进行评价和分析,每部分分值为20.0分,共计100分,评分越高说明完整性越好。结果:全省仅71家(84.52%)三级医疗机构建立了OLDU管理制度,所有OLDU制度组织架构与备案流程的评分中位数为15.0分,使用前提条件的评分中位数为20.0分,循证证据体系的评分中位数为10.0分,知情同意要求的评分中位数为10.0分,其他管理要求的评分中位数为5.0分。71家三级医疗机构OLDU制度完整性总评分中位数为67.0分,只有8家(11.27%)总评分超过了80分。结论:贵州省大部分三级医疗机构都已建立OLDU管理制度,但制度整体的完整性较差,尤其是知情同意和其他管理方面亟需进一步完善,建立健全贵州省统一规范的OLDU管理制度是未来药事管理质控工作的首要任务。

OBJECTIVE To survey the management systems of off-label drug use(OLDU)to provide a basis for construct⁃ing a standard OLDU management system and regulating OLDU in Guizhou Province.METHODS The OLDU management systems of all tertiary hospitals in Guizhou Province were profiled through telephone interviews and emails.Basic institutional information was collected.Based upon the Code for Off-Label Drug Use at Medical Institutions(Exposure Draft),a scoring table was composed of five aspects:organizational structure&filing process of OLDU management,prerequisites for use,evi⁃dence system of OLDU,informed consent and other management requirements.Each aspect was assigned a score of 20 points with a total score of 100.Higher scores hinted at a better degree of completeness.RESULTS Out of 84 tertiary hospitals,only 71(84.52%)have established an OLDU management system.The median scores for organizational structure&filing process,prerequisites for use,evidence systems of OLDU,informed consent requirements and other management requirements were 15.0,20.0,10.0,10.0 and 5.0 respectively.The median overall score for completeness across 71 tertiary hospitals was 67.0.Only the overall score of 8(11.27%)tertiary hospitals surpassed 80.CONCLUSION Most tertiary hospitals in Guizhou Prov⁃ince have established a management system of OLDU.However,overall integrity of these systems has remained poor,particu⁃larly in terms of informed consent and other management aspects.Urgent improvements are required in these areas.Thus it is imperative to establish a sound and standard system for managing OLDU in Guizhou Province.Such a task is essential for future pharmacological management and quality control work.