摘要
目的:了解146家医疗机构超说明书用药的管理现状,为提高超说明书用药管理水平提供参考。方法:通过发放问卷,调查146家医疗机构超说明书用药管理情况,其中三级医院104家,二级医院42家,对基本情况、管理现状、存在的问题、成功经验等方面进行统计分析。结果:146家医疗机构均存在不同程度的超说明书用药,其中125家(占85.62%)开展了超说明书用药管理,管理措施包括建立管理制度(125/125,占100.00%)、制定超说明书用药目录(106/125,占84.80%)、使用过程合理性监管(112/125,占89.60%)等。97.26%(142名)的被调查者认为充分的循证依据是超说明书用药的前提,所在医疗机构超说明书用药证据充分的比例“约50%”的占33.56%(49家),“基本都有”占34.25%(50家),“少数有”占30.14%(44家)。超说明书用药管理面临医师不配合/不重视、不按照规定流程使用(116/146,占79.45%),超说明书现象普遍、难以全面管理(73/146,占50.00%)等问题。超说明书用药管理可采取多部门合作、明确职责,根据循证级别或风险程度分级管理以及引入信息化管理等手段。结论:超说明书现象普遍存在,医疗机构开展超说明书用药管理有一定成效,也面临着困难,应推广成功经验,提升医疗机构超说明书用药管理水平,规范超说明书用药行为。
OBJECTIVE:To investigate the management status of off-label drug use in 146 medical institutions,so as to provide reference for improving the management level of off-label drug use.METHODS:Off-label drug use management in 146 medical institutions was investigated by questionnaire survey,including 104 tertiary hospitals and 42 secondary hospitals.Basic situation,management status,existing problems and successful experience were statistically analyzed.RESULTS:There were different degrees of off-label drug use in 146 medical institutions,of which 125(85.62%)carried out off-label drug use management.The management measures included establishment of management system(125/125,100.00%),formulation of off-label drug use catalogue(106/125,84.80%),and supervision for rationality of use process(112/125,89.60%).Totally 97.26%(142 cases)of the respondents believed that sufficient evidence-based basis was the premise of off-label drug use.The proportion of medical institutions with sufficient evidence of off-label drug use was“about 50%”in 33.56%(49 institutions),“almost all”in 34.25%(50 institutions),and“few”in 30.14%(44 institutions).Off-label drug use management had problems such as clinicians’lack of cooperation/attention,non-use in accordance with prescribed procedures(116/146,79.45%),widespread off-label phenomenon,and difficulty in comprehensive management(73/146,50.00%).Management of off-label drug use can be improved by multi-department cooperation,clear responsibilities,hierarchical management according to the level of evidence or risk,and the introduction of information management.CONCLUSIONS:The phenomenon of off-label drug use is widespread,and medical institutions have made some success in the management of off-label drug use,yet there are also difficulties.Successful experience should be promoted to improve the management level of off-label drug use in medical institutions,so as to standardize the behavior of off-label drug use.
作者
林薇
茅鸯对
马俐丽
于迪
阳丽梅
丁静
LIN Wei;MAO Yangdui;MA Lili;YU Di;YANG Limei;DING Jing(School of Pharmaceutical Business,Zhejiang Pharmaceutical University,Zhejiang Ningbo 315100,China;Dept.of Pharmacy,Ningbo Medical Center of Lihuili Hospital,Zhejiang Ningbo 315100,China;Dept.of Pharmacy,the First Affiliated Hospital of Soochow University,Jiangsu Suzhou 215006,China;Dept.of Pharmacy,Fujian Provincial Hospital/Provincial Clinical Medical College of Fujian Medical University,Fuzhou 350001,China)
出处
《中国医院用药评价与分析》
2024年第5期619-622,626,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
浙江省公益技术研究计划项目(No.LGD19H110001)
浙江省哲学社会科学规划课题(No.20NDJC221YB)
浙江省哲学社会科学规划课题(No.23NDJC446YBM)
浙江省社科联研究课题(No.2024B077)。
关键词
超说明书用药
管理现状
循证证据
知情同意
Off-label drug use
Management status
Evidence based basis
Informed consent
