首页|146家医疗机构超说明书用药管理现状调查

146家医疗机构超说明书用药管理现状调查

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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。
Investigation on Management Status of Off-Label Drug Use in 146 Medical Institutions
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.

Off-label drug useManagement statusEvidence based basisInformed consent

林薇、茅鸯对、马俐丽、于迪、阳丽梅、丁静

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浙江药科职业大学药商学院,浙江 宁波 315100

宁波市医疗中心李惠利医院药剂科,浙江 宁波 315100

苏州大学附属第一医院药学部,江苏 苏州 215006

福建省立医院/福建医科大学省立临床医学院药学部,福州 350001

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超说明书用药 管理现状 循证证据 知情同意

浙江省公益技术研究计划浙江省哲学社会科学规划项目浙江省哲学社会科学规划项目浙江省社科联研究项目

LGD19H11000120NDJC221YB23NDJC446YBM2024B077

2024

中国医院用药评价与分析
中国医药生物技术协会,中国药房杂志社

中国医院用药评价与分析

CSTPCD
影响因子:1.142
ISSN:1672-2124
年,卷(期):2024.24(5)
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