目的:调查贵州省二级及以上医疗机构的超说明书用药(off-label drug use,OLDU)管理现状,为制订全省统一的OLDU管理制度提供参考.方法:根据相关政策法规制订调查问卷,内容包括填表人基本信息、医疗机构基本信息以及OLDU相关调研信息,以"问卷星"方式向贵州省所有二级及以上医疗机构发送问卷进行调研.结果:发放问卷415份,回收问卷415份,回收率为100.00％.调研的415家医疗机构中,204家(49.16％)存在OLDU情况,但有40家(19.61％)仍未制订OLDU管理制度,三级医疗机构存在OLDU比例高于二级医疗机构(91.67％vs.38.37％,P＜0.01),公立医疗机构高于私立医疗机构(72.31％vs.16.76％,P＜0.01).在OLDU的制度建立、流程规范审批(OLDU须经药事会批准)和流程使用(OLDU需要患者/家属知情同意)、目录建立和统一构建目录的需求方面,三级医疗机构明显优于二级医疗机构,公立医疗机构明显优于私立医疗机构.但全省的医疗机构在OLDU事后监管(病案记录事项和原因、患者建档和随访及处方专项点评)方面水平均较低,且不同级别和性质医疗机构间无明显差异.结论:该省二级及以上医疗机构OLDU管理水平较低,亟需建立全省统一的OLDU管理制度.
Status on management of off-label drug use in 415 hospitals of Guizhou Province:a cross-sectional survey
OBJECTIVE To explore the current status of developing a standardized management system for off-label drug use(OLDU)and provide references for standardizing medical behaviors at medical health institutions in Guizhou Province.METHODS A questionnaire on OLDU was formulated according to the relevant policies and regulations,including basic filler information,basic profiles of medical institutions and researches related to OLDU.The questionnaire was distributed to 415 sec-ondary and tertiary medical institutions in Guizhou Province in the form of a"Wenjuanxing"and the collected data were statisti-cally analyzed by Chi-square test.RESULTS A total of 415 questionnaires were distributed and 415 questionnaires were recov-ered with a recovery rate of 100.00％.OLDU existed at 204(49.16％)medical institutions while 40(19.61％)had not developed a management system.The proportion of OLDU at tertiary care institutions was higher than that at secondary care institutions(91.67％vs.38.37％,P＜0.01).And the proportion of OLDU at public care institutions was higher than that at private care institutions(72.31％vs.16.76％,P＜0.01).In terms of establishing an OLDU system,tertiary healthcare institutions were sig-nificantly better than secondary healthcare institutions.It included a standardization of approval process and use process of OLDUs,as well as creating an OLDU catalogue and need for uniformity.Similarly,public healthcare institutions were signifi-cantly superior to private healthcare institutions in the above aspects.However,the level of ex post management of OLDU(e.g.matters and reasons in case records,patient filing and follow-ups & special reviews of prescriptions)was low among healthcare institutions of Guizhou Province.It differed insignificantly between different levels and attributes of healthcare institutions.CONCLUSION Formulation rate and content of OLDU management system at secondary/tertiary medical institutions should be further optimized in Guizhou Province.It is imperative to establish a unified OLDU management system.
Guizhou Provinceoff-label drug usepharmacy administrationquestionnaire survey
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