黔东南州16家医院超说明书用药调查与分析

Investigation and Analysis on Off-label Drug Use in 16 Hospitals from Qiandongnan Prefecture

目的:了解黔东南州16家医院超说明书用药的情况。方法:采用《基层医院超说明书用药现状调查表》对黔东南州16家医院的临床医师进行问卷调查,并对结果进行统计分析。结果:共发放问卷607份,回收有效问卷572份,有效率94.23%。被调查者中本科学历者居多,且多为医师;572人中,265人(占46.33%)认可超说明书用药;多数临床医师认为医院应重视超说明书用药,且认为超说明书用药存在严重或一定的安全隐患。被调查者对超说明书用药的态度不同;多数临床医师所在科室存在超说明书用药,>60%的医师会告知患者并要求其签署知情同意书;超适应证(143人,占25.00%)和超给药途径给药(171人,29.90%)者居多,超说明书用药多以文献报道和诊疗规范为依据。多数人未参加过超说明书用药领域的学习及培训,希望通过培训或会议学习相关知识。结论:超说明书用药与多种因素相关,应加强对超说明书用药的管理,完善与超说明书用药相关的法律法规,并加强对临床医师的培训和学习,促进合理用药。

OBJECTIVE： To investigate the general status of off-label drug use in 16 hospitals from Qiandongnan prefecture. METHODS： Off-label Drug Use Status Questionnaire for Primary Hospital was adopted to conduct questionnaire survey on the clinicians from 16 hospitals from Qiandongnan prefecture. Statistical analysis was conducted on the results of questionnaire. RESULTS： Totally 607 questionnaires had been issued,the effective questionnaires were 572 with the rate of 94. 23%. The investigators with bachelor degree took the lead,and mostly were clinicians. Of the 572 cases,265 cases（ 46. 33%） accepted off-label drug use. Most clinicians considered the hospital had attached importance to off-label drug use,and they also thought off-label drug use had serious or certain security hidden risks. The investigators had different attitudes toward off-label drug use,most departments had off-label drug use, 〉60% clinicians would inform the patients to sign the informed consent. most performed as over indications（ 143 cases,25. 00%） and over route of administration（ 171 cases,29. 90%）,and off-label drug use mainly based on literature reports and rules of diagnosis and treatment. Most people did not participate into the learning and training of off-label drug use,and tended to learn the related knowledge. CONCLUSIONS： Off-label drug use is related to various factors. It is necessary to strengthen the management on off-label drug use,improve the related regulations and strengthen the learning and training on clinicians,so as to promote the rational drug use.