摘要
目的基于2013年广东省人民医院超说明书用药备案申请中唯一被否决的申请,对前列地尔注射剂(Lipo-PGE_1)超说明书剂量用药进行干预以减少不合理的超说明书用药。方法通过宣传教育和沟通监控手段干预Lipo-PGE_1超说明书剂量医嘱,对干预后用药情况进行统计,收集2013年8月至2014年7月全部住院患者在院期间使用Lipo-PGE_1的用药医嘱,计算各用药科室的超说明书剂量用药发生率、处方日剂量(prescribed daily dose,PDD)和药物使用强度(drug use density,DUD),与基线数据对比,分析干预后效果。结果 1本次共分析干预后Lipo-PGE_1用药医嘱78 044条,患者6 426例次,按患者、用药医嘱和药品使用量计算,超说明书用药发生率分别为8.68%、5.87%和10.53%,与干预前的34.43%、25.16%、41.37%比较有显著下降(P<0.05)。干预前全院科室中69.44%(25/36)存在超说明书现象,干预后降为55.56%(20/36)。2干预后有22个科室的超说明书剂量用药发生率有所下降,按用药医嘱数计算,发生率>20%的科室仅有2个,分别是急危重症医学部(39.68%)和心外科(32.78%)。3干预前后全院Lipo-PGE_1的PDD由12.77μg下降到10.52μg(P<0.05),DUD由15.12下降到8.87。干预后仍有20个科室PDD超出说明书规定,有3个科室高于全院平均PDD,分别为急危重症医学部(13.61μg)、心外科(12.68μg)和风湿内科(11.26μg)。结论全院范围的宣传教育、有针对性的沟通交流和定期的监控反馈是干预不合理超说明书用药的有效措施,干预后Lipo-PGE 1超说明书剂量用药现象显著改善,本研究为医院超说明书用药管理提供了一个可行的途径。
Objective Based on the off-label drug use （OLDU） record application of Alprostadil injection （Lipo- PGEt） which was the only one rejected in the Guangdong General Hospital in 2013, the interventional measures were carried out to reduce unreasonable off-label drug use of Lipo-PGEt. Methods Medical orders about OLDU in dosage of Lipo-PGE1 were intervened in through education, communication and monitoring. The situation of drug use was summarized in all departments after intervention through exporting all the medical orders about inpatients＇ use of Lipo- PGE1 during hospitalization in August, 2013 to July, 2014 and OLDU incidence in dosage, prescribed daily dose （PDD） and drug use density （DUD） in each department were calculated. The interventional effect was analyzed by comparing with the baseline data. Results a） A total of 78 044 medical orders involving 6 426 case-times were analyzed. According to the data of cases, medical orders and drug use amount, the OLDU incidences were 8.68%, 5.87% and 10.53%, respectively, compared with 34.43%, 25.16% and 41.37% before intervention had declined significantly （P〈0.05）. OLDU occurred in 69.44% departments （25/36） before intervention and declined to 55.56% （20/36） after intervention, b） OLDU incidences of 22 departments were declined after intervention. There were 2 departments with the OLDU incidence in dose 〉20%： ICU （39.68%） and cardiac surgery （32.78%）. c） After the intervention, the PDD of the whole hospital fell to 10.52 μg from 12.77 μg and DUD fell to 8.87 from 15.12. There were 20 departments whose PDDs were off-label and 3departments whose PDDs were above the average level of the whole hospital after the intervention. The three departments were ICU （13.61 μg）, cardiac surgery （12.68 μg） and rheumatology （11.26 μg）. Conclusion Extensive publicity and education, targeted communication and regular monitoring and feedback are effective measures to intervene in unreasonable OLDU. After intervention, the phenomenon of off-label drug use of Lipo-PGE1 is improved significantly. This study provides a workable avenue to manage off-label drug use in hospital.
出处
《中国循证医学杂志》
CSCD
2016年第8期869-875,共7页
Chinese Journal of Evidence-based Medicine
基金
广州市科技计划项目(编号:201509010012)
关键词
前列地尔注射剂
超说明书用药
干预效果
广东省人民医院
Alprostadil injection
Off-label drug use
Interventional effect
Guangdong General Hospital
