利用循证药学规范超说明书用药的工作实践

Nomalization of off-label drug use by utilizing evidence-based pharmacy

目的:利用循证药学模式规范超说明书用药,为临床合理的超说明书用药提供依据,对不合理的使用给予预警或干预。方法:临床药师2015年每月随机抽取某院门诊处方100份,对有超说明书用药的处方进行分类统计,并通过中外数据库、典籍、指南等循证依据,依照证据质量提出超说明书用药的推荐强度和干预措施。结果:抽调的1 200份处方中有50.08%的处方存在超说明书用药,超说明书用法的分类及各分类所占总处方的比例分别为超用法用量(24.25%)、超适应证用药(13.75%)和超适用人群(12.08%)。对所涉及的23类超说明书使用药品循证分析后,为医生提供了3种公认有益(Ⅰ级推荐)的超说明书用法,并且对10类Ⅱb/Ⅲ级推荐的超说明书用药进行干预,共有6类超说明书用法在处方干预前后得到明显的改善。结论:利用循证药学方法不仅可以为医生合理的超说明书用药提供保障,更有助于医生接受和采纳临床药师的合理建议,减少超说明书用药风险。

OBJECTIVE To normalize off-label drug use by utilizing evidence-based pharmacy,provide the evidence for rational use and give warning or intervention for unreasonable off-label drug use.METHODS Randomly 100 prescriptions were selected from outpatient prescriptions every month from January to December in 2015 to collect and classify off-label drug use.Then the strength of recommendations and interventions were provided according to the Chinese and foreign databases,books,clinical guidelines and other evidences.RESULTS The rate of off-label drug use was 50.08% in 1200 prescriptions.The category and rate of off-label drug use were calculated respectively：usage and dosage（24.25%）,indication（13.75%）and applicable people（12.08%）.Through evidence-based analysis on 23 kinds of off-label use drugs,3 kinds were recommended（classified to levelⅠ）,and ten kinds were irrational off-label drug use（classified to levelⅡb and Ⅲ）which should be intervened.The prescription rates of six kinds in these levelⅡb andⅢ off-label drug use decreased obviously after the intervention.CONCLUSION Evidence-based pharmacy can not noly provide a guarantee for rational off-label drug use but also promote doctors to accept the reasonable suggestions prefered by clinical pharmacists.The off-label drug use should be standardized to reduce risks.