住院患者抗肿瘤药物超说明书用药医嘱点评方法探讨与应用评价

目的: 建立住院患者抗肿瘤药物超说明书用药医嘱点评方法,并将其应用于抗肿瘤药物用药合理性综合评价。方法: 基于循证原则和文献方法,针对抗肿瘤药物使用过程中与超说明书应用相关的适应证、给药剂量、给药途径及给药顺序等主要指标建立了评价标准,这个评价标准还包含了抗肿瘤药物使用过程中其他合理用药的评价指标。依据建立的评价标准,随机抽取我院肿瘤内科住院患者2 050份病历,对抗肿瘤药物用药合理性进行综合评价,并根据点评结果积极干预临床用药。结果: 点评结果显示,抗肿瘤药物的超说明书用药情况主要体现在化疗剂量不准确、给药途径不符合说明书规定或序贯给药顺序不恰当,未发现不符合适应证应用的情况;干预后,化疗剂量和给药顺序等超说明书用药相关指标得到明显改善。结论: 建立了以超说明书用药为主要评价内容的抗肿瘤药物医嘱点评方法,制定的评价标准和调查表能够方便临床药师全面深入判断抗肿瘤药物在超说明书用药环节存在的问题,为进一步开展相关研究提供思路。

Research and evaluation on inpatient medical order for off-label indications of anti-neoplastic drugs

OBJECTIVE To establish an inpatient medical order evaluation method for off-label indications of anti-neoplastic drugs to evaluate comprehensively the rational use of anti-neoplastic drugs. METHODS An evaluation standard for the unconventional and overdose use of anti-neoplastic drugs with different ways of administration was developed based on evidence-based principles and methods of literatures. Other indexes for the rational use of anti-neoplastic drugs were also included in this evaluation standard. A total of 2050 medical records of our hospital were sampled at random, and the medical orders in the selected medical records were assessed comprehensively according to the standard. Interpose steps were taken to regulate the use of anti-neoplastic drugs according to evaluation results.RESULTS The irrational use of anti-neoplastic drugs mainly included inaccurate doses of anti-neoplastic drugs, ways of administration beyond the labels and incorrect administration sequences. The chemotherapies with anti-neoplastic drugs for the patients were in accordance with relevant diagnostic and therapeutic guidelines and standards. The doses and administration sequences, which were correlated with off-label indications of anti-neoplastic drugs, were improved markedly after intervention. CONCLUSION The inpatient medical order evaluation method focused on the off-label indications of anti-neoplastic drugs is developed. The evaluation standards and the questionnaires are established which can help the clinical pharmacists to estimate the off-label indications of anti-neoplastic drugs comprehensively and thoroughly, and carry out the comments on rational off-label use of anti-neoplastic drugs. The results of the research will lay a foundation for further studies on the off-label use of drugs.