Construction And Application Of Evaluation System For Rational Use Of Gemcitabine

Objective: Gemcitabine has been included in the centralized drug procurement catalogue of national organizations,and its application will become more and more extensive.There are many unreasonable situations in its clinical application,and there is a lack of perfect drug evaluation standards and appropriate regulatory measures.This study constructed the evaluation system for the rational use of gemcitabine,evaluated the rationality of clinical use of gemcitabine,and implemented drug intervention to provide reference for promoting the rational use of gemcitabine.Methods: To construct an evaluation system for rational use of gemcitabine:（1）Based on the pharmaceutical instructions,evaluation criteria for rational use of gemcitabine were established with reference to expert consensuses and clinical practice guidelines issued by the National Health Commission and the National Comprehensive Cancer Network（NCCN）,“Martindale Drug Encyclopedia（Original 37 th Edition）” and Thomson grading system of Micromedex database.（2）Referring to the evaluation basis of each index in the evaluation standard,the cases using gemcitabine were evaluated for the rationality of drug use by a single index,and the evaluation results of the rationality of the single index of each case were obtained.（3）Analytic hierarchical model（AHM）was used to assign weights to the relative importance of each index in the evaluation criteria,and technique for order preference by similarity to solution（TOPSIS）was used to comprehensively calculate the evaluation results of rationality of single index in each case,so as to obtain the comprehensive evaluation results of rationality of drug use in each case.Using the gemcitabine rational drug use evaluation system to evaluate the rationality of drug use of the cases who used gemcitabine in a hospital from July 1,2017 to June 30,2019（pre-intervention group）,as the baseline before medication intervention.Based on the results of the baseline evaluation,targeted drug intervention was implemented,and the cases who used gemcitabine from July 1,2019 to June 30,2021（post-intervention group）were revaluated.Results: There were 13 evaluation indexes for rational application of gemcitabine,including performance status assessment,baseline blood routine examination,indications,contraindications,solvent selection,usage and dosage,incompatibility,routine blood monitoring within the treatment cycle,dose adjustment within the treatment cycle,antiemetic pretreatment,administration sequence,adverse reaction monitoring and precautions.The pre-intervention group and the post-intervention group included 172 and 138 gemcitabine cases,respectively.The common types of irrational drug use for single index in cases were routine blood monitoring were not performed within the treatment cycle（38.4% and 22.5%）,administration sequence error（23.8%and 16.7%）and unreasonable dose adjustment within the treatment cycle（20.3% and10.9%）.The cases with reasonable indication evaluation accounted for 93.6% and96.4%,respectively,of which 32.0% and 52.2% were in line with the indications of drug specifications,61.6% and 44.2% were reasonable in off-label indication use supported by evidence-based medical evidence.The three evaluation indexes with the highest relative weight coefficients assigned by AHM were indications（0.1308）,contraindications（0.1006）and usage and dosage（0.0872）.The TOPSIS method comprehensively evaluated the basic rational rate of medication（Ci ≥ 0.6）in the pre-intervention group and the post-intervention group,which were 69.2% and 82.6%（P=0.007）,respectively,and the rational rate of medication（Ci≥0.8）was 27.3% and38.4%（P=0.038）,respectively.Conclusion: It is feasible to comprehensively evaluate gemcitabine cases using the rational drug use evaluation system constructed based on the evaluation criteria for the rational use of gemcitabine and the TOPSIS method empowered by AHM.The clinical use of gemcitabine in this hospital mainly has problems in blood routine monitoring,administration sequence and dose adjustment.Medication intervention can improve the level of rational drug use.In addition,the use of gemcitabine off-label indications is relatively common,but most of them are supported by evidence-based medical evidence,which is generally reasonable.