| Objective To establish the rules and procedures for rational drug use of proton pump inhibitors(PPIs)suitable for computer screening through the literature review and analyzation of actual usage of proton pump inhibitors in sample hospitals.As well as to develop one "special evaluation system for PPIs" which has the accessibility for clinical pharmacists in evaluating medical orders on rational drug use of PPIs among in-patients,achieving the goal of high-efficient advice review.Then the management decision could acquire more data supports to promote the rational use of PPIs in clinical practice.Methods The data of discharged patients were collected from hospital information system(HIS)in sample hospitals between Jan.2015 and Dec.2017.PPIs were screened according to CFDA drug registration information(up to 30 June 2018),APIs and pharmaceutical intermediates were excluded,and drug registration information was standardized,including ingredients,dosage forms,specifications and manufacturers.The consumption of PPIs among in-patients from 2015 to 2017 was analyzed.The investigation includes PPIs varieties,the utilization rate of in-patients,the average treatment course,the proportion of treatment course accounted for length of stay(LOS),the drug utilization index(DUI),the intensity of use,the amount of drug consumption,the daily consumption costs and the proportion of consumption of various PPIs.Relevant laws and regulations,published guidelines,papers and drug instructions issued by the national and regional departments were referenced,combing with the actual situation of sample hospitals,to formulate reasonable drug use auditing rules andprocedure for PPIs injection automatic screening computer program,which was the base of final software design by pharmacists and computer engineers.This software could assist pharmacists to make medical orders evaluation regards to rational drug use;and the effect evaluation of the software contains three aspects: detection rate,accuracy rate and time-consuming.The software was also used to evaluate usage of PPI injection(including irrational medication for treatment,prevention and non-indication)in the inpatients was evaluated retrospectively during Jan.2015-Dec.2017.Results Until June 30,2018,there were totally 6 kinds of marketed PPIs in China:Eprazole,Esomeprazole,Omeprazole,Lansoprazole,Rabeprazole and Pantoprazole,each of which involves oral preparations and injections.There were 23 product specifications and 529 products involving 286 manufacturers.From 2015 to 2017,the total number of discharges from sample hospitals was 309,390.The overall usage rate of PPIs was 62.52%(n=193,448),and the usage rate of injections was 58.88%(n=182,157)with 4 different varieties.The order of consumption amount was lansoprazole,pantoprazole,omeprazole and esomeprazole,which accounted for 91.62% of the total PPIs consumption.The auditing rules and procedure were completed,and the software was designed and developed.The software of PPI audit includes four modules: users and tasks(timing audit),system settings,confirmation of audit results(check the results audited by the software automatically)and reports exporting.For the evaluation of 600 cases who used PPI injections,254(42.23%)inpatients were given preventive drugs,67(11.17%)inpatients were given therapeutic drugs.In total,there were 279(46.50%)inpatients were given unidentified drugs and 447(74.50%)were given irrational drugs.Among them,462 unreasonable cases(77.00%)were detected by computer,454 cases(75.67%)were detected by both people and computer,and 417 cases(69.50%)were detected manually.The detection rate of the manual + machine group was closest to the result of the expert group,and the difference was not statistically significant.There was no statistical difference of detection rate between machine group and manual + machinegroup(P > 0.05).The average time spent by pharmacists with computer-aided evaluation for one case was 1.5 ±0.15 minutes,and that of pure manual evaluation for one case was 9.25±0.48 minutes.The time spent by computer-aided evaluation was significantly lower than that of pure manual evaluation,and the difference was statistically significant(P<0.05).From 2015 to 2017,a total of 182157 inpatients received PPI injection orders,including 140389 cases(77.07%)of unreasonable drug use,4 884 cases(2.68%)of unreasonable drug use for treatment,50 399 cases(27.67%)of unreasonable drug use for prevention,and 85 106 cases(46.72%)of drug use without indications.The software takes about 5 hours for total evaluation,with an average of 0.1seconds per case.Conclusions PPIs listed on the Chinese market have abundant varieties,product specifications and strong clinical accessibility.In sample hospitals of this study,PPIs have high utilization rate,long course of treatment,and unreasonable drug use,which indicates the need of strengthened supervision.The participation of pharmacists throughout the process of the design and development of software,making full use of information technology can significantly shortens the time of pharmacist’s evaluation,improve pharmacists’ evaluation efficiency,and promotes the rational use of PPI in clinic. |
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