| The drug standards prevailing in China consist of Chinese Pharmacopoeia(Ch P),the criteria of the China’s Ministry of Health and of China Food and Drug Administration(CFDA),among which,Ch P,as the technical core of drug utilization,production,selling,inspection and supervision,plays an important role in pharmaceutical administration.However,there is a lack of overall analysis of the drugs recorded in Ch P including clinical utilization and adverse drug reactions(ADR).Therefore,to make up the deficiency,this article employed the drug utilization method recommended by WHO on big data,to provide references of drug collection and evaluation for regulatory departments and basis of drug selection and rational using for clinical.This paper comprises three parts:First of all,we carried out comparative analysis of drug utilization indicators of Chinese Pharmacopoeia standard drugs(Ch PSD)and non Chinese Pharmacopoeia standard drugs(NCh PSD),containing the number of varieties,consumption sum,DDDs and DDDc.The drug use data of a hospital in Jiangsu province from 2011 to2013 were collected and divided into Ch PSD group and NCh PSD group according to their quality standards,the difference of which were analyzed using SPSS20.0 and the Student’s t test.There was no significant difference in variety number and DDDs between two groups(P>0.05).However,the annual drug consumption sum of the former group was lower than the latter(P<0.05),which were(8225.51±762.86)and(14934.08 ±3347.1);The DDDc of the Ch PSD group was as well also significantly lower than that the other one(P<0.01),with(10.47±0.36)and(19.22±2.04)respectively,which indicating that Ch PSD were much less used in hospitals,while due to its lower DDDc,the authorities shall formulate policies to emphasize the authority of the pharmacopoeia,so as to guide the whole society,clinical doctors and patients to give priority to drugs contained in the pharmacopoeia.Secondly,the difference of drug security from two groups was analyzed by comparing their incidence of ADR.The ADR reports of a hospital ranging from 2012 to 2014 were collected,also divided into two groups and compared with t test.The results showed that the incidence of ADR of the NCh PSD group was much higher than the Ch PSD group(P<0.05),suggesting that the authorities should pay more attention to the improvement of drug quality standards to reduce the incidence of adverse drug reactions.The selection of drug catalogue should be strictly demonstrated and the drug quality standard should be as one of the bases for adjusting drug structure.Finally,to explore the safety of Ch PSD and NCh PSD and then to provide a reference for the perfection and medicine selection of Chinese pharmacopoeia based on big data,totally 266 869 ADR reports were collected by ADR Monitoring Center ranging from 2013 to 2015 in Jiangsu province,classified into the two groups.The statistical differences were analyzed according to the new,severe ADR,and the severe ADR of the traditional Chinese medicine and the severe ones of traditional Chinese medicine injections in different standards by Chi-square test.The total ADR reports from the Ch PSD group and NCh PSD group were 121 490 and 145 379,with the new ADR 28 861 and 41 640,and the sever ADRs 8 786 and 11 116,respectively;the ADR of traditional medicine were 15 727 and 35 513,of which the sever ADR were225 and 2 138;the traditional medicine injections ADR were 1 135 and 18 416,of which the sever ADRs were 67 and 1 809;there were statistically significant difference between the two groups(P<0.01).The results presented that the new,sever ADRs,and the sever ones of traditional Chinese medicine and the traditional Chinese medicine injections from the Ch PSD group are much lower than those of NCh PSD group. |
PDF Full Text Request