Establishment Of Drug Shortage Risk Indicator System And Early Warning Model In A Province

Objective From the perspective of the drug supply chain,analyze the current status of domestic drug shortages and find the risk factors of drug shortages in our province.On this basis,the index system of drug shortage risk of the province was obtained and early warning model was established,which can provide the focus and direction for the provincial health departments to manage drug shortage,and methods and approaches for the grass-roots management departments and medical institutions to quickly and scientifically judge the risk value of drug shortage.The methods and methods of risk value can provide a reference for strengthening the early warning mechanism.Method1.Literature reading method and expert interview method were used to determine the risk factor framework of drug shortage in a province.The factors affecting drug shortage in a province were analyzed,and the risk factors affecting drug shortage risk in that province were summarized.According to the expert advice,screening and optimization were carried out to form the risk factor framework of drug shortage in the province.2.Determine the drug shortage risk index system of a province by Delphi and analytic hierarchy process.Based on the framework of drug shortage risk factors in this province,a questionnaire was formed.Delphi method was adopted to carry out the questionnaire and analytic hierarchy process was used to analyze the results of the questionnaire.Finally,the index system of drug shortage risk in this province was obtained.3.Establish mathematical model by multiple linear regression.The indexes that can be detected by grass-roots management institutions and medical institutions were selected as the independent variables in the model,and the risk score values of drugs evaluated by a province were taken as the dependent variables in the model.Combining with the characteristics of the data,a mathematical model is established to judge the risk value of drug shortage.Result1.The current situation of drug shortage in China.By collecting and analyzing the drug shortage catalogue and the cases of national drug shortage,it is concluded that the current drug shortage in China has the following three characteristics: provincial and national shortages coexist;there is a prominent shortage of basic and low-cost medicines,;and the fewer drug manufacturers there are,the more likely shortages there will be.2.Obtained a drug shortage risk indicator system in a certain province.The experts positive coefficient by Delphi method was 100%,indicating the high enthusiasm of experts.Expert’s authority degree(Cr)was greater than 8.0,indicating that the expert had a good degree of authority and a good grasp of the choices made.Coordination degree of expert’s opinions were 0.294 and 0.234,respectively,and the P values were less than 0.05,indicating that the coordination of expert opinions was good.The values of Cronbach’s alpha were 0.908 and 0.892 respectively,both of them were more than 0.8,indicating that the reliability of the questionnaire was good.After the expert evaluation,the questionnaires were considered to be complete and representative, indicating that the validity of the questionnaire is good.The province’s drug shortage risk index system included 5 first-level indicators,12second-level indicators and 43 third-level indicators.The risk degree of each link is ranked according to the weight: production process,government departments,use process,distribution process and procurement process.The major risk factors of shortage in the production process is the number of API and drug manufacturers and their market compliance.Whether to establish the database and information sharing platform or not was the major factor for the shortage risk in the links of government departments.The major risk factors in the use process were the number of alternative drug,whether the drug inventory turnover rate is synchronized with the clinical application,and the stability of the clinical dosage.The major risk factors in distribution process are the growth rate of drug supply in last year and whether the two-vote system can be implemented.The major risk factors in the distribution chain are the growth rate of drug supply in the region last year and whether the two-vote system can be implemented.The major risk factors in the procurement process were the way of drug procurement and whether price inversion occurs.3.Obtain an early warning model of drug shortage risk in a province.The model between risk value and risk factor was established by multiple linear regression.The final warning model was: Y=45.299-1.461X1-0.181X5+15.914X6-7.001X7+12.554X8,where X1 refers to the number of API manufacturers,X5 to the number of local distribution enterprises,X6 to the availability of alternative drugs,the procurement method.X8 is whether it is an essential drug.This model has significant statistical significance(P<0.05),and the regression coefficient estimation of each shortage risk factor has statistical significance(P<0.05).Conclusion The current situation of drug shortage in China is as follows: the provincial shortage coexists with the national shortage and is more serious than the national shortage.Through the establishment of a provincial drug shortage risk index system,it is found that the drug shortage risk of each link in the drug supply chain of this province is ranked as production process,government department,use process,distribution process and procurement process.The early warning model of drug shortage established by multiple linear regression,including 5 risk factors,can be used to predict the risk value of a suspected shortage of drug in a certain region of the province,and the actual shortage level of a suspected drug in a region can be obtained according to the historical shortage level.This establishment method can also provide reference suggestions for other provinces to determine the drug shortage risk factors and establish the early warning model of drug shortage of this province.It is suggested that the province unify the definition of drug shortage,further improve the information reporting network of monitoring points,refine the reporting system of drug suspension and establish the database and information sharing platform of drug shortage.