The introduction of therapeutic equivalence evaluation codes and its influence on the selection of the reference listed drugs in China

The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.

Efficacy of Jian’ganle(健肝乐) versus Hugan Pian(护肝片),Glucuronolactone and Reduced Glutathione in Prevention of Antituberculosis Drug-induced Liver Injury

Summary： Evidence-based medicine is advocated by WHO and adopted by developed countries for many years. In China, however, the selection of essential medicine and various medical insurance reimbursement schemes medicine is usually based on experts＇ experience of prescription practice which is under heavy critics resulting from the lack of related comparative efficacy and evidence-based research. The efficacy of Jian＇ganle in prevention of drug-induced liver injury （DILI） caused by antituberculotics was evaluated in this study by comparison with Hugan Pian, glucuronolactone and reduced glutathione. Evidence was provided for relevant sectors such as Ministry for Human Resources and Social Security of the People＇s Republic of China and National Health and Family Planning Commission of the Peo- ple＇s Republic of China to select and renew the Essential Medicine List （EML）, the new rural cooperative medical scheme in China （NRCMS） list or the reimbursement list of industrial injury insurance. A total of 189 patients with initial pulmonary tuberculosis were divided into four groups who took antituberculotics combined with Jian＇ganle, Hugan Pian, glucuronolactone and reduced glutathione respectively. Their liver function profile including alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, total bilirubin （TBIL）, direct bilirubin （DBIL）, total protein （TP）, albumin （A） and globulin （G） were detected at admission as baseline and after treatment. The Jian＇ganle group was compared with the three others by chi-square tests. In an aspect of maintaining bilirubin indexes normal, Jian＇ganle was more efficacious than glucuronolactone. And Jian＇ganle had a little more efficacy than reduced glutathione to maintain protein indexes normal as well. And the therapeutic regimen of antituberculotics combined with Jian＇ganle was the best in treating tuberculosis and preventing DILI at the same time. The study showed that among the four hepatinicas which demonstrated similar prevention of DILI caused by antituberculotics, Jian＇ganle has more advantages over the three others to some extent, which provides a reliable basis for health sectors to select and renew the EML, NRCMS List or the reimbursement list of industrial injury insurance.

Study on the Matching Degree between Essential Drug List and the Provisions on Drug Coverage in Tertiary Hospitals

Objective To study the relationship between essential drug list and the provisions on the drug coverage in tertiary hospitals,and put forward the corresponding countermeasures and suggestions for the adjustment of essential drug list and the improvement of relevant policies.Methods Expert consultation and statistical methods were used to classify the drugs in the list of essential drugs according to different diseases.Besides,the matching degree of basic drug allocation and prescription policy was analyzed.Results and Conclusion Among the 685 drugs in the national essential drug list of 2018 edition,453 drugs were used to treat minor illness,accounting for 66.1%of the total number of essential drug list.232 drugs were for serious illness or fatal illness,accounting for 33.9%of the total number of essential drug list.The current essential drug list does not match the national requirements for drug plan coverage in tertiary hospitals,which needs further adjustment and improvement.

Impacts of National Basic Medical Insurance Drug List adjustment on drug utilization in China: an interrupted time series study

Under Chinese medicine and health care system, Medicine Catalogue for National Basic Medical Insurance（2009） was issued in 2009 in China to fulfill the basic drug demands of the insured Chinese and to control the medical expenses. In this study, the influence of the list adjustment on drug utilization was investigated. With the comparison between inpatients＇ use of drugs before and after adjustment of Basic Medical Insurance Drug List, we classified the drugs adjusted in national list into six categories： class A to class B, class B to class A, class A to class C, class B to class C, class C to class A, and class C to class B（class A referring to overall insured drugs, class B referring to partial reimbursement drugs, class C referring to self-funded drugs in China）, and drug utilization and expenditure were analyzed with time series model. We analyzed the overall expenditure and average expenditure per 10 000 people based on the comparison before and after the adjustment of 2009 Basic Medical Insurance Drug List. The drug expenditure from class A to class B was decreased by 13.87% of overall expenditure and 16.37% of average expenditure per 10 000 people, and it was decreased by 38.74% and 48.03% from class A to class C; respectively, the drug expenditure from class B to class A was increased by 74.12% and 94.52%, while it was reduced by 19.79% and 14.52% from class B to class C; expenditure declined by 31.77% and 36.22% from class C to class A, and expenditure was increased by 12.42% and 22.05% from class C to class B, respectively, both were lower than before. The adjustment of National Basic Medical Insurance Drug List reduced the overall drug expenditure.