Analysis of medical insurance access policy for rare disease drugs in the United Kingdom and enlightenment to China / 中国药房

OBJECTIVE To provide reference for the access to medical insurance for rare diseases in China based on the existing access pathway and framework by analyzing the access policy of medical insurance for rare diseases in the United Kingdom （UK）. METHODS After collecting relevant guidelines and policy documents related to drug use for rare diseases in the UK， content analysis method was used to analyze the evaluation mechanism of drug use for rare diseases， reimbursement decision- making standards， stakeholder participation， coping strategies for dealing with uncertainties and risks， and policy implementation effects， and extract the key points of medical insurance access for drug use for rare diseases in the UK， to provide some suggestions for the establishment of medical insurance access system for rare diseases in China. RESULTS & CONCLUSIONS From the perspective of access， the UK had adopted a separate approach and clear criteria to assess and reimburse drugs for rare diseases. From the perspective of evaluation mechanism， multi-stakeholders such as doctors， patients and applicants participated in the decision-making process in the UK. The UK addressed uncertainty and risk by gathering better clinical evidence and using the patient access programme. After the implementation of the policy related to drug use for rare diseases， the UK had achieved remarkable results in terms of funding for drug use for rare diseases， the reimbursement rate of drug application， and the number of funded patients. It is suggested that in the process of establishing and improving the evaluation and reimbursement system for rare diseases drugs in China， the availability of rare diseases drugs should be improved by establishing a separate access assessment path for rare diseases drugs and involving more stakeholders.

Keypoint Analysis of Monitoring Plan for Centralized Drug Purchase and Use Project Pilot Launched Organized by State / 中国药房

OBJECTIVE： To provide reference for further evaluating， improving and ensuring the smooth implementation of centralized drug purchase and use pilot organized by the state. METHODS： By using the methods of literature research and investigation， monitoring purpose， monitoring contents （including supply guarantee， use guarantee， quality guarantee and cost control） and monitoring methods of Monitoring Programme for Centralized Drug Purchase and Use Pilot Projects Organized by the State were sorted， summarized and analyzed so as to put forward the suggestions.  RESULTS & CONCLUSIONS： The monitoring purpose was to control the procurement phase from two aspects： policy guidance and information monitoring. In the contents of monitoring， monitoring indicators were set up for supply gurantee from two aspects of production and circulation. The former included seven indicators of production inventory， stop and resume production， source and supply and price of core raw materials and accessories， and the latter included two indicators of channel inventory and days of repayment. For use gurantee， selected drugs， original drugs in the item of generic name， other drugs in the terms of generic name and substitutable drugs of the same kind were monitored in respects of monthly purchase price， purchase quantity， purchase amount， accumulative purchase quantity， accumulative purchase amount， prescription quantity. Quality gurantee indexes included drug stability （batches and projects of unqualified drugs）， safety （ADR， severe ADR， public complaints and reporting incidents） and effectiveness （number of drug-change patients and number of secondary drug-change patients）. For cost control， the monthly drug quantity and cost of selected drugs， original drugs in the item of generic name， other drugs in the terms of generic name and substitutable drugs of the same kind were monitored； original drug cost （for original drugs in the term of same generic name）， the cost of other drugs and the reimbursement ratio of last year’s medical insurance （for other drugs in the term of generic name） were compared with the same period of the previous year， in which the drug quantity was calculated by DDDs. The monitoring methods included three-level monitoring by the national organization office for the contralized procurement and useage of pharmaceuticals， “4+7” city joint procurement office and pilot area， and regular monthly reporting and timely feedback of monitoring information. Monitoring information submission was mainly in the form of standardized report format （filling by manual in monthly， e-mail submission） and automatic system submission （every day， other pilot cities and Shanghai Joint Purchasing Data Exchange Platform established data interface for automatic submission）. According to the fact， author put forward the suggestions to improve the monitoring contents， such as adjusting the measurement standard of inventory turnover days， defining the statistical caliber of purchasing quantity and price monitoring， distinguishing the specifications of pharmaceutical preparations and packaging， defining the every drug DDD value in monitoring range， and so on. At the same time， the author suggests optimizing the reporting mode of monitoring information， interworking the purchasing platform with medical insurance information， and integrating drug supply chain information from manufacturing enterprises， distribution enterprises， medical institutions to patients， providing cross-provincial trading services， etc.， make them play a greater role in drug procurement management of the National Healthcare Security Administration， rational use management of drug by the Nation Health Commission of the People’s Republic of China， and drug traceability management of the National Medical Products Administration.

Effectiveness Analysis of the National Designated Production Pilot Policy for Drug in Shortage ：Taking Chongqing as an Example / 中国药房

OBJECTIVE： To analyze the effect of the national designated production pilot policy for drug in shortage in China. METHODS： Taking 2 batches of drugs from 7 designated production manufacturers in Chongqing from Sept. 2012 to Sept. 2018 as an example， the overall supply situation of designated production （using the average satisfaction rate of medical institution’s order as index）， the changes of drug supply （average satisfaction rate of order） before and after the implementation of national designated production policy （during designated production period and non-designated production period） were all analyzed. According to the level of medical institutions and the order quantity of medical institutions （three sections： small amount， suitable， big amount）， the classification analysis was carried out. At the same time， telephone interview was conducted among the business personnel of related pharmaceutical production enterprises to understand and summarize the reasons for the supply problems of these drugs. RESULTS： Except for the average satisfaction rate of drug order was 0 in one designated production manufacturers， the satisfaction rate of drug order in the other 6 designated production manufacturers ranged from 58.05％ to 92.31％. During the designated production period， the satisfaction rate of drug order was increased significantly， compared with non-designated production period. However， after the expiration of the designated production of drugs， the order satisfaction rate mostly declined， and satisfaction rate of some drug orders were even lower than that before designated production. Average satisfaction rate of drug order in third level medical institution was higher than those of second level， first level or primary medical institutions. During designated production period， the average satisfaction rate of drug order in designated production manufacturers to medical institutions at all levels was higher than during non-designated production period or in non-designated production enterprises. There are 5 kinds of reasons for supply problem of designated production and drug with same specification： the limited price is lower than the cost； the production is stopped due to raw material； the production is stopped because of enterprise； the medical insurance payment price is far lower than the supply price； the hospital demand is small. CONCLUSIONS： The designated production pilot policy has played a significant role in improving the shortage of drug supply， but it still needs to be improved by establishing a dynamic adjustment mechanism for the scope， price and duration of designated drug production.

Study on“Bolar Exception” from the View of Government Regulation Theory / 中国药师

Bolar exception is a patent infringement exemption principle .The article explored the origin ( market failure ) of Bolar ex-ception from the view of government regulation theory , and introduced the production , development and application status of Bolar excep-tion in the world.At the same time, the Bolar exception clauses in our country were also introduced , and the relative regulations in time, place and application scope were discussed in order to provide reference for the perfection of Bolar exception in China .

Analysis of Drug Use in Pediatric Patients from 78 Sample Hospitals in 7 Regions of China from 2013 to 2014 / 中国药房

OBJECTIVE:Analyze drug use of pediatrics in China,and to provide reference for promoting research,develop-ment and supply of pediatric drugs. METHODS:Analyze the data of drug use in 2 632 514 pediatric patients aged from 0 to 14 of 78 sample hospitals from Beijing,Shanghai,Tianjin,Hangzhou,Zhengzhou,Guangzhou and Chengdu in“The Hospital Prescriptions Cooperation Project”of Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association,statistical analysis was performed by using Excel and Access software. RESULTS:Pediatric patients in 78 sample hospitals of 7 regions had used 1 572 kinds of drugs from 2013 to 2014,but only 31.04%of drugs were pediatric drugs;both the ratio of pediatric drug types and the ra-tio of pediatric drugs use frequency had a great gap in different drug classifications. The ratio of drug use frequency in injection ad-ministration was 57.97%,and it was greatly higher than that of oral administration(31.04%). Among oral solid preparations,the ratio of drug use frequency for drugs with unreasonable specification was 29.57%,and ratio of drug types was 40.99%. CONCLU-SIONS:The pediatric patients had a great drug shortage in kinds,dosage forms and specifications in 78 sample hospitals of 7 re-gions during 2013-2014. Off-label drug use,high frequence of injection use,tablets used after breaking and other irrational phenom-ena were found in pediatric patients during clinical drug therapy,which reduced high risk of drug use. It is recommended that gov-ernment should strengthen and improve incentives mechanism of research,development and supply of pediatric drugs,so as to solve pediatric drug shortage in China,promote rational clinical drug therapy for children and guarantee the safety of drug use in pe-diatrics.

Development of therapeutic biologics from 1984 to 2014 / 中国药理学通报

This article is to analyse the development of therapeu-tic biologics from 1984 to 2014. Data were obtained from the Drugs @ FDA, PubMed, Embase. com and ClinicalTrail. Gov. Descriptive analyses were used to classify therapeutic biologics by level of innovation,therapeutic category and the chemical na-ture of the drugs. The results showed that from 1996 the thera-peutic biologics entered the fast development period, especially from 2001 to 2005. The 125 therapeutic biologics focus on the treatment of tumor, immune system disease, endocrine and met-abolic diseases, blood system diseases, skeletal muscle system diseases. Antibody has become the dominant of therapeutic bio-logics. Antibody is widely used in the treatment of cancer, di-gestive diseases, immune diseases, respiratory diseases, urinary diseases, skeletal muscle diseases, etc.

Analysis of the Use of Essential Medicines in 20 Medical and Health Institutions in Beijing from 2013 to the First Half Year of 2014 / 中国药房

OBJECTIVE:To provide reference for the promotion of rational use of essential medicines and further implementa-tion of essential medicines system. METHODS:Depended on the data (including the number of species,the amount of prescrip-tion and prescription departments,etc)of essential medicines(chemical drugs and biological drugs)use in outpatient and emergen-cy departments and wards of 20 sample medical and health institutions fromThe Hospital Prescriptions Cooperation Project,statis-tical analysis was performed by using Excel and Access software. RESULTS:The proportion of the amount of essential medicines included in National Essential Medicines List(2012 edition)or Beijing Essential Medicines(Supplementary list)(2012 edition)to the amount of total medicines(hereinafter referred to as the essential medicines use ratio)in medical and health institutions of Bei-jing from 2013 to the first half year of 2014 was small and showed a slight downward trend. The essential medicines use ratio of grade 2 and grade 3 general hospitals did not reached the required ratio by former Health Department. The essential medicines use ratio in different departments showed great differences,the essential medicines use ratio in imaging department was 100%,while chemotherapy departnent was 4.04%. The essential medicines use ratio in different medicines also showed great differences,5 kinds of drugs(including sulfani lamides)was 100%,while there were 16 kinds of drugs that was less than 0.1%. CONCLUSIONS:The essential medicines use ratio is relatively low in medical and health institutions of Beijing from 2013 to the first half year of 2014 and shows great differences in different departments and different medicines. It is suggested to further improve the essential medi-cines use ratio to better benefit the majority of patients by changing the prescribing habits of physicians,strengthening the advocacy of essential medicines policy and optimizing the use of essential medicines in different departments.

Establishment of Competency Model for Medical Representatives in China / 中国药师

Objective:To establish the competency model for medical representatives in China. Methods:Firstly, the competen-cy elements for medical representatives were defined through the literature research and logic analysis, the importance of each element was then evaluated by a questionnaire, and the survey results were analyzed by a factor analysis approach. Lastly, the weight of each factor was confirmed by analytic hierarchy process. Results & Conclusion: The competency model, which consists of 5 dimensions ( professional quality, professional ethics, knowledge, personal characteristics and relationship management) , 26 competency elements and the weight of each factor, is established successfully.

Opportunities and challenges for private hospitals in the ongoing health reform / 中华医院管理杂志

The paper studied the development opportunities and challenges faced by private hospitals during the ongoing health reform and reviewed the milestones of such hospitals in China.In addition,it compared the developments of both private hospitals and public hospitals since the reform,analyzed the advantages and disadvantages.Based on such analysis,the paper proposed such business strategies as group strategy and differentiation strategy,pointing the way for further development of private hospitals.