Mechanism and enlightenment of public participation in the NICE health technology assessment in England / 中国药房

OBJECTIVE To analyze the public participation mechanism of National Institute for Health and Care Excellence （NICE） health technology assessment in England and to provide experience for the dynamic adjustment of Chinese medical insurance catalog. METHODS By retrieving related literature and official websites， types and mechanisms of public participation （management organization， selection method， participation mode， evaluation feedback） in NICE health technology assessment were analyzed comprehensively； and based on this， suggestions were put forward to adjust the public participation in Chinese medical insurance catalog. RESULTS & CONCLUSIONS The current public participation types of NICE health technology assessment were patient and carer organizations， HTA committee lay members， patient expert and public observers. At the management level， NICE has set up a public participation team and made guidelines on public participation matters. For different public participation types， NICE has established different selection procedures， such as expression of interest， NICE invitation， open recruitment， nomination， NICE decision， etc. The public participation types are various and in the whole assessing process from the initial determination of the scope of the health technology assessment to the final appeal. Also， NICE has established a flexible and dynamic evaluation feedback system to optimize the way of public participation and the health technology assessment process； NICE has undertaken extensive international cooperation and exchanges to promote public participation at the national and international levels. It is suggested that our country should combine the national conditions， clarify the channel of public participation in health technology evaluation， set up a working group of public participation affairs， strengthen patients’ participation in evaluation and feedback， improve decision-making transparency， and improve the public participation mechanism of health technology evaluation from the aspects of channel opening， management mechanism， evaluation feedback， information disclosure and so on.

Construction of the evaluation index system for pharmacist training effectiveness based on Kirkpatrick evaluation model / 药学实践杂志

Objective To construct the evaluation index system for pharmacist training effectiveness in China. Methods The initial framework of index system based on Kirkpatrick evaluation model was constructed through literature research and expert interview method. Delphi method was used to analyze the index system. Results The evaluation index system for pharmacist training effectiveness in China included 4 first-level indicators, reaction evaluation, learning evaluation, behavior evaluation and result evaluation, 9 second-level indicators, training scheme, teaching staff, training conditions, theoretical knowledge, practical skills, the change of work ability, the change of professional attitude, personal income and organizational income, as well as 32 third-level indexes such as pharmaceutical professional knowledge. Conclusion This evaluation index system for pharmacist training result is highly scientific and systematic. It covers the whole-process and follow-up evaluation of the training activities. It can optimize the pharmacist training schedule and improve the program design for the effective pharmacist training evaluation.

CHINA PH ARMACY Volume 33，Number 3，February 15，2022 Semimonthly Table of Contents Study on the action framework and key problem of drug safety governance in China / 中国药房

OBJECTIVE To provide reference for clarifying the action and development direction of China ’s drug safety governance. METHODS Based on governance theory ，an analysis framework of “Motivation-Sharing-Performance and Feedback ” was established to explain the mechanism of cross-sector collaboration governance of drug safety. By constructing the action framework of national drug safety governance of “3 stages+1 incubation period ”，the connotation of each stage and possible challenges were analyzed ，and improvement suggestions were put forward. RESULTS & CONCUSIONS The obstacles that restricted the effectiveness of drug safety governance in China were mainly due to insufficient information ，resource mobilization and power sharing. Therefore ，the“basic collaboration stage ”should expand the scope of information sharing and involve non-governmental entities ；the“legislative coordination stage ”should focuse on the provision of formal legal systems so that non-governmental forces can play a necessary role in governance activities ；the“deepening of the coordination stage ”should promote the formal integration of social forces into governance system ，and truly realize the transition from “passive participation ” to self-management. It is recommended to continuously improve the construction of drug safety governance system in China in terms of governance norms ，communication mechanisms ，capacity development based on a holistic perspective.

Pediatric Drug Pricing and Price Incentive Policy in Japan and Its Enlightenment to China / 中国药房

OBJECTIVE：To learn from pedia tric drug pricing and price incentive policy in Japan ，and to provide reference for the improvement of pediatric drug price system in China. METHODS ：The drug pricing strategy of Japan was analyzed ，and price incentive policy of pediatric drugs in Japan and its implementation status and effect were summarized. The suggestions of perfecting the price system of pediatric drugs in China were put forward . RESULTS & CONCLUSIONS ：The pricing strategy of medical insurance drugs in Japan included two types ，such as access pricing of medical insurance list and price adjustment of drugs in medical insurance list. Among them ，price incentive policy for pediatric drugs mainly included the premium for initial pricing of new pediatric drugs ，the premium for drugs with newly added pediatric indication included in medical insurance list and other measures（such as eligible drugs could obtain indirect price compensation ，and children ’s factors could be considered in health technology assessment ）. Overall ，these measures accelerated the R&D and marketing of Japanese pediatric drugs ，and effectively promoted the development of pediatric drugs in Japan. The author suggests that our country should carry out health technology assessment which reflects the particularity of pediatric drugs ，give appropriate direct price incentives to the payment price of pediatric drugs ，and reasonably set the price of drug specification suitable for children and give price incentives so as to promote the development of pediatric drugs in China.

Research on Self-regulation of Pharmaceutical Advertising Industry in the UK and Enlightenment for China / 中国药房

OBJECTIVE：To provide re ference for promoting the self-regulation development of China ’s pharmaceutical industry. METHODS ：Through in-depth analysis of the self-regulation system of the UK pharmaceutical advertising industry ，this paper focused on the procedures and characteristics of the self-regulation of the UK pharmaceutical advertising industry ，and proposed the suggestions for improving the self-regulation system of China ’s pharmaceutical industry. RESULTS & CONCLUSIONS： Since the 1980s，the self-discipline of the pharmaceutical advertising industry in the UK has officially established its legitimacy in 2012，and distinguished the operation procedures of prescription only medicine and over-the-counter. The characteristics of the self-regulation of the pharmaceutical advertising industry in the UK are to issue guidelines to guide the industry self-regulation ， select appropriate industry associations to become self-regulation institutions ，promote the effective connection between government supervision and industry self-regulation ，and ensure the continuous and effective communication between the government and industry associations. It is suggested that China should develop the guidelines for guiding industry associations to carry out self-regulation，focus on cultivating self-regulation capabilities of industry associations ，establish a cohesive mechanism between government supervision and industry self-regulation ，and build a platform for ensuring continuous and effective communication between the two parties ，thus promoting the development of self-regulation system in the pharmaceutical industry.

Research on Drug Safety Governance in Australia and Its Enlightenment to China / 中国药房

OBJECTIVE：To provide reference for improving the supporting system of drug safety governance in China. METHODS：Through analyzing the main ways ，characteristics and effectiveness of drug safety governance in Australia ，the suggestions for building drug safety governance system in China were put forward initially. RESULTS & CONCLUSIONS ：The methods of Australia ’s drug safety governance are to conduct division of labor between the federal and state/territory governments ， advanced-voluntary-bundled-payment-model. conduct policy consultations with different related entities separately ，guide industry self-discipline based on industrial development level，and support industry to participate in drug advertising supervision. Australia ’s drug safety governance has the characteristics of large information sharing channels ，increasing the transparency of government work ，carrying out targeted education and enhancing the governance capacity of participants etc. It has achieved significant improvement in the occurrence of drug recall events，and significant increase in the satisfaction of stakeholders in the communication activities of drug regulatory authorities. In contrast，the participation consciousness and ability of relevant entities in China are still not strong ，and the system to ensure the participation of these entities is not yet sound. It is recommended that China should pay more attention to the communication between the upper and lower levels of governments ，conduct targeted education or training for principals of non-government entities， implement the policy consultation rights of non-government entities ， as well as guide self-discipline based on self-management ability of industry entities so as to initially establish drug safety governance system in China ，and enhance the governance efficiency.

Establishment of Drug Registration Applicant Compliance Management Organizations in the United States and Its Enlightenment to China / 中国药房

OBJECTIVE：To provide reference for further improving the establishment of drug registration applicant compliance management organizations in China. METHODS ：Through introducing and analyzing the establishment ，responsibility configuration and operation mechanism of drug registration applicant compliance management organizations in the United States ，the suggestions were put forward for improving the establishment of drug registration applicant compliance management institutions in China. RESULTS & CONCLUSIONS ：There were two levels of compliance management organizations for drug registration applicant in the United States ；at Office of the Commissioner of FDA level ，the Compliance Policy Council was responsible for ensuring consistency in the implementation of all compliance policies in the FDA regulated area ；at the level of Center for Drug Evalution and Research （CDER）and Office of Regulatory Affairs （ORA），the compliance management function was mainly undertaken by Office of New Drugs （OND），Office of Generic Drugs （OGD），Office of Compliance （OC） and Office of Communication （OCOMM）under CDER ，as well as Office of Policy and Risk Management （OPRM），OC，Office of Bioresearch Monitoring Operations（OBIMO）and Office of Pharmaceuticl Quality Operations （OPQO）under ORA ，which were responsible for developing compliance documents and procedures ，carrying out compliance education ，compliance guidance ，compliance inspection and punishment for violations. Before submission stage of drug registration application ，the compliance education function of OC and the compliance guidance function of OND/OGD played an important role ；in the application submission stage ，OND/OGD was responsible for the compliance review of application materials ；in the stage of reviewing the application materials ，OND/OGD and OC of CDER ensured drug compliance through collaboration with OC ，OBIMO and OPQO of ORA. The establishment of drug registration compliance management institutions in China was still in the preliminary exploration stage. It is suggested that China can learn from the relevant experience of the United States ，establish a multi-level or ganization structure ，set up an independent compliance education department ， and strengthen thecooperation between evaluation department and compliance inspection department ，and to improve the level of compliance management of drug registration applicants in China.

Analysis of UK Strategy for Rare Diseases and Its Enlightenment to China / 中国药房

OBJECTIVE: To learn from the implementation experience of UK Strategy for Rare Diseases, and to provide reference for the formulation of the rare disease guarantee strategy in China. METHODS: The background, status quo and content of UK Strategy for Rare Diseases were introduced; its implementation experience was analyzed and summarized to provide enlightenment to the construction of relevant mechanism in China. RESULTS & CONCLUSIONS: British government took measure like strengthening the collection of message, improving service quality and uniting patient organization for patient empowerment, while spreading advanced disease screening and gene detection technology, developping training in diagnosis and treatment of rare disease and encouraging patients to participate in the research. The comprehensive and perfect guarantee system of rare disease had been formed. British experience is worth learning. Our country should construct comprehensive guarantee framework of rare disease, support patient organizations, improve service system for patient and strengthen rare disease research to provide health guarantee for rare disease patients.

Legislative Suggestions on Improving Drug Quality Supervision of Medical Institutions in China / 中国药房

OBJECTIVE:To provide reference and basis for strengthening the drug quality supervision of medical institutions.METHODS:The problems about the drug quality supervision of the medical institutions were analyzed from the angle of legislation.Countermeasures for strengthening drug quality supervision of medical institutions in China as well as legislative suggestions on improving drug quality supervision of medical institutions in China were put forward.RESULTS & CONCLUSIONS:At present,the existing problems about drug quality supervision in medical institutions include that pharmacy setting lack mandatory standards;routine drug quality supervision is mainly the formal regulation;the punishment of drug related illegal behavior in medical institutions is too light,etc.To strengthen drug quality supervision of medical institutions in China,it is suggested that the government should establish the mandatory standards for medical institution pharmacy setting,add administrative inspections,and formulate Good Using Practice applicable to the whole country.When perfecting the law of drug quality supervision in medical institutions in China,relevant provisions may be added in The Drug Administration Law of the PRC,Regulations for the Implementation of Drug Administration Law,and the subordinate laws and regulations of Management Regulation of Medical Institutions so as to strengthen drug quality supervision of medical institutions.

Comparison analysis of local invasion between the Chinese 2017 staging system and the 2008 staging system for nasopharyngeal carcinoma / 国际肿瘤学杂志

Objective To compare the difference of T-stage between Chinese 2017 staging system and the 2008 staging system for nasopharyngeal carcinoma,and to investigate the optimization of T-stage and provide suggestions for further revision.Methods The MRI data of 183 patients with histology-proven newly diagnosed nasopharyngeal carcinoma in our hospital were enrolled from September 2009 to May 2017.All the anatomic sites mentioned in the two staging systems were marked,and all patients were staged according to the 2017 staging system and the 2008 staging system for nasopharyngeal carcinoma.Comparisons of T-stage were made between the two staging systems.Results Involvement of oropharynx,nasopharynx,prevertebral muscles,cervical vertebra,hypopharynx and orbit were 100％ accompanied with other same or more advanced T-stage classifications.The invasion rates of the cervical vertebra,orbit and hypopharynx were very low (all ＜ 5.00％).The incidence of involvement of pterygoid structure was 15.30％,most of which incorporated with erosion of skull base,only 1 case was invaded alone.All cases of involvement of paranasal sinuses were incorporated with erosion of skull base.Compared with the 2008 staging system,the consti-tuent ratio of T1 + T2 in the 2017 staging system increased from 36.61％ to 61.75％,and that of T3 + T4decreased from 63.39％ to 38.25％,the constituent ratio of T-stage between the 2017 staging system and the 2008 staging system was significantly different (x2 =26.94,P ＜ 0.001).There was moderate consistency of T-stage between these two staging systems (Kappa =0.514,P ＜ 0.001).Conclusion The T-stage of 2017 staging system still has a larger simplification and optimization space.Therefore,according to the principle of concise,the T-stage parameters including oropharynx,nasopharynx,prevertebral muscles,paranasal sinuses,cervical vertebra,orbit and hypopharynx are recommend to delete,and it does not have an impact on the composition of T-stage.We suggest that the pterygoid structure shall combine with the skull base to be one anatomical structure.

Practice of the Responsibility Development of Community Pharmacists in USA,UK,Australia and Its En-lightenment to China / 中国药房

OBJECTIVE:To provide reference for the development of community pharmacists in China. METHODS:Accord-ing to reviewing the practice in the responsibility development of community pharmacists in USA,UK,Australia,relevant experi-ence was summarized and relevant suggestions were put forward. RESULTS & CONCLUSIONS:Responsibility development of community pharmacists in USA,UK,Australia had made great progress,and their levels of practice and their own quality also made continuously improvement. Besides,they made certain achievements in prevention of chronic disease,minor illness manage-ment in community pharmacy,drug use review and prescription drug intervention,and health mission pharmacy,etc. In China, our government should promote the transforming of the responsibility of community pharmacists by considering the differences of re-gions in stage and step by step,encourage pharmacists actively and orderly expand the business scope,actively explore from sys-tem and develop multiple authentication,and steadily improve the service skills of pharmacists. Meanwhile,domestic pharmacies and pharmacists should take the initiative to change the concept to get ready for the coming changes.

Performance of registration regulation policies on biosimilars in Japan and its enlightenment / 中国卫生政策研究

Objective:This paper intends to provide reference for consummation of biosimilar registration poli-cies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimi-lars by analyzing the procedure and reviewing the features of biosimilars. Results and Conclusions:According to the findings of the present investigation, the availability and affordability of biosimilars have been improved, and the bio-medicine industry has achieved great development. On the other hand, it's recommended that the guideline for the de-velopment and evaluation of biosimilars should be amended on the principle of appropriate simplification, which means to simplify the research and development procedure and exempt partial application dossier. Besides, the regis-tration procedures should be adopted continuously to ensure the stability of biosimilars' R&D and registration.

Comparisons of the 2015 edition of WHO model list of essential medicines for children and the 2012 edition of list of national essential medicines for children / 国际药学研究杂志

This study focuses on comparing the 2015 edition of WHO model list of essential medicines for children with the 2012 edition of list of national essential medicines for children in respects of drug categories,dosage forms,specifications and medica?tion information. The number of essential medicines available for children in China roughly equals to that of WHO model list of essen?tial medicines for children. Though China′s list provides more specific and children-agreeable specifications,it lags behind the WHO list with respect to the number of dosage forms and information concerning pediatric weight limitation ,drug combination and alterna?tives. It is recommended that research and development on dosage forms for children should be strengthened to solve the problem of pe?diatric drugs shortage. Also,more clinical trials should be developed as supporting evidence. Based on adapting to the needs of basic health services of children,essential medicines list for children in China should be established.

Diagnostic value of bone metabolic markers for bone metastasis of non-small cell lung cancer analyzed by Logistic regression combined with ROC curve / 肿瘤研究与临床

Objective To investigate the diagnostic value of bone metabolic markers (BGP, β-CTX and PINP) for bone metastasis of non-small cell lung cancer (NSCLC) analyzed by Logistic regression combined with ROC curve.Methods A total of 65 patients with stage Ⅳ NSCLC were enrolled in this study.The patients were divided into two groups based on radiological imaging, includirg bone metastasis group (30 cases) and non-bone metastasis group (35 cases).The serum concentrations of BGP, β-CTX and PINP were measured by electrochemical method.Logistic regression and ROC curve were applied to analyze the data and evaluate the diagnostic values.Results The concentrations of β-CTX [(0.54±0.39) ng/ml] and PINP [(103.64±81.86) ng/ml] were significantly higher in bone metastasis group than those [(0.31±0.16) ng/ml and (48.37±27.76) ng/ml, respectively] in non-bone metastasis group (P ＜ 0.01), while the level of BGP did not differ between two groups (P ＞ 0.05).The area under the ROC curve (AUC) for β-CTX and PINP was 0.662 and 0.678, respectively.The AUC for the new predictive variables created by Logistic regression was 0.761.Conclusion Combined detection of β-CTX and PINP in the serum and application of Logistic regression combined with ROC curve analysis can increase diagnostic accuracy on bone metastasis of NSCLC.

Problems and Countermeasures of Public Participation in the Food and Drug Safety Administration in Chi-na / 中国药房

OBJECTIVE:To perfect public participation system of food and drug safety in China and establish“society multi-governance”of food and drug safety. METHODS:The problems of public participation in food and drug safety administration were analyzed in China. Referring to the experience of USA,Japan,South Korea and other developed countries in stage of food and drug safety legislative decision-making,regulation and enforcement and dispute settlement,the countermeasures were put forward to perfect public participation system of food and drug safety. RESULTS & CONCLUSIONS:The public is in a passive position and shows weak right of speech in legislative decision-making stage;the public is not active and shows weak awareness of partici-pating in management in regulation and enforcement stage;public interest litigation system in dispute settlement stage has not been established. Those problems impede the generation of“society multi-governance”of food and drug safety in China. In United States,Japan,South Korea and other developed countries,the position and right of the public participation can be guaranteed com-pletely through establishing complete legal system,strengthening government information transparency,improving complaints sys-tem and public interest litigation system,etc. Our country can perfect the system of public participation in the food and drug safety and promote the generation of“society multi-governance”of food and drug safety by detailing the regulations in legislative deci-sion-making,emphasizing the information opening and feedback,strengthening the propaganda of public responsibility conscious-ness,setting up scientific food and drug safety complaint and reparting system and establishing public interest litigation system.

Establishment of Evaluation Model of O2O Platform Service Quality Based on SERVQUAL Scale / 中国药房

OBJECTIVE:To establish a pharmacy online to offline (O2O) platform service quality evaluation model,and to provide reference for platform operators to improve the service quality. METHODS:Using SERVQUAL scale,combining the situa-tion of pharmacy O2O platform development in China,the reliability,safety and aspects of O2O platform were analyzed to sum up primary evaluation index of pharmacy O2O platform service quality. Based on this,the expert interviews questionnaire was de-signed. According to the questionnaire results,indicators were modified and empowered to construct the pharmacy O2O platform service quality evaluation model;the reliability and validity of model were validated. RESULTS & CONCLUSIONS:According to the connotations of each dimension analysis in the SERVQUAL scale and expert interview results of pharmacy O2O platform ser-vice quality,pharmacy O2O platform service quality evaluation model is constructed,including five indicators as“reliability”“se-curity”,and 18 secondary indexes as the“number of platform pharmacy”“pharmacy qualification show”“pharmacy type”. The re-sults of model index reliability and validity verification show that model construction is reasonable and can provide reference for platform operators improving service quality. Follow-up research should give full consideration to the Chinese consumer behavior habits,personal preferences and other factors to build more suitable pharmacy O2O platform service quality evaluation model in China.

Analysis of the high value medical consumables procurement in foreign countries and its inspi-ration to China / 中国卫生政策研究

The main intention of this paper is to propose suggestions for optimizing China 's high-value medical consumables centralized procurement .In this paper , we have analyzed the developed countries 'best practices in high-value medical consumables procurement from the perspectives of procurement principle ( s), key procurement bodies, procurement patterns, supervision, and management.The results of our analysis show that “Value for mon-ey” is the core principle in procurement and hospital route , national/regional centralized route ( s) , and group pur-chase organization ( GPO) route are four primary procurement patterns in foreign countries .Procurement management is optimized through improving product coding system and encouraging health technology assessment ( HTA) and clin-ical practitioners'involvement in procurement decision-making.In that perspective, it's been suggested that China's high-value medical consumables centralized procurement could be improved from three aspects:referring partial HTA indicators so as to enhance tender evaluation and realize value-based purchasing;establishing a standard and unified coding system for medical devices;introducing GPO route and make market surveillance mechanism into full play .

Comparative analysis on price negotiation models of patented drugs in Korea and Germany and its implications for China / 中国卫生政策研究

Objective: To provide policy recommendations for improving price negotiation system of patented drugs in China. Methods: This paper comparatively analyzes the commonalities and characteristics between Korea’ and Germany’s price negotiation models for patented drugs from three aspects of their goals, procedures and effects. Results:The key objective of both Korea’ and Germany’s price negotiation systems for patented drugs is to efficiently improve the utilization of national health insurance services, and responsibilities are properly assigned among differ-ent institutions to ensure the equity and efficiency of negotiations. However, due to the differences in national cir-cumstances, there is a big difference in the selection of technical assessment criteria. Conclusion: This paper sug-gests China to strengthen the convergence between price negotiations for patented drugs and medical insurance reim-bursement policy, to establish a technical assessment system with the innovation extent for patented drugs as its core, and to develop scientific and rational negotiation procedures and division of responsibilities as well.

A short-term curative observation of nimotuzumab combined with concurrent intensity-modulated radiotherapy and chemotherapy in the treatment of locally advanced cervical cancer / 国际肿瘤学杂志

Objective To explore the efficacy and adverse effects of nimotuzumab combined with chemotherapy and radiotherapy in the treatment of locally advanced cervical cancer.Methods Sixty patients with stage Ⅲ cervical cancer by the histopathologic diagnosis were collected,and they were randomly divided into two groups using the random number table method.The control group (n =30)using intensity-modulated radiotherapy,intracavitary afterloading therapy and periodic chemotherapy,the observation group (n =30)in addition to the intensity-modulated radiotherapy,intracavitary afterloading therapy and periodic chemotherapy, the nimotuzumab (200 mg)was given to the patients before weekly radiotherapy.All patients were received 6 to 7 times of treatment.Results The curative effects of all the patients were evaluated after radiotherapy 3 months.In the observation group,there were 20 cases of CR,5 cases of PR,4 cases of SD,1 case of PD,the total effective rate (CR +PR)was 83.3%.In the control group,there were 1 8 cases of CR,3 cases of PR,6 cases of SD,3 cases of PD,the total effective rate was 70.0%.The difference was statistically significant (χ2 =8.356,P reaction obviously.

Preliminary study on Chinese standards for defining rare diseases / 中国卫生政策研究

Objective:To suggest approaches for the establishment of Chinese standards for defining rare disea-ses and advance corresponding Chinese legislation. Methods:By comparing the standards for defining rare diseases in Europe, the United States, and other countries and studying key influencing factors of standards, this paper proposes suggestions for the establishment of proper Chinese standards for defining rare. Results and Conclusion:Social and e-conomic development levels, medical development levels and social security levels influence the establishment of standards. It is recommended that the national conditions should be taken into consideration and the number of pa-tients, severity of the diseases and economic indicators of orphan drugs be used to define rare diseases in China.