Research on the optimization of pharmaceutical care in Chinese social pharmacy based on Kano theory / 中国药房

OBJECTIVE To identify the demand levels and specific connotations of pharmaceutical care in social pharmacy based on Kano theory， and to provide suggestions for the optimization of pharmaceutical care in Chinese social pharmacy. METHODS Using Kano theory as the analysis framework， the needs of consumer for different levels of pharmaceutical care in social pharmacy were identified through literature combing. The ideas and suggestions were proposed for the optimization of pharmaceutical care in Chinese social pharmacy based on the content and characteristics of different levels of needs. RESULTS & CONCLUSIONS The demands for pharmaceutical care in Chinese social pharmacy were divided into three levels， among which the basic demand included ensuring the accessibility， safety and effectiveness of drugs； the expectation demand included personalized medication guidance and management， convenient and efficient medication purchasing services triggered by consumer upgrading； the charming demand included health services and management， professional and high-quality service experience. Social pharmacies should take drug security as the core， achieve high quality and good price， and fully meet basic demand； take patient medication management as the grip， conduct double-drive professional services and model innovation to fully respond to expectation demand； take public health as the goal， broaden service content and experience value， and meet the charming demand of consumer at the right time.

Study on the varieties included in the List of Overseas New Drugs Urgently Needed in Clinic in China and the optimization strategy / 中国药房

OBJECTIVE To study the variety included in the List of Overseas New Drugs Urgently Needed in Clinic in China and optimization strategy， in order to better meet the needs of patients. METHODS The release process of List of Overseas New Drugs Urgently Needed in Clinic， the characteristics and attributes of the new drugs urgently needed abroad， and the problems in the implementation process were all analyzed to put forward some suggestions for optimizing the List of Overseas New Drugs Urgently Needed in Clinic. RESULTS & CONCLUSIONS The release process of the List of Overseas New Drugs Urgently Needed in Clinic was roughly divided into incubation stage， preparation stage and implementation stage. The treatment fields of 3 batches of overseas new drugs urgently needed in clinic were relatively concentrated on endocrine and metabolic diseases，tumor and skin diseases. Of included 73 varieties， 50 varieties have been approved for market，and 26 varieties have been included in the medical insurance， 4 varieties were included in the Catalogue of Encouraged Generic Drugs. At present， there are still some problems in our country， such as the shortage monitoring system needs to be established and improved； the linkage with medical insurance is weakened； the encouragement of generic drugs is insufficient. It is necessary to strengthen the cooperation of monitored departments in the shortage of new overseas drugs，establish a medical insurance payment system oriented by clinical value， and improve the incentive mechanism to encourage the imitation of overseas new drugs urgently needed in clinic.

Enlightenment of Japan expanded access clinical trial system to China’s compassionate drug use system / 中国药房

The system of compassionate drug use in China is in the preliminary exploration stage， and the formal management methods and specific implementation rules have not been promulgated， which needs to be further optimized and perfected. Japan realizes the advanced use of unapproved drugs by expanded access clinical trial system， and makes clear provisions on information acquisition， target patient， informed consent， subject of application， implementation plan， handling of refusal to administer medication， drug expenses， implementation deadline， compensation for accidental damages， post-approval data review after expanded access clinical trials. When the enterprise refuses to give drugs because of the “legitimacy reasons of the system”， the attending physician can also apply to the Ministry of Health， Labor and Welfare， and the Ministry of Health， Labor and Welfare will conduct the licensing evaluation to maximize the drug for patients. This “refusal to administer” reprocessing is a unique regulation in Japan， which ensures the accessibility of drugs to the greatest extent possible. Based on the analysis of the expanded access clinical trial system in Japan， it is found that our country could further build the information platform for compassionate drug use， play the leading role of physicians， protect the interests of enterprises， pay attention to the ethical review， and make drug cost payment problems further clear in order to improve and optimize the system of compassionate drug use.

Research on the institutions of dispensing and use for preparations of medical institutions of China / 中国药房

OBJECTIVE To understand the future development trend of dispensing and use for preparations of medical institutions，and to provide countermeasures and suggestions for promoting the high-quality development of application and dispensing use for preparations of medical institutions . METHODS The development history of dispensing and use for preparations of medical institutions of China was reviewed as a whole ，and then the differences of domestic dispensing and use institutions for preparations of medical institutions over the years were compared from different perspectives ；and the differences between domestic institutions and Japan ’s hospital preparation dispensing and use institutions were compared. The development trend of dispensing and use for preparations of medical institutions of China was summarized to put forward countermeasures and suggestions. RESULTS & CONCLUSIONS The development process of dispensing and use for preparations of medical institutions of China could be roughly divided into the initial stage （2001-2004），the forming stage （2005-2018） and the development stage （2019-present）. Year by year ，the dispensing and use institutions of preparations of medical institutions had shown that the scope of dispensing and use had been expanded ；the approval process had been accelerated ，and the responsibilities of all parties had been clearly defined. Compared with Japan ，regulatory model for preparations of medical institutions was relatively simple in China. In the future ，the large-scale promotion and application of preparations of medical institutions will be normalized ，the time limit for dispensing approval will be shortened ，the approval process will be simplified ，the access threshold for dispensing and use will be gradually lowered ，and the supervision of dispensing and use will be strengthened during and after the event. It is recommended to strictly control the quality and safety of preparations of medical institutions ，implement classified management of use for preparations of medical institutions ，and further improve the supervision mechanism during and after the event.

Study on the Policy Trends of Encouraged Generic Drug Catalogue in China / 中国药房

OBJECTIVE：To know about the current situation and trend of encouraged generic drug catalogue policy in China ， and to put forward countermeasures and suggestions for the better implementation of the policy. METHODS ：The evolution of encouraged generic drug catalogue policy in China ，the characteristics of 2 batches of included types in encouraged generic drug catalogue，the implementation effect of the first batch of encouraged generic drug catalogue ，the development trend and existing problems of encouraged generic drug catalogue policy were analyzed to put forward corresponding suggestions. RESULTS & CONCLUSIONS：The evolution of encouraged generic drug catalogue policy in China can be roughly divided into embryonic stage，policy design stage and policy implementation and adjustment stage. The first batch of included types in encouraged generic drug catalogue are mainly drugs whose patents are about to expire and the competition is insufficient ，drugs with clinical necessity ， definite curative effect and short supply ，and varieties for special clinical purposes such as the prevention and treatment of major infectious diseases and rare diseases ，and children ’s use. The second batch of included types in encouraged generic drug catalogue are mainly those with expired patents （about to expired ）and insufficient competition ，and also those with special clinical uses. Among the types of the first batch of encouraged generic drug catalogue ，the number of abbreviated new drug application （ADNA） increased by 18，involving a total of 8 varieties；only 3 ADNA were included in the priority review ，accounting for 16.67％. In 2019 and 2020，218 and 119 varieties were newly included in the medical insurance catalogue ，and 3 varieties were newly included in the encouraged generic drugs catalogue （accounting for 1.4％ and 2.5％ respectively）. At present ，encouraged generic drug catalogue policy in China has the trend and characteristics of patent oriented regression ，lack of priority review and approval system，and enhanced linkage with the medical insurance catalogue. It is suggested to adhere to the original intention of the Opinions of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices in 2017，continue to adhere to the patent orientation of encouraged generic drug catalogue ，and improve the priority review system of generic drugs in the catalogue ，explore the “first imitation market monopoly period ”system in line with the characteristics of encouraged generic drug catalogue policy in China with reference to the U.S. FDA competitive imitation therapy guidelines ，and further strengthen the cooperation between government departments in the implementation of the encouraged generic drug catalogue policy.

Development of a dysmenorrhea quality of life scale based on Traditional Chinese Medicine theory / 国际中医中药杂志

Objective:Dysmenorrhea is the common gynecological problem among adolescent girls and women of reproductive age. This study aim to develop a dysmenorrhea Quality of Life (QoL) scale based on Traditional Chinese Medicine (TCM) theory.Methods:We conducted focus group discussions and in-depth interviews with TCM gynecologists and patients, and adapted items from previously published scales. We generated an initial pool of 41 items with 8 domains. Delphi method was used to item preliminary selection. Then, we administered the items to a sample of adolescent girls ( n=200), and the distribution of survey items, discrete trend, factor analysis, correlation coefficient, Cronbach’s α coefficient were used to select items. Results:After two rounds of Delphi, a total of thirty items were included in the dysmenorrhea QoL scale. The expert positive coefficient were 100% and 83.3% with high motivation. The authoritative coefficient were greater than 0.7, the results showing authoritative and reliable. The Kendall’s coefficient of concordance W was 0.333 ( χ2=128.271, P<0.001). In sample analysis, the items were deleted when they met more than two standards. The final scale retained 20 items, covering 8 dimensions. Conclusions:The methods for selection of dysmenorrhea QoL scale based on TCM theory were preferable. Given the paucity of research in this area, this new dysmenorrhea QoL scale may provide opportunities for the patient-reported outcome (PRO) evaluation in the field of TCM.

Study on the Optimization of Family Doctor Team Based on Rational Drug Use in Primary Medical Institutions / 中国药房

OBJECTIVE： To provide reference for optimizing the structure of family doctor team and improving rational drug use in primary medical institutions of China. METHODS： Combined with relevant literatures and author’s work experience， the situation of rational drug use in primary medical institution and the development of family doctors team were reviewed. The problems existing in the rational drug use service provided by family doctor team were analyzed to put forward relevant suggestions. RESULTS & CONCLUSIONS： There are some problems in primary medical institutions， such as blind selection or abuse of antibiotics， high frequency of injection use. Provinces and municipalities that implement the family doctor model in China have gradually formed five kinds of family doctor contract service modes， such as “1+1+1” contract service mode， “basic package+personality package” contract service mode. The existing family doctors team have problems in the development of rational drug use services， such as lack of pharmaceutical service personnel， low business ability， limited pharmacy knowledge of team members， and insufficient participation of pharmacists. A reasonable family doctor team should pay attention to the cultivation of pharmacy service pharmacists， strengthen pharmacy professional knowledge training of medical staff， and build a corresponding “pharmaceutical joint” platform by means of the medical association platform if necessary so as to promote rational drug use in primary medical institutions.

Study on the social and economic burden of antiseptic resistance of two popular drug-resistant bacteria / 中华医院管理杂志

Objective@#To study the socioeconomic burden of bacterial resistance incurred by taking carbapenem-resistant Klebsiella pneumoniae and cefotaxime-resistant Escherichia coli as examples.@*Methods@#Such indexes as disability-adjusted life years and health utility values were used to conduct a socioeconomic analysis of drug resistance.@*Results@#The economic burden caused by Klebsiella pneumoniae and Escherichia coli resistance among inpatients of 187 members of the national antiseptic drug clinical application monitoring network in 2015 was as high as 260.498 9 million yuan and 352.325 8 million yuan respectively. The years of healthy life lost due to disability were 4 658.02 years and 6 346.97 years respectively.@*Conclusions@#This study introduced indexes such as disability-adjusted life years and health utility values, to scientifically innovate the measurement of the economic burden of drug resistance from the perspective of economic burden of diseases.

Dynamic study on the use of antiseptic drugs at tertiary public hospitals: basis on clinical application monitoring network for antiseptic drugs / 中华医院管理杂志

Objective@#To dynamically study the use of antiseptic drugs at tertiary public hospitals in the localities for general information.@*Methods@#In this paper, the panel data were analyzed using dynamic monitoring data from the " monitoring network for clinical application of antiseptic drugs" . Such means as descriptive statistical analysis, single-factor analysis and logistic regression analysis were used to learn the use and monitoring of such drugs.@*Results@#We found that the use of such drugs at tertiary hospitals has improved significantly nationwide in recent years, yet with some gaps up to the standard. Given such progress, the economic and social burden caused by the unreasonable use of antiseptic drugs calls for more attention.@*Conclusions@#It is imperative to strengthen the supervision of such drugs and promote their rational use so as to reduce the social and economic burden.

Problems and countermeasures on the management and application of antiseptic drugs in Chinese hospitals / 中华医院管理杂志

Antiseptic drugs are the most popular anti-infectious drugs in daily use in hospitals, making significant contribution to public health. In view of the increasingly serious problems in the use and management of antiseptic drugs, the Chinese government has taken a series of measures to guide their rational use. However, due to the imperfect regulatory mechanism and weak sense of rational drug use, the problem of irrational use of antiseptic drugs is still existing. By studying the current situation and existing problems of antiseptic drugs in the country, this paper discussed the effective management means of such drugs, and provided feasible strategies and suggestions for standardizing their rational use.

Management of Non-medical Prescribing in Britain and Its Enlightenment to China / 中国药房

OBJECTIVE:To systematically investigate the management mode of non-medical prescribing in Britain and its enlightenment to the establishment and implementation of non-medical prescribing in China. METHODS:By retrieving domestic and foreign literatures,non-medical prescribing in Britain was introduced systematically in terms of development history,types, core elements,implementation status and effect;the suggestions were put forward for the development of non-medical prescribing in China. RESULTS & CONCLUSIONS:Britain implemented non-medical prescribing since 1994. After years of practice and a series of legislation and revision,independent prescribers (including nurses and pharmacists) have owned the statutory right to prescribe any medicine for patients by 2012. In Britain,non-medical prescribing is divided into independent prescribing which mainly exists in community pharmacies and is limited to specific diseases,supplementary prescribing which exists in hospitals or clinic and needs to be signed with doctors. The management institutions are mainly composed of one state administrative department (British Department of Health) and three professional associations (British Nursing and Midwifery Council,The Royal Pharmaceutical Society of Great Britain,The Pharmaceutical Society of Northern Ireland). There are detailed and strict stipulations on the qualification and corresponding responsibilities of the prescribing authority. The British government has provided legal protection for the development of the non-medical prescribing model,and the number of non-medical prescribers is increasing. The implementation of this model has increased the patients'access to medical services. Drawing lessons from the development of non-medical prescribing management in Britain,our country needs to improve legislation,provide legislative protection for the implementation of non-medical prescribing,expand the scope of practice of nurses and pharmacists,establish and improve the training program of non-medical prescribing professionals to promote the development of non-medical prescribing model in China.

Analysis of the Legislation on Pediatric Drug Use in US and Its Enlightenment to China / 中国药房

OBJECTIVE:To provide reference for promoting the development of related legislation work on ensuring pediatric drug use in China. METHODS:The legislation process of pediatric drug use in US,the effects of current Best Pharmaceuticals for Children Act and Pediatric Research Equity Act on pediatric drug use in US were intrduced and analyzed,suggestions on guarantee-ing the accessibility and safety on pediatric drug use in China were put forward. RESULTS & CONCLUSIONS:The policy6-month period of pediatric exclusive protectionin Best Pharmaceuticals for Children Act has motivated the enthusiasm of phar-maceutical companies developing pediatric studies,while it affects the marketing of generic drugs. Pediatric Research Equity Act has achieved remarkable effect in terms of ensuring the safety of pediatric drug use by forcing pharmaceutical companies to carry out pediatrics assessments,while there is no enough force for the marketed drugs that has not been widely used for children. En-couragement and enforcement are useful methods for promoting development of pediatric drug use. It is suggested to take measures like modifingone drug two formsin Prescription Management Regulations,accelerating approvals of related pediatric drugs on the premise that safety is guaranteed,implementing tax preference for related pharmaceutical companies that produced pediatric drugs,promoting the entry of drug reimbursement list and empowering CFDA to force pharmaceutical companies to implement pedi-atric studies to promote the accessibility and safety of pediatric drugs.

Discussion on the Draft of Chinese Medicine Act / 中国中医药信息杂志

Publishment of the draft of Chinese Medicine Act shows that the legislative work for TCM has achieved substantial progress. But after careful analysis on the legislative bills, there are some controversial questions, such as integration of traditional Chinese and western medicine, the setting of Chinese medicine clinics, Chinese medicine personnel training, the prescription-based processing Chinese medicine decoction pieces and dispensing Chinese materiamedica preparations by medical institutions. These all need to be further perfected.

Origin and Role Evolution of Pharmacists and the Enlightenment to the Legislation of Pharmacists Law in China / 中国药房

OBJECTIVE:To investigate the role orientation of pharmacists in China,and to provide legislative suggestions for the formulation of pharmacist law in China. METHODS:Through literature study,the career and evolution process of pharmacists at home and abroad were traced. The obstacles of the role change of pharmacists in China were analyzed to put forward the enlight-enment to the legislation of pharmacist law in China. RESULTS & CONCLUSIONS:Pharmacists in the world had generally en-tered the stage of"taking medication safety of patients as the center"pharmaceutical care,but pharmacists in China were still in the transition stage from"taking drugs as the center"traditional pharmacy to"taking safe medication as the center"clinical phar-macy. The role cognition of pharmacists needed to be improved. Pharmaceutical care should be taken as the role orientation,and the scope of pharmacist law adjustment should be defined;the qualification admittance threshold of pharmacists should be im-proved with the goal of pharmaceutical care-oriented talents;Taking pharmaceutical care as the content,the rights and obligations of pharmacists should be defined. The legislation of pharmacists should be conducted in China to speed up the transformation of pharmacist's role into pharmaceutical care.

Discuss on Clinical Pharmacists’Prescribing Rights in China / 中国药房

OBJECTIVE:To discuss the way to realizing clinical pharmacists’prescribing rights,and to provide reference for the revise of related policies and regulations. METHODS:The clinical pharmacists prescribing rights and its necessity were inter-preted. Referring to pharmacists’prescribing rights in Canadian limited prescription mode,British dispensatory mode,United States consultative prescription mode,clinical pharmacists’prescribing rights in China were expounded. RESULTS & CONCLU-SIONS:It is necessary and feasible to achieve clinical pharmacists’prescribing rights in China. Clinical pharmacists’prescribing rights can be realized and the pharmaceutical role of clinical pharmacists can be played through conducting clinical pharmacist pre-scription training,establishing chronic disease,common disease,mild disease and other disease dispensatory,gradually revising the concept of“prescription”and“prescribing rights”,promoting the legislation of pharmacists and clinical pharmacists’prescrib-ing rights,promoting the realization of the prescription right of clinical pharmacist,prompting clinical pharmacist to play the role of pharmacy.

The system of the intellectual property of Chinese medicine studied on the current situation of the protection of Chinese medicine / 国际中医中药杂志

The literature analysis and case analysis were used to analyze the current situation and problems of the patent protection of Chinese medicine.The patent of artemisinin was registered abroad as the failure case, while Tasly developed the construction of the patent net overseas as a successful case. The intellectual property right of traditional Chinese medicine has started late in China, so the Chinese pharmaceutical enterprises lacked awareness of the intellectual property protection of Chinese medicine, and it is difficult for us to have comprehensive intellectual propertyright protection in traditional Chinese medicine. The intellectual property system of Chinese medicine in China needs improvement.

Research on problem of exogenous pollution of Chinese medicine resources from perspective of circular economy / 中国中药杂志

Based on the in-depth analysis of the current situation of the exogenous pollution of Chinese medicine resources, this research mainly discusses the intrinsic link and practical significance between the development of circular economy in Chinese medicine resources and the control of the problem of the exogenous pollution from the perspective of circular economy, and proposes some suggestions to develop the recycling economy of Chinese medicine resources from the establishment of legal system, mechanism of development, production norms, industry standards and regulatory system of the recycling of Chinese medicine resources.

Legal Protection of Subjects' Informed Consent in Clinical Drug Trials / 中国药房

OBJECTIVE:To provide the reference for the improvement of GCP(good clinical practice)regulations and protection of subject's human rights.METHODS:The status quo of the protection of subject's right of informed consent and the elements for the right of informed consent and the existing problems in its practice in China were analyzed.RESULTS & CONCLUSIONS:China should further promote the legislation of clinical trials,reinforce the legal education of researchers,and emphasize the supervision on the illegal tort act.

Legislation on the Relief of Adverse Drug Reactions-induced Harm / 中国药房

OBJECTIVE: To explore the ways to evolve the current domestic legislation on the relief of adverse drug reactions(ADR)-induced harm.METHODS: Suggestions on the improvement of the existing related legal systems were put forward by analyzing the status quo of the current legal regulations on the relief of ADR-induced harm.RESULTS & CONCLUSIONS: The relief pattern,liability principle,the scope of paying and the time limit of lawsuit etc should be given into full consideration in the legislation on the relief of ADR-induced harm.

Status Quo and Defects of Legal Regulations on Adverse Drug Reactions / 中国药房

OBJECTIVE:To explore the ways to consummate the current domestic legal regulations on adverse drug reactions(ADRs).METHODS:The status quo and the defects of the current legal regulations on ADRs were analyzed;and taking ADR damage relief systems adopted in some countries as reference,we put forward some suggestions on the improvement of the existing related legal regulations.RESULTS & CONCLUSIONS:The existing related legal regulations should be consummated as early as possible in respect of constitutive requirements of ADRs,legal obligation,identification system etc via suitable legislation channel so as to protect patients' rights.