Interpretation on Consensus on drug-induced liver injury by CIOMS Working Group:liver injury attributed to herbal and dietary supplements / 中国中药杂志

With the increase in the medical level, the improvement of adverse drug reaction(ADR) monitoring systems, and the enhancement of public awareness of safe medication, drug safety incidents have been frequently reported. Drug-induced liver injury(DILI), especially liver injury attributed to herbal and dietary supplements(HDS), has globally attracted high attention, bringing great threats and severe challenges to the people for drug safety management such as clinical medication and medical supervision. Consensus on drug-induced liver injury had been published by the Council for International Organizations of Medical Sciences(CIOMS) in 2020. In this consensus, liver injury attributed to HDS was included in a special chapter for the first time. The hot topics, including the definition of HDS-induced liver injury, epidemiological history, potential risk factors, collection of related risk signals, causality assessment, risk prevention, control and management were discussed from a global perspective. Based on the previous works, some experts from China were invited by CIOMS to undertake the compilation of this chapter. Meanwhile, a new causality assessment in DILI based on the integrated evidence chain(iEC) method was widely recognized by experts in China and abroad, and was recommended by this consensus. This paper briefly introduced the main contents, background, and characteristics of the Consensus on drug-induced liver injury. Significantly, a brief interpretation was illustrated to analyze the special highlights of Chapter 8, "Liver injury attributed to HDS", so as to provide practical references for the medical staff and the researchers who worked on either Chinese or Western medicine in China.

Guideline for the prevention and control of occupational exposure risks to cytotoxic drugs in medical institutions / 中国药房

To provide prevention and control strategies of occupational exposure risks to cytotoxic drug in medical institutions， improve the awareness of protection among medical staff，and reduce potential occupational exposure risks，the Guidelines for the Prevention and Control of Occupational Exposure Risk to Cytotoxic Drugs in Medical Institutions is developed. Based on the World Health Organization Guidelines Development Manual，the exposure risk issues of the cytotoxic drug collected from the time that it entered the hospital to the several stages after delivery to hospital，such as transportation，receipt，storage，unpacking，dispensing，use of finished products，and waste disposal. Delphi method is used to construct identification of clinical issues，and evidence-based research method is used to develop relevant evidence. Quality evaluation is conducted by using the recommended GRADE method. The consensus is reached on the recommendation opinions and evidence levels through expert consensus method. By combining engineering controls，administrative controls and personal protective equipment at different levels，a graded control approach is established. A total of 37 clinical issues are identified，resulting in 36 recommendations. This guideline provides reference and supplementation for the formulation of cytotoxic drug prevention and control measures in medical institutions.

Research on supervision strategy of high risk areas of hospital incorrupt government based on traditional chinese medical theory of preventing diseases / 中华医院管理杂志

In recent years, the frequency of corruption incidents in public hospitals in China has increased, and it is particularly important to strengthen the construction of hospital incorrupt politics. Based on the traditional chinese medical theory of preventing diseases, the author deeply discusse the prevention and control strategies in high-risk areas of public hospitals incorrupt from 3 aspects: prevention before disease onset, prevention of disease from exacerbating and prevention of recovery from relapse. Based on the common problems found in the political inspection of Beijing municipal health system and large-scale hospitals in the latest years, an incorrupt government risks list of high-risk areas in hospital had been sorted out; A tertiary hospital and its 4 entrusted hospitals were selected to conduct self-inspection on the key links of important power activities and authority behaviors in accordance with the incorrupt government risks list, and putting forward targeted supervision strategies for these problems. Since the implementation of supervision strategy for high-risk areas in the tertariy hospital and its 4 entrusted hospitals in May 2021, the number of letters and visits in the 5 aspects of medicine procurement, equipment procurement, consumables and reagents procurement, engineering construction and logistics service procurement were significantly reduced. Based on the traditional chinese medical theory of preventing diseases, the supervision strategy in high-risk areas could effectively improve the pertinence, operability and effectiveness of discipline inspection and supervision in hospital, and provide a reference for the construction of incorrupt government in public hospitals.

Practical exploration of constructing a new system of medical risk prevention and control based on the integration of medical and law / 中华医院管理杂志

Peking Union Medical College Hospital has carried out the practical exploration of a new system of medical risk prevention and control based on the integration of medical and law, broken the traditional practice of legal counsel only handling medical disputes after the event, explored the pre-management and control mode of medical risks. The hospital established a whole process medical risk management mode in which legal counsel, medical administrators and clinical medical staff cooperated and participated, further standardized the medical behavior, legal concept and legal practice awareness of medical personnel, realized standardized management and formed a long-term mechanism. It could not only effectively integrate the fragmented clinical legal service needs and extensively enhance the sense of occupational security of clinical medical staff, but also effectively improve the operation quality of medical safety indicators and promote the high-quality development of the hospital.

Internal control development at public hospitals in Ya'an city: problems and countermeasures / 中华医院管理杂志

Internal control of public hospital can prevent and control risk exposure of public hospitals in their economic activities,in order to reasonably guarantee their legal compliance,safety and effective use of assets,as well as their authenticity and integrity of financial information.It can also effectively fend off fraud,corruption,and improve the quality of public health services and service efficiency.The authors analyzed the present situation and existing problems of internal control efforts at public hospitals in Ya'an city,and put forward countermeasures and suggestions as well.

Collaborative innovation boosting the safe and rational use of traditional Chinese medicines / 中国中药杂志

As entering a new era,our country has introduced a series of favorable policies,which may provide the powerful and new momentum for the development of traditional Chinese medicine( TCM). However,more and more attentions have been paid to the safety and effectiveness of TCM. Tripterygium wilfordii Hook.f. is one of Chinese herbs with clinical efficacy and safety risk. In recent years,accumulating groups have carried out a series of exploratory studies on the clinical rational use of T. wilfordii-related preparations. Considering this situation,the goal of this special issue is to bring together a collection of original research and review articles addressing the expanding field of T. wilfordii. The special issue covers the clinical application,pharmacodynamics,toxicology,pharmacodynamics,resource identification and molecular pharmacognosy of T. wilfordii-related preparations. It focuses on the multi-disciplinary collaborative innovation,and may provide a stimulating resource for the fascinating subject of the safe and rational use of TCM,as well as have important practical significance and promotion value for the healthy development of TCM industry.

Analysis of Risk in Production for PET/MR and Suggestions for Field Inspection / 中国医疗器械杂志

PET/MR is a high-end medical imaging equipment with integrating PET and MR equipment into the highly sophisticated one and has rich clinical and molecular diagnosis functions, can obtain comprehensive information about the human body structure, function and metabolism, is of great value for the diagnosis and treatment of disease improvement. In this paper, through the analysis of existing production risk points on one of the primary stages of the whole product life cycle, combining with the medical device good manufacture practice, some suggestions have been put forward exploratively to field inspection for PET/MR manufacturers. It has certain significance for regulators of medical devices to clear the production risk point and improve verification efficiency during field inspection.

Analysis of Risk Prevention and Control in Production for Medical X-ray CT System and Some Suggestions for Field Inspection / 中国医疗器械杂志

In recent years, the R&D and production level for Computed Tomography(short for CT) have been greatly improved and developed in China. In fact, it leads to higher requirements for medical device regulators. In order to clear key points in field inspection for regulators, this article analyzes the risk prevention and control points in the production process of CT based on the 5M1E analysis, and combined with medical device good manufacturing practice (short for GMP), presents exploratively some suggestions on the field inspection of CT manufacturers. This article also has important sense for regulators to clear the pertinence and improve the efficiency during the field inspection.

Hidden risks of medical equipment during clinical operation and their effects on medical treatment / 医疗卫生装备

Object To analyze the potential risks and possible influencing factors of medical equipment during clinical operation, and to propose feasible measures to weaken the influences to medical treatment.Methods The hidden risks were analyzed from the aspects of equipment, environment, personnel and etc, and adverse events supervision mechanism was established to eliminate the risks.Results The hidden risks had to be supervised during daily clinical operation according to ISO 14971 standard, and the staffs such as clinical technician, electrical network system maintenance engineer and medical equipment supplier were suggested to be gifted with the responsibilities to recognize, find and treat hidden risks.Conclusion The supervision of hidden risks of medical equipment contributes to enhancing its safety and efficiency during clinical opera-tion.

Study and thought on the safety of traditional Chinese medicines under Healthy China strategy / 中国中药杂志

As the Healthy China planning has been implemented, traditional Chinese medicine (TCM) has witnessed unprecedented developmental opportunities. However, the safety of TCM has always been like The Sword of Damocles in TCM area, endangering the healthy and sustainable development of TCM. In order to solve the problem of TCM safety in China as soon as possible, the author puts forward that the situation and issues of TCM safety should be considered with the change of the times. At the same time, it is suggested that the research on TCM safety should be listed as the most important project in TCM science and technology field. The safety evaluation and risk control system in line with China national situation and TCM characteristics should be established as soon as possible. The research strategy of TCM safety should be innovated from "five changes". The transition of adverse drug reactions of TCM from "still not clear" to "basically clear" should be tried to realize, which allow TCM inherited from our ancestors to make a greater contribution to human's health.

Construction and Implementation of Risk Prevention and Control System on Essential Medicine in Our Hospital / 中国药房

OBJECTIVE:To provide reference for promoting rational use of essential medicines. METHODS:Combined with the actual situation of our hospital,a set of risk prevention and control system on essential medicine was constructed on the basis of relevant laws and regulations and support of information,and then implemented. RESULTS:The implementation of the system greatly promoted cognition of all medical staffs on reasonable,economical and safe use of essential drugs,standardized medication behavior and improved essential medicine use more reasonable. After the implementation of risk prevention and control system on essential medicines,medicine ratio of whole hospital decreased from 34.62% to 32.64%,inpatient medicine ratio decreased from 33.02% to 27.89%;essential medicine ratio of whole hospital rose from 31.22% to 43.34%,inpatient essential medicine ratio in-creased from 23.46%to 39.17%;the proportion of outpatient antibiotics prescriptions decreased from 15.04%to 13.46%,the utili-zation of inpatient antibiotics decreased from 62.11% to 48.47%. Various early warning were sent out 104 times in total,and 23 medical staff were punished due to irrational drug use. The prescription form and rationality of drug use were improved gradually. CONCLUSIONS:The construction of risk prevention and control system on essential medicine is one of the keys to the success of health care reform. It is suggested to make full use of thesystem+technologymeans,establish long-term mechanism for risk pre-vention and control,and constantly improve the system.

Investigation on Doctors Occupational Safety and Risk Prevention and Control Mechanism---Taking Beijing Middle-aged and Young Medical Workers as Example / 中国医学伦理学

Objective:To define doctors professional risk connotation , the scientific judgment doctors profes-sional risk fact , seek medical professional risk guard against and dissolve the long -term mechanism , maintaining safety and legitimate rights and interests of the doctor′s body and mind .Methods:Using doctor -patient relation-ship as the research background , adopts the questionnaire survey , through the survey data analysis of the correla-tion between the doctor-patient relationship and the doctor professional risk , on the basis of the young workers , for example , the empirical research doctors professional risk existing conditions and the reality .Results:The doctor-patient relationship nervous career anxiety and unease , doctor of job burnout and the harm done by the profession itself, complicated medical environment cannot effectively solve the doctor occupational safety crisis , institutional arrangements and the prevention and control mechanism is not reasonable career crisis .Conclusion:The govern-ment should strengthen the professional risk management system design and the prevention and control institutions and hospitals to strengthen the construction of professional risk management and prevention and control system , the doctor should promote occupational consciousness of risk prevention and control and doctor -patient communication ability, the society should strengthen professional risk management and the prevention and control of environmental regulation .