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OBJECTIVE To analyze the situation and causes of the shortage of drugs in centralized volume-based procurement， and to put forward countermeasures and suggestions for optimizing centralized procurement rules and improving the drug shortage supply guarantee system. METHODS The shortage data of the first five batches of centralized purchasing drugs during January 2019 and December 2021 were collected from the Shortage Database of Chinese medicine economic information； descriptive statistical analysis was performed for shortage frequency， varieties and reasons. RESULTS & CONCLUSIONS After the first five batches of centralized volumetric procurement policy landed， the frequency of drug shortage reported for selected specifications and selected enterprises increased significantly， mainly drug shortage of selected enterprises. The shortage of some varieties from selected enterprises in the short term was obvious， and most of them were commonly used clinical drugs. The occurrence of drug shortages was affected by various links such as the production， circulation and use， and the main reasons were shortage or monopoly of raw materials. In order to ensure the drugs supply， the government should scientifically assess the risk of production interruption of enterprises， further optimize centralized procurement rules， improve the reporting system for drug shortages， and attach importance to the supply of key drugs； in addition， hospitals should take a variety of measures within the scopes of policies to flexibly respond to drug shortages so as to avoid delaying the treatment of patients.
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OBJECTIVE:To provide references for perfecting the drug safety supervision mechanisms in China. METHODS:Based on the theory of“market failure”“contract failure”and“government failure”,representative drug safety supervision mecha-nisms were selected from USA for analysis and evaluation. RESULTS & CONCLUSIONS:USA has made some achievements in the implementation and application of drug safety supervision mechanisms. The representative drug safety supervision mechanisms included prescription drug applicant payment mechanism,drug safety information communication mechanism,punishment and in-centive mechanism, public-private partnership mechanism, passive monitoring and active monitoring combination mechanism. These mechanisms relieved“government failure”of FDA,and solved the problems of“market failure”and“contract failure”to cer-tain extent. In China,drug safety supervision mechanisms should be perfected from refining the legal guarantee,mobilizing exter-nal forces completely,absorbing and applying modern information technology,focusing on both prevention and disposal,paying at-tention to the coordination of different mechanism,striving for open procedure and transparent result.
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OBJECTIVE:To provide references and suggestions for building and improving the R&D incentive policies for or-phan drugs in China. METHODS:The R&D incentive policies for orphan drugs in USA and the EU were compared in aspects of its legislative history,incentive measures and effects. And suggestions for improving related policies in China were put forward. RE-SULTS & CONCLUSIONS:The R&D incentive policies for orphan drugs in USA and the EU respectively started from Orphan Drug Act in USA(1983)and Orphan Drug Management Specification in the EU(1999),then formed relatively complete system by continuous improvement. The USA and the EU showed differences in its certification standard,procedure and specific incentives [R&D funding,tax deduction,fee reduction,additional incentives for micro and small and medium enterprises (SMEs),market exclusivity and special approval procedure],etc. In terms of fee reduction,for example,prescription application fee,production cost and drug confirmation fee were exempted in USA,while arrangement assist fee,initial and follow-up fee,checking fee before approval,initial listing type were reduced to a certain percentage in the EU. After developing incentive policies for orphan drugs, there is great increase in numbers of recognized qualifications and listing,SMEs have become new force in orphan drug R&D, R&D investment covers all types of diseases,orphan drug R&D are becoming the main direction of drug innovation and biotechnol-ogy development. China should determine the relevant legislation of R&D incentives for orphan drugs as soon as possible,set certi-fication and improve specific measures of R&D incentives for orphan drugs from multiple aspects,while strengthen the cooperation with other countries in qualification and R&D incentives.
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Objective:To investigate the present situation of humanity education for medical students and to provide theoretical evidence for establishing appropriate interventions. Methods:This paper surveyed and analyzed the present situation of humanity education for medical students in a medical university using questionnaires. Re-sults:18. 7% of medical students entirely remembered the specific content of Hippocratic Oath, 7. 3% of medical students had never heard about the concepts such as humanistic quality, 31. 7% of medical students had never bor-rowed humanity and social science books from the school library, 79. 3% of medical students thought it necessary to strengthen humanity education. Some results showed that there were significant differences in different grades and specialties. Conclusion:It is necessary to further strengthen humanity education for medical students, improve the quality of humanity curriculum, and make a fusion of humanity education and the medical professional education. At the meantime, the humanity courses should be increased and the educational program should be diversified.
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Objective:To analyze the current status of medical students′ humanity education satisfaction rate and present situation of humanity quality and thus provide evidence to better practice of humanity education. Meth-ods:According to the random stratified cluster sampling method, the researchers selected 1146 medical students from Harbin Medical University and then investigated the objects′ humanity education satisfaction rate and general humanity situation. The data was analyzed using χ2 test in SPSS 17. 0. Results:①Satisfaction status of humanity education:the students′satisfaction to teachers′humanity quality, effect of course and library resources were low.② The present situation of humanity quality:80 . 2% of the medical students thought it was necessary to strengthen the medical students′humanity education;18. 1% of the medical students remembered the medical student oath, and there existed significant differences between different specialties;11 . 9% of the medical students could clear connotation of the humanistic concept, and there were significant differences between various grades;24. 4% and 14 . 5% of the medical students couldn′t clear the humanistic attribute of Marxist political theory course and moral course respectively; rural students′ humanity quality was statistically lower than the urban ones. Conclusion:Through optimizing the structure of humanity courses, strengthening the construction of teaching staff and attaching great importance of the library to humanity education effect, so as to improve medical students′ satisfaction of hu-manity education. The government should increase investment in rural education to narrow the gap of basic humani-ty quality education between urban and rural.
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Objective To evaluate the clinical curative effect of acupuncture and moxibustion treatment for children with cerebral palsy by Meta analysis.Methods The Chinese biomedical literature database (CBM), CNKI and Wanfang data, Weipu data, PubMed, EMbase and Cochrane central registration of controlled clinical trials were searched. All the randomized controlled trials (RCTs) of acupuncture and other conventional treatment for infantile cerebral palsy before December 2013 were retrieved. Meta analysis was conducted with Review Manage 5.2 software.Results Finally, 11 reports of RCT were enrolled in the study, including 979 patients. Meta analysis showed that the total effective rate of acupuncture treatment for infantile cerebral palsy was significantly higher than that in the control group [odds ratio (OR) = 4.08, 95% confidence interval (95%CI) = 2.86 - 5.83,P < 0.000 01]. Funnel chart analysis showed no publication bias in the chosen literature.Conclusion The therapeutic effect of acupuncture combined with rehabilitation therapy is superior to that of other conventional treatment for children with cerebral palsy.
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Objective To study the effect of Sopfrology childbirth method training,Kegel training and Lamaze respiratory training (SLK training) on depression and sexual life of perinatal pregnant woman..Methods The women in 24 weeks of pregnancy who came to the clinic to receive the pregancy test were divided into study group(n=232) and control group(n=126) according whether they voluntered to participate the study.All the women in two group were subjected to regular prenatal care and the women in study group received SLK training additionally.The depression,pelvic floor muscle tension and female sexual function index were evaluated by Self Rating Depression Scale(SDS),the Pelvic Floor Muscle Examination Grading Standards and the Female Sexual Function Inventory (FSFI) respectively.Results 6 months after delivery,the incidence of depression,SDS score,pelvic floor muscle tension score and live index standard rate in study group and the control group respectivelywere(10.3％ vs 18.3％),((43.6±5.1) vs(45.3±6.3)),((3.36±0.33) vs(2.46±0 89)),(81.5％ vs 65.9％),and the differences were statistically significant(P＜0.05).Conclusion SLK training program for perinatal women has the effects of preventing,treating prenatal depression and postpartum depression,improves pregnancy index and the quality of sexual life,worthy of further study.
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OBJECTIVE:To change Chinese current irrational drugs use condition so as to promote rational drug use.METHODS:To analysis the causes of the irrational use of drugs in our country and some countermeasures were put forward.RESULTS&CONCLUSION:The situation of irrational use of drugs in our country is quite serious,there is a long way to go before we can use drugs in a rational way,which needs the co-efforts of functional authority department of the government,hospitals,doctors and pharmacists,as well as the attention and cooperation of people in the whole society.
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OBJECTIVE:To strengthen people's awareness of pharmacovigilance.METHODS:The pharmacovigilance associated knowledge was introduced,and the status quo about pharmacovigilance working in China and the challenge posed by which were analyzed,then the corresponding countermeasures were presented.RESULTS&CONCLUSIONS:Only through strengthening people's pharmacovigilance can the adverse drugs reactions and the related problems be reduced,and only by so people's level of rational use of drugs could be improved.