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OBJECTIVE To provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues. METHODS Based on literature research， practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed， and the problems existing in the application of the system were compared to propose corresponding solutions. RESULTS & CONCLUSIONS China has issued two batches of encouraged generic drug catalogues， and there were 49 varieties of generic drugs included in the catalogues. In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues， there were some problems in legislation， incentive system for the first generic drug， post-marketing re-evaluation system， and cross-departmental coordination and linkage mechanism. It is suggested to strengthen legislation， improve the “first generic market exclusivity period” system， perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety， effectiveness and accessibility of generic drugs in China.
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Capability Accreditation Program of Ethics Review for Chinese Medicine Research (CAP Accreditation) is the first medical ethics certification project in China. Institutions can further improve their ethics review work level after passing the CAP accreditation. However, the operational efficiency of each department in the ethics review system needs to be further improved when performing relevant functions in accordance with the certification requirements. Based on the experience and summary in the work of the ethical review system, this paper analyzed the main factors that affect the efficiency of the ethical review system and put forward improvement strategies from six aspects: organizational leadership, incentive policies, quality supervision, system construction, talent training, and promotion through evaluation, with a view to providing reference for improving the efficiency of ethical review, and promoting multi-department coordination and system integration.
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Objective To better carries out the review of the interaction between triazole antifungal drugs and statins, ensure drug safety for patients and improve the efficiency of the manual review of pharmacists. Methods The advantageous combination with less interaction between the two kinds of drug was obtained by summarizing the interaction information of triazole antifungal drugs and statins. At the same time, optimizing the process of full manual reviews for drug interaction, and the advantageous combination of the two kinds of drug will be set up in advance on the doctor side of the review system. Doctors can adjust the drug in time according to the prompts of the information system when there is a significant interaction of the two kinds of drug in the prescription or medical order, which is issued by the doctors. Results After optimization, most doctors choose the drug combination of less interaction between the two kinds of drug according to the system prompts. The number of drug combinations of significant interaction which is manually reviewed by pharmacists is significantly reduced (P<0.05), and the review efficiency is improved, the drug safety risks brought by drug interactions to patients are reduced. Conclusion Refinement review of drug interactions between triazole antifungal agents and statins based on the optimization of the pre-audit system plays a positive role in improving the safety of patients’ medication and the efficiency of pharmacists' manual auditing.
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The necessity of establishing the review system in the administration of national drug standards was analyzed, in order to provide suggestions for improving the national drug standard work. The problems existed in national drug standard administration were analyzed and summarized, the purpose and significance of standard review system was analyzed, and the implementation of standard review system in other industries was reviewed. At present, there are some problems in the administration of national drug standards, such as imperfect working mechanism, unsatisfactory progress in the improvement of standards, low participation of manufacturers in the work of national standards, and unsmooth elimination mechanism of standards. The establishment of standard review system in national drug standard administration conforms to the objective law of standard management, which is helpful to improve the top-level design of national drug standard activities, solve the bottleneck problems in the durg standard work, realize the dynamic management of national drug standard, and promote the re-evaluation work of drugs after being put on the market. In a word, the establishment and implementation of the standard review system is conducive to the development of national drug standards.
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OBJECTIVE: To present the design scheme of up-front outpatient prescription review system based on C/S (Client/Server) & B/S (Browser/Server) mixed-architecture in our hospital. METHODS: The core-technology and implementation procedure of up-front outpatient prescription review system were elaborated at length from the aspects of overall design, system developing environment,system function modules,realization of individualized review indexes, etc. At the same time, interrupted time series(ITS) analysis was used to analyze the changes in qualification rate of outpatient prescriptions. RESULTS: The implementation of up-front outpatient prescription review system reduced the rate of unqualified prescriptions effectively. During the implementation period, a total of 501 986 prescriptions were examined, and 31 161 prescriptions were successfully intervened. The qualification rate of prescription increased significantly. CONCLUSION: Up-front prescription review/intervention system is successfully developed in our hospital and is deserved to be generalized to promote rational use of drugs.
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Based on the data obtained from the questionnaire survey and personal in-depth interviews, this study preliminarily formulated the "selection guidelines for the doctoral application review system of Capital Medical University" (draft). In addition, through Delphi method and chi-square test, the author formulated the "selection guidelines for the doctoral application review system of Capital Medical University". The guide contained four primary indicators of scientific literacy, academic ability, scientific research ability and personality quality and 27 secondary indicators. The respondents generally believed that quality, ability and moral character were the core contents of the doctoral selection guide. The doctoral advisors attached great importance to the personality quality of the applicants while having high requirements on the quality and ability. Meanwhile, the doctoral advisors also had high requirements on the scientific research ability of doctoral students in professional degrees.
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OBJECTIVE： To promote the implementation of the pre-prescription review work， and to ensure the rational drug use of patients. METHODS： With the idea of PDCA （Plan， Do， Check， Action） cycle management， the phased improvement of three PDCA cycles was gradually implemented in the operation of the pre-prescription review system， aiming at the establishment of the working mode of the prescription review work， the improvement of the rules of knowledge base in the review system and the improvement of the ability of pharmacists to review prescriptions. The operation results of the system were evaluated by comparing the irrational prescription rate of outpatient pharmacies before and after the operation of pre-prescription review system. RESULTS： Through adopting the prescription review mode of “rigid” and “flexible” interception， regular revision of knowledge base rules， regular training and examination of prescription pharmacists， pre-prescription review system operated smoothly， and the pre-prescription review work was carried out in the process of continuous improvement. In the three PDCA cycles， the irrational rate of prescriptions decreased significantly， such as after the first PDCA cycle， the irrational rate of TCM outpatient prescriptions decreased from 22.0％ （1 393/6 332） in Jan. 2017 to 7.4％ （416/5 627） in Jun. 2017； after the second PDCA cycle， the irrational rate of outpatient prescriptions in hospital decreased from 4.87％ （5 244/107 691） in Mar. 2018 to 2.21％ （2 219/100 412） in Aug. 2018. After the third PDCA cycle， the percentage of over-treatment course prescriptions in total prescriptions decreased from 16.97％ （15 728/92 684） in Jun. 2018 to 5.55％ （5 394/97 275） in Sept. 2018. CONCLUSIONS： The pre-prescription review system can effectively intercept and interfere with irrational prescriptions， and PDCA cycle management can effectively promote the operation of the pre-prescription review work.
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OBJECTIVE: The objective of the present study was to evaluate the effects of implementing a systematic Drug Utilization Review (DUR) system on contraindicated drug use and pharmaceutical expenditures in Korea. METHODS: A literature search was conducted using search engines such as PubMed, EMBASE, NDSL, and RISS for relevant systematic studies. The database search was performed and updated in April 2018. Two independent reviewers evaluated the abstracts to find potentially eligible articles. RESULTS: In total, 1433 potentially eligible studies were selected, and 11 articles were eventually shortlisted for inclusion in the present review system. The outcome showed that contraindicated drug use decreased after implementation of the DUR system in Korea. The analysis also showed that the DUR system contributed to a reduction in pharmaceutical expenditures. CONCLUSION: Our study showed that implementing the DUR system reduced both contraindicated drug use and pharmaceutical expenditures in Korea.
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Drug Utilization Review , Drug Utilization , Health Expenditures , Korea , Search EngineABSTRACT
Based on the data obtained from the questionnaire survey and personal in-depth interviews,this study preliminarily formulated the "selection guidelines for the doctoral application review system of Capital Medical University"(draft).In addition,through Delphi method and chi-square test,the author formulated the "selection guidelines for the doctoral application review system of Capital Medical University".The guide contained four primary indicators of scientific literacy,academic ability,scientific research ability and personality quality and 27 secondary indicators.The respondents generally believed that quality,ability and moral character were the core contents of the doctoral selection guide.The doctoral advisors attached great importance to the personality quality of the applicants while having high requirements on the quality and ability.Meanwhile,the doctoral advisors also had high requirements on the scientific research ability of doctoral students in professional degrees.
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Through analyzing the problems of time,selection mode,research plan,and tracking review in the ethical review of scientific research projects,this paper put forward the corresponding countermeasures:standardized application procedures,diverse selection mode,standardized research plan,and strict tracking review.It aimed to improve the quality of ethical review of scientific research projects and improve the ethical review system.
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OBJECTIVE:To improve the level of rational drug use,and to reduce the workload of clinical pharmacists. METH-ODS:Established“Intelligent Management and Solution for Clinical Rational Drug Use”of our hospital was introduced,including post-prescription review(all prescriptions review)system, self-maintenance system for rational drug use knowledge base,pre-pre-scription review (rational drug use real-time review) early warning system. The effects of intelligent system were evaluated. RE-SULTS & CONCLUSIONS:After the application of the system,the following aspects could be achieved,including“all prescrip-tions review”,“multi-prescriptions/longitudinal review”,system knowledge base real-time update and autonomous definition of re-view rules,effective communication and intervention between physicians and pharmacists before printing prescription by Yaozhidao instant messaging system. Through related trial evaluation,the proportion of false positive prescriptions decreased by 17.65% after 4 months of the application of the system;drug consultation prescriptions review average score of outpatient pharmacists increased from 81 to 94.85;the time of prescription review decreased by 4.72-5.46 times. Through mandatory interception of unqualified pre-scriptions,severe warning,timely prompt and pharmacists’intervention,the rate of unqualified prescriptions pre-reviewed by the system in respiration department decreased from 32% in Jan. 2015 and 21% in May to 4.62% in Dec. So,the application of the system promotes rational drug use in outpatient department,reduces the workload of pharmacists and ensures the safety of drug use comprehensively.
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OBJECTIVE: Based on Guideline for Comprehensive Evaluation of Medicine in China, to make a comprehensive evaluation of Recombinant Human Interferon beta 1a, Rebif®. METHODS: Induction, summary and analyses were used, mainly according to National Pharmacopeias, diagnosis and treatment guidelines, drug instruction, clinical study literatures and official data related with Rebif, based on the nine sections of the Guideline including safety, efficiency, compliance, pharmaco economics and so on. RESULTS AND CONCLUSION: The evaluation of Rebif is objective and comprehensive. The Guideline for Comprehensive Evaluation of Medicine in China is a relatively complete pharmaceutical review system.
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This paper discussed the roots of American ethical review system, the development of twists and turns, and puts forward the enlightenment to our country, the ethical review system mainly include:perfecting the ethical review at the top of specification design, improve specification status;improve the system of education and training, to strengthen the construction of information communication channels, establish standard operating proce-dures, improve the regulatory system;improve the system of continuous review, formulate specific implementation specification.
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The anonymous review system for doctoral dissertations is an effective way of comprehensively evaluating the research capability and academic cultivation of doctoral students. It brings remarkable results in the quality control process of doctoral dissertations. However, the anonymous review system for doctoral dissertations also has some limitations. Unceasing development and improvement are needed in the practice, as well as continuous creation and exploration.
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Drug utilization review (DUR) system has been defined as "structured, ongoing initiatives that interpret patterns of drug use in relation to predetermined criteria, and attempt to prevent or minimize inappropriate prescribing." This paper introduces the concept, purpose, and effective application of DUR in Korea. DUR can be classified as retrospective DUR, prospective DUR, and concurrent DUR based on the time direction of applying DUR. DUR can also be classified as quantitative DUR defined by retrospective DUR using databases including previously prescribed medicines, and qualitative DUR defined by DUR reflecting patient's clinical condition. We described the history of developing DUR in the United States and the Europe. Finally current status of DUR in Korea is described and the strategy of future settlement of DUR system in Korea is suggested.