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The development of quality Chinese medicine is an important way to improve the quality of Chinese medicine, and ensure the safety and effectiveness of Chinese medicine. This article systematically elaborates the definition, classification, standard and mana-gement certification strategy of quality Chinese medicine. We present the quality Chinese medicine which is higher quality than that of eligible Chinese medicine based on quality control standards. Quality Chinese medicine is strictly in accordance with management procedures, likely GAP and GMP et al, during the productive process, which quality indicators is higher than that of the current relevant national quality standards, such as Chinese Pharmacopoeia(ChP) et al; its limited indicators such as exogenous pollutants and endogenous toxic substances are lower than that of the current relevant national quality standards, likely ChP et al; meanwhile these Chinese herbal medicine, medicinal pieces, patent medicines, and health products and foods with Chinese medicine raw materials are been certificated by quality Chinese medicine. At the same time, this article systematically expounds the five major management systems of quality Chinese medicine, including technical training management for practitioners, productive process management, standard mana-gement, quality inspection and certification management, and product traceability management. And we put forward strategies to improve the supervision and management system, and promote the standardization and development of quality Chinese medicine by improving the technical management system of quality Chinese medicine, strengthening the quality management system and six sigma(6σ) management in the company. These strategies will provide a reliable basis and effective way to improve the quality of Chinese medicine.
Subject(s)
Drugs, Chinese Herbal , Food , Medicine, Chinese Traditional , Quality Control , Reference StandardsABSTRACT
OBJECTIVE:To analyze the rationality of tamoxifen for ovulation induction,and to provide reference for the stan-dardization of off-label use of tamoxifen. METHODS:Takingtamoxifen,ovulation inductionandpolycystic ovarian syn-dromeas keywords,relevant literatures about off-label use of tamoxifen for ovulation induction were analyzed and summarized by a search of CNKI,Wanfang database,PubMed database up to July 2015. RESULTS:58 literatures were searched,among which clinical trial or systematic review about the effect of tamoxifen on ovulation induction were selected. 11 valid literatures were col-lected to confirm clinical efficacy of tamoxifen for ovulation induction. Referring to Diagnosis and Treatment of Polycystic Ovary Syndrome:An Expert Consensus,pharmaceutical affairs council of our hospital had agreed to off-label use of tamoxifen for induc-tion ovulation,and formulated the standard of off-label use of tamoxifen. CONCLUSIONS:Standard management of off-label use of tamoxifen could be better protect the rights both of patient and doctor.
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OBJECTIVE:To discuss the application practice of PIVAS standardization in pharmacy intravenous admixture ser-vice(PIVAS)of our hospital. METHODS:Based on JCI,the design concept and management mode of PIVAS were analyzed and summarized from PIVAS design,management,job and medical order time arrangement,staff management,infusion quality or fault emergency plan,etc. RESULTS:After introducing JCI standards,the improvement was conducted in respects of management system and work flow design,purification system and logistics division design,information system design,etc. Working hour was arranged according to the workload or work flow and the actual needs of clinical departments. Medical orders,1 batch per hour,24 batches one day,were delivered to clinical departments according the time point. The positivity of the staff had been improved, and work quantization and performance appraisal had been achieved. Those improvement optimized drug dispensing process, cleared the responsibility of information management and guaranteed the quality of infusion. Work error analysis and summary were monthly conducted;the number of work error decreased from 562 cases before JCI introduction(2013)to 264 cases after JCI intro-duction (2014),decreasing by 112.87% annually. CONCLUSIONS:JCI standard is of significance to the promotion of PIVAS management,work level and quality,and safe and rational use of drugs in the clinic.
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OBJECTIVE:To reduce the types of drugs which was not consistent with the accounts in monthly checking of out-patient department,reduce the wastage of dismounted drugs and improve dismounted drug management. METHODS:Through qual-ity control circle(QCC),analyzing the reasons for inconformity of accounts and drugs,adopting relevant countermeasures of staff training,cipher prescription,counter storage,managed by designated person,expiry data management and so on,the process of dismounted drug management was formulated and implemented. The types of drugs which was not consistent with the accounts and activity growth value of circle members were analyzed statistically before,during and after QCC. RESULTS:The types of drugs which was not consistent with the accounts were 33.6,21.2 and 13.6 before,during and after QCC,decreasing by 59.5%. The ac-tivity growth value of circle members were all positive value. CONCLUSIONS:QCC of outpatient pharmacy can effectively reduce the types of drugs which is not consistent with the accounts in monthly checking,standardize dismounted drug management and im-prove pharmaceutical care quality.
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Objective: To evaluate the effect of standard management for hypertension in community population of Suzhou city. Methods: We conducted a prospective study of standard management for hypertension in community population of Suzhou city. The project included 3 groups: Standard group, the patients received standardized management,n=81 711, Control group, the patients received general management, n=38 944, and No-management group,n=1 644 249. The incidence rate of stroke and coronary artery disease (CAD) were compared among different groups according to 2010 chronic disease report of Suzhou city. Results: Compared with initial condition, the final average blood pressure drop in Standard group was (13.78/7.06) mmHg, which was better than that in Control group, X2=1852.91,P<0.01. The incidence rate of stroke in Standard group, Control group and No-management group were 1.72%, 2.41% and 3.59%, the incidence rate of CAD were 0.43%, 0.66% and 1.29% respectively. Conclusion: Standard management for hypertension was better than general management for preventing and controlling the incidence of stroke and CAD in community population.
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Aiming to improve the quality of teaching international students and enhance the international cooperation of medical teaching,this article discusses the teaching to international students from the aspects such as enhancing the recognition,breaking through language communication obstacles,careful preparation and teaching,and strict regular management by combining practice and research obtained from recent years of international student teaching.
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Objective To discuss the experimental equipment management of the digital microscope mutual laboratory, and improve the qualities and levels of the experimental teaching in medical colleges. Methods On the basis of the core thoughts and basic framework of quality management for teaching equipment in universities, the principles and approaches of TQC were applied to quality management for experimental teaching equipment. Results Some management measures and rules were proposed. A serial of reasonable and effective performing system and management system were constructed. Conclusion The experimental teaching equipment management of the digital microscope mutual laboratory greatly advances the standard, scientific and informational process of the management work for the experimental teaching, and provides the powerful assurance for the experimental teaching quality of medical colleges.
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With more details of end-of-life-care such as moral principle and standard management,the development condition of end-of-life-care in China is compendiously introduced, and "1,3,9——PSD"service mode of end-of-life-care is also put forward in this artical.