Drug administration is an extremely important aspect in the design and conduct of randomized controlled trials, which can influence the reliability and quality of the trials’ results. This topic covers issues such as blinding, preparation, packaging, labeling, shipping, dispensing and returning of test articles. Good drug administration procedures should ensure the smooth implementation of large-scale multi-center randomized controlled trials and increase their reliability and usefulness.
摘要:目的:优化药品单剂量调剂,加强信息化管理,优化操作流程。 方法:采用东华软件:住院药房管理系统(DTCISIP)和住院药品调剂系统(DTCISID) 实施。结果:东华软件成功实现了我院4300病床的药品单剂量调剂及各部门管理联网,优化了操作系统及流程,且系统运行稳定。结论:东华软件进行药品单剂量调剂,加强了药品的出入管理,优化了药品单剂量调剂的操作流程。Abstract: Objective: To improve united dose dispension, enhance the utilization of information technology in management of united dose dispension and optimize clinical human resource. Methods: DONG HUA software, which included DTCISIP system(system for management of medicine for inpatients) and DTCISID system(system for dispension of medicine for in-patients), was used to carry out united dose dispension. Results: United dose dispension of 4300 beds were easy to achieve by using DONG HUA software. The system worked smoothly and received lots of praise. Conclusion: The management of medicine is enhanced and clinical human resource is optimized by using DONG HUA software to carry out united dose dispension
Objective To imitate and calculate the ways, input amount and feasibility of governmental compensation to municipal public hospitals in Shenyang city after abolishing drug retail mark-up policy under existing conditions, so as to provide regional demonstration for the decision-making and smooth implementation of public hospital reform. Methods The relevant information of 18 municipal public general hospitals or specialized hospitals during 2008-2010, such as annual basic numeration tables, summary and detailed statements of income and expenditure were collected, and the average data of both national and provincial hospitals in the same or similar level during 2009-2011 were retrieved from China Health Statistics Yearbook. The Questionnaire of Compensation to Medical Institutions was self-designed, distributed and reclaimed in order to get the data of respective hospitals during 2008-2010. Then the following 4 compensation ways were calculated: governmental input compensation, price compensation of medical service, pharmaceutical affairs compensation for price difference, and integrated way of the former 3 compensations; and the feasibility of compensation after health system reform was analyzed. Results a) If the drug retail mark-up policy was abolished in municipal hospitals, the total loss of hospitals would increase from RMB 200 million yuan in 2008 to approximately RMB 330 million yuan in 2010. b) The balance of payments and patient’s cost of Shenyang municipal public hospitals were basically similar to those of both national and provincial hospitals in the same level. c) As for the year of 2010, the new governmental compensation after implementation of new health system reform was at least RMB 438 million yuan, accounted for about 1.8 % of general budget expenditure in Shenyang municipal level. d) The results of the imitation and calculation of 3 price adjustment schemes of medical service showed that, only the third could completely compensate the abolition of drug retail mark-up. e) As to the pharmaceutical service charge based on compensation for pharmaceutical administration, it was RMB 115.6921 million yuan in Shenyang municipal public hospitals in 2010, and it could compensate 58.6% of the drug price difference. f) Compared with the former 3 compensation ways, the integrated compensation way could make public hospitals have general balance of payments which were RMB 115 million yuan, 172 million yuan and 268 million yuan, respectively. Conclusion a) After the abolition of the hospital expense covered by drug revenue, it is reasonable and feasible in increasing governmental compensation according to the annual depreciation cost of permanent assets, adjustment of medical service price, and increase income of pharmaceutical service. b) The second integrated scheme of comprehensive compensation schemes can make most hospitals have some favorable balance; the slightly increasing charge of medical care is affordable by patients and medical insurance departments, so it is operable. c) The successful and sustainable implementation of public hospitals compensation policy depends on the reform of both structure and mode of payment in medical insurance system.
ObjectiveTo propose policy recommendations for improvement of the affordability of high cost medicines with significant public health implications under the patent system in China. MethodsThrough literature analysis and market investigation, this study targeted expensive life saving medicines under the patent protection, which are critical for the treatment of eight diseases with the most significant disease burden and critical social, economic and political impact for case studies, estimated the individual and insurance direct economic burden of medicines treatment. ResultsChemical product patent protection enhanced medicines price monopoly. The targeted medicines brought huge financial burden to Chinese citizens, especially to the rural residents. Breaking chemical product patent protection, achieving parallel importation or making generic drugs enter into the China's market, can save huge amount of medicines procurement budget for the government, and benefit the general public. ConclusionDeveloping and implementing medicines registration and intellectual property right protection strategies with public health perspective, adding continuously improved basic health insurance programs, can effectively promote the affordability of high cost medicines with significant public health, social, political and economic implications.
Medical ethics must be considered for protecting the fights and interests of patients in clinical trials. Now the fights of the subjects are more and more emphasised, but there are some problems. It is evidence-based medicine (EBM) and emphasis of evidence that need the high-quality clinical trials, yet it violates the principle of ethics in some degree. It will be helpful for the administrators to supervise the clinical trials on drugs well from the point of ethical views.
Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.
摘要:目的:了解2007~2008年成都地区17家医院生物制品及生化药品的使用状况。方法:采用限定日剂量(DDD)的方法,对成都地区2007~2008年17家医院生物制品及生化药品的销售金额、用药频度(DDDs)等进行统计分析。结果:2007年、2008年成都地区17家医院生物制品及生化药品销售总额分别为7338万元、9786万元;分别占总销售额的4.83%、5.00%。销售金额进入总销售额排名前100位的生物制品及生化药品有:人血白蛋白、胸腺肽、丙种球蛋白、促白细胞生长素和环磷腺苷。环磷腺苷在生物制品及生化药品中的DDDs最高。结论:生物制品及生化药品的价格及供给对其临床使用有较大的限制。Abstract: Objective: To evaluate the current situation and the trend of biological products and biochemical drugs used in Chengdu city in 2007 to 2008. Methods: Consumption of biological products and biochemical drugs used in 17 hospitals of Chengdu city in 2007 to 2008 were analyzed by the way of sum DDD and DDDs ranking. Results: The total cost of the biological products and biochemical drugs used in Chengdu city in was 73.38 and 97.86 million yuan in 2007 to 2008, it accounted for 4.83% and 5.00% of the total cost. Human serum albumin, thymosin, gamma globulin, interleukin promoting growth hormone and adenosine cyclophosphate were the drugs in the first 100 cost list. The DDDs of adenosine cyclophosphate was highest among biological products and biochemical drugs. Conclusion: The cost and supply of biological products and biochemical drugs were great limitations of their clinical application.
Objective To analyze chemical drugs included in the National Essential Medicines List (EML) of China, to provide reference on how to improve the selection criteria and strengthen management and supply of essential medicines. Methods Dosage form, specification and manufacturers of 201 kinds of chemical drugs included in the EML were retrieved through SFDA website, data collection and analysis were conducted using Excel software. Results Domestic chemical drugs in EML involved 24 kinds of dosage forms, 644 kinds of specifications, 37 854 kinds of drugs for sales, and 2 908 manufacturers. Imported chemical drugs in EML involved 12 kinds of dosage forms, 43 kinds of specifications, 113 kinds of drugs for sales, and 53 manufacturers. Included drugs were primarily normal dosage forms while chemical drugs had many different specifications. Medicines duplication in production was serious and the distribution in market was unbalanced. The sole and exclusive dosage form variety lacked of effective evidence. Selection mechanism and reevaluation needed to be developed. Conclusion It is suggested to include drug specification in EML, and refer to spectrum of diseases for detailed selection mechanism of essential drugs, reevaluation of the listed drugs and formulate strict drug bidding rules so as to optimize EML.
ObjectiveTo investigate the development, production and use of children’s drugs in Sichuan Province, analyze the problems existing in these links, and provide suggestions for ensuring that children’s needs for drugs are met. MethodsThe self-filling electronic questionnaire was used to investigate the production, procurement and use of children’s drugs in 14 pharmaceutical companies producing children’s drugs and 20 general hospitals with pediatric departments or children’s hospitals in Sichuan province. ResultsThe 14 surveyed pharmaceutical companies reported that 116 children’s drugs were being developed or produced (75 first-class children’s drugs with exact medication information for children, 41 second-class children’s drugs only noted as children's discretionary reduction or use according to clinician’s instructions), out of which 109 (93.97%) drugs had been approved for marketing, 21 (18.10%) were national essential medicines and 76 (65.52%) were covered by national basic medical insurance. The dosage forms of first-class children's drugs were mainly tablets (28, 37.34%) and granules (19, 25.34%), while oral solution (3, 4.00%), syrup (5, 6.67%) and other dosage forms suitable for children were less. According to the surveyed results on the use of children's drugs in hospitals, there were 57 children’s drugs whose minimum use units needed to be manually divided into smaller ones on average in each hospital, and it was the most common operation pattern that pharmacists informed nurses, patients or patients’ family members of the dose splitting methods and then splitting drugs’ minimum use units by themselves. ConclusionThere is a great demand for splitting minimum use units of drugs whose strength is too big for children in medical institutions, and some children’s drugs need to be developed and further modified to meet the clinical children’s drug needs. We should further increase investments and policy supports for the children’s drugs, promote children’s clinical trials, and encourage the research and development of children’s drugs.