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.
In recent years, real-world evidence data (RWD) and real-world evidence (RWE) have gained substantial attentions from healthcare practitioners and health authorities worldwide. In particular, the needs from regulatory bodies have promoted the production and use of real-world evidence. In the context of drug and device evaluation and regulation decisions, the pattern for using real world evidence may differ. This article aimed to discuss the potential uses of RWE for pre-approval clinical evaluation, post-approval monitoring and evaluation, and associated regulatory decisions, which may ultimately improve the production and use of RWE for regulatory decisions.
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.
目的 分析都江堰市人民医院药品不良反应（ADR）的发生情况及引发ADR的相关因素，为临床合理用药及正确评价ADR的发生提供参考。 方法 对医院2009年1月－2011年12月收集上报至全国ADR监测网络的168例ADR报告，进行回顾性分类与统计分析。 结果 ADR报告例数最多的为临床科室，男女病例数比为0.87∶1，静脉给药途径引发的ADR最多（占77.98%）；抗感染药物的ADR发生率最高（占61.90%）；皮肤及其附件损害最常见占（27.98%）。 结论 抗感染药物和中药注射剂是ADR监测的重点药物，应加强ADR监测及相关知识的宣传，提高合理用药水平，减少药源性疾病的发生。
Objective To investigate the information of label use of high-alert drugs for children of high risk population, in the Military General Hospital of Beijing PLA. Methods We selected high-alert drugs used in this hospital as objectives. The package inserts of these drugs were investigated and medication parts for children were analyzed. Results 201 drugs regarded as high-alert drugs were included, of which only 78 drugs have accurate detailed description of medication for children, accounting for 38.8% of the total of investigated high-alert drugs. Conclusion Children, as high-risk population, needs more attention concerning the use of high-alert drugs. However, risks in the use of high-alert drugs increased due to the lack of the information of label use of high-alert drugs. To ensure the safety of drug use in children, the information of drug use for children in the package inserts should be urgently supplemented.
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.