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Abstract Diversion of substances from the care of the intended patient is a significant problem in healthcare. Patients are harmed by the undertreatment of pain and suffering, transmission of disease, as well as the risk associated with impaired vigilance. Healthcare providers may be harmed by the physical and mental impact of their addictions. Healthcare systems are placed in jeopardy by the legal impact associated with illegal routes of drug release including sanction and financial liability and loss of public trust. Healthcare institutions have implemented many measures to reduce diversion from the perioperative area. These efforts include education, medical record surveillance, automated medication dispensing systems, urine drug testing, substance waste management systems, and drug diversion prevention teams. This narrative review evaluates strengths, weaknesses, and effectiveness of these systems and provides recommendations for leaders and care providers.
Subject(s)
Humans , Substance-Related Disorders/prevention & control , Anesthesiologists , Pain , Health Personnel , Prescription Drug Diversion/prevention & controlABSTRACT
Dry eye is the most common eye illness which manifests as a chronic inflammation on ocular surface and imposes significant threat to vision.Though dry eye is high prevalent,specific medication to treat this refractory disorder is very limited.The paucity of new drugs available can be attributed to wide range of severity distribution as well as lack of appropriate animal model.Animal disease model plays a significant role in preclinical drug screening and testing prior to clinical trial.Various techniques have been explored to create dry eye models for drug testing,including surgical removal of lacrimal gland,systemic or local drug induction,autoimmune eliciting,and genetic manipulation.This article reviewed the important dry eye models and their roles in development of dry eye drugs to provide insight and inspiration for clinicians and researchers.
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An open-access microfluidic chip which enabled automatic cell distribution and complex multi-step operations was developed.The microfluidic chip featured a key structure in which a nanoporous membrane was sandwiched by a cell culture chamber array layer and a corresponding media reservoir array layer.The microfluidic approach took advantage of the characteristics of the nanoporous membrane.On one side, this membrane permitted the flow of air but not liquid, thus acting as a flow-stop valve to enable automatic cell distribution.On the other side, it allowed diffusion-based media exchange and thus, mimicked the endothelial layer.In synergy with a liquid transferring platform, the open-access microfluidic system enabled complex multi-step operations involving medium exchange, drug treatment, and cell viability testing.By using this microfluidic protocol, a 10 × 10 tissue arrays was constructed in 90 s, followed by schedule-dependent drug testing.Morphological and immunohistochemical assays results indicated that the resultant tumor tissue was faithful to that in vivo.Drug testing assays showed that the microfluidic tissue array promised multi-step cell assays under biomimetic microenvironment, thus providing an advantageous tool for cell research.
ABSTRACT
Dry eye is the most common eye illness which manifests as a chronic inflammation on ocular surface and imposes significant threat to vision. Though dry eye is high prevalent, specific medication to treat this refractory disorder is very limited. The paucity of new drugs available can be attributed to wide range of severity distribution as well as lack of appropriate animal model. Animal disease model plays a significant role in preclinical drug screening and testing prior to clinical trial. Various techniques have been explored to create dry eye models for drug testing,including surgical removal of lacrimal gland,systemic or local drug induction,autoimmune eliciting,and genetic manipulation. This article reviewed the important dry eye models and their roles in development of dry eye drugs to provide insight and inspiration for clinicians and researchers.
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OBJECTIVE: To discuss the role of proficiency testing program for pharmaceutical dissolution determination in the capacity building of relevant laboratories. METHODS Based on the results of the two proficiency testing programs carried out in recent years, analyze the difference of the quality management and the level of dissolution determination among the participating laboratories and discuss on the way that the proficiency testing programs carried out in future. RESULT: There is difference among the laboratories in both the quality management and the level of dissolution determination, the "unsatisfactory" laboratories mainly concentrated in local drug control institutes and pharmaceutical manufacturers. The three "unsatisfactory" laboratories in the first program, took corrective and preventive measures, participated in the later program, and achieved "satisfactory" results. CONCLUSION: The proficiency testing program is effective in improving the dissolution determination capacity of the participating laboratories and is recommended to be conducted continually in the pharmaceutical industry.
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Microbiological data deviations ( MDD) investigation differs from out of the standard ( OOS) investigation in chemical inspection items. Investigating Out-of-Specification( OOS) Test Results for Pharmaceutical Production issued by FDA specifically ex-cludes microbiological and other biological assays. Until recently, there is not a definitive guideline for MDD investigation in the world. Some institutions and experts have explored the practice and theory of MDD investigation. Referred to the existing practical experience and theoretical achievement and based on the provisions of Chinese GMP (2010 revision) and the requirements of Chinese Pharmaco-poeia Ⅱ(2010 edition) Appendix XIX Q, the article discussed the methods for MDD laboratory investigation.
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To understand the status of testing skills and quality management in drug testing laboratories. Methods:The items, pass rate and type of participating laboratories of measurement audit were analyzed during 2011-2014. Results:The number of application items was increased year by year, more than half of which focused on the content determination, and the overall pass rate was over 80%. Conclusion:The measurement audit is important for laboratories, which should be further strengthened and standard-ized.
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Objective:To provide the basic data for the further revision of mycoplasma test method described in Chinese Pharma-copoeia and some references for the operation standardization of drug mycoplasma test. Methods:Two incubation conditions,namely aerobic conditions and microaerophilic conditions,were compared with respect to the growth status of mycoplasma in liquid and solid media. Results:The growth of mycoplasma was obvious difference between the two incubation conditions,and the microaerophilic con-ditions were better than the aerobic conditions. Conclusion:The microaerophilic conditions can be used in the incubation of mycoplas-ma test,which should be defined and standardized in the future Chinese Pharmacopoeia.
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OBJECTIVE: To introduce the implementation method and design ideas to achieve automatic NIR (near-infrared spectroscopy) modeling and comparison function during the construction of "National Rapid Drug Testing Database Network Platform" and investigate and verify the feasibility of constructing the automatic rapid drug testing module using workflow technology. METHODS: Both the scientific data workflow and analysis tool Pipeline Pilot and the basic principle of two quick comparison algorithms of NIR were employed to construct a spectral processing and modeling workflow of drugs. Moreover, validation and comparison were carried out between our method and the instrument workstation software OPUS. RESULTS: The established workflow method was not only consistent with the results of OPUS, but also had the advantages of automation and easinessto use. CONCLUSION: The scientific workflow technology can be used to achieve automatic modeling and comparison function of NIR and easily introduce other chemometrics method in the future.
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Current therapy for pancreatic cancer is multimodal, involving surgery and chemotherapy. However, development of pancreatic cancer therapies requires a thorough evaluation of drug efficacy in vitro before animal testing and subsequent clinical trials. Compared to two-dimensional culture of cell monolayer, three-dimensional (3-D) models more closely mimic native tissues, since the tumor microenvironment established in 3-D models often plays a significant role in cancer progression and cellular responses to the drugs. Accumulating evidence has highlighted the benefits of 3-D in vitro models of various cancers. In the present study, we have developed a spheroid-based, 3-D culture of pancreatic cancer cell lines MIAPaCa-2 and PANC-1 for pancreatic drug testing, using the acid phosphatase assay. Drug efficacy testing showed that spheroids had much higher drug resistance than monolayers. This model, which is characteristically reproducible and easy and offers rapid handling, is the preferred choice for filling the gap between monolayer cell cultures and in vivo models in the process of drug development and testing for pancreatic cancer.