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framework medication safety

Wolfgang Wiedemair, Zeljko Tukovic, Hrvoje Jasak, Dimos Poulikakos, Vartan Kurtcuoglu
Encapsulated microbubbles (MBs) serve as endovascular agents in a wide range of medical ultrasound applications. The oscillatory response of these agents to ultrasonic excitation is determined by MB size, gas content, viscoelastic shell properties and geometrical constraints. The viscoelastic parameters of the MB capsule vary during an oscillation cycle and change irreversibly upon shell rupture. The latter results in marked stress changes on the endothelium of capillary blood vessels due to altered MB dynamics...
October 12, 2016: Biomechanics and Modeling in Mechanobiology
Peri Kocabayoglu, Martin Husen, Oliver Witzke, Andreas Kribben, Fuat H Saner, Ali Canbay, Guido Gerken, Andreas Paul
BACKGROUND: Morbidity and mortality conferences (MMCs) provide powerful opportunities for learning, reflection, and improvement. The current literature gives examples of how MMCs can be designed; however, no systematic review of cases and no original data related to liver transplantation are available. Liver transplantation requires a multidisciplinary approach to case identification, presentation, and analysis. Framework structures that guide case investigation are needed to successfully follow up on outcome measures and provide the basis for quality assessment and transparency in transplant programs...
August 2016: Visc Med
Jennifer C Nelson, Robert Wellman, Onchee Yu, Andrea J Cook, Judith C Maro, Rita Ouellet-Hellstrom, Denise Boudreau, James S Floyd, Susan R Heckbert, Simone Pinheiro, Marsha Reichman, Azadeh Shoaibi
INTRODUCTION: The large-scale assembly of electronic health care data combined with the use of sequential monitoring has made proactive postmarket drug- and vaccine-safety surveillance possible. Although sequential designs have been used extensively in randomized trials, less attention has been given to methods for applying them in observational electronic health care database settings. EXISTING METHODS: We review current sequential-surveillance planning methods from randomized trials, and the Vaccine Safety Datalink (VSD) and Mini-Sentinel Pilot projects-two national observational electronic health care database safety monitoring programs...
2016: EGEMS
Catherine Picton, Claire Loughrey, Andrew Webb
The original requirement for a competency framework for prescribers was to identify the essential skills for non-medical prescribers. However, core prescribing competencies are relevant to any prescriber. The new, revised version is especially relevant for doctors/physicians. Doctors are the most frequent prescribers - prescribing is the most common therapeutic intervention. The quantity and complexity of medicine use is increasing through multiple treatment strategies/pathways for multiple comorbidities, resulting in polypharmacy - especially with long-term conditions...
October 2016: Clinical Medicine: Journal of the Royal College of Physicians of London
Yuan-Chuan Chen, Hwei-Fang Cheng, Ming-Kung Yeh
Cell therapy is not only a novel medical practice but also a medicinal product (cell therapy product, CTPs). More and more CTPs are approved for marketing globally due to the rapid development of biomedicine in the cell culture, preservation and preparation. However, the regulation is the most important criterion for the development of CTPs. Regulations must be flexible to expedite the process of marketing for new CTPs. Recently, Taiwan Food and Drug Administration (TFDA) elaborates the related regulation such as regulatory development, current regulatory framework and process of application and evaluation...
September 30, 2016: Cell Transplantation
Arielle M Fisher, Michael Q Ding, Harry Hochheiser, Gerald P Douglas
BACKGROUND: Free and charitable clinics are a critical part of America's healthcare safety net. Although informatics tools have the potential to mitigate many of the organizational and service-related challenges facing these clinics, little research attention has been paid to the workflows and potential impact of electronic systems in these settings. In previous work, we performed a qualitative investigation at a free clinic dispensary to identify workflow challenges that may be alleviated through introduction of informatics interventions...
September 29, 2016: BMC Health Services Research
Krisztina B Gecse, Péter L Lakatos
Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed...
October 2016: Drugs
John Trusheim, Erin Dunbar, James Battiste, Fabio Iwamoto, Nimish Mohile, Denise Damek, Daniela A Bota, Jennifer Connelly
Tumor treating fields (TTFields) are an integral treatment modality in the management of glioblastoma and extend overall survival when combined with maintenance temozolomide in newly diagnosed patients. Complexities exist regarding correct selection of imaging sequences with which to perform TTFields treatment planning. Guidelines are warranted first, to facilitate treatment planning standardization across medical disciplines and institutions, to ensure optimal TTFields delivery to the tumor and peritumoral brain zone while maximizing patient safety, and also to mitigate the risk of premature cessation of a potentially beneficial treatment...
September 15, 2016: CNS Oncology
Eric S Holmboe, Tina C Foster, Greg Ogrinc
For most of the 20th century the predominant focus of medical education across the professional continuum was the dissemination and acquisition of medical knowledge and procedural skills. Today it is now clear that new areas of focus, such as interprofessional teamwork, care coordination, quality improvement, system science, health information technology, patient safety, assessment of clinical practice, and effective use of clinical decision supports are essential to 21st century medical practice. These areas of need helped to spawn an intense interest in competency-based models of professional education at the turn of this century...
2016: Journal of Continuing Education in the Health Professions
Antonella Casiraghi, Silvia Franzè, Paolo Rocco, Paola Minghetti
PURPOSE: The different stages of antineoplastic agent management build up a complex process, from supply to prescription, preparation, and administration. All steps in this process must be carefully monitored in order to control/reduce the risk of errors that can impact on patient safety. This work overviews the prevention of medication errors in oncology, including regulatory and legislative frameworks with specific reference to the Raccomandazione 14 (Recommendation 14) issued by the Italian Ministry of Health...
August 29, 2016: Tumori
Yan Li, Yun-Feng Zhou, Han Liang, Hua-Qing Wang, Ji-Hui Hao, Zheng-Gang Zhu, De-Seng Wan, Lun-Xiu Qin, Shu-Zhong Cui, Jia-Fu Ji, Hui-Mian Xu, Shao-Zhong Wei, Hong-Bin Xu, Tao Suo, Shu-Jun Yang, Cong-Hua Xie, Xiao-Jun Yang, Guo-Liang Yang
Locoregional spread of abdominopelvic malignant tumors frequently results in peritoneal carcinomatosis (PC). The prognosis of PC patients treated by conventional systemic chemotherapy is poor, with a median survival of < 6 mo. However, over the past three decades, an integrated treatment strategy of cytoreductive surgery (CRS) + hyperthermic intraperitoneal chemotherapy (HIPEC) has been developed by the pioneering oncologists, with proved efficacy and safety in selected patients. Supported by several lines of clinical evidence from phases I, II and III clinical trials, CRS + HIPEC has been regarded as the standard treatment for selected patients with PC in many established cancer centers worldwide...
August 14, 2016: World Journal of Gastroenterology: WJG
Chen-Yang Cheng, Kuo-Liang Chiang, Meng-Yin Chen
Forecasts of the demand for medical supplies both directly and indirectly affect the operating costs and the quality of the care provided by health care institutions. Specifically, overestimating demand induces an inventory surplus, whereas underestimating demand possibly compromises patient safety. Uncertainty in forecasting the consumption of medical supplies generates intermittent demand events. The intermittent demand patterns for medical supplies are generally classified as lumpy, erratic, smooth, and slow-moving demand...
October 2016: Journal of Medical Systems
Mark D Huffman, Kunal N Karmali, Mark A Berendsen, Adin-Cristian Andrei, Jane Kruse, Patrick M McCarthy, S C Malaisrie
BACKGROUND: People with atrial fibrillation (AF) often undergo cardiac surgery for other underlying reasons and are frequently offered concomitant AF surgery to reduce the frequency of short- and long-term AF and improve short- and long-term outcomes. OBJECTIVES: To assess the effects of concomitant AF surgery among people with AF who are undergoing cardiac surgery on short-term and long-term (12 months or greater) health-related outcomes, health-related quality of life, and costs...
August 22, 2016: Cochrane Database of Systematic Reviews
Wei Liu, Marie Gerdtz, Elizabeth Manias
AIMS AND OBJECTIVES: This paper examines the communication strategies that nurses, doctors, pharmacists and patients use when managing medications. BACKGROUND: Patient-centred medication management is best accomplished through interdisciplinary practice. Effective communication about managing medications between clinicians and patients has a direct influence on patient outcomes. There is a lack of research that adopts a multidisciplinary approach and involves critical in-depth analysis of medication interactions among nurses, doctors, pharmacists and patients...
October 2016: Journal of Clinical Nursing
Maxine Trent, Kimberly Waldo, Hania Wehbe-Janek, Daniel Williams, Wendy Hegefeld, Lisa Havens
BACKGROUND: Health care providers often experience traumatic events and adversity that can have negative emotional impacts on the profession and on patients. These impacts are typically multifaceted and can result from many different events, such as unanticipated outcomes, licensing board complaints, claims, and litigation. Because health care providers are exposed to diverse situations, they require adequate and timely support, imperative for provider resilience and patient safety. This study evaluated the success of an institution's second victim health care support program and best practices in responding to these traumatic experiences effectively...
August 2016: Journal of Healthcare Risk Management: the Journal of the American Society for Healthcare Risk Management
Ian Shemilt, Nada Khan, Sophie Park, James Thomas
BACKGROUND: Meta-research studies investigating methods, systems, and processes designed to improve the efficiency of systematic review workflows can contribute to building an evidence base that can help to increase value and reduce waste in research. This study demonstrates the use of an economic evaluation framework to compare the costs and effects of four variant approaches to identifying eligible studies for consideration in systematic reviews. METHODS: A cost-effectiveness analysis was conducted using a basic decision-analytic model, to compare the relative efficiency of 'safety first', 'double screening', 'single screening' and 'single screening with text mining' approaches in the title-abstract screening stage of a 'case study' systematic review about undergraduate medical education in UK general practice settings...
2016: Systematic Reviews
Daniel Skinner, William Gardner, Kelly J Kelleher
Written from the perspective of hospitals, this article examines, in theory and in practice, challenges associated with hospitals' efforts to engage in neighborhood development more fully with the communities that neighbor them. Increasingly, these efforts include significant investments in housing, safety, and educational initiatives. These investments stretch the traditional expertise of medical practitioners and administrators and raise ethical and political questions about how best to engage and work with communities...
2016: Journal of Health Care for the Poor and Underserved
Shunaha Kim-Fine, Erin A Brennand
Simulation in surgical training is playing an increasingly important role as postgraduate medical education programs navigate an environment of increasing costs of education, increased attention on patient safety, and new duty hour restrictions. In obstetrics and gynecology, simulation has been used to teach many procedures; however, it lacks a standardized curriculum. Several different simulators exist for teaching various routes and aspects of hysterectomy. This article describes how a formal framework of increasing levels of competencies can be applied to simulation in teaching the procedure of hysterectomy...
September 2016: Obstetrics and Gynecology Clinics of North America
Maki Matsuhama, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, Kenichi Mikami
PURPOSE: A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. METHODS: We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers...
April 2016: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
M Kwapisz, R Kieszek, K Jędrzejko, P Domagała, M Bieniasz, J Gozdowska, D Zygier, J Drozdowski, M Zatorski, M Nowaczyk, P Palczewski, L Pączek, M Durlik, A Chmura, A Kwiatkowski
Kidney donation should not lead to deterioration of the donor's health condition, both during the perisurgical period and in the long term. Safety of a living kidney donor becomes a prerequisite for his/her qualification. Detailed diagnostic procedures are performed to exclude any abnormalities of his/her health condition. Additionally, a long-term post-donation follow-up system for kidney donors has been set up in Poland besides the restrictive qualification system. Transplantation centers are obligated to provide a diagnostic procedures for living organ donors as a part of the monitoring of their health condition and to ensure them a medical follow-up for 10 years after the donation...
June 2016: Transplantation Proceedings
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