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Safety alert

Beata Powroźnik, Karolina Słoczyńska, Krzysztof Marciniec, Paweł Zajdel, Elżbieta Pękala
Purpose: Determination of the mutagenic potential of new biologically active compounds is of great concern for preliminary toxicity testing and drug development. Methods: The mutagenic and antimutagenic effects of some quinoline- and isoquinolinesulfonamide analogs of aripiprazole (1-8), which display potent antidepressant, anxiolytic, and antipsychotic properties, were evaluated using the Vibrio harveyi assay and OSIRIS Property Explorer software. Additionally, the Ames test was used as the reference. Results: In silico prediction showed that compounds 5 (N-(3-(4-(2,3- dichlorophenyl)piperazin-1-yl)propyl)quinoline-7-sulfonamide) and 6 (N-(4-(4-(2,3- Dichlorophenyl)piperazin-1-yl)butyl)quinoline-7-sulfonamide) trigger a mutagenic structural alert...
September 2016: Advanced Pharmaceutical Bulletin
Insa Joost, Johannes Steinfurt, Philipp T Meyer, Winfried V Kern, Siegbert Rieg
BACKGROUND: Ustekinumab (Stelara®), a human monoclonal antibody targeting the p40-subunit of interleukin (IL)-12 and IL-23, is indicated for moderate to severe plaque psoriasis and psoriatic arthritis. In large multicenter, prospective trials assessing efficacy and safety of ustekinumab increased rates of severe infections have not been observed so far. CASE PRESENTATION: Here, we report the case of a 64-year old woman presenting with chills, pain and swelling of her right foot with dark maculae at the sole, and elevated inflammatory markers...
October 20, 2016: BMC Infectious Diseases
Flavia Petrini, Ida Di Giacinto, Rita Cataldo, Clelia Esposito, Vittorio Pavoni, Paolo Donato, Antonella Trolio, Guido Merli, Massimiliano Sorbello, Paolo Pelosi
Proper management of obese patients requires a team vision and appropriate behaviors by all health care providers in hospital. Specialist competencies are fundamental, as are specific clinical pathways and good clinical practices designed to deal with patients whose body mass index is ≥30 kg/m2. Standards of care for bariatric and non-bariatric surgery and for the critical care management of this population exist but are not well defined nor clearly followed in every hospital. Thus every anesthesiologist is likely to deal with this challenging population...
October 19, 2016: Minerva Anestesiologica
Shota Nakashima, Shingo Aramaki, Yuhki Kitazono, Shenglin Mu, Kanya Tanaka, Seiichi Serikawa
The number of accidents involving elderly individuals has been increasing with the increase of the aging population, posing increasingly serious challenges. Most accidents are caused by reduced judgment and physical abilities, which lead to severe consequences. Therefore, studies on support systems for elderly and visually impaired people to improve the safety and quality of daily life are attracting considerable attention. In this study, a road surface condition distinction method using reflection intensities obtained by an ultrasonic sensor was proposed...
October 12, 2016: Sensors
Jennifer L Schroeck, James Ford, Erin L Conway, Kari E Kurtzhalts, Megan E Gee, Krista A Vollmer, Kari A Mergenhagen
PURPOSE: Insomnia is problematic for older adults. After behavioral modifications fail to show adequate response, pharmacologic options are used. The pharmacokinetics of agents used to treat insomnia may be altered. This review focuses on the safety and efficacy of medications used to treat insomnia. METHODS: A literature search of Medline, PubMed, and Embase was conducted (January 1966-June 2016). It included systematic reviews, randomized controlled trials, observational studies, and case series that had an emphasis on insomnia in an older population...
October 14, 2016: Clinical Therapeutics
Kimberly A Randell, Danica Harris, Jennifer Stallbaumer-Rouyer
Childhood exposure to intimate partner violence (IPV) results in numerous, lifelong, negative health outcomes, underscoring the American Academy of Pediatrics' recommendation for IPV screening and intervention in the pediatric health care setting. We report a case in which a mother denied IPV during routine IPV screening in a pediatric emergency department (ED). However, subsequent discussion with health care providers during the ED visit revealed IPV. The mother declined to meet with an IPV advocate because the abuser was texting repeatedly to ask about the duration of the ED visit...
October 4, 2016: Pediatric Emergency Care
Alan Cowley, Ashley Hague, Neal Durge
Techniques for extricating vehicle occupants after road-traffic collisions have evolved largely through fear of worsening a cervical spine injury, rather than being evidence-based. Recent research has looked at the safety of allowing the alert patient to self-extricate, rather than being assisted with equipment such as long spinal boards and semirigid cervical collars. This review aims to elucidate whether it is safe to allow an alert, ambulant patient to self-extricate from a vehicle with minimal or no cervical spine immobilization...
September 29, 2016: European Journal of Emergency Medicine: Official Journal of the European Society for Emergency Medicine
Pina Violano, Linda Roney, Kirsten Bechtel
BACKGROUND: Pedestrians distracted by digital devices or other activities are at a higher risk of injury as they cross streets. We sought to describe the incidence of pedestrians distracted by digital devices or other activities at two highly traveled urban intersections after the implementation of a pedestrian safety intervention at one of the intersections. METHODS: This was an observational field study of two urban intersections. Two investigators were stationed at each of the four corners of the intersection...
December 2015: Injury Epidemiology
Andrew A M Ibey, Derek Andrews, Barb Ferreira
The authors present a case in which a physical anomaly with an infusion pump resulted in an unforeseen fault that the nurse's attempts to resolve unknowingly exacerbated. This case study presents the first report in the literature to detail the difficulty in recreating a patient safety event using smart pump logs, support server continuous quality improvement (CQI) data, and the drug order entry system to elucidate the clinical scenario. A 75-year-old male patient presented to a major teaching hospital and was admitted to the intensive care unit (ICU) with a massive gastrointestinal bleed and myocardial infarction, then stabilized...
December 2016: Drug Saf Case Rep
Radhe Sharan, Brij Mohan, Harkomal Kaur, Anju Bala
BACKGROUND: Fiberoptic intubation is a technique commonly used for difficult airways. Conscious sedation is desirable to make this procedure tolerable, and it is essential that patients are cooperative, relaxed, and comfortable especially when difficult airway anatomy or pathology is encountered. OBJECTIVE: To compare the safety and efficacy of propofol versus midazolam in oral fiberoptic endotracheal intubation in terms of hemodynamic changes, level of sedation, ease of intubation, and patient comfort and complications...
September 2016: Anesthesia, Essays and Researches
Dominic Way, Hortense Blazsin, Ragnar Löfstedt, Frederic Bouder
This paper reviews the main tools for communicating benefit-risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Arcady A Putilov, Olga G Donskaya, Evgeniy G Verevkin
One of the critical barriers to reducing the threats of sleep loss to public health, safety, and productivity is a lack of practical tools for quick identification of objective level of sleepiness. We examined a novel sleepiness measure named "spectral drowsy component score" to provide evidence for generalizability of a frequency weighting curve required for calculation of this measure. Each spectral drowsy component score is a sum of 16 weighted ln-transformed single-Hz power densities (1-16 Hz) obtained by the fast Fourier transformation of an electroencephalographic signal recorded during the first minute after closing the eyes...
October 11, 2016: Clinical EEG and Neuroscience: Official Journal of the EEG and Clinical Neuroscience Society (ENCS)
Amy Tanti, Benjamin Micallef, Anthony Serracino-Inglott, John-Joseph Borg
Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems...
October 12, 2016: Expert Opinion on Drug Safety
Leah Potts, Peter Buzzacott, Petar Denoble
INTRODUCTION: Cave divers enter an inherently dangerous environment that often includes little visibility, maze-like passageways and a ceiling of rock that prevents a direct ascent to the surface in the event of a problem. METHODS: Reports of cave diving fatality cases occurring between 01 July 1985 and 30 June 2015 collected by Divers Alert Network were reviewed. Training status, safety rules violated, relevancy of the violations, and root causes leading to death were determined...
September 2016: Diving and Hyperbaric Medicine: the Journal of the South Pacific Underwater Medicine Society
Falko Brieger, Robert Hagen, Daniela Vetter, Carsten F Dormann, Ilse Storch
Every year, approximately 500 human fatalities occur due to animal-vehicle collisions in the United States and Europe. Especially heavy-bodied animals affect road safety. For more than 50 years, light-reflecting devices such as wildlife warning reflectors have been employed to alert animals to traffic when crossing roads during twilight and night. Numerous studies addressed the effectiveness of light-reflecting devices in reducing collisions with animals in past decades, but yielded contradictory results. In this study, we conducted a systematic literature review to investigate whether light-reflecting devices contribute to an effective prevention of animal-vehicle collisions...
October 4, 2016: Accident; Analysis and Prevention
Ahmed Al-Mandhari, Ibrahim Al-Zakwani, Samir Al-Adawi, Samra Al-Barwani, Lakshmanan Jeyaseelan
BACKGROUND: The pressing need to reduce burgeoning poor safety measures affecting millions worldwide has alerted World Health Assembly to set-up mechanisms to increase patient safety. In response to such needs, World Health Organization (WHO) formulated nine life-saving patient safety solutions that would be essential to lower reduce healthcare-related harm. There is a paucity of research examining awareness of such nine patient safety solutions. This study has been designed and conducted to compare self-estimated awareness and practice of the World Health Organization's nine "Life-saving Patient Safety Solutions" aide memoirs among different groups of healthcare workers in Oman...
September 30, 2016: BMC Health Services Research
Rashid Haidarimoghadam, Reza Kazemi, Majid Motamedzadeh, Rostam Golmohamadi, Alireza Soltanian, Mohamad Reza Zoghipaydar
INTRODUCTION: The aim of this study was to evaluate the effects of consecutive night shifts (CNS) and shift length (SL) on cognitive performance and sleepiness. MATERIALS AND METHODS: This study evaluated the sleepiness and performance of 30 control rooms operators (CROs) working in a 7 nights, 7 days, 7 days off (7N7D7O) and 30 CROs working in a 4 nights, 7 days, 3 nights, 7 days off (4N7D3N7O) shift pattern in a petrochemical complex in the last night shift before swinging into the day shift...
October 4, 2016: International Journal of Occupational Safety and Ergonomics: JOSE
I Cuesta López, M Sánchez Cuervo, Á Candela Toha, J Benedí González, T Bermejo Vicedo
WHAT IS KNOWN AND OBJECTIVE: The correct management of high-alert medications is a priority issue in expert recommendations for improving the clinical safety of patients. Objectives were to assess the impact of the implementation of vasoactive drug (VAD) protocols on safety and efficacy in the treatment of critically ill patients. METHODS: A prospective before-and-after study on the implementation of different VAD protocols, comparing medication errors (MEs) rates, mean intensive care unit (ICU) stay, mean blood pressure (MAP), heart rate (HR) and oxygen saturation...
October 4, 2016: Journal of Clinical Pharmacy and Therapeutics
Edward V Nunes, Joshua D Lee, Dominic Sisti, Andrea Segal, Arthur Caplan, Marc Fishman, Genie Bailey, Gregory Brigham, Patricia Novo, Sarah Farkas, John Rotrosen
We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition-detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed...
September 28, 2016: Contemporary Clinical Trials
Q Lam, E Ajzner, C A Campbell, A Young
Direct communication of significant (often life-threatening) results is a universally acknowledged role of the pathology laboratory, and an important contributor to patient safety. Amongst the findings of a recent survey of 871 laboratories from 30 countries by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), only 3 tests were noted to be common to 90% of alert lists, and only 48% of laboratories consulted clinicians in developing these alert lists despite ISO15189 recommendations to do so...
February 2016: EJIFCC
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