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https://www.readbyqxmd.com/read/28944731/the-fda-unapproved-drugs-initiative-an-observational-study-of-the-consequences-for-drug-prices-and-shortages-in-the-united-states
#1
Ravi Gupta, Sanket S Dhruva, Erin R Fox, Joseph S Ross
BACKGROUND: Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28944533/parents-spend-an-average-of-nine-hours-a-day-providing-palliative-care-for-children-at-home-and-need-to-maintain-an-average-of-five-life-saving-devices
#2
P Lazzarin, B Schiavon, L Brugnaro, F Benini
AIM: This Italian study investigated home-based palliative care for young children and how long it took parents to meet their needs. METHODS: The study population consisted of 33 families with a child under the responsibility of the Veneto Regional Center for Pediatric Palliative Care, northern Italy, who needed medical support in at least two of the following areas: respiratory, feeding, pain and seizures. RESULTS: The children had a mean age of 6...
September 25, 2017: Acta Paediatrica
https://www.readbyqxmd.com/read/28943818/factors-associated-with-dispensing-dosage-delivery-devices
#3
Eva Wojewoda, Katherine J Chou
OBJECTIVES: A potential cause of medication errors in children is imprecise measurements, particularly using household spoons. There are no regulations requiring dispensing dose delivery devices (DDDs) with liquid prescription medications. Local, regional, and national pharmacy practice patterns are largely unknown. This study sought to determine how frequently devices are provided with prescription pediatric liquid medications with instructions for their use at pharmacies in Bronx, New York, and to examine which pharmacy and pharmacist characteristics are associated with reported practices...
July 2017: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
https://www.readbyqxmd.com/read/28943307/the-role-of-ultrasound-technology-in-plastic-surgery
#4
REVIEW
Tyler Safran, Kevin Gorsky, Alex Viezel-Mathieu, Jonathan Kanevsky, Mirko S Gilardino
INTRODUCTION: The modern medical era is in part characterized by the increased availability of portable imaging devices. Ultrasound devices are used for either high-resolution non-invasive imaging or as a focused acoustic energy source capable of sculpting and shaping tissue. Given the broad scope of the field, plastic and reconstructive surgeons have the unique ability to implement and tailor the use of ultrasound in a variety of clinical situations. This article will review novel uses for ultrasound in the field of plastic surgery...
September 13, 2017: Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS
https://www.readbyqxmd.com/read/28942783/japanese-registry-for-mechanically-assisted-circulatory-support-first-report
#5
Takeshi Nakatani, Kazuhiro Sase, Hiroaki Oshiyama, Masatoshi Akiyama, Masao Horie, Kan Nawata, Tomohiro Nishinaka, Yoshihisa Tanoue, Koichi Toda, Masao Tozawa, Shunichi Yamazaki, Masanobu Yanase, Hiroshi Ohtsu, Michiko Ishida, Ayaka Hiramatsu, Kensuke Ishii, Soichiro Kitamura
BACKGROUND: In Japan, ventricular assist devices (VADs) have been used for patients with severe heart failure as a bridge to transplantation (BTT) since 1992. However, it was not until 1997, when the Organ Transplant Law was enacted, that medical devices received approval by the national health insurance system for that use. To encourage research and development of innovative medical devices, the Pharmaceuticals and Medical Devices Agency has established a public-private partnership in collaboration with academic societies, hospitals and manufacturers...
October 2017: Journal of Heart and Lung Transplantation
https://www.readbyqxmd.com/read/28942762/clinical-use-of-a-home-sleep-apnea-test-an-american-academy-of-sleep-medicine-position-statement
#6
Ilene M Rosen, Douglas B Kirsch, Ronald D Chervin, Kelly A Carden, Kannan Ramar, R Nisha Aurora, David A Kristo, Raman K Malhotra, Jennifer L Martin, Eric J Olson, Carol L Rosen, James A Rowley
The diagnosis and effective treatment of obstructive sleep apnea (OSA) in adults is an urgent health priority. It is the position of the American Academy of Sleep Medicine (AASM) that only a physician can diagnose medical conditions such as OSA and primary snoring. Throughout this statement, the term "physician" refers to a medical provider who is licensed to practice medicine. A home sleep apnea test (HSAT) is an alternative to polysomnography for the diagnosis of OSA in uncomplicated adults presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA...
September 20, 2017: Journal of Clinical Sleep Medicine: JCSM: Official Publication of the American Academy of Sleep Medicine
https://www.readbyqxmd.com/read/28942384/transcatheter-mitral-valve-replacement-device-landscape-and-early-results
#7
Amisha Patel, Vinayak Bapat
Mitral regurgitation (MR) is the second most common valvular heart disease in the western world with a prevalence in the USA alone of two to four million people. MR is age-dependent and hence the MR burden is expected to increase with the increase in life expectancy observed in Europe and the USA. Medical and surgical treatment has been the cornerstone of the treatment as untreated MR results in poor prognosis. However, only a fraction of patients are offered surgical treatment due to high risk. With the success of transcatheter aortic valve implantation (TAVI), many transcatheter options have emerged to provide a less invasive option for these patients...
September 24, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28941608/economic-evaluation-of-left-ventricular-assist-devices-for-patients-with-end-stage-heart-failure-who-are-ineligible-for-cardiac-transplantation
#8
Derek S Chew, Braden Manns, Robert J H Miller, Nakul Sharma, Derek V Exner
BACKGROUND: Continuous flow (CF) left ventricular assist devices (LVADs) improve survival in end-stage heart failure patients who are ineligible for cardiac transplantation. Their use in this population (referred to as destination therapy) is increasing in many countries, yet they are not routinely funded for this indication in Canada. We assessed the cost-effectiveness of destination therapy CF-LVADs from the perspective of the Canadian health care payer. METHODS: A Markov model was used to project the outcomes and costs of 2 treatment pathways, CF-LVAD implantation and medical management alone, in an end-stage heart failure patient cohort ineligible for transplantation...
October 2017: Canadian Journal of Cardiology
https://www.readbyqxmd.com/read/28941569/wound-ballistics-and-blast-injuries
#9
N J Prat, J-L Daban, E J Voiglio, F Rongieras
Wounds due to gunshot and explosions, while usually observed during battlefield combat, are no longer an exceptional occurrence in civilian practice in France. The principles of wound ballistics are based on the interaction between the projectile and the human body as well as the transfer of energy from the projectile to tissues. The treatment of ballistic wounds relies on several principles: extremity wound debridement and absence of initial closure, complementary medical treatment, routine immobilization, revision surgery and secondary closure...
September 20, 2017: Journal of Visceral Surgery
https://www.readbyqxmd.com/read/28941327/the-influence-of-two-common-sterilization-techniques-on-the-corrosion-of-mg-and-its-alloys-for-biomedical-applications
#10
Sean Johnston, Zhiming Shi, Cherilyn Hoe, Peter J Uggowitzer, Martina Cihova, Jörg F Löffler, Matthew S Dargusch, Andrej Atrens
This paper studied the influence of two common sterilization techniques, ethylene oxide (EO) and gamma irradiation (GI), on the corrosion rate of four Mg-based materials in CO2 -bicarbonate buffered Hanks' solution. The four materials were: high-purity (HP)-Mg, ZE41, ultra-high purity (XHP)-Mg, and XHP-ZX00. The corrosion rate was measured through mass loss (Pm ) and hydrogen evolution (PH ). Two-way analysis of variance (ANOVA) was conducted to assess the effect of the sterilization techniques on the corrosion rates across the four materials...
September 23, 2017: Journal of Biomedical Materials Research. Part B, Applied Biomaterials
https://www.readbyqxmd.com/read/28941127/a-comparison-of-the-fully-repositionable-and-retrievable-boston-lotus-and-direct-flow-medical-valves-for-the-treatment-of-severe-aortic-stenosis-a-single-center-experience
#11
Francesco Giannini, Azeem Latib, Matteo Montorfano, Neil Ruparelia, Vittorio Romano, Matteo Longoni, Luca Ferri, Richard Jabbour, Antonio Mangieri, Damiano Regazzoli, Marco Ancona, Nicola Buzzatti, Lorenzo Azzalini, Akihito Tanaka, Eustachio Agricola, Alaide Chieffo, Ottavio Alfieri, Antonio Colombo
BACKGROUND: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL. OBJECTIVES: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices...
September 20, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28941021/immobilization-of-vitronectin-binding-heparan-sulfates-onto-surfaces-to-support-human-pluripotent-stem-cells
#12
Lynn Yap, Sadasivam Murali, Gajadhar Bhakta, Drew M Titmarsh, Allen Kuan-Liang Chen, Lyn Chiin Sim, Muriel Bardor, Yu Ming Lim, James C H Goh, Steve K W Oh, Andre B H Choo, Andre J van Wijnen, David E Robinson, Jason D Whittle, William R Birch, Robert D Short, Victor Nurcombe, Simon M Cool
Functionalizing medical devices with polypeptides to enhance their performance has become important for improved clinical success. The extracellular matrix (ECM) adhesion protein vitronectin (VN) is an effective coating, although the chemistry used to attach VN often reduces its bioactivity. In vivo, VN binds the ECM in a sequence-dependent manner with heparan sulfate (HS) glycosaminoglycans. We reasoned therefore that sequence-based affinity chromatography could be used to isolate a VN-binding HS fraction (HS9) for use as a coating material to capture VN onto implant surfaces...
September 20, 2017: Journal of Biomedical Materials Research. Part B, Applied Biomaterials
https://www.readbyqxmd.com/read/28940574/balloon-dilation-of-the-eustachian-tube-for-dilatory-dysfunction-a-randomized-controlled-trial
#13
Dennis Poe, Vijay Anand, Marc Dean, William H Roberts, Jose Pablo Stolovitzky, Karen Hoffmann, Nathan E Nachlas, Joshua P Light, Mark H Widick, John P Sugrue, C Layton Elliott, Seth I Rosenberg, Paul Guillory, Neil Brown, Charles A Syms, Christopher W Hilton, John T McElveen, Ameet Singh, Raymond L Weiss, Moises A Arriaga, John P Leopold
OBJECTIVES/HYPOTHESIS: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. STUDY DESIGN: In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone...
September 20, 2017: Laryngoscope
https://www.readbyqxmd.com/read/28940249/protection-against-cold-a-survey-of-available-equipment-in-swedish-pre-hospital-services
#14
O Henriksson, U Björnstig, B-I Saveman, P J Lundgren
BACKGROUND: The aim of this study was to survey the current equipment used for prevention, treatment and monitoring of accidental hypothermia in Swedish pre-hospital services. METHODS: A questionnaire was sent to all road ambulance services (AS), the helicopter emergency medical services (HEMS), the national helicopter search and rescue service (SAR) and the municipal rescue services (RS) in Sweden to determine the availability of insulation, active warming, fluid heating, and low-reading thermometers...
September 21, 2017: Acta Anaesthesiologica Scandinavica
https://www.readbyqxmd.com/read/28940248/can-a-left-ventricular-assist-device-in-individuals-with-advanced-systolic-heart-failure-improve-or-reverse-frailty
#15
Mathew S Maurer, Evelyn Horn, Alex Reyentovich, Victoria Vaughan Dickson, Sean Pinney, Deena Goldwater, Nathan E Goldstein, Omar Jimenez, Sergio Teruya, Jeff Goldsmith, Stephen Helmke, Melana Yuzefpolskaya, Gordon R Reeves
BACKGROUND/OBJECTIVES: Frailty, characterized by low physiological reserves, is strongly associated with vulnerability to adverse outcomes. Features of frailty overlap with those of advanced heart failure, making a distinction between them difficult. We sought to determine whether implantation of a left ventricular assist device (LVAD) would decrease frailty. DESIGN: Prospective, cohort study. SETTING: Five academic medical centers. PARTICIPANTS: Frail individuals (N = 29; mean age 70...
September 21, 2017: Journal of the American Geriatrics Society
https://www.readbyqxmd.com/read/28940225/treatment-of-refractory-ascites-with-an-automated-low-flow-ascites-pump-in-patients-with-cirrhosis
#16
G Stirnimann, T Berg, L Spahr, S Zeuzem, S McPherson, F Lammert, F Storni, V Banz, J Babatz, V Vargas, A Geier, A Stallmach, C Engelmann, C Trepte, J Capel, A De Gottardi
BACKGROUND: Refractory ascites (RA) is a frequent complication of cirrhosis, requiring large volume paracentesis or placement of a transjugular intrahepatic portosystemic shunt (TIPSS). The automated low-flow ascites pump (alfapump, Sequana Medical AG, Zurich, Switzerland) is an innovative treatment option for patients with RA. AIM: To assess safety and efficacy of this treatment in patients with a contraindication to TIPSS. METHODS: Fifty-six patients (43 males; mean age 62 years) from centres in Germany, Switzerland, UK and Spain were included and followed for up to 24 months...
September 21, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28940163/predicting-the-dimensions-of-an-intracardiac-partial-assist-pump-for-percutaneous-delivery-by-analytical-and-numerical-methods
#17
Robert E Smith, P Alex Smith, William E Cohn
A minimally invasive ventricular assist device is under development for percutaneous insertion into the left atrium via transseptal access from the right atrium (RA). This study aimed to mathematically describe the vascular anatomy along possible insertion pathways to determine the device's maximum outer dimensions. We developed 2-dimensional mathematical models describing the vascular anatomy to the RA from three access points: subclavian vein (SCV), internal jugular vein (IJV), and femoral vein (FV). All pathways terminated by turning from the superior or inferior vena cava (SVC/IVC) into the RA...
September 22, 2017: Cardiovascular Engineering and Technology
https://www.readbyqxmd.com/read/28939900/fluoxetine-and-thioridazine-inhibit-efflux-and-attenuate-crystalline-biofilm-formation-by-proteus-mirabilis
#18
Jonathan Nzakizwanayo, Paola Scavone, Shirin Jamshidi, Joseph A Hawthorne, Harriet Pelling, Cinzia Dedi, Jonathan P Salvage, Charlotte K Hind, Fergus M Guppy, Lara M Barnes, Bhavik A Patel, Khondaker M Rahman, Mark J Sutton, Brian V Jones
Proteus mirabilis forms extensive crystalline biofilms on indwelling urethral catheters that block urine flow and lead to serious clinical complications. The Bcr/CflA efflux system has previously been identified as important for development of P. mirabilis crystalline biofilms, highlighting the potential for efflux pump inhibitors (EPIs) to control catheter blockage. Here we evaluate the potential for drugs already used in human medicine (fluoxetine and thioridazine) to act as EPIs in P. mirabilis, and control crystalline biofilm formation...
September 22, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28939546/using-smart-technology-to-improve-outcomes-in-myocardial-infarction-patients-rationale-and-design-of-a-protocol-for-a-randomized-controlled-trial-the-box
#19
Roderick Willem Treskes, Louise Anna van Winden, Nicole van Keulen, Douwe Ekke Atsma, Enno Tjeerd van der Velde, Elske van den Akker-van Marle, Bart Mertens, Martin Jan Schalij
BACKGROUND: Recent evidence suggests that frequent monitoring using smartphone-compatible wearable technologies might improve clinical effectiveness and patient satisfaction of care. OBJECTIVE: The aim of this study is to investigate the clinical effectiveness and patient satisfaction of a smart technology intervention in patients admitted with a ST elevation myocardial infarction (STEMI) or non-ST acute coronary syndrome (NST-ACS). METHODS: In this single center, open, randomized controlled trial patients who suffered from STEMI or NST-ACS will be randomized 1:1 to an intervention group or control group...
September 22, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28939354/a-deep-learning-approach-to-estimate-chemically-treated-collagenous-tissue-nonlinear-anisotropic-stress-strain-responses-from-microscopy-images
#20
Liang Liang, Minliang Liu, Wei Sun
Biological collagenous tissues comprised of networks of collagen fibers are suitable for a broad spectrum of medical applications owing to their attractive mechanical properties. In this study, we developed a noninvasive approach to estimate collagenous tissue elastic properties directly from microscopy images using Machine Learning (ML) techniques. Glutaraldehyde-treated bovine pericardium (GLBP) tissue, widely used in the fabrication of bioprosthetic heart valves and vascular patches, was chosen to develop a representative application...
September 19, 2017: Acta Biomaterialia
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