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https://www.readbyqxmd.com/read/28727871/biosimilars-in-oncology-in-the-united-states-a-review
#1
Chadi Nabhan, Sandeep Parsad, Anthony R Mato, Bruce A Feinberg
Importance: Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. The availability of biosimilars might provide an opportunity to lower health care expenditures as a result of the inherent price competition with their reference product. Understanding how biosimilar cancer drugs are regulated, approved, and paid for, as well as their impact in a value-based care environment, is essential for physicians and other stakeholders in oncology...
July 20, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28724335/exploring-the-potential-for-using-drug-indications-to-prevent-look-alike-and-sound-alike-drug-errors
#2
Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff
BACKGROUND: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs. RESEARCH DESIGN AND METHODS: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities...
July 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28722604/classification-and-visualization-of-physical-and-chemical-properties-of-falsified-medicines-with-handheld-raman-spectroscopy-and-x-ray-computed-tomography
#3
Tomoko Kakio, Naoko Yoshida, Susan Macha, Kazunobu Moriguchi, Takashi Hiroshima, Yukihiro Ikeda, Hirohito Tsuboi, Kazuko Kimura
Analytical methods for the detection of substandard and falsified medical products (SFs) are important for public health and patient safety. Research to understand how the physical and chemical properties of SFs can be most effectively applied to distinguish the SFs from authentic products has not yet been investigated enough. Here, we investigated the usefulness of two analytical methods, handheld Raman spectroscopy (handheld Raman) and X-ray computed tomography (X-ray CT), for detecting SFs among oral solid antihypertensive pharmaceutical products containing candesartan cilexetil as an active pharmaceutical ingredient (API)...
June 19, 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28721311/from-kaua-i-to-hawai-i-island-interisland-differences-in-emergency-contraceptive-pill-availability
#4
Holly Bullock, Mary Tschann, Jennifer Elia, Bliss Kaneshiro, Jennifer Salcedo
Emergency contraceptive pills (ECPs) are medications used after unprotected intercourse, underprotected intercourse, or sexual assault to decrease the risk of pregnancy. Availability of ECPs in Hawai'i's retail pharmacies was last assessed in 2007, following over-the-counter access to levonorgestrel ECPs (LNG-ECP) for women age 18 years or older and prior to U.S. Food and Drug Administration (FDA) approval of prescription-only ulipristal acetate (UPA). We conducted a county-by-county subanalysis from a larger observational population-based study on statewide availability of ECPs in Hawai'i's pharmacies...
July 2017: Hawai'i Journal of Medicine & Public Health: a Journal of Asia Pacific Medicine & Public Health
https://www.readbyqxmd.com/read/28719222/how-drug-life-cycle-management-patent-strategies-may-impact-formulary-management
#5
Jan Berger, Jeffrey D Dunn, Margaret M Johnson, Kurt R Karst, W Chad Shear
Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers...
October 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28717153/proton-pump-inhibitors-and-the-risk-for-fracture-at-specific-sites-data-mining-of-the-fda-adverse-event-reporting-system
#6
Liwei Wang, Mei Li, Yuying Cao, Zhengqi Han, Xueju Wang, Elizabeth J Atkinson, Hongfang Liu, Shreyasee Amin
Proton pump inhibitors (PPIs) are widely used to treat gastric acid-related disorders. Concerns have been raised about potential fracture risk, especially at the hip, spine and wrist. However, fracture risk at other bone sites has not been as well studied. We investigated the association between PPIs and specific fracture sites using an aggregated knowledge-enhanced database, the Food and Drug Administration Adverse Event Reporting System Data Mining Set (AERS-DM). Proportional reporting ratio (PRR) was used to detect statistically significant associations (signals) between PPIs and fractures...
July 17, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28716156/generic-atorvastatin-is-as-effective-as-the-brand-name-drug-lipitor-%C3%A2-in-lowering-cholesterol-levels-a-cross-sectional-retrospective-cohort-study
#7
Alexander Loch, Jan Philipp Bewersdorf, Daniel Kofink, Dzafir Ismail, Imran Zainal Abidin, Ramesh Singh Veriah
BACKGROUND: In a world of ever increasing health care costs, generic drugs represent a major opportunity to ensure access to essential medicines for people who otherwise would be unable to afford them. However, some clinicians and patients are still questioning the safety and effectiveness of generic formulations compared to the proprietary drugs necessitating further systematic research analyzing the generic drugs' efficacy. Our objective was to compare the lipid lowering effects of generic and branded atorvastatin...
July 17, 2017: BMC Research Notes
https://www.readbyqxmd.com/read/28707643/assessing-reading-levels-of-health-information-uses-and-limitations-of-flesch-formula
#8
Pranay Jindal, Joy C MacDermid
BACKGROUND: Written health information is commonly used by health-care professionals (HCPs) to inform and assess patients in clinical practice. With growing self-management of many health conditions and increased information seeking behavior among patients, there is a greater stress on HCPs and researchers to develop and implement readable and understandable health information. Readability formulas such as Flesch Reading Ease (FRE) and Flesch-Kincaid Reading Grade Level (FKRGL) are commonly used by researchers and HCPs to assess if health information is reading grade appropriate for patients...
January 2017: Education for Health: Change in Training & Practice
https://www.readbyqxmd.com/read/28707284/fixed-dose-versus-off-label-combination-of-isosorbide-dinitrate-plus-hydralazine-hydrochloride-retrospective-propensity-matched-analysis-in-black-medicare-patients-with-heart-failure
#9
Elizabeth Ofili, Inder Anand, Richard Allen Williams, Ola Akinboboye, Liou Xu, Gary Puckrein
INTRODUCTION: Based upon the findings of the African-American Heart Failure Trial, the US Food and Drug Administration approved the fixed-dose combination of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) (FDC-ISDN/HYD) as a new drug for treatment of heart failure (HF) in self-identified African Americans. According to the FDA, FDC-ISDN/HYD has no therapeutic equivalent. However, off-label combinations of the separate generic drugs ISDN and HYD (OLC-ISDN+HYD) or isosorbide mononitrate (ISMN) and HYD (OLC-ISMN+HYD) are routinely substituted without any supporting outcome data...
July 13, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28706331/bioequivalence-of-generic-and-branded-amoxicillin-capsules-in-healthy-human-volunteers
#10
Priyanka Pathak, Vijaya A Pandit, Priti P Dhande
CONTEXT: The Medical Council of India urges doctors to prescribe generic drugs as far as possible. The Indian Medical Association had responded earlier saying that it requires guarantees on the quality of generic forms of drugs. Although no published scientific reports are available on the issue of therapeutic inequivalence, unconfirmed clinician accounts and newspaper reports of therapeutic inequivalence exist. AIM: This study was planned to ascertain whether bioequivalence of branded and generic amoxicillin capsule is comparable...
March 2017: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28705243/trends-in-treatment-with-antipsychotic-medication-in-relation-to-national-directives-in-people-with-dementia-a-review-of-the-swedish-context
#11
Staffan Karlsson, Ingalill Rahm Hallberg, Patrik Midlöv, Cecilia Fagerström
BACKGROUND: The aim of this study was to explore trends in treatment with antipsychotic medication in Swedish dementia care in nursing homes as reported in the most recent empirical studies on the topic, and to relate these trends to directives from the national authorities. METHODS: The study included two scoping review studies based on searches of electronic databases as well as the Swedish directives in the field. RESULTS: During the past decade, directives have been developed for antipsychotic medication in Sweden...
July 14, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28701161/podiatry-intervention-versus-usual-care-to-prevent-falls-in-care-homes-pilot-randomised-controlled-trial-the-pirfect-study
#12
Gavin Wylie, Hylton B Menz, Sarah McFarlane, Simon Ogston, Frank Sullivan, Brian Williams, Zoe Young, Jacqui Morris
BACKGROUND: Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents...
July 12, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28698798/patients-expectations-and-fulfilment-of-expectations-before-and-after-treatment-for-suspected-coronary-artery-disease-assessed-with-a-newly-developed-questionnaire-in-combination-with-established-health-related-quality-of-life-questionnaires
#13
Annika Odell, Angela Bång, Paulin Andréll, Charlotte Widell, Henrik Fryklund, Anders Kallryd, Hans Tygesen, Lars Grip
BACKGROUND: Clinical decision-making is often based on evidence of outcome after a specific treatment. Healthcare providers and patients may, however, have different perceptions and expectations of what to achieve from a certain healthcare measure. AIMS: To evaluate patients' expectations, perceptions and health related quality of life (HRQoL) before a care process including coronary angiography for suspected coronary artery disease and to evaluate the fulfilment of these expectations in relation to established patient reported outcome measures (PROMs) 6 months later...
2017: Open Heart
https://www.readbyqxmd.com/read/28698645/heart-rhythm-characterization-through-induced-physiological-variables
#14
Jean-François Pons, Zouhair Haddi, Jean-Claude Deharo, Ahmed Charaï, Rachid Bouchakour, Mustapha Ouladsine, Stéphane Delliaux
Atrial fibrillation remains a major cause of morbi-mortality, making mass screening desirable and leading industry to actively develop devices devoted to automatic AF detection. Because there is a tendency toward mobile devices, there is a need for an accurate, rapid method for studying short inter-beat interval time series for real-time automatic medical monitoring. We report a new methodology to efficiently select highly discriminative variables between physiological states, here a normal sinus rhythm or atrial fibrillation...
July 11, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28697045/patient-characteristics-menopause-symptoms-and-care-provided-at-an-interdisciplinary-menopause-clinic-retrospective-chart-review
#15
Beate C Sydora, Nese Yuksel, Nicole L Veltri, Justin Marillier, Christoph P Sydora, Maryna Yaskina, Lori Battochio, Tami M L Shandro, Sue Ross
OBJECTIVE: The goal of this study was to describe the characteristics, menopause symptoms, and treatment progressions in women cared for at an interdisciplinary menopause clinic. METHODS: We conducted a retrospective review of patient charts from women attending a multidisciplinary menopause clinic. Data collected from the charts included patient demographics, menopause symptoms, other concurrent medical conditions, and treatment recommendations. Data were entered into Research Electronic Data Capture database and analyzed descriptively...
July 10, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28694797/genome-data-provides-high-support-for-generic-boundaries-in-burkholderia-sensu-lato
#16
Chrizelle W Beukes, Marike Palmer, Puseletso Manyaka, Wai Y Chan, Juanita R Avontuur, Elritha van Zyl, Marcel Huntemann, Alicia Clum, Manoj Pillay, Krishnaveni Palaniappan, Neha Varghese, Natalia Mikhailova, Dimitrios Stamatis, T B K Reddy, Chris Daum, Nicole Shapiro, Victor Markowitz, Natalia Ivanova, Nikos Kyrpides, Tanja Woyke, Jochen Blom, William B Whitman, Stephanus N Venter, Emma T Steenkamp
Although the taxonomy of Burkholderia has been extensively scrutinized, significant uncertainty remains regarding the generic boundaries and composition of this large and heterogeneous taxon. Here we used the amino acid and nucleotide sequences of 106 conserved proteins from 92 species to infer robust maximum likelihood phylogenies with which to investigate the generic structure of Burkholderia sensu lato. These data unambiguously supported five distinct lineages, of which four correspond to Burkholderia sensu stricto and the newly introduced genera Paraburkholderia, Caballeronia, and Robbsia...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28693395/an-ideal-hospital
#17
Singithi Sidney Chandrasiri
Purpose The purpose of this paper is to explore a novel overarching strategy in tackling the key issues raised by the recent inquiry into bullying, harassment and discrimination in surgical practice and surgical training in Australian and New Zealand hospitals. Design/methodology/approach The approach taken is an analysis of the available evidence-based literature to inform the proposed viewpoint. The theoretical subject scope presented is a discussion of how and why the various strategies put forward in this paper should be integrated into and led from an overarching workforce engagement platform...
July 3, 2017: Leadership in Health Services
https://www.readbyqxmd.com/read/28691382/variation-in-prescription-drug-coverage-for-triptans-analysis-of-insurance-formularies
#18
Mia T Minen, Kate Lindberg, Aisha Langford, Elizabeth Loder
OBJECTIVES: To analyze triptan coverage by insurers to examine (1) possible disparities in coverage for different formulations (oral, intranasal, etc) and (2) quantity limits and stepped care requirements to obtain triptans. BACKGROUND: Triptans are FDA approved migraine abortive medications. Patients frequently state that they have difficulty accessing triptans prescribed to them. METHODS: We searched the 2015 drug formularies of commercial and government health insurers providing coverage in NY State...
July 9, 2017: Headache
https://www.readbyqxmd.com/read/28686780/a-survey-assessment-of-us-dermatologists-perception-of-biosimilars
#19
Alexandra Barsell, Monica Rengifo-Pardo, Alison Ehrlich
<p>BACKGROUND: Biologics have transformed the treatment of psoriasis and psoriatic arthritis, but at a significant cost to payers and patients. The introduction of biosimilars into the US market could reduce costs while increasing access to biologic medications.</p> <p>OBJECTIVE: We sought to identify gaps in biosimilar knowledge and perception among US dermatologists.</p> <p>METHODS: An online survey was sent to dermatologists from January to April 2015.</p> <p>RESULTS: Ninety-seven US dermatologists responded, of which 84% state they prescribe biologics in their practice...
June 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28676255/an-ontology-based-approach-to-patient-follow-up-assessment-for-continuous-and-personalized-chronic-disease-management
#20
Yi-Fan Zhang, Ling Gou, Tian-Shu Zhou, De-Nan Lin, Jing Zheng, Ye Li, Jing-Song Li
OBJECTIVE: Chronic diseases are complex and persistent clinical conditions that require close collaboration among patients and health care providers in the implementation of long-term and integrated care programs. However, current solutions focus partially on intensive interventions at hospitals rather than on continuous and personalized chronic disease management. This study aims to fill this gap by providing computerized clinical decision support during follow-up assessments of chronically ill patients at home...
July 1, 2017: Journal of Biomedical Informatics
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