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https://www.readbyqxmd.com/read/28569278/governance-and-oversight-of-researcher-access-to-electronic-health-data-the-role-of-the-independent-scientific-advisory-committee-for-mhra-database-research-2006-2015
#1
P Waller, J A Cassell, M H Saunders, R Stevens
In order to promote understanding of UK governance and assurance relating to electronic health records research, we present and discuss the role of the Independent Scientific Advisory Committee (ISAC) for MHRA database research in evaluating protocols proposing the use of the Clinical Practice Research Datalink. We describe the development of the Committee's activities between 2006 and 2015, alongside growth in data linkage and wider national electronic health records programmes, including the application and assessment processes, and our approach to undertaking this work...
March 2017: Journal of the Royal College of Physicians of Edinburgh
https://www.readbyqxmd.com/read/28498889/uk-anaesthetists-perspectives-and-experiences-of-severe-perioperative-anaphylaxis-nap6-baseline-survey%C3%A2
#2
H I Kemp, T M Cook, M Thomas, N J N Harper
Background: There is limited information on UK anaesthetists' perspectives and experiences of perioperative anaphylaxis. This baseline survey of the Sixth National Audit Project (NAP6) aimed to identify relevant departmental preparedness and practices, and individual experiences, perceptions and drug-avoidance patterns. Methods: All anaesthetists in 356 UK NHS hospitals were invited to complete an electronic survey. Results: 11 104 anaesthetists (77% crude response rate) from 341 (96%) hospitals responded...
May 12, 2017: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28465369/statins-time-to-rationalise-lfts
#3
(no author information available yet)
Statins: time to rationalise LFTs? ● Limited evidence for low-cost devices to improve adherence ● MHRA safety alert: hyoscine butylbromide (Buscopan) injection ● Faecal microbiota transplantation for ulcerative colitis ● Magnesium for nocturnal leg cramps ● NSAIDs and risk of out-of-hospital cardiac arrest ● Off-label antidepressant prescribing.
May 2, 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28465364/mhra-safety-alert-hyoscine-butylbromide-buscopan-injection
#4
(no author information available yet)
No abstract text is available yet for this article.
May 2, 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28333317/characterisation-of-a-gene-encoding-a-membrane-protein-that-affects-exopolysaccharide-production-and-intracellular-mg2-concentrations-in-ensifer-meliloti
#5
Justin P Hawkins, Ivan J Oresnik
Exopolysaccharides play an important role in the physiology of a bacterial cell. Ensifer meliloti is capable of producing at least two types of exopolysaccharides (EPS): succinoglycan and galactoglucan. In E. meliloti, EPS are best known for their role in mediating interaction with its symbiotic hosts. It was previously shown that high concentrations of Mg2+ or K+ were capable of suppressing the mucoid phenotype associated with galactoglucan production in an expR+ derivative of Rm1021. In an attempt to determine how Mg2+ regulates galactoglucan production, SRmD363 was mutagenised and screened for mutants which were visibly mucoid at high concentrations of magnesium...
April 1, 2017: FEMS Microbiology Letters
https://www.readbyqxmd.com/read/28273884/2d-qsar-and-3d-qsar-comsia-studies-on-a-series-of-r-2-2-1h-indol-2-yl-ethyl-amino-1-phenylethan-1-ol-with-human-%C3%AE-%C3%A2-adrenergic-activity
#6
Gastón Apablaza, Luisa Montoya, Cesar Morales-Verdejo, Marco Mellado, Mauricio Cuellar, Carlos F Lagos, Jorge Soto-Delgado, Hery Chung, Carlos David Pessoa-Mahana, Jaime Mella
The β₃ adrenergic receptor is raising as an important drug target for the treatment of pathologies such as diabetes, obesity, depression, and cardiac diseases among others. Several attempts to obtain selective and high affinity ligands have been made. Currently, Mirabegron is the only available drug on the market that targets this receptor approved for the treatment of overactive bladder. However, the FDA (Food and Drug Administration) in USA and the MHRA (Medicines and Healthcare products Regulatory Agency) in UK have made reports of potentially life-threatening side effects associated with the administration of Mirabegron, casting doubts on the continuity of this compound...
March 5, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28248619/chewing-gum-vs-ibuprofen-in-the-management-of-orthodontic-pain-a-multi-centre-randomised-controlled-trial-the-effect-of-anxiety
#7
Anthony J Ireland, Pamela Ellis, Abbie Jordan, Rebecca Bradley, Paul Ewings, Nicola E Atack, Helen Griffiths, Kate House, Matthew B Moore, Scott Deacon, Nicholas Wenger, Victoria Worth, Emma Scaysbrook, Julie C Williams, Jonathan R Sandy
OBJECTIVES: Pain is a common side effect of orthodontic treatment. An objective of this study, part of a large previously reported RCT on pain and analgesic use, was to determine the effect of anxiety on perceived pain and use of analgesia. METHODS: 1000 patients aged 11-17 years, undergoing upper and lower fixed appliance treatment in nine hospital departments were recruited into this two-arm parallel design randomised controlled trial. One arm was given sugar-free chewing gum and the other arm ibuprofen for pain relief...
March 2017: Journal of Orthodontics
https://www.readbyqxmd.com/read/28148539/dtb-select-2-february-2017
#8
(no author information available yet)
MHRA clarifies spironolactone advice ● Statin dosing: morning or evening? ● PPI use and risk of community-acquired pneumonia ● Non-inferiority trials: caution needed ● CV safety of celecoxib? ● ADRs and emergency department visits ● Study questions use of duloxetine in stress incontinence ● New oral anticoagulants: more on GI bleeding risk.
February 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28018878/regulatory-approval-time-for-hormonal-contraception-in-canada-the-united-states-and-the-united-kingdom-2000-2015-a-retrospective-data-analysis
#9
Christine Troskie, Judith A Soon, Arianne Y Albert, Wendy V Norman
BACKGROUND: Access to a wide range of contraceptive methods improves prevention of unintended pregnancy by ensuring the best method fit for each individual. We compared approval times of new hormonal contraceptives by Health Canada, the US Food and Drug Administration (FDA), and the UK Medicines and Healthcare Products Regulatory Agency (MHRA). METHODS: We obtained dates of applications to Health Canada, the FDA and the MHRA for contraceptive methods approved from January 2000 to January 2015...
October 2016: CMAJ Open
https://www.readbyqxmd.com/read/27924372/mesh-removal-after-vaginal-surgery-what-happens-in-the-uk
#10
Jonathan Duckett, Roland Morley, Ash Monga, Tim Hillard, Dudley Robinson
INTRODUCTION AND HYPOTHESIS: There is little objective evidence regarding complication rates for mesh procedures outside clinical trials. Current coding poorly collects complications of prolapse and continence surgery using mesh. This survey was designed to identify surgeons performing mesh removal and reporting patterns in the UK. METHODS: An electronic questionnaire was sent to all members of the Royal College of Obstetricians and Gynaecologists and members of the Section of Female Neurological and Urodynamic Urology of the British Association of Urologists in the UK...
July 2017: International Urogynecology Journal
https://www.readbyqxmd.com/read/27857110/mhra-joins-forces-with-bdia-against-counterfeit-devices
#11
(no author information available yet)
No abstract text is available yet for this article.
November 18, 2016: British Dental Journal
https://www.readbyqxmd.com/read/27829734/601-metal-on-metal-total-hip-replacements-with-36%C3%A2-mm-heads-a-5-minimum-year-follow-up-levels-of-armd-remain-low-despite-a-comprehensive-screening-program
#12
Amit Atrey, Alister Hart, Nasir Hussain, Jonathon Waite, Andrew J Shepherd, Steve Young
BACKGROUND: We conducted a retrospective study to assess the clinical outcome, failure rate, and reason for failure of a large consecutive series of 36 mm MoM Corail/Pinnacle total hip replacements (THRs). METHODS: Between 2006 and 2011, 601 consecutive 36 mm MoM THRs were performed (585 patients). Patients were followed according to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) guidelines. All patients were accounted for and 469 patients (78%) were clinically and radiographically assessed...
March 2017: Journal of Orthopaedics
https://www.readbyqxmd.com/read/27597136/spontaneous-adverse-drug-reaction-reports-for-neonates-and-infants-in-the-uk-2001-2010-content-and-utility-analysis
#13
Daniel B Hawcutt, Nicki-Jayne Russell, Hannah Maqsood, Koushan Kouranloo, Simon Gomberg, Catriona Waitt, Andrew Sharp, Andrew Riordan, Mark A Turner
AIMS: The UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card [YC] Scheme) to collect 'suspected' adverse drug reaction (ADR) data. We aim to describe the content and utility of YC reports received for patients aged <2 years. METHODS: Data on all ADRs reported using YC in infants aged <2 years from the years 2001-10 were supplied by the MHRA. RESULTS: For infants age <2 years, 3496 suspected ADRs were reported using YC (paternal medication pre-conception n = 3, transplacental n = 246, transmammary n = 30, neonates n = 97, infant n = 477, and vaccinations n = 2673), averaging 0...
December 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27580254/uk-medicines-regulation-responding-to-current-challenges
#14
REVIEW
Natalie Richards, Ian Hudson
The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development...
December 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27370155/upper-limits-of-the-photon-fluence-rate-on-ct-detectors-case-study-on-a-commercial-scanner
#15
Mats Persson, Robert Bujila, Patrik Nowik, Henrik Andersson, Love Kull, Jonas Andersson, Hans Bornefalk, Mats Danielsson
PURPOSE: The highest photon fluence rate that a computed tomography (CT) detector must be able to measure is an important parameter. The authors calculate the maximum transmitted fluence rate in a commercial CT scanner as a function of patient size for standard head, chest, and abdomen protocols. METHODS: The authors scanned an anthropomorphic phantom (Kyoto Kagaku PBU-60) with the reference CT protocols provided by AAPM on a GE LightSpeed VCT scanner and noted the tube current applied with the tube current modulation (TCM) system...
July 2016: Medical Physics
https://www.readbyqxmd.com/read/27364828/dtb-select-7-july-2016
#16
(no author information available yet)
MHRA: avoid live vaccines in immunosuppressed patients ● Topical NSAIDs for musculoskeletal pain in adults ● Adherence to pregnancy prevention measures during isotretinoin treatment ● Impact of the NHS Health Check programme ● Ibuprofen: first choice for migraine in young people? ● Neuropsychiatric safety of ▼ varenicline and bupropion ● Effects of anticholinergic medication in cognitively normal older adults ● New NICE guidance for controlled drugs.
July 2016: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/27239307/improving-the-safety-of-prescriptions-of-domperidone-in-primary-care-implementing-mhra-advice
#17
William Hall
Domperidone is a dopamine D2 receptor antagonist acting on the chemoreceptor trigger zone in the medulla and also in the gut, causing antiemetic and gastrokinetic effects respectively. In the past, domperidone was considered largely safe, with many indications and few contraindications listed in the product literature. In 2014, Domperidone became indicated only for the prevention of nausea and vomiting and the duration of treatment was limited to seven days. Furthermore, the maximum daily dose was limited to thirty milligrams...
2016: BMJ Quality Improvement Reports
https://www.readbyqxmd.com/read/27238553/early-patient-access-to-medicines-health-technology-assessment-bodies-need-to-catch-up-with-new-marketing-authorization-methods
#18
Lada Leyens, Angela Brand
National and international medicines agencies have developed innovative methods to expedite promising new medicines to the market and facilitate early patient access. Some of these approval pathways are the conditional approval and the adaptive pathways by the European Medicines Agency (EMA); the Promising Innovative Medicine (PIM) designation and the Early Access to Medicines Scheme (EAMS) by the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as the Fast Track, Breakthrough or Accelerated Approval methods by the Food and Drug Administration (FDA)...
2016: Public Health Genomics
https://www.readbyqxmd.com/read/27173783/midodrine-for-severe-orthostatic-hypotension
#19
REVIEW
(no author information available yet)
Midodrine (Bramox-Brancaster Pharma Limited) was authorised in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in March 2015 for "the treatment of severe orthostatic hypotension due to autonomic dysfunction in adults when corrective factors have been ruled out and other forms of treatment are inadequate".(1) Previously, midodrine had only been available in the UK as an unlicensed product used on a named-patient basis. It is the first drug to be licensed in the UK for the treatment of orthostatic hypotension...
May 2016: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/27146687/how-memory-of-direct-animal-interactions-can-lead-to-territorial-pattern-formation
#20
Jonathan R Potts, Mark A Lewis
Mechanistic home range analysis (MHRA) is a highly effective tool for understanding spacing patterns of animal populations. It has hitherto focused on populations where animals defend their territories by communicating indirectly, e.g. via scent marks. However, many animal populations defend their territories using direct interactions, such as ritualized aggression. To enable application of MHRA to such populations, we construct a model of direct territorial interactions, using linear stability analysis and energy methods to understand when territorial patterns may form...
May 2016: Journal of the Royal Society, Interface
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