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https://www.readbyqxmd.com/read/29779231/specialist-perioperative-allergy-clinic-services-in-the-uk-2018-results-from-the-royal-college-of-anaesthetists-sixth-national-audit-project-nap6-investigation-of-perioperative-anaphylaxis
#1
W Egner, T M Cook, T Garcez, S Marinho, H Kemp, D N Lucas, K Floss, S Farooque, H Torevell, M Thomas, K Ferguson, S Nasser, S Karanam, K-L Kong, N McGuire, M Bellamy, A Warner, J Hitchman, L Farmer, N J N Harper
BACKGROUND: The Royal College of Anaesthetists 6th National Audit Project examined Grade 3-5 perioperative anaphylaxis for one year in the UK. OBJECTIVE: To describe the causes and investigation of anaphylaxis in the NAP6 cohort, in relation to published guidance and previous baseline survey results. METHODS: We used a secure registry to gather details of Grade 3-5 perioperative anaphylaxis. Anonymous reports were aggregated for analysis and reviewed in detail...
May 19, 2018: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29725942/exploring-the-potential-routine-use-of-electronic-healthcare-record-data-to-strengthen-early-signal-assessment-in-uk-medicines-regulation-proof-of-concept-study
#2
Katherine Donegan, Rebecca Owen, Helena Bird, Brian Burch, Alex Smith, Phil Tregunno
INTRODUCTION: Electronic healthcare record (EHR) databases are used within pharmacoepidemiology studies to confirm or refute safety signals arising from spontaneous adverse event reports. However, there has been limited routine use of such data earlier in the signal management process, to help rapidly contextualise signals and strengthen preliminary assessment or to inform decisions regarding action including the need for further studies. This study explores the value of EHR used in this way within a regulatory environment via an automated analysis platform...
May 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29714593/risk-of-cleft-lip-and-or-palate-associated-with-antiepileptic-drugs-postmarketing-safety-signal-detection-and-evaluation-of-information-presented-to-prescribers-and-patients
#3
Bita Rezaallah, David John Lewis, Hans-Florian Zeilhofer, Britt-Isabelle Berg
BACKGROUND: The aim was to analyze safety data associated with the maternal use of antiepileptic drugs in pregnancy and to assess the risk of cleft lip and/or palate (CL/P) as an outcome in the neonate. A parallel objective was to assess the completeness of the safety information concerning pregnancy exposures in the Summary of Product Characteristics (SmPCs) and the Patient Information (PI) in the USA and the UK. METHODS: We analyzed individual case safety reports of CL/P associated with antiepileptic drugs in the FDA Adverse Event Reporting System...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29695479/mhra-bans-valproate-prescribing-for-women-not-in-pregnancy-prevention-programme
#4
Gareth Iacobucci
No abstract text is available yet for this article.
April 25, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29615444/home-interventions-and-light-therapy-for-the-treatment-of-vitiligo-hi-light-vitiligo-trial-study-protocol-for-a-randomised-controlled-trial
#5
Rachel H Haines, Kim S Thomas, Alan A Montgomery, Jane C Ravenscroft, Perways Akram, Joanne R Chalmers, Diane Whitham, Lelia Duley, Viktoria Eleftheriadou, Garry Meakin, Eleanor J Mitchell, Jennifer White, Andy Rogers, Tracey Sach, Miriam Santer, Wei Tan, Trish Hepburn, Hywel C Williams, Jonathan Batchelor
INTRODUCTION: Vitiligo is a condition resulting in white patches on the skin. People with vitiligo can suffer from low self-esteem, psychological disturbance and diminished quality of life. Vitiligo is often poorly managed, partly due to lack of high-quality evidence to inform clinical care. We describe here a large, independent, randomised controlled trial (RCT) assessing the comparative effectiveness of potent topical corticosteroid, home-based hand-held narrowband ultraviolet B-light (NB-UVB) or combination of the two, for the management of vitiligo...
April 3, 2018: BMJ Open
https://www.readbyqxmd.com/read/29523131/traditional-chinese-medicine-pharmacovigilance-in-signal-detection-decision-tree-based-data-classification
#6
Jian-Xiang Wei, Jing Wang, Yun-Xia Zhu, Jun Sun, Hou-Ming Xu, Ming Li
BACKGROUND: Traditional Chinese Medicine (TCM) is a style of traditional medicine informed by modern medicine but built on a foundation of more than 2500 years of Chinese medical practice. According to statistics, TCM accounts for approximately 14% of total adverse drug reaction (ADR) spontaneous reporting data in China. Because of the complexity of the components in TCM formula, which makes it essentially different from Western medicine, it is critical to determine whether ADR reports of TCM should be analyzed independently...
March 9, 2018: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/29502080/mhra-confusion-over-drug-names
#7
(no author information available yet)
No abstract text is available yet for this article.
March 2018: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/29440064/follow-up-for-patients-with-metal-on-metal-hip-replacements-are-the-new-mhra-recommendations-justified
#8
Gulraj S Matharu, Andrew Judge, Hemant G Pandit, David W Murray
No abstract text is available yet for this article.
February 13, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29431613/mhra-quinine-qt-prolonging-effects-and-drug-interactions
#9
(no author information available yet)
No abstract text is available yet for this article.
February 2018: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/29365071/trends-in-prescribing-of-non-steroidal-anti-inflammatory-drugs-in-patients-with-cardiovascular-disease-influence-of-national-guidelines-in-uk-primary-care
#10
Ying Chen, John Bedson, Richard A Hayward, Kelvin P Jordan
Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat pain, but have potential side effects in patients with cardiovascular disease (CVD). Objectives: To determine trends in NSAIDs prescribing between 2002 and 2010 in patients with CVD, and ascertain whether prescribing patterns changed following publication of major national (the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Clinical Excellence (NICE)) guidance to GPs...
January 22, 2018: Family Practice
https://www.readbyqxmd.com/read/29208618/feasibility-study-of-a-randomised-controlled-trial-to-investigate-the-treatment-of-sarcoidosis-associated-fatigue-with-methylphenidate-fast-mp-a-study-protocol
#11
Christopher Atkins, Richard Fordham, Allan B Clark, Andrea Stockl, Andrew P Jones, Andrew M Wilson
INTRODUCTION: Fatigue is a frequent and troublesome manifestation of chronic sarcoidosis. This symptom can be debilitating and difficult to treat, with poor response to the treatment. Symptomatic management with neurostimulants, such as methylphenidate, is a possible treatment option. The use of such treatment strategies is not without precedent and has been trialled in cancer-related fatigue. Their use in sarcoidosis requires further evaluation before it can be recommended for clinical practice...
December 4, 2017: BMJ Open
https://www.readbyqxmd.com/read/28914335/regulatory-experience-of-tops-an-internet-based-system-to-prevent-healthy-subjects-from-over-volunteering-for-uk-clinical-trials
#12
C Allen, G Francis, J Martin, M Boyce
PURPOSE: The aim was to review the use of The Over-volunteering Prevention System (TOPS) since the HRA began hosting it in 2013, and the Medicines and Healthcare products Regulatory Agency (MHRA) experience of monitoring its use by UK clinical research units. METHODS: The HRA searched the TOPS database for the number, type and location of units and the number of entries. The MHRA inspectors reviewed their findings from routine inspections. RESULTS: Twenty-two additional UK units registered to use TOPS during 2013-2016, making a total of 84 units since TOPS was established in 2002...
December 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28801439/validation-of-asthma-recording-in-the-clinical-practice-research-datalink-cprd
#13
Francis Nissen, Daniel R Morales, Hana Mullerova, Liam Smeeth, Ian J Douglas, Jennifer K Quint
OBJECTIVES: The optimal method of identifying people with asthma from electronic health records in primary care is not known. The aim of this study is to determine the positive predictive value (PPV) of different algorithms using clinical codes and prescription data to identify people with asthma in the United Kingdom Clinical Practice Research Datalink (CPRD). METHODS: 684 participants registered with a general practitioner (GP) practice contributing to CPRD between 1 December 2013 and 30 November 2015 were selected according to one of eight predefined potential asthma identification algorithms...
August 11, 2017: BMJ Open
https://www.readbyqxmd.com/read/28781016/blood-metal-ion-levels-have-limited-utility-in-the-surveillance-of-asymptomatic-large-head-metal-on-metal-total-hip-arthroplasties
#14
Manish Kiran, Catherine Armstrong, Deepak Shivarathre, Viju K Peter
BACKGROUND: Blood cobalt (Co) and chromium (Cr) ion levels have been used as surveillance tools for adverse reaction to metal debris (ARMD) in metal-on-metal (MoM) articulations with varying thresholds in different countries. The aim of our study is to present the serial 12-year blood Co and Cr levels in a cohort of MoM total hip arthroplasties (THAs) with femoral head size ≥36 mm and analyze their utility in asymptomatic patients at current thresholds. METHODS: A total of 256 patients with unilateral MoM THA with femoral head size ≥36 mm were included in this study with data collected prospectively...
December 2017: Journal of Arthroplasty
https://www.readbyqxmd.com/read/28676483/all-patients-with-metal-on-metal-hip-implants-should-undergo-tests-says-mhra
#15
Deborah Cohen
No abstract text is available yet for this article.
July 4, 2017: BMJ: British Medical Journal
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
#16
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
#17
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...
July 1, 2017: British Journal of Anaesthesia
https://www.readbyqxmd.com/read/28465369/statins-time-to-rationalise-lfts
#18
(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 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28465364/mhra-safety-alert-hyoscine-butylbromide-buscopan-injection
#19
(no author information available yet)
No abstract text is available yet for this article.
May 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
#20
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
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