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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...
September 6, 2016: British Journal of Clinical Pharmacology
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 globalisation of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also impact the regulatory environment. In the UK the MHRA regulates medicines, medical devices and blood products to protect and improve public health; and supports innovation through scientific research and development...
August 31, 2016: British Journal of Clinical Pharmacology
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
(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
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
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
(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
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
John Wilkinson, Andy Crosbie
Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting...
April 1, 2016: Biomedizinische Technik. Biomedical Engineering
Sonia Malik, Korukonda Krishnaprasad
Role of progesterone in reproductive medicine is evolving with its suggested clinical role for the hormonal and nonhormonal actions in reproductive medicine. The main function of progesterone is to induce 'secretory' changes in endometrium that is further complimented by its immunomodulatory and anti-inflammatory actions. It positively modulates PIBF, NK cells and HOXA 10 genes for better implantation. MHRA recommends Serum Progesterone levels ≥14ng/ml in the mid-luteal phase for supporting pregnancy adequately...
February 2016: Journal of Clinical and Diagnostic Research: JCDR
Satish V Dhotare, Deepak G Shivarathre, Cristina Croitoru, Catherine Armstrong, Birender Kapoor, Viju K Peter
PURPOSE: The main aim of our study is to report the medium-term survivorship of Birmingham Hip Resurfacing (BHR) cup and a large modular metal head (MMT) on an uncemented Freeman femoral stem. No results have been reported till date with these implants combinations. METHODS: A total of 205 metal-on-metal total hip replacements (MoM THRs) were performed on 190 patients from October 2002 to November 2004. Prior to the Medicines and Healthcare Products Regulatory Agency (MHRA) guidelines, the patients were followed up at 3, 6 and 12 months postoperatively and annually thereafter...
May 16, 2016: Hip International: the Journal of Clinical and Experimental Research on Hip Pathology and Therapy
Matthew J Carr, Darren M Ashcroft, Evangelos Kontopantelis, David While, Yvonne Awenat, Jayne Cooper, Carolyn Chew-Graham, Nav Kapur, Roger T Webb
BACKGROUND: Little is known about the clinical management of patients in primary care following self-harm. METHODS: A descriptive cohort study using data from 684 UK general practices that contributed to the Clinical Practice Research Datalink (CPRD) during 2001-2013. We identified 49,970 patients with a self-harm episode, 41,500 of whom had one complete year of follow-up. RESULTS: Among those with complete follow-up, 26,065 (62.8%, 62.3-63...
June 2016: Journal of Affective Disorders
(no author information available yet)
CREATED BY the Medicines and Healthcare products Regulatory Agency (MHRA), this app collects and reviews reports of adverse reactions to medicines and vaccines.
February 2016: Nursing Management (Harrow)
P N Deslandes, K S L Jenkins, K E Haines, S Hutchings, R Cannings-John, T L Lewis, R C Bracchi, P A Routledge
WHAT IS KNOWN AND OBJECTIVE: The tricyclic antidepressant dosulepin has been associated with an increased risk of toxicity in overdose compared with other antidepressants. In the UK, the MHRA and NICE have issued advice on the prescribing of dosulepin, and a National Prescribing Indicator (NPI) to monitor usage was introduced in Wales in 2011. The aim of this study was to assess whether trends in dosulepin usage in Wales and NE England changed following the two pieces of safety guidance and the introduction of the National Prescribing Indicator in Wales...
April 2016: Journal of Clinical Pharmacy and Therapeutics
Jaideep Malhotra, Korukonda Krishnaprasad
BACKGROUND: Unexplained infertility remains as one of the important subtype of infertility that follows expectant management with Intrauterine Insemination (IUI) in most cases. AIM: To evaluate the clinical role of progesterone supplement as luteal phase support for women with unexplained infertility following stimulation protocol with Clomiphene Citrate (CC)/Human Menopausal Gonadotropin (HMG). MATERIALS AND METHODS: An investigator initiated study to survey the success rate for first cycle of IUI following stimulation protocol with CC/HMG & luteal phase support with oral natural or synthetic progesterone was conducted...
January 2016: Journal of Clinical and Diagnostic Research: JCDR
Adam Ioannou, Alka Jain, George Kassianos, Constantinos Missouris
PURPOSE OF THE STUDY: Domperidone is associated with QTc prolongation, predisposing to the development of ventricular arrhythmias. In 2014, The Medicines and Healthcare Regulatory Agency (MHRA) recommended restricting its use. We assessed whether these recommendations have been implemented in a general practice. STUDY DESIGN: We conducted a prospective study using the general practitioner (GP) computer database on patients who had at least one repeat prescription for domperidone in 12 months...
July 2016: Postgraduate Medical Journal
Phillip Molloy, Ruth Chambers, Tania Cork
OBJECTIVE: To determine whether non-pharmaceutical retail outlets are aboding to the current Medicines and Healthcare products Regulatory Agency (MHRA) national guidelines for over-the-counter (OTC) sales of aspirin and paracetamol. METHODS: Stages 1 and 2 of the study deployed eight and four medical students, respectively, to undertake a mystery shopper style investigation. Stage 1: eight medical students attempted to buy ≥ 96 tablets/capsules aspirin or paracetamol in one transaction in 62 shops...
2016: BMJ Open
Sue Elliott, Sarah Langfield
This paper discusses the implications following a recall of all metal-on-metal hip replacements by the Medicines and Healthcare products regulatory Agency (MHRA). Issues identified were the release of metal ions from the metal implants. These ions were found to seep into local tissues and cause reactions that destroyed muscle and bone leaving some patients with long term disability. At the centre surveillance was monitored by an extension of the current Nurse Led services using existing staff and resources...
February 2016: International Journal of Orthopaedic and Trauma Nursing
(no author information available yet)
Safety alerts The Medicines & Healthcare products Regulatory Agency (MHRA) has produced a new Yellow Card app, available now for iOS and Android devices. The app helps health professionals, patients, parents and carers to monitor safety alerts and track and review updates about their medication. It also supports the reporting of suspected side effects of medication. The MHRA has produced the app to enhance user engagement in the reporting of adverse reactions and side effects. The app is free to download.
December 2015: Nursing Children and Young People
N F Fayzrakhmanov
BACKGROUND: The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat to economy and health of populations of most countries, including the Russian Federation. OBJECTIVE: To identify the main achievements and challenges in the fight against trafficking of falsified and substandard medicinal products in the Russian Federation, to formulate possible solutions to these problems. METHODS: The study of criminal cases and statistical information about the level of crime in the Russian Federation; legal analysis of regulatory legal acts in the sphere of criminal law and turnover of medicinal products; review of scientific and practical publications...
2015: International Journal of Risk & Safety in Medicine
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