Addressing the uncertainty around implementation of the Medical Devices Regulation (MDR) The new European regulations on medical devices entered into force in 2017 and must be fully implemented by 26th May 2020. As the deadline approaches, there is still a lot of confusion amongst device manufacturers about interpretation of the regulations and the practical implications. We have developed this training course in consultation with experts in devices vigilance in order to address the uncertainty and to provide clear practical guidance on handling the changes to vigilance requirements. The course would be of interest to staff working in Quality Assurance, Regulatory Affairs, [...]
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Improvements needed in recording brand and batch numbers for biological medicines to ensure patient safetydsru2020-01-03T12:03:15+00:00
Health professionals need to improve how they record brand and batch numbers for biologic medicines to ensure patients stay safe, according to a new study published this week. The research, carried out by the UK’s Drug Safety Research Unit (DSRU) and Dutch not-for-profit organisation, Lygature, and published in the journal Drug Safety, shows hospital pharmacists, doctors and nurses only recorded batch numbers for biologic medicines between 38 per cent and 58 per cent of the time during routine hospital practice. The analysis of UK data showed brand names were recorded more frequently – between 79 per cent and 91 per cent [...]
The DSRU had coverage in the BMJ last week following the issue of the press release below. The article is available to BMJ subscribers here. "The DSRU is calling on GPs to help improve patient safety by providing vital information on possible adverse drug reactions. DSRU conducts Post Authorisation Safety Studies (PASS) in which the safety of newly licensed drugs is monitored using its own bespoke data collection methodology, known as Modified Prescription Event Monitoring (MPEM). This allows DSRU direct access to GPs to request information about any events experienced by patients after they’ve been prescribed a specific drug. DSRU collates [...]
The DSRU team is delighted to be at the Annual Conference of the Royal College of General Practitioners (RCGP) in Liverpool. Our medics are on hand at our booth in the exhibition to explain the vital role that GPs have played in our work to monitor prescription medicines for side effects. The team will also be providing delegates with information about our popular GP Masterclass in Effective Prescribing, which will take place on 13th November at the RCGP in London. The Masterclass has booked up quickly but there are a few places left.
DSRU Director, Professor Saad Shakir, attended a three day meeting in Erice in Sicily on “Improving the Detection Analysis and Reporting Harms in Medicines”. The meeting was organised by the Uppsala Monitoring Centre and the Centre for Evidence Based Medicine in Oxford. The areas addressed at the meeting were the problems and proposed solutions for monitoring adverse drug reactions in clinical trials, the problems and proposed solutions for postmarketing pharmacovigilance and the problems and possible solutions for communications of drug safety. Professor Shakir chaired the session and led the discussion on the proposed solutions for postmarketing pharmacovigilance. He said that a [...]
Our Principal Research Fellow, Vicki Osborne, writes: The opioid crisis in the US is well known and the subject of much debate and media coverage; overdoses involving opioids contributed to over two thirds (67.8%) of overdose deaths in the US in 2017 alone, with 47,600 deaths in total (1,2). Currently, 175 Americans die daily from drug overdoses and the majority of these involve opioids (3). In the UK, we have generally not seen the same levels of use which would cause concern in past years, though it would be complacent to assume that we do not have an issue. According [...]
The DSRU is delighted to be collaborating with the Royal Pharmaceutical Society to deliver two new training days. The courses are designed to introduce the core concepts of the field of drug safety (pharmacovigilance) as well as provide insights into the many career options available. Thinking about a career in the pharmaceutical industry? - Monday 18th November at the Royal Pharmaceutical Society, London Do you know anyone looking to kick start their career in drug safety? This collaborative course is aimed at anyone with an interest in pharmacovigilance and related job roles, no previous experience required. Delegates will be introduced to: [...]
DSRU Consultancy has a small flexible team of epidemiologists, clinicians and pharmacists. Watch this short video to find out how DSRU Consultancy provides advice in pharmacoepidemiology, pharmacovigilance, risk minimisation and risk management. We can provide one-off or ongoing advice or we may give advice that leads to provision of a full study service. We also provide a special consultation service to smaller companies. The initial consultation is free! Watch this video to find out more or get in touch to discuss your enquiry (with no commitment): Dr Liz Lynn, Head of Scientific & Educational Development, email@example.com
The DSRU’s Second Conference on Big Data for Pharmacovigilance has been a great success. Delegates from regulatory bodies, the pharmaceutical industry and academia have heard presentations from high calibre speakers, examining the challenges and opportunities for use of big data sources for the benefit of pharmacovigilance. Gianluca Trifirò from the University of Messina set the scene with an overview of the current status of big data in pharmacovigilance, including developments since our first Conference on Big Data for Pharmacovigilance in 2018. Niklas Noren from the Uppsala Monitoring Centre detailed some lessons learned in developing and deploying machine learning for pharmacovigilance, including [...]
The DSRU team is attending the International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE) in Philadelphia. Come and meet our team at booth 204, where you can find out about our hospital PASS studies, our CPRD studies and DSRU Consulting. Find out about our research from our posters: Monday 26th August Characterisation of Drug Interaction Related Signals Leading to EU Regulatory Action and a Methodological Review of Novel Drug Interaction Signal Detection Methods in the Post-Marketing Setting D Roy, L Hazell, V Osborne, S Shakir Impact Analyses of European Pharmacovigilance Interventions on Public Health Burden S Lane, E Lynn, J [...]