The OPERAM study has reached its goal to include 2000 patients. OPERAM studies the use of the STRIP-assistant, a digital tool for appropriate and cost-effective prescribing in hospitals. The OPERAM consortium is a cooperation of clinical centres in Bern (Switzerland), Brussels (Belgium), Cork (Ireland) and Utrecht (Netherlands). Leader of the project is prof. Rodondi from Bern.
Prof. Mirko Petrovic, geriatrician and clinical pharmacologist from Ghent University Belgium, was newly appointed EuGMS Academic Director for 2018-2021. Many congratulations!
In Europe, two thirds of people above 65 are suffering from multi-morbidity. This leads to polypharmacy and often to adverse drug events due to inappropriate prescribing. The European funded SENATOR project has therefore developed and tested a highly efficient software engine for the assessment and optimization of drug and non-drug therapy in multi-morbid older people.
In 3 minutes video’s the importance of the Senator project is presented.
The SENATOR Patient Recruitment is finished. In total 1.537 patients are recruited for the SENATOR trial. This trial studies the effect of a systematic and computerized medication review for older patients with use of the STOPP and START criteria. The Senator team is looking forward to completing Time Point 2 and 12 week follow-ups before the final lock-down of the trial database.
The reflexion paper on physical frailty is approved and published at the EMA website. The reflection paper describes how to characterise the baseline frailty status of older patients enrolled in clinical trials other than by their age. The aim is to ensure that clinical trial populations are representative of the users of the medicine, as the benefit-risk balance in older patients may depend on their physical frailty status. The reflection paper is available at this website: teaching/info/EMA and Geriatric Expert Group.
The European Medicines Agency (EMA) has published an action plan to improve the product information (PI) for EU medicines, an information package for patients and healthcare professionals that accompanies every single medicine authorised in the EU and explains how it should be used and prescribed. This action plan follows a report in March 2017 which concluded that despite ongoing efforts to make the PI easy to read and useful, there is a need to improve how information on medicines is conveyed to patients and healthcare professionals. One of the key areas of this plan is to explore how electronic or digital means can be used to improve accessibility to medicines’ information by patients and healthcare professionals. The action plan is available at this website: Teaching/Info/information EMA
The Expertisecentre Pharmacotherapy in Old Persons (Ephor) from the Netherlands has read the ‘Reflection paper on the pharmaceutical development of medicines for use in the older population’.
We consider this reflection paper as a very important paper and underscore the conclusions and advices.
However, Ephor would like to stress that this paper should become a Guideline.
The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken tby the EU 27 Member States. The Agency take up its operations in Amsterdam on 30 March 2019 at the latest. The representatives of the Geriatric Expert Group, that give advices to the EMA, will be welcomed in Amsterdam.
The Geriatric Expert Group (GEG) is very pleased to announce that the nomination of Katarina Vučić as the new Chair of the GEG will be adopted in CHMP December meeting, as well as the nomination of Elina Rönnemaa as a new member of the GEG. Katarina Vučić is a Senior Advisor – specialist for Non-Clinical and Clinical Assessment, Department for Assessment of Quality, Safety and Efficacy of the Croatian Agency for Medicinal Products and Medicinal Devices. Elina Rönnemaa is specialist in Geriatrics, Clinical Assessor Efficacy and Safety, of the Medical Products Agency in Uppsala Sweden. Other members of the GEG are Antonio Cherubini from Italy, Adalsteinn Gudmundson from Iceland, Paul Jansen from the Netherlands, Susan Morgan from the UK, Mirko Petrovic from Belgium, Hildrun Sundseth from Ireland, Barbro Westerholm from Sweden and Hans Wildiers from Belgium. The GEG representatives at the EMA are Francesca Cerreta and Maria Silvia Orbe Izquierdo.
Article BJCP 2017: Prescribing Safety Assessment 2016: delivery of a national prescribing assessment to 7343 UK final-year medical students.
Newly graduated doctors write a large proportion of prescriptions in UK hospitals but recent studies have shown that they frequently make prescribing errors. The prescribing safety assessment (PSA) has been developed as an assessment of competence in relation to prescribing and supervising the use of medicines. This report describes the delivery of the PSA to all UK final-year medical students in 2016 (PSA2016). PSA2016 demonstrated the feasibility of delivering a standardized national prescribing assessment online. The vast majority of UK final-year medical students were able to meet a prespecified standard of prescribing competence.
This article can be found at this website: research – articles.