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.
In the Netherlands elderly patients use many medicines. A list of the 15 most used drugs shows that at least 20% is used by patients over 65 years of age. Of seven medicines more than half of the users are patients over 65 years of age. Also patients over 75 years of age are using many of these medicines. The overview is available at this website at Teaching/info/Information EMA and GEG.
The evidence found in the studies of this thesis provide insights into the pathways that influence CE participation, lifelong learning and adaptability and thus the professional development of pharmacists. The Universities could prioritize and stimulate more research in the direction of postgraduate pharmaceutical education.
The SENATOR Coordinating Team is pleased to announce that the 1000th patient was randomised to SENATOR. Congratulations to the team in Aberdeen for randomising this milestone patient.
The SENATOR study is a randomized controlled trials (RCTs) towards optimization of pharmacotherapy in old patients. The RCT use software which include also the STOPP/START criteria. The aim of the study is to avoid the prescription of inappropriate medicines and avoidable adverse drug reactions.
EMA has published an article in the Journal of Geriatric Oncology about regulatory considerations on the enrollment of older adults in oncology clinical trials
The authors are: Bahijja Tolulope Raimi-Abraham, Maria Silvia de Orbe Izquierdo, Olivier Collignon, Francesca Cerreta
Astrid van Strien describes in her thesis different aspects of adverse drug reactions of antipsychotics in frail older patients. As well as clinical pharmacological mechanisms, as the correlation between blood and liquor haloperidol concentrations, as epidemiological studies towards falls caused by antipsychotics are studied. A new adverse effect of antipsychotics that she detected is an association with urinary tract infections.
The thesis, that will be defended at September 14 in Amsterdam (VU promotor prof. R. van Marum) is partly available at this website, partly under embargo.
Regulatory Rapporteur, the journal for regulators, focus in May ( Vol 14, No 5, May 2017) at the older populations. Consulting editors Richard Huckle and Anita Sibal for this edition say:
First considerations with the design and development of medicines are not with the older population in mind, despite them contributing significantly to overall pharmaceutical sales and having the longest contributions into healthcare sectors. As with all populations, there are many considerations and practical aspects to be addressed when designing medicines. For the older generation, as well as safety and efficacy of the medicine itself, a patient friendly tablet design, easy-to-use packaging and ease of review of information leaflets, even down to details of font size, are all important considerations. This patient population also requires specifically targeted risk minimisation materials as well as education for healthcare professionals, patients and care providers. All these factors and much more have been addressed in our three focus articles on older adult populations. These articles include an interview provided by Dr Diana Van Riet, senior assessor at the Netherlands MEB, and a co-author of “Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects” (International Journal of Pharmaceutics, Volume 512, Issue 2, 30 October 2016). This informative and wide-reaching interview discusses the importance of collaboration with all stakeholders to include patient groups, healthcare professionals, care-givers as well as regulatory and HTA assessors, and pharmaceutical companies.
The OPERAM study has started recently and over 100 patients are included in the participating centra (Bern, Louvain, Utrecht). The expectation is that in Cork inclusion will start soon as well. In this study the effect of a systematic medication review will be investigated in old patients admitted to a hospital. The goal is to improve avoidable hospital admission by reducing adverse effects and inappropriate medication. The study uses the STRIPassistant, a computerized support system for the Systematic Tool to Reduce Inappropriate Prescribing (STRIP). The results of the study are expected in 2020.
The 1,000th study has recently been uploaded in the European Union electronic Register of Post-Authorisation Studies (EU PAS Register). A filter is present to search for elderly (65-74 and over 75 years). The EU PAS Register provides a wealth of information on the safety and effectiveness of authorised medicines. It is an openly accessible platform with information on post-authorisation research in medicines already marketed in Europe, and includes study protocols, study results, related publications and other relevant information. The link to the EU PAS Register is : http://www.encepp.eu/encepp/studySearch.htm