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
This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to older patients. The book wil provide valuable information for students, scientists, regulators, practitioners and industry. Sven Stegeman is the editor of the book entitled Developing Drug Products in an Aging Society. Paul Jansen from Ephor has contributed with a chapter to the book. The costs of the e-book are 190,39 euro and hard-cover 242,74 euro. Publisher Springer, ISBN 978-3-319-43097-3.
A double-blind, parallel-arm, dose-titrated randomized clinical trial was conducted at 11 Australian inpatient hospice or hospital palliative care services to relieve symptoms of delirium. Risperidone or haloperidol were compared to placebo in patients with a delirium symptoms score (sum of Nursing Delirium Screening Scale behavioral, communication, and perceptual items) of 1 or more. Age-adjusted titrated doses of oral risperidone, haloperidol, or placebo solution were administered every 12 hours for 72 hours, based on symptoms of delirium. Patients also received supportive care, individualized treatment of delirium precipitants, and subcutaneous midazolam hydrochloride as required for severe distress or safety. Two hundred forty-seven participants (mean [SD] age, 74.9 [9.8] years; 85 women [34.4%]; 218 with cancer [88.3%]) were included in intention-to-treat analysis (82 receiving risperidone, 81 receiving haloperidol, and 84 receiving placebo). In the primary intention-to-treat analysis, participants in the risperidone arm had delirium symptom scores that were significantly higher than those among participants in the placebo arm (on average 0.48 Units higher; 95%CI, 0.09-0.86; P = .02) at study end. Similarly, for those in the haloperidol arm, delirium symptom scores were on average 0.24 Units higher (95%CI, 0.06-0.42; P = .009) than in the placebo arm. Compared with placebo, patients in both active arms had more extrapyramidal effects (risperidone, 0.73; 95%CI, 0.09-1.37; P = .03; and haloperidol, 0.79; 95%CI, 0.17-1.41; P = .01). Participants in the placebo group had better overall survival than those receiving haloperidol (hazard ratio, 1.73; 95%CI, 1.20-2.50; P = .003), but this was not significant for placebo vs risperidone (hazard ratio, 1.29; 95%CI, 0.91-1.84; P = .14). CONCLUSIONS AND RELEVANCE In patients receiving palliative care, individualized management of delirium precipitants and supportive strategies result in lower scores and shorter duration of target distressing delirium symptoms than when risperidone or haloperidol are added.
Agar et al. JAMA Intern Med. doi:10.1001/jamainternmed.2016.7491 Published online December 5, 2016.