Medication use among older people in Europe: Implications for regulatory assessment and co-prescription of new medicines.

AIMS: The aim of this study was to elucidate drug prescription patterns in older European people with the objective to support regulatory contextualisation of (1) the suitability of enrolment criteria for new clinical trials; and (2) the understanding of the potential interactions/incompatibilities of newly authorised medicines with those most frequently used by older people. METHODS: Medicines agencies in Portugal, Poland, Slovakia and England were approached to provide a list of the 10 most frequent prescriptions in 2016 for systemically used medicines per active substances (i.e. ATC level 5), in older people. For each active substance and for the most common therapeutic subgroups (i.e. ATC level 2), the percentages of older patients receiving at least one prescription were calculated per older age categories (65-74; 75-84; 85+) and gender. RESULTS: There was considerable alignment in the most commonly prescribed active substances and therapeutic subgroups represented; these were gastroprotectants (A02), lipid-modifying agents (C10) and analgesics (N02). Some gender differences were observed (A02 and N02 were prescribed more frequently to women), but trends on age categories were consistent; A02 and N02 prescriptions continued to rise with age, while C10 slightly decreased in the 85+ age group in all countries. CONCLUSIONS: The findings of this study are consistent with the major chronic diseases reported in the older European population. Evidence on co-medication of newly applied medicines with the currently identified most commonly used medicines in older people should be generated during the (non)clinical development of new medicines to support regulatory assessment and adequate user information.

Medicines for older people: assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products.

PURPOSE: To describe whether for the cardiovascular and antithrombotic medicines approved in the period 2006-2016 (a) the pivotal trial was designed with an upper ageexclusion criterion, (b) the age distribution of the participants in the registration trials reflected expected use, (c) post-authorisation studies were planned, and d) the age distribution of participants was clearly presented in the approval documents. METHODS: The data provided to EMA in support of centralized marketing authorisations of were analysed. RESULTS: Two out of 19 protocols excluded patients over 80 and 85 years old. In the heart failure, atrial fibrillation and antithrombotic drug registration trials, the proportion of patients aged 65-74 years was 33-50%, and 13-20% over 75 years. For antithrombotic drugs, it was 25-35% for the 65-74 age, and around 15% for the 75+ age. For statins and antihypertensives, it was 20-40% for the 65-74 age and 3-6% for 75+ age. Post-authorisation studies were planned in two cases. An improvement on the transparency of public data is apparent, although information is not always presented clearly and uniformly. CONCLUSIONS: There is more publicly available information since 2006, but data on older patients with frailty and multimorbidity are generally scant. To address this, CHMP Geriatric Expert Group has currently published a Reflection paper on physical frailty to support subgroup categorisation of older patients beyond age with the aim of ensuring that clinical trial populations are representative of the users of the medicine.