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.