title: Results from a preliminary review of scientific evidence for appropriateness of preparations, dosage forms and other product design elements for older adult patients.
abstract: The aging population and the growing multimorbidity of the major patient population as well as the advanced (pharmaco)therapeutic treatment options are increasing the complexity of independent drug therapy management and administration. The increased complexity may have an impact on drug adherence (including any need for patients initiated coping strategies), and consequently on the safety and efficacy of the medicine. To overcome adherence issues caused by the design of the medicine, it is crucial that developers consider the age appropriateness of the medicine (route of administration, dosage form, excipients in the composition, frequency of dosing) in meeting patients' needs to manage their therapy without the support of a care giver. In order to understand the scientific evidence on such age appropriately designed medicines for use by older adults, a literature search was performed in the Medline database (all languages included). The search produced 34 publications that met the inclusion and exclusion criteria for the patient population of 65 years an older. An in-depth analysis of the included publications with respect to the methodological quality (study design, data collection, endpoints chosen) and results showed that none of these publications had adequately investigated the age appropriateness of the medicine for use by older adults. The authors consider that the knowledge gap in this area requires attention of all stakeholders in the healthcare community.
authors.affiliation: Aptalis S.p.A., Pessano con Bornago (Milano), Italy.
authors.forename: Rossella
authors.initials: R
authors.lastname: Messina
authors.affiliation: Impala Pharma Consulting, Munich, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Becker
authors.affiliation: Medicines Evaluation Board, Utrecht, The Netherlands; Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
authors.forename: Diana A
authors.initials: DA
authors.lastname: van Riet-Nales
authors.affiliation: Graz University of Technology, Graz, Austria. Electronic address: sven.stegemann@tugraz.at.
authors.forename: Sven
authors.initials: S
authors.lastname: Stegemann
mesh_terms: D000368:Aged; D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms; D004333:Drug Administration Routes; D004363:Drug Utilization; D006801:Humans; D008508:Medication Errors; D010349:Patient Compliance; D004364:Pharmaceutical Preparations
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations
keywords: Drug administration; Formulation appropriateness; Older adults; Patient centric drug delivery; Scientific evidence