Patients' appropriateness, acceptability, usability and preferences for pharmaceutical preparations: Results from a literature review on clinical evidence.

Patients play an important role in achieving the desired therapeutic outcomes, as they are frequently responsible for their own medication management. To facilitate drug administration and overcome medication issues, the patients' needs and preferences should be considered in the pharmaceutical drug product design. With the aim to evaluate the current state of evidence for patient appropriateness, acceptability, usability and preference for aspects of this design, a literature search was performed. Comparative clinical studies that assessed such endpoints for different patient populations were included and summarized descriptively. The search identified 45 publications that met the inclusion criteria. A detailed analysis of the studies identified two main areas investigating either packaging design (n=10) or dosage form design (n=35). Studies on packaging design showed preferences for wing top and screw cap openings, push-through blisters and suppositories with slide system. Additionally, child-resistant containers should be avoided concerning specific patient populations. Regarding dosage form design, sprinkles and minitablets were the most preferred in studies involving young patients, while preferences varied considerably depending on route of administration and geographical region in studies with adult patients. Review of the methodology used in the studies revealed that ten studies had used well-defined protocols and observational endpoints to investigate patient appropriateness. Studies focusing on methodology for testing the appropriateness and usability of drug products by patients were not found. In conclusion, more interdisciplinary scientific efforts are required to develop and increase research in understanding patient needs and preferences.