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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., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The clear identification of drug products by the patients is essential for a safe and effective medication management. In order to understand the impact of shape, size and color on medication identification a study was performed in subjects with type 2 diabetes mellitus (T2D). Ten model drugs differentiated by shape, size and color were evaluated using a mixed method of medication schedule preparation by the participants followed by a semi-structured interview. Detection times were fastest for the large round tablet shape and the bi-chromatic forms. Larger size was easier to identify than the smaller sizes except for the bi-chromatic forms. The shape was the major source of errors, followed by the size and the color dimension. The results from this study suggests that color as a single dimension are perceived more effectively by subjects with T2D compared to shape and size, which requires a more demanding processing of three dimension and is dependent on the perspective., (Copyright © 2016 Elsevier B.V. All rights reserved.)