Evidence-Based Design of Prescription Medication Information: An Updated Scoping Review

Background: Well-designed prescription medication information (PMI), defined as materials which communicate the essential information needed for a patient to safely and accurately self-administer a medication at or near the time of prescribing, is important for patient education. A previous review identifying best practices in the design of PMI was last completed using studies published through 2015.

Objective: The aim of this review was to present an updated description of studies comparing one or more types of PMI, including details of if or how patients were involved in PMI design, and to consolidate design elements associated with positive outcomes.

Methods: Four databases (Ovid, Embase, CINAHL, and Cochrane) were searched for studies comparing one or more types of PMI using a specified literature search with follow-up citation searching of included articles. Eligible studies were (1) conducted in English-speaking countries, (2) randomized controlled trials, and (3) published in 2016 or later. Consistent findings from at least two well-conducted studies were deemed 'strong' evidence and inconsistency in study findings or quality were deemed 'moderate' evidence.

Results: Thirty-two articles were included and most had some risk (n = 24) or high risk of bias (n = 4). Two-thirds of articles (n = 21) reported on the details of PMI development, and over half (n = 14) conducted formal pilot testing or obtained feedback from patients. Findings suggested benefits when patients were involved in PMI development. Twelve studies examined written medication information (e.g., leaflets), ten examined pharmacy-generated contained labelling (e.g., instructions printed on pill bottles), two examined supplemental information (e.g., medication regimen charts), and fourteen examined PMI delivered using technology-supported tools (e.g., text message instructions). The most prevalent assessed outcomes were knowledge (n = 19), behaviors (n = 17), attitudes/beliefs (n = 11), and clinical outcomes, such as blood pressure (n = 3). Several studies demonstrated positive outcomes when PMI was designed according to health literacy principles of plain language, typographic cues, actionable instructions, large font, and white space. Multiple trials of pictograms and illustrations alongside paired text and text messages to deliver PMI also had positive outcomes. Although there were several studies that examined interactive websites, audio, and video delivery of PMI, mixed findings resulted in moderate evidence. Novel methods of PMI delivery were identified: a plain language label for as-needed medications, strategic memory training, inclusion of patient photos and quotes, Quick Response codes, and electronic health record strategies.

Conclusions: Overall, a high proportion of studies included patients in the development of PMI and focused on behavioral outcomes. However, clinical outcomes appear to be understudied. In addition to health literacy principles, there is strong evidence for pictograms with paired text when used in written medication information and pharmacy-generated labels. There is moderate evidence for using text messages to deliver PMI. Novel methods require additional study to determine best practices in design.