The package barrier to user adherence: Comparative analysis of various types of opening instructions on the ease of opening comprising effectiveness, efficiency and user satisfaction

Abstract

Aims: Adequate user access to drug therapy can only be ensured when the drug can be removed from its package. The aim of this study was to investigate the influence of a variety of opening instructions on the ease of opening a user package and user satisfaction. Methods: This experiment was conducted according to CEN/TS 15945. Ease of opening was defined as the ability to open a package within a defined time frame (effectiveness) and the learning effect by repeated opening (efficiency). (Dis)satisfaction ranged from −2 to +2. Empty bottles with left threat screw caps (rather than the standard right) were studied following 4 different types of instructions: none, arrow in the screw cap, package leaflet, video. Each instruction was studied in a group of 20 different healthy older adult volunteers (65–80 years). No opening aid was permitted. Data were captured in forms and on video. Results: Nine (45%) participants could open the package without any instruction, 19 (95%) with an arrow marked bottle and 20 (100%) with a package leaflet or video. No notable differences were observed in median times for first and repeated opening. Participants were most often (n = 11) dissatisfied (score −2) without any instruction and neutral to most satisfied (0–2) with a video (n = 17). Conclusion: The effectiveness, efficiency and user satisfaction to open a package is strongly influenced by the type of opening instruction. This conclusion requires further consideration in drug product packaging and labelling.