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.

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.