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.

Evaluation of Newly Designed Blister Packs for Easier Handling to Prevent Pill Dropping

“…7 , 8 These situations are closely related in that healthy older adults and patients with RA both make substantial efforts in terms of drug-taking in their daily lives, including the use of personal devices to improve the ease of opening ( Table 5 ). 9 , 10 Patients with RA tend to have weak pinch power, so these issues could pose more serious problems. The fact that a high percentage of patients use their own devices also suggests the need for better drug-taking support.…”

“…5 I could remove the pill from type B smoothly, but not as smoothly from type A. (4 participants) 9 Because the perforation was firm in type B, I was not able to break it with one hand.…”

Opportunities for changes in the drug product design to enhance medication safety in older people: Evaluation of a national public portal for medication incidents

“…Currently, there are numerous publications discussing a specific MRP connected with the drug product design. Examples include studies that show that tablets may be difficult to swallow, 38,39 packages difficult to open 40,41 and/or user instructions not well understood 12 . However, general research on this subject matter is scarce and fragmented 12,42,43 .…”

Commentary on the EMA reflection paper on the pharmaceutical development of medicines for use in the older population

“…Future lessons may be learned from post marketing data, dedicated scientific studies and experiences from other disciplines. [47][48][49] A well-known coping strategy in older people with polypharmacy and/or impaired cognition or motor function is the use of multiple compliance aids (MCAs) and multiple drug dispensing systems (MDDs)…”