Lukas Mühlfeld1, Peter Langguth, Heribert Häusler, Hansjörg Hagels. 1. Department of Biopharmaceutics and Pharmaceutical Technology, Institute of Pharmacy and Biochemistry, Johannes Gutenberg-University of Mainz, Staudinger Weg 5, 55099, Mainz, Germany. lukas.muehlfeld@gmx.de
Abstract
BACKGROUND: Blisters packs are commonly used as packaging for oral drug products. Utilization problems among older adults with pharmaceutical packaging are well known from investigations of multi-unit dose containers, but there is a lack of studies focusing on blister packaging. This study was performed to identify design parameters that should be considered when developing blister packaging for drug products intended to be used by older adults. OBJECTIVES: To investigate the relationship between blister pack design and utilization problems among older adults. SETTING: Community-based study including 141 volunteers (age 80+) living at home and in assisted-living facilities. METHOD: In random order 5 blister packs of uniform shape but with different opening characteristics (variation of the force required to open the blisters and different mechanisms of opening) were tested by each participant. MAIN OUTCOME MEASURE: Opening was evaluated (difficulty, pain perception and overall assessment) by questioning of the participants. Additionally, data were collected as to whether participants managed to take out 4 tablets within 4 min test duration and whether they gave up opening. Reasons for utilization problems were examined by subgroup analysis, frequently made observations, and technological characterization of blisters. Results Blisters with thicker push-through foils were assessed as being inferior. Anyhow, most of participants (>84 %) were capable of opening each type of push-through blister within 4 min. By contrast, many of the participants were unable to open peel (30 %) and child-resistant peel-off push-through blisters (44 %) or gave up trying before the end of the test. In addition to medical conditions, vision and age of participants correlated with utilization problems. CONCLUSION: Blister pack design, including opening force and opening mechanism, can have significant impact on the usability of blister packs by older adults. The study identified several parameters that should be considered with respect to older adults when developing blister packaging for drug products.
BACKGROUND: Blisters packs are commonly used as packaging for oral drug products. Utilization problems among older adults with pharmaceutical packaging are well known from investigations of multi-unit dose containers, but there is a lack of studies focusing on blister packaging. This study was performed to identify design parameters that should be considered when developing blister packaging for drug products intended to be used by older adults. OBJECTIVES: To investigate the relationship between blister pack design and utilization problems among older adults. SETTING: Community-based study including 141 volunteers (age 80+) living at home and in assisted-living facilities. METHOD: In random order 5 blister packs of uniform shape but with different opening characteristics (variation of the force required to open the blisters and different mechanisms of opening) were tested by each participant. MAIN OUTCOME MEASURE: Opening was evaluated (difficulty, pain perception and overall assessment) by questioning of the participants. Additionally, data were collected as to whether participants managed to take out 4 tablets within 4 min test duration and whether they gave up opening. Reasons for utilization problems were examined by subgroup analysis, frequently made observations, and technological characterization of blisters. Results Blisters with thicker push-through foils were assessed as being inferior. Anyhow, most of participants (>84 %) were capable of opening each type of push-through blister within 4 min. By contrast, many of the participants were unable to open peel (30 %) and child-resistant peel-off push-through blisters (44 %) or gave up trying before the end of the test. In addition to medical conditions, vision and age of participants correlated with utilization problems. CONCLUSION: Blister pack design, including opening force and opening mechanism, can have significant impact on the usability of blister packs by older adults. The study identified several parameters that should be considered with respect to older adults when developing blister packaging for drug products.
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