|Blister Packages for Objective Therapy Compliance Measurement
Validity of an innovative system for compliance measurement
Carola Jekle, Irene Kraemer
Pharmacy Department, University Medical Center, Johannes Gutenberg University, Mainz (Germany)
Corresponding author: Carola Jekle, Apotheke der Universitätsmedizin, Langenbeckstraße 1, 55131 Mainz, e-mail: firstname.lastname@example.org
Purpose: The OtCM system is an innovative method for electronic compliance measurement based on blister packages. The aim of the following validation study was to examine the functionality and reliability of the OtCM system to demonstrate its suitability for compliance measurement.
Methods: Two subsequent studies with 116 and 130 OtCM activated blister packages, respectively, were conducted to evaluate functionality, accuracy and robustness. The tests exposed the blisters to different environmental conditions. Capsules or tablets were removed from the blister packages in predefined sequences. Date and time of the medication removals were simultaneously measured with a radio controlled clock and documented. The electronically generated and online retrieved data were matched to the data in the written documentation. Tests performed under normal laboratory conditions served as reference for robustness tests.
Results: Functionality (64.7 % in study 1 versus 89.2 % in study 2) and accuracy (88.0 % in study 1 versus 94.0 % in study 2) improved after detecting and resolving a minor technical problem in the manufacturing process. In both studies Fisher’s Exact Test showed no significant differences with regard to the accuracy of the OtCM blisters tested under various environmental conditions in comparison to normal laboratory conditions (p-values: 0.154 up to 1.000).
Conclusions: The OtCM blisters are functional and robust under various conditions. Further, the OtCM system appears to be an appropriate tool for compliance measurement in clinical studies and clinical practice.
Keywords Compliance measurement • Electronic blister packages, accuracy, functionality • Objective therapy compliance measurement system