Valentyn Mohylyuk1, Ralf Troebs2, Andriy Dashevskiy3*
The problem of non adherence is a challenge for contemporary medicine. A modern smart container/electronic monitoring approach are pharmaceutical packaging Connect-E-Cap® (CEC) which provides many helpful features to reduce non adherence. The objective was the identification of therapeutic areas/drugs critical in terms of non adherence, PK modeling of non adherence scenarios for certain medicinal products and discussion around strategies for further features for CEC. Based on the scientific literature, the therapeutic areas where provided non adherence has a crucial impact on therapy, including drugs with reported non adherence, NTI, as well as drugs requiring TDM. The multiple dosing PK profiles were modeled by the summation of reported single PK profiles including various non adherence scenarios. Unintentional non adherence would be not very critical for drug products with relatively short t½. In contrast, for drug products with longer t½, missing, postponing, taking of compensation dose, as well as miscounting would lead to fluctuations in plasma concentrations. Therefore, monitoring of intake, as well as active help (e.g., reminder) to the patients by application of e.g., CEC functions would help solve the problem of non intentional adherence. Further strategies for further features of smart containers/electronic monitoring devices as CEC were also discussed.