Abstract

Patient nonadherence to prescribed medicines is endemic and thus a central issue in the quality and economics of ambulatory medical care and drug trials. To be efficacious, a course of drug treatment must have a timely initiation, and treatment persistence is required for an evidence-based period of time. Precision medicine is currently facing additional requirements where, for most therapeutic areas under investigation, the drugs’ therapeutic windows are narrow. These are pre-conditions for identifying optimal dosage regimens that best balance safety and efficacy, and require precise implementation of the dosing regimen for optimal outcomes of treatment. Yet adherence research shows wide variability in ambulatory patients' timing and taking of doses, relative to protocol-specified, or label-specified, dosing regimens, thereby creating a major source of variance in drug exposure. This situation points to the need for adherence-informed research in which exposure to the test drugs is measured with high fidelity to assess dose-dependent effectiveness. Non-intrusive, reliable, and continuous assessment of patient adherence can be achieved by automatic compilation of drug dosing history data using electronic detection methods with conventionally designed drug packages (“smart packages”). The resulting data provide dosing histories, which allow one to identify crucial errors in dosing that can jeopardize treatment outcomes, and can, in turn, be used to focus intervention to achieve precise implementation of, and long-term persistence with, the dosing regimen that is optimal for each drug being prescribed or studied.

Presenter’s Bio 

Bernard Vrijens, Ph.D., is Chief Science Officer at WestRock Healthcare. He was General Manager of the AARDEX Group, prior to AARDEX becoming part of WestRock Healthcare. He is also Associate Professor of Biostatistics at the University of Liège, Belgium.

Dr. Vrijens holds a PhD from the Department of Applied Mathematics and Informatics at the University of Ghent, Belgium. 

Dr Vrijen’s currently leads a research program investigating  (a) the most common errors in dosing using a simple but robust taxonomy, (b) particular dosing errors that can jeopardize the efficacy of a drug, and (c) the optimal measurement-guided medication management program that can enhance adherence to medications and maintain long-term persistence.

Dr. Vrijens is a co-author of five book chapters, over 75 peer-reviewed scientific papers, and named as inventor on two patents. He is a founding member and managing director of the European Society for Patient Adherence, Compliance, and Persistence, and an active member of several EU- and US-funded collaborative projects around the theme of adherence to medications.