Breaking barriers: Microsampling strategies to redefine therapeutic drug monitoring

The advancement of microsampling technologies is revolutionising Therapeutic Drug Monitoring (TDM), particularly within the framework of precision medicine. This lecture will explore the transformative potential of microsampling strategies, significantly enhancing patient-centric care and therapeutic efficacy. TDM is a cornerstone of precision medicine, essential for optimising pharmacotherapy by ensuring therapeutic drug levels, assessing compliance and adjusting dosages to mitigate adverse effects and toxicity. Traditional TDM practices, reliant on venipuncture, present logistical challenges and patient discomfort [1]. Recent advancements based on microsampling offer a minimally invasive alternative, overcoming these barriers and fostering greater patient compliance and engagement. The adoption of microsampling methodologies, ranging from dried blood spots (DBS) to advanced volumetric, adsorptive, and microfluidic platforms, marks a paradigm shift in TDM [2]. These techniques enable the collection of minute biological samples, providing a patient-friendly approach that is particularly advantageous for vulnerable populations and remote monitoring scenarios. The portability and ease of use associated to microsampling empower patients, facilitating home sampling and self-sampling, and enhancing adherence to therapeutic regimens. The integration of advanced microsampling techniques with fully automated, end-to-end sample pretreatment workflows emphasizes synergy with HPLC-MS/MS analysis for high precision and accuracy. The Research Group of Pharmaco-Toxicological Analysis (PTA Lab) of Alma Mater Studiorum - University of Bologna has developed innovative methodologies, platforms and protocols for a wide range of target compounds and applications, coupling microsampling and TDM. The data and results obtained on CNS drugs, including second- and third-generation antipsychotics and antidepressants, particularly demonstrates the efficacy of microsampling in generating robust, reliable data for clinical decision-making. Key challenges for widespread clinical adoption, such as standardisation, assay validation and regulatory compliance, will be addressed. The stability of dried specimens for longitudinal monitoring will also be discussed, enabling proactive interventions and real-time dose adjustments, crucial for optimising therapeutic outcomes. Microsampling transcends traditional TDM limitations, supporting remote and telemedicine applications that expand access to specialised care. This shift is particularly significant in the context of frequent TDM for CNS drugs, where rapid and accurate results are essential. By breaking down barriers to compliance and facilitating precision medicine, microsampling strategies promise improved patient health, reduced hospitalisations and lower healthcare costs. Comprehensive insights and recommendations for best practices will be provided, aiming to redefine TDM through the innovative application of microsampling technologies in clinical settings.