Linked to EAHP Statements
Section 1 – Introductory Statements and Governance: Statements 1.1, 1.2, 1.3, 1.5, 1.6
Section 4 – Clinical Pharmacy Services: Statements 4.1, 4.3, 4.6, 4.7, 4.8
Section 5 – Patient Safety and Quality Assurance: Statements 5.1, 5.2, 5.4, 5.8, 5.9
Section 6 – Education and Research: Statements 6.2, 6.3, 6.5
Therapeutic Drug Monitoring (TDM) is expanded by omics technology in a way that drug selection and dose adaption can be justified on a scientific basis of genes, enzyme activities, and metabolites.
A response of a medicines as expected for an average patient group depends on normal functions of enzymes on the pharmacokinetic pathway and on normal structures of the receptors. Genomics gives the answers on whether inherited inborn errors afford a specific kind of treatment.
Today's TDM still consists of snapshots representing the status at the moment of the blood sampling. Continued monitoring is needed to assess the adequate plasma level of a physiological or xenobiotic intermediate or metabolite. To be correctly interpreted, and for legal reason such as in doping scenarios, not only an accurate value is needed, but sometimes more information such as a genetic profile of the patient or the athlete, in order to assess precisely if a high plasma level of hormones or their metabolites is genetically explainable or not.
This seminar focuses on the analytical techniques followed up by interpretational challenges encountered in today's pharmacotherapy, sports and black-market scenes.
After the seminar, participants should be able to:
• Take into consideration typical analytical challenges of the omics technologies;
• Recognise limits of methodologies used in genetic analyses, sports and doping analytics;
• Assume best practices and safety criteria as related to omics-based pharmacotherapy;
• Apply omics data for tailoring individual pharmacotherapy in cases of cardio-vascular diseases, diabetes mellitus type 2, obesity, drug-drug and food-drug interactions, adaption of modified doses for several ethnicities / migrants;
• Detect sources of inaccurate laboratory results and interpretations; and,
• Positively use commonalities in clinical and sports laboratory methodologies for their own activity as hospital pharmacists.
Educational need addressed
In recent years, from the year 2000, omics technologies have emerged to analyse - among others - the genome, proteome, and metabolome, facilitated by robotic analysers such as the Illumina®. In this way, not only orphan genetic diseases can be diagnosed treated in time to prevent outbreak of metabolic deterioration, but also life-style behaviour bound to non-communicable diseases with relevance for public health.
Hospital pharmacists are widely concerned by the new technologies as to whether pharmacotherapy will remain a trial-and-error approach or turn to become rather a fine-tuning of precision medicine.
Keywords: tailored doses based on omics, clinical pharmacokinetics and dynamics, functionality of hepatic and intestinal CYP450-isoenzymes and receptors as drug and metabolite targets, doping.