Publications by authors named "Tatjana Huebner"
Background: Pharmacogenetic testing in routine care could provide benefits for patients, doctors and statutory health insurances. Therefore, the aim of the retrospective, observational study Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung (EMPAR) was to analyze the relationship between pharmacogenetic profiles, the risk of adverse drug reactions, and patients' perceptions of drug therapy in 10748 adult (≥18 years) participants in Germany.
Methods: A questionnaire was used to assess views and beliefs about medicines and participants individual perception of sensitivity to drug therapies.
Article Synopsis
- Analytical validity is essential for using next generation sequencing (NGS) tests as diagnostics, but current U.S. and EU guidelines don't clearly include pharmacogenetic testing for drug therapies.
- A systematic review of literature on NGS validation for specific drug metabolizing enzymes revealed a lack of comprehensive data, highlighting that the status of analytical validation in this area is limited.
- There is no established standard for reporting analytical validation of NGS tests, leading to gaps in crucial performance metrics which are necessary for effective clinical application of these tests.
The impact of genetic variability of pharmacogenes as a possible risk factor for adverse drug reactions is elucidated in the EMPAR (Einfluss metabolischer Profile auf die Arzneimitteltherapiesicherheit in der Routineversorgung/English: influence of metabolic profiles on the safety of drug therapy in routine care) study. EMPAR evaluates possible associations of pharmacogenetically predicted metabolic profiles relevant for the metabolism of frequently prescribed cardiovascular drugs. Based on a German study population of 10,748 participants providing access to healthcare claims data and DNA samples for pharmacogenetic assessment, first analyses were performed and evaluated.
View Article and Find Full Text PDFOn the basis of scientific evidence, information on the option, recommendation or requirement to test for pharmacogenetic or pharmacogenomic biomarkers is incorporated in the Summary of Product Characteristics of an increasing number of drugs in Europe. A screening of the Genetic Testing Registry (GTR) showed that a variety of molecular genetic testing methods is currently offered worldwide in testing services with regard to according drugs and biomarkers. Thereby, among the methodology indicated in the screened GTR category 'Molecular Genetics', next-generation sequencing is applied for identification of the largest proportion of evaluated biomarkers that are relevant for therapeutic management of centrally approved drugs in Europe.
View Article and Find Full Text PDFFor many authorized drugs, accumulating scientific evidence supports testing for predictive biomarkers to apply personalized therapy and support preventive measures regarding adverse drug reactions and treatment failure. Here, we review cytogenetic and biochemical genetic testing methods that are available to guide therapy with drugs centrally approved in the European Union (EU). We identified several methods and combinations of techniques registered in the Genetic Testing Registry (GTR), which can be used to guide therapy with drugs for which pharmacogenomic-related information is provided in the European public assessment reports.
View Article and Find Full Text PDFArticle Synopsis
- Pre-emptive pharmacogenetic testing can help prevent adverse drug reactions and therapy resistance, but it's not commonly used in Germany due to insufficient clinical and economic evidence.
- The EMPAR study will analyze the impact of pharmacogenetic profiles on healthcare service usage by examining data from around 10,000 patients, focusing on those prescribed anticoagulants and cholesterol-lowering drugs.
- The study will look into healthcare utilization, work incapacity rates, and treatment costs to determine the benefits and cost-effectiveness of routine pharmacogenetic testing in the German healthcare system.