gms | German Medical Science

25. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

22.11. - 23.11.2018, Bonn/Bad Godesberg

Influence of metabolic profiles on drug safety in routine care in Germany – the EMPAR project

Meeting Abstract

  • author presenting/speaker Tatjana Huebner - Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
  • author Michael Steffens - Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
  • author Jochen Fracowiak - Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany
  • author Willy Gomm - German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany
  • author Christoph Roethlein - German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany
  • Marco Garling - Techniker Krankenkasse, Hamburg, Germany
  • author Daria Langner - Techniker Krankenkasse, Hamburg, Germany
  • author Roland Linder - Techniker Krankenkasse, Hamburg, Germany
  • author Britta Haenisch - Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany; German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany; Center for Translational Medicine (University of Bonn), Bonn, Germany
  • corresponding author Julia Stingl - Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany; Center for Translational Medicine (University of Bonn), Bonn, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 25. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Bonn/Bad Godesberg, 22.-23.11.2018. Düsseldorf: German Medical Science GMS Publishing House; 2018. Doc18gaa19

doi: 10.3205/18gaa19, urn:nbn:de:0183-18gaa191

Veröffentlicht: 23. November 2018

© 2018 Huebner et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Background: Adverse drug reactions (ADRs) are a problem in clinical practice because they complicate drug therapy, increase morbidity and mortality of patients and exert an economic burden on the health care system [1], [2]. Individual genetic profiles have an influence on how drugs are metabolized. Thus, the metabolic profiles contribute to the patient’s individual drug response and the occurrence of ADRs [3]. Although not yet considered for drug prescription in routine care in Germany, pharmacogenetic profiles can help to improve the adjustment of medical treatments. Therefore, preemptive pharmacogenetic testing can help physicians to apply medication more accurately to decrease the risk of ADRs by a more individual treatment approach [1], [3].The EMPAR project addresses the question whether different metabolic profiles have an impact on the use of statutory health insurance services.

Materials and methods: We aim to include a study sample of about 10,000 patients (aged 18 years or older) insured by the health insurance provider Techniker Krankenkasse (TK). Included patients take at least one drug whose metabolization is known to depend on genetic variants. This means, there is clinical evidence that genetic differences have an impact on the pharmacokinetics and/or pharmacodynamics of the drug in question. A panel of pharmacogenetically important markers will be genotyped from buccal swabs of the patients. The analysis then combines pharmacogenetic data on drug metabolism and elimination with health insurance data provided by the TK. Outcomes include the utilization of health insurance services, the incidence of incapacity for work, and costs for drugs and treatment. Pharmacogenetic, -epidemiologic and -economic analyses using health care utilization data will be applied. Also machine learning techniques will be used.

Results: The cohort study EMPAR investigates the influence of metabolic profiles on the effectiveness and safety of drug therapies in routine care. By applying the optimal drug dosage there could be less ADRs and the quality of patient care increases.

Conclusion: The long-term goal is to examine the feasibility of preemptive pharmacogenetic testing of metabolic profiles in routine care in Germany.


References

1.
Lee JW, Aminkeng F, Bhavsar AP, Shaw K, Carleton BC, Hayden MR, Ross CJ. The emerging era of pharmacogenomics: current successes, future potential, and challenges. Clin Genet. 2014 Jul;86(1):21-8.
2.
Meier F, Maas R, Sonst A, Patapovas A, Müller F, Plank-Kiegele B, Pfistermeister B, Schöffski O, Bürkle T, Dormann H. Adverse drug events in patients admitted to an emergency department: an analysis of direct costs. Pharmacoepidemiol Drug Saf. 2015;24:176-86.
3.
Maggo SD, Savage RL, Kennedy MA. Impact of New Genomic Technologies on Understanding Adverse Drug Reactions. Clin Pharmacokinet. 2016 Apr;55(4):419-36.