Georgios Schoretsanitis1,2, Michael Paulzen2,3, Stefan Unterecker4, Markus Schwarz5, Andreas Conca6, Gerald Zernig7,8, Gerhard Gründer9, Ekkerhard Haen10, Pierre Baumann11, Niels Bergemann12, Hans Willi Clement13, Katharina Domschke14, Gabriel Eckermann15, Karin Egberts16, Manfred Gerlach16, Christine Greiner17, Ursula Havemann-Reinecke18, Gudrun Hefner19, Renate Helmer20, Ger Janssen21, Eveline Jaquenoud-Sirot22, Gerd Laux23, Thomas Messer24, Rainald Mössner25, Matthias J Müller26, Bruno Pfuhlmann27, Peter Riederer4, Alois Saria7, Bernd Schoppek28, Margarete Silva Gracia10, Benedikt Stegmann10, Werner Steimer29, Julia C Stingl17, Manfred Uhr30, Sven Ulrich31, Roland Waschgler32, Gabriela Zurek33, Christoph Hiemke34,35. 1. a Department of Psychiatry , University of Bern , Bern , Switzerland. 2. b Department of Psychiatry, Psychotherapy and Psychosomatics , RWTH Aachen University, JARA - Translational Brain Medicine , Aachen , Germany. 3. c Alexianer Hospital Aachen , Aachen , Germany. 4. d Department of Psychiatry, Psychosomatics and Psychotherapy , University Hospital of Würzburg , Germany. 5. e Department of Laboratory Medicine , Ludwig Maximilian University , Munich , Germany. 6. f Servizio Psichiatrico del Comprensorio Sanitario di Bolzano , Bolzano , Italy. 7. g Experimental Psychiatry Unit, Department of Psychiatry and Psychotherapy , Medical University of Innsbruck , Innsbruck , Austria. 8. h Private Practice for Psychotherapy and Court-Certified Witness , Hall in Tirol , Austria. 9. i Department of Molecular Neuroimaging , Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg , Mannheim , Germany. 10. j Clinical Pharmacology, Department of Psychiatry and Psychotherapy and Department of Pharmacology and Toxicology , University of Regensburg , Regensburg , Germany. 11. k Department of Psychiatry , University of Lausanne , Lausanne , Switzerland. 12. l Kitzberg Hospitals, Center for Psychosomatic Medicine and Psychotherapy , Bad Mergentheim , Germany. 13. m Department of Child and Adolescent Psychiatry , University of Freiburg , Freiburg , Germany. 14. n Department of Psychiatry and Psychotherapy , Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg , Freiburg , Germany. 15. o Psychiatric Hospital , Kaufbeuren , Germany. 16. p Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy , Center of Mental Health, University Hospital of Würzburg , Germany. 17. q Federal Institute for Drugs and Medical Devices (BfArM) , Bonn , Germany. 18. r Department of Psychiatry and Psychosomatics , University of Göttingen , Göttingen , Germany. 19. s Psychiatric Hospital, Vitos Klinik Hochtaunus , Friedrichsdorf , Germany. 20. t Center of Epilepsy , Bielefeld , Germany. 21. u Medical Laboratory Stein , Limbach Group , Mönchengladbach , Germany. 22. v Psychiatric Hospital , Brugg , Switzerland. 23. w Institute of Psychological Medicine , Haag in Oberbayern , Germany. 24. x Danuviuskliniken, Psychiatric Hospital , Pfaffenhofen , Germany. 25. y Department of Psychiatry and Psychotherapy , University of Tübingen , Tübingen , Germany. 26. z Psychiatric Hospitals Oberberggruppe , Berlin , Germany. 27. aa Psychiatric Hospital Weisser Hirsch , Dresden , Germany. 28. ab kbo-Isar-Amper Klinikum München-Ost, Psychiatric Hospital , Munich , Germany. 29. ac Institute of Clinical Chemistry and Pathobiochemistry, Technical University Munich , Munich , Germany. 30. ad Max Planck Institute of Psychiatry , Munich , Germany. 31. ae Aristo Pharma GmbH , Berlin , Germany. 32. af Psychiatric Hospital , Feldkirch , Austria. 33. ag Medical Laboratory Bremen , Bremen , Germany. 34. ah Department of Psychiatry and Psychotherapy , University Medical Center of Mainz , Mainz , Germany. 35. ai Institute of Clinical Chemistry and Laboratory Medicine , University Medical Center of Mainz , Mainz , Germany.
Abstract
OBJECTIVES: Therapeutic drug monitoring (TDM) combines the quantification of drug concentrations in blood, pharmacological interpretation and treatment guidance. TDM introduces a precision medicine tool in times of increasing awareness of the need for personalized treatment. In neurology and psychiatry, TDM can guide pharmacotherapy for patient subgroups such as children, adolescents, pregnant women, elderly patients, patients with intellectual disabilities, patients with substance use disorders, individuals with pharmacokinetic peculiarities and forensic patients. Clear indications for TDM include lack of clinical response in the therapeutic dose range, assessment of drug adherence, tolerability issues and drug-drug interactions. METHODS: Based upon existing literature, recommended therapeutic reference ranges, laboratory alert levels, and levels of recommendation to use TDM for dosage optimization without specific indications, conversion factors, factors for calculation of dose-related drug concentrations and metabolite-to-parent ratios were calculated. RESULTS: This summary of the updated consensus guidelines by the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie offers the practical and theoretical knowledge for the integration of TDM as part of pharmacotherapy with neuropsychiatric agents into clinical routine. CONCLUSIONS: The present guidelines for TDM application for neuropsychiatric agents aim to assist clinicians in enhancing safety and efficacy of treatment.
OBJECTIVES: Therapeutic drug monitoring (TDM) combines the quantification of drug concentrations in blood, pharmacological interpretation and treatment guidance. TDM introduces a precision medicine tool in times of increasing awareness of the need for personalized treatment. In neurology and psychiatry, TDM can guide pharmacotherapy for patient subgroups such as children, adolescents, pregnant women, elderly patients, patients with intellectual disabilities, patients with substance use disorders, individuals with pharmacokinetic peculiarities and forensic patients. Clear indications for TDM include lack of clinical response in the therapeutic dose range, assessment of drug adherence, tolerability issues and drug-drug interactions. METHODS: Based upon existing literature, recommended therapeutic reference ranges, laboratory alert levels, and levels of recommendation to use TDM for dosage optimization without specific indications, conversion factors, factors for calculation of dose-related drug concentrations and metabolite-to-parent ratios were calculated. RESULTS: This summary of the updated consensus guidelines by the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie offers the practical and theoretical knowledge for the integration of TDM as part of pharmacotherapy with neuropsychiatric agents into clinical routine. CONCLUSIONS: The present guidelines for TDM application for neuropsychiatric agents aim to assist clinicians in enhancing safety and efficacy of treatment.
Entities:
Keywords:
Therapeutic drug monitoring; drug therapy; neuropsychopharmacology; pharmacokinetics; pharmacovigilance
Authors: Jacob T Brown; Jeffrey R Bishop; Katrin Sangkuhl; Erika L Nurmi; Daniel J Mueller; Jean C Dinh; Andrea Gaedigk; Teri E Klein; Kelly E Caudle; James T McCracken; Jose de Leon; J Steven Leeder Journal: Clin Pharmacol Ther Date: 2019-04-13 Impact factor: 6.875
Authors: Georgios Schoretsanitis; Olav Spigset; Julia C Stingl; Kristina M Deligiannidis; Michael Paulzen; Andreas A Westin Journal: Expert Opin Drug Metab Toxicol Date: 2020-04-10 Impact factor: 4.481
Authors: Nicole Moschny; Gudrun Hefner; Renate Grohmann; Gabriel Eckermann; Hannah B Maier; Johanna Seifert; Johannes Heck; Flverly Francis; Stefan Bleich; Sermin Toto; Catharina Meissner Journal: Pharmaceuticals (Basel) Date: 2021-05-27