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Peer-reviewedCC BYPharmacopsychiatry

Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2026 – Pharmacokinetic, pharmacogenetic and clinical aspects

38 more authors
40 affiliations
  1. 1Keio University School of Medicine, Japan
  2. 2Medical Faculty Mannheim, University of Heidelberg, BW, Germany
  3. 3University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany
  4. 4partner site Mannheim – Heidelberg – Ulm, Mannheim, Germany
  5. 5Social Foundation Bamberg, Germany
  6. 6University Hospital of Würzburg, Germany
  7. 7Lausanne University Hospital and University of Lausanne, Switzerland
  8. 8Psychiatric University Hospital Zürich, ZH, Switzerland
  9. 9University Medical Center Mainz, Germany
  10. 10University of Göttingen, Faculty of Medicine, NDS, Germany
  11. 11Regena Private Clinic Bad Brückenau, Germany
  12. 12Trier University, Germany
  13. 13University Hospital Heidelberg, Germany
  14. 14Krankenhaus Mara gGmbh, NRW, Germany
  15. 15University of Freiburg, Germany
  16. 16Bolzano Hospital, Trentino-Alto Adige, Italy
  17. 17Klinikum am Weissenhof, BW, Germany
  18. 18BKH Kaufbeuren, Germany
  19. 19Reinier van Arkel groep’s, Netherlands
  20. 20University of Würzburg, BY, Germany
  21. 21Klinikum Starnberg, BY, Germany
  22. 22Vitos Clinic for Forensic Psychiatry, HE, Germany
  23. 23Institut AGATE gGmbH, Germany
  24. 24Universität Regensburg, Germany
  25. 25Goethe-Universität Frankfurt am Main, Germany
  26. 26Varisano Hospital Frankfurt Hoechst, Germany
  27. 27Vitos Clinic for Forensic Psychiatry, Germany
  28. 28Parkinson-Klinik Ortenau GmbH & Co. KG, BW, Germany
  29. 29Saarland University, SL, Germany
  30. 30Oberberg Specialist Clinic Rhein-Jura, Germany
  31. 31Institute of Psychological Medicine, Germany
  32. 32Ludwig Maximilian University of Munich, BY, Germany
  33. 33MVZ Waldkraiburg of Mühldorf Clinics/Hospital, Germany
  34. 34German Center for Mental Health (DZPG), partner site Munich/Augsburg (FKZ 1EE2503B 2025-2030 and FKZ 01EE2303B 2023-2025), BY, Germany
  35. 35TUM School of Medicine and Health, Technical University of Munich, BY, Germany
  36. 36Medical Park Chiemseeblick in Bernau-Felden, BY, Germany
  37. 37Danuviusklinik Pfaffenhofen, Germany
  38. 38German Center for Mental Health Tübingen, BW, Germany
  39. 39University of Toronto, Canada
  40. 40St. Joseph Hospital Berlin Weissensee, BE, Germany

Abstract

TDM involves measuring and interpreting drug concentrations in blood plasma or serum to optimize pharmacotherapy. In psychiatry and neurology, TDM is a well-established tool for personalized drug treatments. The AGNP-TDM task force initially published guidelines for best practice TDM in 2004, 2011, and 2017. A fundamental methodological revision has now been carried out on how to determine therapeutic reference ranges and dose-related reference ranges transparently and systematically. In the current edition, 50 experts in neuropsychopharmacology offer a complete update of both ranges for each substance following an evidence-based approach. Various types of data were considered for reference range determination, ranging from meta-analyses to drug concentrations expected under recommended doses. Therapeutic reference ranges are now listed for 160 neuropsychiatric drugs, newly included for 30 drugs and revised for 88 drugs. Expected drug concentrations can be calculated based on a revised formula for 162 drugs. Obligatory TDM (i.e. for dose titration) is strongly recommended for 15 neuropsychiatric drugs and recommended for 39 drugs. TDM is classified as useful for 49 drugs and potentially useful for 62 drugs, indicating that it is recommended in specific clinical situations, such as suspected non-adherence, insufficient clinical response despite recommended doses, relapse during maintenance treatment, and many more. The 2026 update includes practical pharmacogenetic recommendations that are directly relevant to TDM. This work integrates a combination of strategies to guide drug treatments in clinical practice using all available tools. A consistent implementation of TDM and pharmacogenetic recommendations will enhance neuropsychopharmacotherapy, improve patient outcomes, and reduce healthcare costs.

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BibTeX
@article{hart2026consensus,
  title = {{Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2026 – Pharmacokinetic, pharmacogenetic and clinical aspects}},
  author = {Xenia Marlene Hart and Gerhard Gründer and Stefan Unterecker and Georgios Schoretsanitis and Christoph Hiemke and I Adamovic and Friederike Amann and Pierre Baumann and Niels Bergemann and Christian Brandt and Hans‐Willi Clement and Andreas Conca and Jürgen Deckert and Otto Dietmaier and Gabriel Eckermann and Karin Maria Egberts and Katharina Endres and Nicole Erlacher and Stefanie Fekete and Stefano Ferrea and Vincenzo Florio and Manfred Gerlach and Ekkehard Haen and Martina Hahn and Ursula Havemann‐Reinecke and Gudrun Hefner and Wolfgang H. Jost and M. I. Kuzin and Gerd Laux and Stefan Leucht and Ignazio Maniscalco and Andreas Menke and Thomas Messer and Rainald Moessner and Daniel J. Müller and Thomas Müller and Michael Paulzen and Holger Petri and Philippe Pfeifer and Bruno Pfuhlmann and Peter Riederer and Sibylle Christine Roll and Maike Scherf‐Clavel and Markus Schwarz and Werner Steimer and Julia Stingl and Sermin Toto and Sven Ulrich and Gerald Zernig and Gabriela Zurek},
  journal = {Pharmacopsychiatry},
  year = {2026},
  month = jul,
  doi = {10.1055/a-2860-7861},
  url = {https://doi.org/10.1055/a-2860-7861},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2026 – Pharmacokinetic, pharmacogenetic and clinical aspects
AU  - Xenia Marlene Hart
AU  - Gerhard Gründer
AU  - Stefan Unterecker
AU  - Georgios Schoretsanitis
AU  - Christoph Hiemke
AU  - I Adamovic
AU  - Friederike Amann
AU  - Pierre Baumann
AU  - Niels Bergemann
AU  - Christian Brandt
AU  - Hans‐Willi Clement
AU  - Andreas Conca
AU  - Jürgen Deckert
AU  - Otto Dietmaier
AU  - Gabriel Eckermann
AU  - Karin Maria Egberts
AU  - Katharina Endres
AU  - Nicole Erlacher
AU  - Stefanie Fekete
AU  - Stefano Ferrea
AU  - Vincenzo Florio
AU  - Manfred Gerlach
AU  - Ekkehard Haen
AU  - Martina Hahn
AU  - Ursula Havemann‐Reinecke
AU  - Gudrun Hefner
AU  - Wolfgang H. Jost
AU  - M. I. Kuzin
AU  - Gerd Laux
AU  - Stefan Leucht
AU  - Ignazio Maniscalco
AU  - Andreas Menke
AU  - Thomas Messer
AU  - Rainald Moessner
AU  - Daniel J. Müller
AU  - Thomas Müller
AU  - Michael Paulzen
AU  - Holger Petri
AU  - Philippe Pfeifer
AU  - Bruno Pfuhlmann
AU  - Peter Riederer
AU  - Sibylle Christine Roll
AU  - Maike Scherf‐Clavel
AU  - Markus Schwarz
AU  - Werner Steimer
AU  - Julia Stingl
AU  - Sermin Toto
AU  - Sven Ulrich
AU  - Gerald Zernig
AU  - Gabriela Zurek
PY  - 2026
DA  - 2026/07/01
JO  - Pharmacopsychiatry
DO  - 10.1055/a-2860-7861
UR  - https://doi.org/10.1055/a-2860-7861
AB  - TDM involves measuring and interpreting drug concentrations in blood plasma or serum to optimize pharmacotherapy. In psychiatry and neurology, TDM is a well-established tool for personalized drug treatments. The AGNP-TDM task force initially published guidelines for best practice TDM in 2004, 2011, and 2017. A fundamental methodological revision has now been carried out on how to determine therapeutic reference ranges and dose-related reference ranges transparently and systematically. In the current edition, 50 experts in neuropsychopharmacology offer a complete update of both ranges for each substance following an evidence-based approach. Various types of data were considered for reference range determination, ranging from meta-analyses to drug concentrations expected under recommended doses. Therapeutic reference ranges are now listed for 160 neuropsychiatric drugs, newly included for 30 drugs and revised for 88 drugs. Expected drug concentrations can be calculated based on a revised formula for 162 drugs. Obligatory TDM (i.e. for dose titration) is strongly recommended for 15 neuropsychiatric drugs and recommended for 39 drugs. TDM is classified as useful for 49 drugs and potentially useful for 62 drugs, indicating that it is recommended in specific clinical situations, such as suspected non-adherence, insufficient clinical response despite recommended doses, relapse during maintenance treatment, and many more. The 2026 update includes practical pharmacogenetic recommendations that are directly relevant to TDM. This work integrates a combination of strategies to guide drug treatments in clinical practice using all available tools. A consistent implementation of TDM and pharmacogenetic recommendations will enhance neuropsychopharmacotherapy, improve patient outcomes, and reduce healthcare costs.
SN  - 0176-3679
SN  - 1439-0795
ER  -