Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017

C Hiemke^{1

2}, N Bergemann³, H W Clement⁴, A Conca⁵, J Deckert⁶, K Domschke⁷, G Eckermann⁸, K Egberts⁹, M Gerlach⁹, C Greiner¹⁰, G Gründer¹¹, E Haen¹², U Havemann-Reinecke¹³, G Hefner¹⁴, R Helmer¹⁵, G Janssen¹⁶, E Jaquenoud¹⁷, G Laux¹⁸, T Messer¹⁹, R Mössner²⁰, M J Müller²¹, M Paulzen¹¹, B Pfuhlmann²², P Riederer⁶, A Saria²³, B Schoppek²⁴, G Schoretsanitis²⁵, M Schwarz²⁶, M Silva Gracia¹², B Stegmann¹², W Steimer²⁷, J C Stingl¹⁰, M Uhr²⁸, S Ulrich²⁹, S Unterecker⁶, R Waschgler³⁰, G Zernig^{23

31}, G Zurek³², P Baumann³³

Affiliations

¹ Department of Psychiatry and Psychotherapy, University Medical Center of Mainz, Mainz, Germany.
² Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center of Mainz, Mainz, Germany.
³ Kitzberg Hospitals, Center for Psychosomatic Medicine and Psychotherapy, Bad Mergentheim, Germany.
⁴ Department of Child and Adolescent Psychiatry, University of Freiburg, Freiburg, Germany.
⁵ Servizio Psichiatrico del Comprensorio Sanitario di Bolzano, Bolzano, Italy.
⁶ Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Würzburg, Germany.
⁷ Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
⁸ Psychiatric Hospital, Kaufbeuren, Germany.
⁹ Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Germany.
¹⁰ Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
¹¹ Department of Psychiatry, Psychotherapy and Psychosomatics, RWTH Aachen University, Aachen, and JARA - Translational Brain Medicine, Aachen, Germany.
¹² Clinical Pharmacology, Department of Psychiatry and Psychotherapy and Department of Pharmacology and Toxicology, University of Regensburg, Regensburg, Germany.
¹³ Department of Psychiatry and Psychosomatics, University of Göttingen, Göttingen, Germany.
¹⁴ Psychiatric Hospital, Vitos Klinik, Eichberg, Eltville, Germany.
¹⁵ Center of Epilepsy, Bielefeld, Germany.
¹⁶ Medical Laboratory Stein, Limbach Group, Mönchengladbach, Germany.
¹⁷ Psychiatric Hospital, Königsfelden, Brugg, Aargau, Switzerland.
¹⁸ Institute of Psychological Medicine, Haag in Oberbayern, Germany.
¹⁹ Danuviuskliniken, Psychiatric Hospital, Pfaffenhofen, Germany.
²⁰ Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.
²¹ Psychiatric Hospitals Oberberggruppe, Berlin, Germany.
²² Psychiatric Hospital Weisser Hirsch, Dresden, Germany.
²³ Experimental Psychiatry Unit, Department of Psychiatry 1, Medical University of Innsbruck, Innsbruck, Austria.
²⁴ kbo-Isar-Amper Klinikum München-Ost, Psychiatric Hospital, Munich-Haar, Germany.
²⁵ Department of Psychiatry, University of Bern, Bern, Switzerland.
²⁶ Department of Laboratory Medicine, Ludwig Maximilian University, Munich, Germany.
²⁷ Institute of Clinical Chemistry and Pathobiochemistry, Technical University Munich, Munich, Germany.
²⁸ Max Planck Institute of Psychiatry, Munich, Germany.
²⁹ Aristo Pharma GmbH, Berlin, Germany.
³⁰ Psychiatric Hospital, Feldkirch, Austria.
³¹ Private Practice for Psychotherapy and Court-Certified Witness, Hall in Tirol, Austria.
³² Medical Laboratory Bremen, Bremen, Germany.
³³ Department of Psychiatry, University of Lausanne, Prilly-Lausanne, Switzerland.

PMID: 28910830
DOI: 10.1055/s-0043-116492

Free article

Review

Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017

C Hiemke et al. Pharmacopsychiatry. 2018 Jan.

Free article

. 2018 Jan;51(1-02):9-62.

doi: 10.1055/s-0043-116492. Epub 2017 Sep 14.

Authors

Affiliations

¹ Department of Psychiatry and Psychotherapy, University Medical Center of Mainz, Mainz, Germany.
² Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center of Mainz, Mainz, Germany.
³ Kitzberg Hospitals, Center for Psychosomatic Medicine and Psychotherapy, Bad Mergentheim, Germany.
⁴ Department of Child and Adolescent Psychiatry, University of Freiburg, Freiburg, Germany.
⁵ Servizio Psichiatrico del Comprensorio Sanitario di Bolzano, Bolzano, Italy.
⁶ Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Würzburg, Germany.
⁷ Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
⁸ Psychiatric Hospital, Kaufbeuren, Germany.
⁹ Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Germany.
¹⁰ Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany.
¹¹ Department of Psychiatry, Psychotherapy and Psychosomatics, RWTH Aachen University, Aachen, and JARA - Translational Brain Medicine, Aachen, Germany.
¹² Clinical Pharmacology, Department of Psychiatry and Psychotherapy and Department of Pharmacology and Toxicology, University of Regensburg, Regensburg, Germany.
¹³ Department of Psychiatry and Psychosomatics, University of Göttingen, Göttingen, Germany.
¹⁴ Psychiatric Hospital, Vitos Klinik, Eichberg, Eltville, Germany.
¹⁵ Center of Epilepsy, Bielefeld, Germany.
¹⁶ Medical Laboratory Stein, Limbach Group, Mönchengladbach, Germany.
¹⁷ Psychiatric Hospital, Königsfelden, Brugg, Aargau, Switzerland.
¹⁸ Institute of Psychological Medicine, Haag in Oberbayern, Germany.
¹⁹ Danuviuskliniken, Psychiatric Hospital, Pfaffenhofen, Germany.
²⁰ Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.
²¹ Psychiatric Hospitals Oberberggruppe, Berlin, Germany.
²² Psychiatric Hospital Weisser Hirsch, Dresden, Germany.
²³ Experimental Psychiatry Unit, Department of Psychiatry 1, Medical University of Innsbruck, Innsbruck, Austria.
²⁴ kbo-Isar-Amper Klinikum München-Ost, Psychiatric Hospital, Munich-Haar, Germany.
²⁵ Department of Psychiatry, University of Bern, Bern, Switzerland.
²⁶ Department of Laboratory Medicine, Ludwig Maximilian University, Munich, Germany.
²⁷ Institute of Clinical Chemistry and Pathobiochemistry, Technical University Munich, Munich, Germany.
²⁸ Max Planck Institute of Psychiatry, Munich, Germany.
²⁹ Aristo Pharma GmbH, Berlin, Germany.
³⁰ Psychiatric Hospital, Feldkirch, Austria.
³¹ Private Practice for Psychotherapy and Court-Certified Witness, Hall in Tirol, Austria.
³² Medical Laboratory Bremen, Bremen, Germany.
³³ Department of Psychiatry, University of Lausanne, Prilly-Lausanne, Switzerland.

PMID: 28910830
DOI: 10.1055/s-0043-116492

Erratum in

Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017.
Hiemke C, Bergemann N, Clement HW, Conca A, Deckert J, Domschke K, Eckermann G, Egberts K, Gerlach M, Greiner C, Gründer G, Haen E, Havemann-Reinecke U, Hefner G, Helmer R, Janssen G, Jaquenoud E, Laux G, Messer T, Mössner R, Müller MJ, Paulzen M, Pfuhlmann B, Riederer P, Saria A, Schoppek B, Schoretsanitis G, Schwarz M, Gracia MS, Stegmann B, Steimer W, Stingl JC, Uhr M, Ulrich S, Unterecker S, Waschgler R, Zernig G, Zurek G, Baumann P. Hiemke C, et al. Pharmacopsychiatry. 2018 Jan;51(1-02):e1. doi: 10.1055/s-0037-1600991. Epub 2018 Feb 1. Pharmacopsychiatry. 2018. PMID: 29390205 No abstract available.

Abstract

Therapeutic drug monitoring (TDM) is the quantification and interpretation of drug concentrations in blood to optimize pharmacotherapy. It considers the interindividual variability of pharmacokinetics and thus enables personalized pharmacotherapy. In psychiatry and neurology, patient populations that may particularly benefit from TDM are children and adolescents, pregnant women, elderly patients, individuals with intellectual disabilities, patients with substance abuse disorders, forensic psychiatric patients or patients with known or suspected pharmacokinetic abnormalities. Non-response at therapeutic doses, uncertain drug adherence, suboptimal tolerability, or pharmacokinetic drug-drug interactions are typical indications for TDM. However, the potential benefits of TDM to optimize pharmacotherapy can only be obtained if the method is adequately integrated in the clinical treatment process. To supply treating physicians and laboratories with valid information on TDM, the TDM task force of the Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP) issued their first guidelines for TDM in psychiatry in 2004. After an update in 2011, it was time for the next update. Following the new guidelines holds the potential to improve neuropsychopharmacotherapy, accelerate the recovery of many patients, and reduce health care costs.

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Conflict of interest statement

Christoph Hiemke has received speaker’s and consultancy fees from Janssen, Stada, Servier. He is managing director of the psiac GmbH (www.psiac.de) which provides an internet based drug-drug interaction program. Pierre Baumann has received speaker’s or consultancy fees from almost all pharmaceutical companies selling psychotropic drugs in Switzerland. Niels Bergemann received speaker‘s or consultancy fees and/or educational grants from AstraZeneca, Bristol-Myers Squibb, Janssen, Lilly, Otsuka, Pfizer, Servier. Andreas Conca has served as a consultant for Lilly, Bristol-Myers Squibb, Pfizer. He has served on the speakers’ bureau of Lilly, BMS, Astra Zeneca, Lundbeck, Italfarma, Janssen. Gabriel Eckermann has received speaker’s fees from almost all pharmaceutical companies selling psychotropic drugs in Germany. He is shareholder of the psiac GmbH (www.psiac.de), which provides an internet based drug-drug interaction program. Karin Egberts participated in performing clinical trials for AstraZeneca, Janssen-Cilag, Lilly, Shire and has received research grants pertaining to pharmacovigilance in children and adolescents from the German Federal Institute for Drugs and Medical Devices. Ursula Havemann-Reinecke has received speaker’s and consultancy fees and unrestricted educational grants from AstraZeneca, Bristol-Myers Squibb, Cephalon, Essex, Janssen Cilag, Lundbeck, Pfizer, Schering-Plough, Wyeth. Ekkehard Haen is chairman and managing director of the AGATE (www.amuep-agate.de) that supports reasonable and economic drug therapy. He is shareholder of the psiac GmbH (www.psiac.de), which provides an internet based drug-drug interaction program. Manfred Gerlach has received research grants pertaining to pharmacovigilance in children and adolescents from the German Federal Institute for Drugs and Medical Devices. He has also received royalties from Springer Vienna for editing a German and English textbook on child and adolescent psychiatry. Gerhard Gründer has served as a consultant for Astra Zeneca, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Otsuka. He has served on the speakers’ bureau of Astra Zeneca, Bristol-Myers Squibb, Eli Lilly, Janssen Cilag, Otsuka, Pfizer, Servier, Wyeth. He has received grant support from Alkermes, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson. He is co-founder of Pharma-Image – Molecular Imaging Technologies GmbH. Eveline Jaquenoud is a member of mediQ (www.mediq.ch) which provides an internet based drug-drug interaction program for psychiatry. Gerd Laux has received speaker’s or consultancy fees or unrestricted educational grants from AstraZeneca, Bayer, Eli Lilly, Lundbeck, Merz, Pfizer, Servier, Wyeth. Thomas Messer has received speaker’s or consultancy fees or unrestricted educational grants from Eli Lilly, Bristol-Myers Squibb, Janssen, Servier, Pfizer, Lundbeck, Bayer Vital Health Care. Matthias J. Müller has received speaker’s or consultancy fees from Janssen, Lundbeck, Servier. Bruno Pfuhlmann has received speaker’s or consultancy fees from AstraZeneca, Janssen, Pfizer. Sven Ulrich is an employee of Ariston Pharma GmbH, Berlin, Germany. Gerald Zernig has received speaker’s or consultancy fees or educational grants from AlcaSynn, AstraZeneca, Bio-Rad, Bristol-Myers Squibb, Eli Lilly, Lundbeck, Mundipharma, Novartis, Pfizer, Wyeth. Hans Willi Clement, Jürgen Deckert, Katharina Domschke, Christine Greiner, Gudrun Hefner, Renate Helmer, Ger Janssen, Rainold Mössner, Michael Paulzen, Peter Riederer, Alois Saria, Bernd Schoppek, Georgios Schoretsanitis, Markus Schwarz, Margarete Silva Gracia, Benedikt Stegmann, Werner Steimer, Julia C. Stingl, Manfred Uhr, Stefan Unterecker and Roland Waschgler were not supported by pharmaceutical industry.

Comment in

[Unappropriate recommendation grades for carbamazepine and valproate].
Greil W. Greil W. Nervenarzt. 2020 Jan;91(1):73-74. doi: 10.1007/s00115-019-0763-x. Nervenarzt. 2020. PMID: 31324933 German. No abstract available.

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Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017

Affiliations

Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017

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