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1.
World J Biol Psychiatry. 2018 Apr;19(3):162-174. doi: 10.1080/15622975.2018.1439595. Epub 2018 Mar 1.

TDM in psychiatry and neurology: A comprehensive summary of the consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology, update 2017; a tool for clinicians<sup/>.

Author information

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.

KEYWORDS:

Therapeutic drug monitoring; drug therapy; neuropsychopharmacology; pharmacokinetics; pharmacovigilance

PMID:
29493375
DOI:
10.1080/15622975.2018.1439595
[Indexed for MEDLINE]
Icon for Taylor & Francis
2.
Pharmacopsychiatry. 2018 Jan;51(1-02):e1. doi: 10.1055/s-0037-1600991. Epub 2018 Feb 1.

Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017.

Author information

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.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

3.
Pharmacopsychiatry. 2018 Jan;51(1-02):9-62. doi: 10.1055/s-0043-116492. Epub 2017 Sep 14.

Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017.

Author information

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.

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.

PMID:
28910830
DOI:
10.1055/s-0043-116492
[Indexed for MEDLINE]
Free full text
Icon for Georg Thieme Verlag Stuttgart, New York

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.

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