Pharmacovigilance and therapeutic drug monitoring

Our projects pursue the goal of improving the safety and effectiveness of drug therapy for children and adolescents with mental illness. For several commonly used substances, we have already been able to propose age- or indication-specific therapeutic serum level ranges for children and adolescents.

Background

Research projects of the ‘AG TDM’ aim to optimize the safety and effectiveness of drug therapies in children and adolescents with psychiatric disorders. Except for stimulants, most psychotropic drugs are not approved for children and adolescents and are administered off-label. However, kids are not “small adults”, which is why for example dosages or therapeutic concentration ranges cannot simply be derived from data from adults. Systematic research on the use of these drugs must also carried out for this age group.

Research in the TDM Lab

In the joint special laboratory for Therapeutic Drug Monitoring (TDM) of the Center for Mental Health at the UKW, we examine the relationships between dose, drug concentration, therapeutic effect and adverse drug reactions (ADRs) for various psychotropic drugs in use for different indications and patient groups. We also test the suitability of child-friendly, alternative matrices for measuring concentrations (for example saliva, tear fluid). Our working group has already been able to suggest age- and indication-specific therapeutic serum levels for children and adolescents for various frequently used substances.

Study TDM-VIGIL

In order to expand upon drug safety data for child and adolescent psychiatry using a prospective, systematic approach, the multicenter pharmacovigilance study 'TDM-VIGIL' (subproject 1 as a phase IIIb clinical trial, subproject 2 as an observational study) was carried out under the direction of our clinic. This project is funded by the Institute for Drugs and Medical Devices (BfArM). Epidemiological data from 1.200 children and adolescents treated with various psychotropic drugs were collected using standardized psychometric instruments.

Competence Network TDM

Our working group cooperates in a leading role with the “Competence Network TDM in Child and Adolescent Psychiatry”, an international research group of 42 child and adolescent psychiatric hospitals from five European countries and which operates an internet-based database (TDM patient registry). From the naturalistic data generated independently of the product-developing industry, treatment recommendations for optimized patient care should be derived as an essential supplement to the results of randomized controlled clinical trials.

Network Project KIDsafe

A drug information system is being introduced in various regions in Germany as part of the Network Projekt KIDsafe. This project aims to reduce inpatient stays in pediatric clinics due to side effects. The Clinic and Polyclinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy (CAPPP) Würzburg is the only child and adolescent psychiatric consortium partner and is investigating the applicability of the information system to the psychopharmacological treatment of children and adolescents in a subproject. KIDsafe is supported by the Innovation Fund of the Federals Joint Committee (G-BA).

Research Team

Leader:
Prof. Dr. med. Marcel Romanos

Team:
Dr. med. Karin Egberts
Dr. med. Stefanie Fekete
PD Dr. med. Regina Taurine
Prof. Dr. rer. nat. Manfred Gerlach, Emeritus
Rainer Burger, Medical Technical Assistant (MTA)
Malin Hager, Assistant Scientist (Hiwi)

Doctoral Students:
Tim Güntzel
Gesa Kunkel
Sophie Charlotte Ortsmann
Tom Rösch
Monika Schrauth
Wiebke Warrings
Christopher Wohkittel

Selected Publications

Egberts K, Karwautz A, Plener PL, Mehler-Wex C, Kölch M, Dang SY, Taurines R, Romanos M, Gerlach M
[Pharmacovigilance in child and adolescent psychiatry].
Z Kinder Jugendpsychiatr Psychother. 2015 Jan; 43(1):21-8
Go to publication

Wohkittel C, Gerlach M, Taurines R, Wewetzer C, Unterecker S, Burger R, Schreck D, Mehler-Wex C, Romanos M, Egberts K
Relationship between clozapine dose, serum concentration, and clinical outcome in children and adolescents in clinical practice.
J Neural Transm. 2016 Aug; 123(8):1021-31
Go to publication

Gerlach M, Egberts K, Dang SY, Plener P, Taurines R, Mehler-Wex C, Romanos M
Therapeutic drug monitoring as a measure of proactive pharmacovigilance in child and adolescent psychiatry.
Expert Opin Drug Saf. 2016 Nov; 15(11):1477-1482
Go to publication

Hiemke C, (...) Egberts K, Gerlach M et al.
Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology: Update 2017.
Pharmacopsychiatry. 2018 Jan; 51(1-02):9-62
Go to publication

Contact

Portraitfoto von Univ. Prof. Dr. med. Marcel Romanos

Univ.-Prof. Dr. med.
Marcel Romanos

Klinikdirektor Kinder- und Jugendpsychiatrie

+49 931 201-78000

Portraitfoto von Dr. med. Stefanie Fekete

Dr. med.
Stefanie Fekete

Funktionsoberärztin

+49 931 201-78010

Contact

Telefon

Klinik und Poliklinik für KJPPP
Poliklinik und Privatambulanz
+49 931 201-78600

Zentrale Dienstnummer & Dienstarzt
+49 931 201-78888

Pforte Zentrum für Psychische Gesundheit
+49 931 201-76050

Sekretariat Tagesklinik
+49 931 250-8040

Direktion
Prof. Dr. Marcel Romanos
+49 931 201-78000

Stellvertretende Direktion
PD Dr. Regina Taurines
+49 931 201-78010

E-Mail

Direktion / Prof. Dr. Marcel Romanos
kj_office@ ukw.de 

PD Dr. Regina Taurines
taurines_r@ ukw.de

Fax

Direktion
+49 931 201-78040

Ambulanzsekretariat
+49 931 201-78620


Anschrift

Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie des Universitätsklinikums | Margarete-Höppel-Platz 1 | 97080 Würzburg | Deutschland

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