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Pharmacopsychiatry 2007; 40(3): 121-127
DOI: 10.1055/s-2007-977712
Original Paper

© Georg Thieme Verlag KG Stuttgart · New York

Value and Actuality of the Prescription Information for Therapeutic Drug Monitoring of Psychopharmaceuticals: A Comparison with the Medico-Scientific Evidence

S. Ulrich 1 , C. Hiemke 2 , G. Laux 3 , B. Müller-Oerlinghausen 4 , U. Havemann-Reinecke 5 , P. Riederer 6 , G. Zernig 7 , P. Baumann 8 , TDM group of the Arbeitsgemeinschaft Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP)[*]
  • 1esparma GmbH Osterweddingen, Germany
  • 2Psychiatric Clinic University Hospital Mainz, Mainz, Germany
  • 3Psychiatric Clinic Gabersee, Wasserburg/Inn, Germany
  • 4Drug Commission of the German Medical Association Berlin, Germany
  • 5Psychiatric Clinic University Hospital Göttingen, Göttingen, Germany
  • 6Psychiatric Clinic University Hospital Würzburg, Würzburg, Germany
  • 7Experimental Psychiatry Unit, Department of Psychiatry, Medical University Innsbruck, Austria
  • 8Psychiatric Clinic University Hospital Prilly-Lausanne, Switzerland
Further Information

Publication History

received 29. 3. 2007 revised 2. 4. 2007

accepted 4. 4. 2007

Publication Date:
01 June 2007 (online)

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Abstract

Therapeutic drug monitoring (TDM) of psychopharmaceuticals, i.e., the assay of plasma concentrations, is a practical therapeutic application of pharmacokinetic principles in psychiatry. The prescription information (summary of product characteristics, SPC) is provided by pharmaceutical companies according to the requirements of regulatory authorities. The present study investigated the degree of agreement of German SPCs for 48 psychopharmaceuticals with the existing medico-scientific evidence in the area of TDM. For this aim, an empirical summary score of SPC content related to TDM (SPCCTDM) was calculated and compared with the level of recommendation of TDM (LOR) of the AGNP-TDM expert group consensus guidelines. Considerable disagreement was found between the information on TDM in SPCs and existing medico-scientific evidence, e.g., in the case of antidepressant and antipsychotic drugs. Even for well studied compounds, such as amitriptyline and clozapine, insufficient information on TDM is included in German SPCs. Small differences existed in the TDM-related information in SPCs of generic drugs with, however, much variance between Germany, Austria and Switzerland. Generally, it must be concluded that deficits exist in the preparation of German SPCs for psychopharmaceutical drugs with respect to empirical pharmacokinetic data, i.e., TDM-relevant information. It is recommended that SPCs of psychopharmaceuticals should be improved in terms of TDM-related information and that target plasma concentrations be adjusted according to the guidelines of the AGNP-TDM expert group. A higher level of good pharmacokinetic practice may be thus achieved.

Key words

therapeutic drug monitoring - prescription information - pharmacovigilance - amitriptyline - haloperidol

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1 Other members of the AGNP-TDM expert group N. Bergemann, Heidelberg; M. Dobmeier, Cham; G. Eckermann, Kaufbeuren; M. Gerlach, Würzburg; E. Haen, Regensburg; E. Jaquenoud-Sirot, Königsfelden; M. Köhnke, Rostock; H. J. Kuss, München; T. Messer, Augsburg; B. Pfuhlmann, Würzburg; M. L. Rao, Bonn; B. Schoppek, Haar, M. Schwarz, München

Correspondence

PD Dr. S. Ulrich

Lange Göhren 3

39 171 Osterweddingen

Germany

Phone: 039/205/422 143

Fax: 039/205/422 222

Email: s.ulrich@esparma.de

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