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

S. Ulrich; C. Hiemke; G. Laux; B. Müller-Oerlinghausen; U. Havemann-Reinecke; P. Riederer; G. Zernig; P. Baumann; TDM group of the Arbeitsgemeinschaft Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP)

doi:10.1055/s-2007-977712

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

Original Paper

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

S. Ulrich¹ , C. Hiemke² , G. Laux³ , B. Müller-Oerlinghausen⁴ , U. Havemann-Reinecke⁵ , P. Riederer⁶ , G. Zernig⁷ , P. Baumann⁸ , 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

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 (SPCC_TDM) 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

Full Text

References

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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