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Monitoring of Plasma Concentrations of Psychotropic Drugs in Pharmacovigilance

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Pharmacovigilance in Psychiatry

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Abstract

The primary aims of pharmacovigilance are supervision and prevention of medication-related problems under everyday conditions. Pharmacovigilance is an indication for monitoring plasma concentrations, i.e. conducting therapeutic drug monitoring (TDM). Using TDM, it can be clarified if observed unwanted drug effects may be attributed to abnormally high or low drug concentrations. Utmost benefits from TDM are obtained for pharmacovigilance when the method is adequately integrated into the clinical treatment process. How to do this is described in consensus guidelines for TDM in psychiatry. During the last 20 years, TDM was very successful for detection of multiple pharmacokinetic drug-drug interactions. Many of them were discovered in individual cases. This gave rise to systematic prospective studies to verify or falsify such observations. Confirmatory studies, however, are critical when drug combinations are potentially harmful. Then TDM databases should be used for retrospective analysis. They enable to study retrospectively the safety and tolerability of psychotropic drugs and drug combinations taken in a broad spectrum of patients, including risk patients like children or adolescent patients, old-aged patients or patients with comorbid diseases. For such studies, however, TDM databases must contain not only laboratory but also clinical data. This is actually quite rare. Work in this regard is necessary. When functioning TDM software is available and TDM is widely used in psychiatry, data can be pooled to emerge large databases for data mining. TDM has thus the potential to be and become a valuable part of pharmacovigilance.

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Authors and Affiliations

  1. Department of Psychiatry and Psychotherapy, University Medical Center of Mainz, Untere Zahlbacher Str. 8, Mainz, 55101, Germany

    Christoph Hiemke

  2. Department of Psychiatry and Psychotherapy and Department of Pharmacology and Toxicology, University of Regensburg, Universitätsstr. 31, Regensburg, 93053, Germany

    Ekkehard Haen

  3. Institute AGATE e.V., Nelkenweg 10, Pentling, 93080, Germany

    Ekkehard Haen

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  1. Christoph Hiemke
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Correspondence to Christoph Hiemke .

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  1. University of Messina, Department of Clinical and Experimental Medicine, Messina, Italy

    Edoardo Spina

  2. University of Messina, Department of Clinical and Experimental Medicine, Messina, Italy

    Gianluca Trifirò

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Hiemke, C., Haen, E. (2016). Monitoring of Plasma Concentrations of Psychotropic Drugs in Pharmacovigilance. In: Spina, E., Trifirò, G. (eds) Pharmacovigilance in Psychiatry. Adis, Cham. https://doi.org/10.1007/978-3-319-24741-0_6

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