SPCCTDM, a Catalogue for Analysis of Therapeutic Drug Monitoring Related Contents in the Drug Prescription Information

SPCCTDM, a Catalogue for Analysis of Therapeutic Drug Monitoring Related Contents in the Drug Prescription Information

Sven Ulrich (Pharmaceutical Consultant, Germany), Pierre Baumann (University of Lausanne, Switzerland), Andreas Conca (Regional Hospital of Bolzano, Italy), Hans-Joachim Kuss (University of Munich, Germany), Viktoria Stieffenhofer (University of Mainz, Germany) and Christoph Hiemke (University of Mainz, Germany)
Copyright: © 2010 |Pages: 11
DOI: 10.4018/jkdb.2010040101
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Abstract

Therapeutic drug monitoring (TDM) has consistently been shown to be useful for optimization of drug therapy. For the first time, a method has been developed for the text analysis of TDM in SPCs in that a catalogue SPC-ContentTDM (SPCCTDM) provides a codification of the content of TDM in SPCs. It consists of six structure-related items (dose, adverse drug reactions, drug interactions, overdose, pregnancy/breast feeding, and pharmacokinetics) according to implicit or explicit references to TDM in paragraphs of the SPC, and four theory-guided items according to the information about ranges of plasma concentrations and a recommendation of TDM in the SPC. The catalogue is regarded as valid for the text analysis of SPCs with respect to TDM. It can be used in the comparison of SPCs, in the comparison with medico-scientific evidence and for the estimation of the perception of TDM in SPCs by the reader. Regarding the approach as a model of text mining, it may be extended for evaluation of other aspects reported in SPCs.
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Methods And Results

SPC analysis was done by a recently established algorithm as described in the SPCCTDM-catalogue (Ulrich, 2009). Briefly, the SPC-paragraphs “dose” (item 1), “adverse drug reactions” (item 2), “drug interactions” (item 3), “overdose” (item 4), “pregnancy/breast feeding” (item 5), and “pharmacokinetics” (item 6) are assessed in a manual process for the occurrence of implicit (1 point) or explicit (2 points) references to TDM (0 points for no references to TDM). Thus, items 1 to 6 are analysed strictly according to the paragraphs of the SPC.

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