Instructions for monitoring clinical parameters in the Summary of Product Characteristics (SmPC) for psychotropic drugs: overview and applicability for clinical practice

The Summary of Product Characteristics (Smpc) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. To evaluate which monitoring instructions are given in the Smpc and to assess the applicability in clinical practice....

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Bibliographic Details
Published inTijdschrift voor psychiatrie Vol. 58; no. 8; p. 593
Main Authors Nederlof, M, Stoker, L J, Egberts, A C G, Heerdink, E R
Format Journal Article
LanguageDutch
Published Netherlands 2016
Subjects
Biomarkers - analysis
Drug Labeling
Drug Monitoring - methods
Humans
Patient Safety
Psychotropic Drugs - analysis
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Summary:The Summary of Product Characteristics (Smpc) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. To evaluate which monitoring instructions are given in the Smpc and to assess the applicability in clinical practice. The reasons and requirements for monitoring in Smpcs for psychotropic drugs were assessed and somatic parameters were distinguished from non-somatic parameters, thereby the applicability was assessed. An average of 3.3 instructions per drug label was found. Monitoring was primarily for safety reasons (78%). Requirement was predominantly mandatory (71%). Somatic parameters were most often mentioned (80%). Only 34% of the instructions were determined applicable. Monitoring instructions for psychotropic drugs are aimed at improving safe use. However, most instructions on monitoring do not provide sufficient information to be applicable in clinical practice.
ISSN:0303-7339