Instructies voor monitoren van klinische parameters in de registratieteksten van psychofarmaca: Overzicht en toepasbaarheid voor de klinische praktijk

Abstract

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