title: [Instructions for monitoring clinical parameters in the Summary of Product Characteristics (SmPC) for psychotropic drugs: overview and applicability for clinical practice].
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.<br/>
  
  
  OBJECTIVE
  To evaluate which monitoring instructions are given in the Smpc and to assess the applicability in clinical practice.<br/>
  
  
  METHODS
  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.<br/>
  
  
  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. <br/>
  
  
  CONCLUSIONS
  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.
authors.forename: M
authors.initials: M
authors.lastname: Nederlof
authors.forename: L J
authors.initials: LJ
authors.lastname: Stoker
authors.forename: A C G
authors.initials: AC
authors.lastname: Egberts
authors.forename: E R
authors.initials: ER
authors.lastname: Heerdink
mesh_terms: D015415:Biomarkers / Q000032:analysis; D004348:Drug Labeling; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D061214:Patient Safety; D011619:Psychotropic Drugs / Q000032:analysis*
chemical_list: D015415:Biomarkers; D011619:Psychotropic Drugs