title: Instructions for clinical and biomarker monitoring in the Summary of Product Characteristics (SmPC) for psychotropic drugs: Overview and applicability in clinical practice.
abstract: The Summary of Product Characteristics (SmPC) for psychotropic drugs includes instructions for clinical and biomarker monitoring intended to optimise effectiveness and minimise harm. The present study evaluated which monitoring instructions are given in the SmPCs, and assessed whether instructions are informative enough to be applicable in clinical practice. Monitoring instructions were collected from complete SmPCs for psychotropic drugs (n=70). Reasons and requirements for monitoring were assessed and somatic parameters were distinguished from non-somatic parameters. Instructions were evaluated using the Systematic Information for Monitoring (SIM) score and considered applicable when a SIM score of ⩾ 3 was found. An average of 3.3 (range 0-13) 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. Overall, an average SIM score of 2.0 (SD=1.7) was found (out of a maximum possible score of 6). In conclusion, prescribing of psychotropic drugs is accompanied by diverse instructions aimed at improving safe use. However, most instructions on monitoring do not provide sufficient information to be applicable in clinical practice.
authors.affiliation: Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands Brocacef Ziekenhuisfarmacie, Maarssen, the Netherlands.
authors.forename: Mariëtte
authors.initials: M
authors.lastname: Nederlof
authors.affiliation: Brocacef Ziekenhuisfarmacie, Maarssen, the Netherlands Saltro Diagnostic Center for Primary Care, Utrecht, the Netherlands.
authors.forename: Lennart J
authors.initials: LJ
authors.lastname: Stoker
authors.affiliation: Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands Clinical Pharmacy, Utrecht University Medical Center, Utrecht, the Netherlands.
authors.forename: Toine C G
authors.initials: TC
authors.lastname: Egberts
authors.affiliation: Department of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands Clinical Pharmacy, Utrecht University Medical Center, Utrecht, the Netherlands e.r.heerdink@uu.nl.
authors.forename: Eibert R
authors.initials: ER
authors.lastname: Heerdink
mesh_terms: D015415:Biomarkers / Q000378:metabolism*; D004348:Drug Labeling / Q000379:methods; D011307:Drug Prescriptions; D006801:Humans; D011619:Psychotropic Drugs / Q000627:therapeutic use*
chemical_list: D015415:Biomarkers; D011619:Psychotropic Drugs
keywords: Psychiatry; drug safety; monitoring; psychotropic drugs