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.

Compliance with the guidelines for laboratory monitoring of patients treated with lithium: A retrospective follow‐up study among ambulatory patients in the Netherlands

“…Mood stabilizers aim to prevent manic and depressive relapses in patients with bipolar disorder during maintenance therapy . The balance between benefit and harm of pharmacotherapy needs to be monitored and evaluated for each patient before and periodically during treatment . Clinical practice guidelines (CPGs) provide instructions regarding both clinical and biomarker monitoring .…”

“…The balance between benefit and harm of pharmacotherapy needs to be monitored and evaluated for each patient before and periodically during treatment . Clinical practice guidelines (CPGs) provide instructions regarding both clinical and biomarker monitoring . Clinical monitoring includes monitoring of both signs and symptoms, while biomarker monitoring can be divided into monitoring of physical parameters and of laboratory parameters .…”

“…Clinical practice guidelines (CPGs) provide instructions regarding both clinical and biomarker monitoring . Clinical monitoring includes monitoring of both signs and symptoms, while biomarker monitoring can be divided into monitoring of physical parameters and of laboratory parameters . Although the need for monitoring of patients treated with psychotropic drugs is widely recognized, adherence to monitoring guidelines is often found to be suboptimal .…”

Evaluation of clarity of presentation and applicability of monitoring instructions for patients using lithium in clinical practice guidelines for treatment of bipolar disorder

“…CPGs should preferably include monitoring parameters that are specific, sensitive, accessible, affordable and applicable, and that provide early results to enable intervention . Previous studies by our group revealed that instructions for monitoring in Summary of Product Characteristics of (psychotropic) drugs in general were often found to be too ambiguous to be applicable in clinical practice . The applicability of monitoring instructions for patients using lithium in CPGs for treatment of BD is still unknown.…”

Patient monitoring: the hidden costs of treatment with antipsychotics

“…All oral formulations of antipsychotic agents with a European or Dutch marketing authorization and available in the Netherlands in April 2014 were included in this study. Patient monitoring instructions vary among antipsychotic drugs and were found in the most recent Summary of Product Characteristics (SmPC) at the website of the Dutch Medicines Evaluation Board or European Medicines Agency by searching on the generic name . Patient monitoring was defined as a statement to do something prior to or during drug treatment, including measurements of (possible) side effects and comorbidities.…”