Het monitoren van bijwerkingen van geneesmiddelen op de poliklinieken van GGZ Drenthe/Monitoring of side effects of medication at outpatient departments of Mental Health Services Drenthe

Rationale: Psychiatric patients often have somatic comorbidities and other risk factors that render them vulnerable to the diverse and severe side effects of psychiatric pharmacotherapy. In outpatient clinics of institutions of Mental Health Services (MHS; in Dutch: GGZ) in the Netherlands it is suggested that information regarding effectiveness of the prescribed drugs is not routinely collected using standardised monitoring protocols. It therefore is unclear to which extent the drugs used by the patients visiting these outpatient clinics are prescribed effectively and safely.
Objectives: In the project ‘Monitoring Outcomes of Pharmacotherapy in the Assen Region’ (MOPHAR), an infrastructure will be created in which - using standardised protocols - longitudinal monitoring data will be collected regarding Routine Outcome Monitoring (ROM), medication usage and monitoring of side effects of psychiatric pharmacotherapy in outpatients at MHS Drenthe, thereby enabling research. Research objectives are:

1. To investigate the association between patient characteristics and outcomes (e.g. efficacy, (cost)effectiveness, profiles of adverse effects) of psychiatric pharmacotherapy. Among others the association between biomarkers/ pharmacogenetic determinants and the prevalence of adverse events of antidepressants will be investigated.

2. To investigate the association between the use of specific psychotropic drugs and adverse outcomes like metabolic abnormalities.

Study design: Prospective observational cohort study
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Study population: All newly referred and current adult patients from outpatient departments of MHS Drenthe, starting with patients from the Mood and Anxiety Disorder team in Emmen.

Main study parameters/endpoints: The efficacy, (cost)effectiveness and safety of psychiatric pharmacotherapy (after implementation of a monitoring programme).

Psychiatric patients often have somatic comorbidities and other risk factors that render them vulnerable to the diverse and severe side effects of psychiatric pharmacotherapy. In outpatient clinics of institutions of Mental Health Services (MHS; in Dutch: GGZ) in the Netherlands it is suggested that information regarding effectiveness of the prescribed drugs is not routinely collected using standardised monitoring protocols. It therefore is unclear to which extent the drugs used by the patients visiting these outpatient clinics are prescribed effectively and safely.

In the project ‘Monitoring Outcomes of Pharmacotherapy in the Assen Region’ (MOPHAR), an infrastructure will be created in which - using standardised protocols - longitudinal monitoring data will be collected regarding Routine Outcome Monitoring (ROM), medication usage and monitoring of side effects of psychiatric pharmacotherapy in outpatients at MHS Drenthe, thereby enabling research to investigate associations between patient characteristics and outcomes (e.g. efficacy, (cost)effectiveness, profiles of adverse effects) of psychiatric pharmacotherapy and associations between the use of specific psychotropic drugs and adverse outcomes like metabolic abnormalities.

All patiënts will undergo somatic screening and medication reconciliation at baseline and will be asked to fill in a couple of questionnaires following protocol. Patients will be followed during the rest of their treatment at the outpatient department following specific protocols depending on the psychotropic medication usage.

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