Monitoring patients using psychotropic drugs

Abstract

Mental illnesses are highly prevalent and cause a significant burden to patients, society and health care systems. Pharmacotherapy is a pivotal part of treatment of patients with mental illnesses. However, treatment with psychotropic drugs may result in a wide range of effects, not only on mental symptoms, but also as unwanted (somatic) side effects. For patients and health care professionals it is therefore important to determine whether the benefits outweigh the harms. Evaluation of disease symptoms and patient monitoring are crucial risk mitigating strategies. The aim of this thesis was to assess the need, availability, applicability and implementation of clinical and biomarker monitoring instructions for patients treated with psychotropic drugs. The need for monitoring of patients using psychotropic drugs was addressed in two patient case reports. The first case describes the need to monitor the free (unbound) concentration of valproic acid in hypoalbuminemic patients. The second case shows that re-exposure to clozapine after a dilated cardiomyopathy was successful for at least 2 years under strict monitoring of the patient’s cardiac function. In focus group discussions patients’ needs and suggestions for improvement of guidance by physicians and pharmacists during second generation antidepressant therapy was assessed. Improvement of content of information during decisional moments, patient-health care professional communication and communication between health care professionals, and finally, organisation of guidance and monitoring were suggested. Monitoring instructions in drug labels of psychotropic drugs were evaluated. An average of 3.3 (range 0 – 13) instructions for clinical and biomarker monitoring were identified of which only 34% were determined applicable. The proportion of patient monitoring costs as a part of antipsychotic treatment costs was assessed. Total drug treatment costs consisted of >20% mandatory monitoring costs for over one third of all antipsychotics. Therefore, we advocate using drug treatment costs including monitoring costs for decision-making in clinical practice for antipsychotics. Monitoring instructions in Clinical Practice Guidelines (CPGs) for the treatment of bipolar disorders for patients using lithium were assessed on clarity of presentation and applicability. Overall, the clarity of presentation was good, but improvement of the applicability of CPGs is recommended. In an international survey all lithium prescribing health care professionals stated to monitor patients using lithium. They reported to monitor lithium serum levels, creatinine and thyroid stimulating hormone (TSH) on a regular basis. However, little over one-third (36%) of patients were monitored adherent to the Dutch Multidisciplinary Clinical Guideline Bipolar Disorders for lithium serum levels, creatinine and TSH during total follow-up. In conclusion, the findings from this thesis show that there is a need for improved monitoring of patients using psychotropic drugs, based on two cases and suggestions from patients during focus group discussions. SmPCs as well as CPGs contain many monitoring instructions for patients using psychotropic drugs, but the applicability of sections on monitoring in CPGs and of monitoring instructions in SmPCs needs to be improved. Although prescribers of lithium do state to monitor patients using lithium, adherence to monitoring instructions in guidelines for patients treated with lithium can be further improved.