Audit of therapeutic drug monitoring of ‘clozapine plasma levels’

AimsTo re audit the monitoring of Plasma Clozapine levels in Rehabilitation setting in CNTW Trust as per Trust Guidelines PGN on “Safe prescribing of Clozapine”.Objectives:To determine if1. The reason for a clozapine plasma level request is recorded.2. Results are recorded correctly.3. Appropriate action is taken and recorded when results are significant.BackgroundClozapine plasma level monitoring is useful when assessing adherence, adjusting the dose, monitoring the effects of changes in smoking habit, investigating clozapine side effects and when toxicity is suspected.An initial audit was carried out within the Trust in 2015 and the following recommendations were made:Check and record clozapine plasma levelAt baseline (a level should be taken once the patient has been on the target dose for at least a week)Annually.When clinically relevant to optimise therapy.An entry must be made in the patient's progress notes recording the reason of requesting the test.On receipt of results, the paper copy must be scanned & an entry made in progress notes.The clinician should comment on the significance of the results and propose an action plan.We re-audited compliance with the guidance in Rehabilitation (inpatients and community) by reviewing patient notes for a 2 year period of 2017–2018.MethodThe audit work involved a review of 31 case records of patients prescribed Clozapine whose last plasma level was taken between 2017–2018. Patient's details were identified from a randomly generated list by the Trust pharmacy.Result<50% compliance was seen with baseline, annual monitoring, reason for recording and proposed action plan by clinician.>50% compliance was seen with scanned results and levels checked when clinically relevant.No significant improvement from the previous audit except improvement in compliance with documentation of levels.ConclusionDissemination of Clozapine Key cards within teams.

Paliperidone LAI and Aripiprazole LAI Plasma Level Monitoring in the Prophylaxis of Bipolar Disorder Type I with Manic Predominance

Introduction The objective of this study was the evaluation of utility of plasma level monitoring in the clinical stabilizing efficacy and tolerability of paliperidone palmitate (PP) vs. aripiprazole monohydrate (AM) in bipolar disorder I (BD I) with manic predominance. Methods Fifty-six outpatients of both sexes, age ranging from 18 to 65 years, affected by BD I with manic predominance, orally treated and stabilized after acute episode for at least 2 weeks with paliperidone or aripiprazole (n=31, paliperidone; n=25, aripiprazole) underwent a prospective observational study of switching to the corresponding long-acting injection (LAI) on the basis of clinical evaluation. The efficacy and tolerability of the 2 treatments were assessed by BPRS, PANSS, HAMD21, and MRS rating scales and a check list every month for 12 months. Drug plasma levels determinations (PLs) were performed at the same times. Results A good clinical stability and tolerability of both drugs were reported. Lower mean PLs of PP showed a positive effect on depressive symptoms. AM PLs variability was associated with greater instability of manic symptoms whereas intermediate PLs seem to have more influence on depressive symptomatology. Discussion PLs drug monitoring has been proven to be useful, and further investigations to identify optimal therapeutic ranges for LAI formulations are needed.

Paliperidone Long-Acting Plasma Level Monitoring and a New Method of Evaluation of Clinical Stability

The second generation long-acting antipsychotics can be a pharmacologic strategy, both in the early phase of illness and in the case of low compliance. The aim of the study was to evaluate the clinical efficacy and tolerability of one monthly injection of paliperidone palmitate (PP1M), paliperidone plasma levels (PLs), and the clinical outcome. 21 outpatients, affected by Schizophrenia or Schizoaffective Disorder, were recruited. PP1M started with 150 mg on day 1 and 100 mg on day 8. Following patients were given a dosage ranging from 50 mg to 150 mg every 28 days. At baseline, and then monthly, patients were clinically evaluated. BPRS and PANSS total score showed a statistically significant decrease from T2 (after 2 months) to T12 (after 12 months). The PLs steady-state was approximatively reached after the fifth injection (T4). All the patients showed a clinical stabilization: BPRS and PANSS scores showed a significant improvement from T2. PLs data seems to suggest the initial possibility of an oral supplementation, although clinical evaluation demonstrated no relapse during the study.

Intramuscular maintenance treatment with ultra-high-dose long-acting injectable aripiprazole in an elderly patient suffering from chronic refractory schizophrenia: A case report

Long-acting injectable (LAI) aripiprazole is increasingly appreciated in the course of a maintenance treatment of schizophrenia due to efficacy in delaying – and decreasing relapse, and low rates of feared side effects. In line with the prescribing information, the maximal starting – as well as maintenance dose was restricted to 400 mg following a 26-day interval between the single doses.We present a 72-year-old female inpatient (66 kg) with an acute exacerbation of chronic refractory schizophrenia, exhibiting primarily positive symptoms including excessive persecutory delusions, self-care deficit, poor insight and insufficient adherence to continuous intake of oral medication. Since she developed a post-injection syndrome after an accidental intravascular administration of olanzapine LAI 405 mg, the antipsychotic treatment was switched to aripiprazole LAI 300 mg once monthly. Due to insufficient clinical response, aripiprazole LAI was gradually increased up to 1200 mg per month under continuous plasma level monitoring. Here, 2 single injections of aripiprazole LAI 300 mg were delivered into both gluteal muscles concurrently, every 14 days.Consequently, we observed a clinically meaningful improvement (a total-score reduction from 111 to 75 on the Positive and Negative Syndrome Scale), as well as no objectifiable side effects, assessed by “The Dosage Record Treatment Emergent Symptom Scale” and “The Barnes Akathisia Rating Scale”, despite multi-morbidity and rather advanced age of the patient.Our safe experience with applying the almost threefold higher monthly dose over 12 weeks may encourage researchers to further investigate the efficacy, tolerability as well as handling of highly dosed aripiprazole LAI in refractory schizophrenia.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Therapeutic issues

Medication adherence 924 Off-label prescribing 926 Plasma level monitoring 928 Paradoxical reactions to benzodiazepines 929 Weight gain with psychiatric medication 930 Antipsychotics and diabetes 934 Hyperprolactinaemia with antipsychotics 936 Sexual dysfunction and psychiatric medication 938 Priapism 942 Antipsychotic-induced Parkinsonism 944 Akathisia 946 Tardive dyskinesia 950...