Clozapine and incidence of myocarditis and sudden death - Long term Australian experience.

BACKGROUND: Clozapine is the cornerstone of therapy for refractory schizophrenia; however, the potential for cardiotoxicity is an important limitation in its use. In the current analysis we sought to evaluate the long term cardiac outcomes of clozapine therapy. METHODS: All-cause mortality, incidence of sudden death and time to myocarditis were assessed in a cohort of patients maintained on clozapine between January 2009 and December 2015. All patients had regular electrocardiograms, complete blood count, clozapine levels and echocardiography as part of a formal protocol. RESULTS: A total of 503 patients with treatment-resistant schizophrenia were maintained on clozapine during the study period of which 93 patients (18%) discontinued therapy with 29 (6%) deaths. The incidence of sudden death and myocarditis were 2% (n=10) and 3% (n=14) respectively. Amongst patients with sudden death, 7 out of 10 (70%) were documented to have used illicit drugs prior to death, with a tendency to weight gain also noted. The mean time to myocarditis post clozapine commencement was 15±7days. The reduction in left ventricular ejection fraction in those with myocarditis was 11±2%. CONCLUSION: Myocarditis and sudden cardiac death are uncommon but clinically important complications in a cohort of patients followed while maintained on clozapine undergoing regular cardiac assessment. Further studies are required to document the role of preventive measures for left ventricular dysfunction and sudden cardiac death in this population.

Droperidol v. haloperidol for sedation of aggressive behaviour in acute mental health: randomised controlled trial.

BACKGROUND: Agitation and aggression are significant problems in acute psychiatric units. There is little consensus on which drug is most effective and safest for sedation of these patients. AIMS: To compare the effectiveness and safety of haloperidol v. droperidol for patients with agitation and aggression. METHOD: In a masked, randomised controlled trial (ACTRN12611000565943) intramuscular droperidol (10 mg) was compared with intramuscular haloperidol (10 mg) for adult patients with acute behavioural disturbance in a psychiatric intensive care unit. The primary outcome was time to sedation within 120 min. Secondary outcomes were use of additional sedation, adverse events and staff injuries. RESULTS: From 584 patients, 110 were randomised to haloperidol and 118 to droperidol. Effective sedation occurred in 210 (92%) patients within 120 min. There was no significant difference in median time to sedation: 20 min (interquartile range 15-30, range 10-75) for haloperidol v. 25 min (IQR 15-30, range 10-115) for droperidol (P = 0.89). Additional sedation was used more often with haloperidol (13% v. 5%, P = 0.06), but adverse effects were less common with haloperidol (1% v. 5%, P = 0.12). There were 8 staff injuries. CONCLUSIONS: Both haloperidol and droperidol were effective for sedation of patients with acute behavioural disturbance.

Care zoning in a psychiatric intensive care unit: strengthening ongoing clinical risk assessment.

AIMS AND OBJECTIVES: To implement and evaluate the care zoning model in an eight-bed psychiatric intensive care unit and, specifically, to examine the model's ability to improve the documentation and communication of clinical risk assessment and management. BACKGROUND: Care zoning guides nurses in assessing clinical risk and planning care within a mental health context. Concerns about the varying quality of clinical risk assessment prompted a trial of the care zoning model in a psychiatric intensive care unit within a regional mental health facility. The care zoning model assigns patients to one of 3 'zones' according to their clinical risk, encouraging nurses to document and implement targeted interventions required to manage those risks. DESIGN: An implementation trial framework was used for this research to refine, implement and evaluate the impact of the model on nurses' clinical practice within the psychiatric intensive care unit, predominantly as a quality improvement initiative. METHODS: The model was trialled for three months using a pre- and postimplementation staff survey, a pretrial file audit and a weekly file audit. Informal staff feedback was also sought via surveys and regular staff meetings. RESULTS: This trial demonstrated improvement in the quality of mental state documentation, and clinical risk information was identified more accurately. There was limited improvement in the quality of care planning and the documentation of clinical interventions. Nurses' initial concerns over the introduction of the model shifted into overall acceptance and recognition of the benefits. CONCLUSIONS: The results of this trial demonstrate that the care zoning model was able to improve the consistency and quality of risk assessment information documented. Care planning and evaluation of associated outcomes showed less improvement. RELEVANCE TO CLINICAL PRACTICE: Care zoning remains a highly applicable model for the psychiatric intensive care unit environment and is a useful tool in guiding nurses to carry out routine patient risk assessments.

A prospective study of high dose sedation for rapid tranquilisation of acute behavioural disturbance in an acute mental health unit.

BACKGROUND: Acute behavioural disturbance (ABD) is a common problem in psychiatry and both physical restraint and involuntary parenteral sedation are often required to control patients. Although guidelines are available, clinical practice is often guided by experience and there is little agreement on which drugs should be first-line treatment for rapid tranquilisation. This study aimed to investigate sedation for ABD in an acute mental healthcare unit, including the effectiveness and safety of high dose sedation. METHODS: A prospective study of parenteral sedation for ABD in mental health patients was conducted from July 2010 to June 2011. Drug administration (type, dose, additional doses), time to sedation, vital signs and adverse effects were recorded. High dose parenteral sedation was defined as greater than the equivalent of 10 mg midazolam, droperidol or haloperidol (alone or in combination), compared to patients receiving 10 mg or less (normal dose). Effective sedation was defined as a fall in the sedation assessment tool score by two or a score of zero or less. Outcomes included frequency of adverse drug effects, time to sedation/tranquilisation and use of additional sedation. RESULTS: Parenteral sedation was given in 171 cases. A single drug was given in 96 (56%), including droperidol (74), midazolam (19) and haloperidol (3). Effective sedation occurred in 157 patients (92%), and the median time to sedation was 20 min (Range: 5 to 100 min). The median time to sedation for 93 patients receiving high dose sedation was 20 min (5-90 min) compared to 20 min (5-100 min; p = 0.92) for 78 patients receiving normal dose sedation. Adverse effects occurred in 16 patients (9%); hypotension (14), oxygen desaturation (1), hypotension and oxygen desaturation (1). There were more adverse effects in the high dose sedation group compared to the normal dose group [11/93 (12%) vs. 5/78 (6%); p = 0.3]. Additional sedation was given in 9 of 171 patients (5%), seven in the high dose and two in the normal dose groups. CONCLUSIONS: Large initial doses of sedative drugs were used for ABD in just over half of cases and additional sedation was uncommon. High dose sedation did not result in more rapid or effective sedation but was associated with more adverse effects.

Pro re nata use in a psychiatric intensive care unit.

Pro re nata (PRN) or 'as required' medication is a regular part of mental health nursing practice. This retrospective study accessed data recorded for all PRN being given to patients within an eight-bed psychiatric intensive care unit. Data from the same consecutive 4-month period from 2005 and from 2007-2009 were analysed for trends in overall rates, time of administration, and type of medication given. PRN administration was identified to each patient, but no demographic information was analysed. Results of this study demonstrated a gradual decline in the total number of PRN given, reducing from an average of 314 PRN per month in 2005, to 181 PRN per month in 2009. The typical number of patients per month receiving any PRN did not change, with 41 out of a total of 72 patients receiving at least one PRN in 2005, and 40 out of 64 patients receiving PRN in 2009. These results suggest that over the study timeframe, nurses became more selective as to which patients received PRN. This discussion examined the possible reasons for this result, including unit leadership style, changes in staffing levels, a new nursing model and group programme, and the relocation to a new facility.