Abstract:Implementation efforts to organize, streamline, and simplify clozapine processes; development of a multidisciplinary clozapine clinic; increased capacity of existing clinics; and provision of transportation are reasonable targets to increase clozapine utilization.
“…This study was the first randomized controlled trial to examine the effect of an intervention to stimulate the use of clozapine. The findings of our study are in line with those of the study of Goren et al (2016). In their study, Goren et al interviewed psychiatrists over the phone to identify facilitators of and barriers to clozapine use.…”
To test whether: (1) psychiatrists will prescribe clozapine more often if they can delegate the monitoring tasks to an advanced nurse practitioner (ANP), (2) clozapine monitoring by an ANP is at least as safe as monitoring by a psychiatrist. Patients from 23 Dutch outpatient teams were assessed for an indication for clozapine. ANPs affiliated to these teams were randomized to Condition A: clozapine monitoring by an ANP, or Condition B: monitoring by the psychiatrist. The safety of monitoring was evaluated by determining whether the weekly neutrophil measurements were performed. Staff and patients were blinded regarding the first hypothesis. Of the 173 patients with an indication for clozapine at baseline, only seven in Condition A and four in Condition B were prescribed clozapine (Odds Ratio = 2.24, 95% CI 0.61-8.21; p = 0.225). These low figures affected the power of this study. When we considered all patients who started with clozapine over the 15-month period (N = 49), the Odds Ratio was 1.90 (95% CI 0.93-3.87; p = 0.078). With regard to the safety of the monitoring of the latter group of patients, 71.2% of the required neutrophil measurements were performed in condition A and 67.3% in condition B (OR = 0.98; CI = 0.16-3.04; p = 0.98). Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring. Clozapine-monitoring performed by an ANP seemed as safe as that by a psychiatrist.
“…This study was the first randomized controlled trial to examine the effect of an intervention to stimulate the use of clozapine. The findings of our study are in line with those of the study of Goren et al (2016). In their study, Goren et al interviewed psychiatrists over the phone to identify facilitators of and barriers to clozapine use.…”
To test whether: (1) psychiatrists will prescribe clozapine more often if they can delegate the monitoring tasks to an advanced nurse practitioner (ANP), (2) clozapine monitoring by an ANP is at least as safe as monitoring by a psychiatrist. Patients from 23 Dutch outpatient teams were assessed for an indication for clozapine. ANPs affiliated to these teams were randomized to Condition A: clozapine monitoring by an ANP, or Condition B: monitoring by the psychiatrist. The safety of monitoring was evaluated by determining whether the weekly neutrophil measurements were performed. Staff and patients were blinded regarding the first hypothesis. Of the 173 patients with an indication for clozapine at baseline, only seven in Condition A and four in Condition B were prescribed clozapine (Odds Ratio = 2.24, 95% CI 0.61-8.21; p = 0.225). These low figures affected the power of this study. When we considered all patients who started with clozapine over the 15-month period (N = 49), the Odds Ratio was 1.90 (95% CI 0.93-3.87; p = 0.078). With regard to the safety of the monitoring of the latter group of patients, 71.2% of the required neutrophil measurements were performed in condition A and 67.3% in condition B (OR = 0.98; CI = 0.16-3.04; p = 0.98). Identifying patients with an indication for clozapine does not automatically lead to improved prescription rates, even when an ANP is available for the monitoring. Clozapine-monitoring performed by an ANP seemed as safe as that by a psychiatrist.
“…Goren et al 26 carried out 70 semi-structured interviews with stakeholders such as psychiatrists, mental health nurses, and pharmacy and laboratory staff at five sites with high clozapine use and five low-utilization sites. Low utilization of clozapine was associated with a lack of champions to support the clozapine process.…”
Section: Resultsmentioning
confidence: 99%
“…A lack of standardised materials for shared decision-making, complex protocols for treatment monitoring and management of side-effects, formulary issues and costs of ancillary services such as transportation and service coordination were also identified as barriers (Box 1). 27 Barriers to clozapine use and strategies to overcome theseBarriers to clozapine usePatient/drug-related barriers Refusal of blood tests 17 – 19 Tolerating clozapine and side-effects 17 Age > 20 19 , 20 Patients prescribed polypharmacy 21 Benign ethnic neutropenia 27 Clinician-related barriers Inadequate knowledge of or experience in clozapine use 17 , 22 – 24 Fear of side-effects for patient/lack of knowledge about clozapine side-effects 13 , 17 , 19 , 22 , 24 Lack of adherence to guidance 13 , 17 , 22 Difficulty identifying suitable patients and unclear diagnoses 22 Need for intense monitoring 22 , 24 Perception that patients may not comply with treatment 19 , 22 Health system-related barriers Not enough resources, including not enough staff resources to monitor clozapine inititation 17 Shortage of beds 17 Service fragmentation 21 Lack of champions to support the clozapine process 26 Complex and time-consuming paperwork 26 Lack of standardised shared decision-making 27 Complex protocols for treatment monitoring 27 Formulary issues and costs of ancillary services such as transport and service coordination 27 Strategies to overcome barriers to clozapine use Use of POC devices 29 Support for prescribers and decision-aid tool for consumers grounded in principles of shared decision-making 27 Internet-based educational programmes to provide information for consumers, family members and clincians 27 …”
Aims and methodTo systematically review the literature on barriers to the use of clozapine and identify any interventions for optimizing clozapine use in treatment-resistant schizophrenia. Journal databases were searched from 1972 to March 2018. The following search terms were used: treatment-resistant schizophrenia, clozapine, barriers, use, prescription rates, implementation, clozaril and prescribing practices. Following a review of the literature, 15 papers were included in the review.ResultsThe major barriers that were identified included mandatory blood testing, fear of serious side-effects and lack of adherence by the patients, difficulty in identifying suitable patients, service fragmentation, and inadequate training in or exposure to using clozapine.Clinical implicationsIn view of consistent evidence across the studies on inadequate knowledge and skills as a significant barrier, we suggest that a certification requiring competence in initiating and managing side-effects of clozapine becomes a mandatory requirement in training programmes.Declarations of interestNone.
“…These include providing easy access to clozapine, offering appropriate safety monitoring of patients receiving it, encouraging prescribers to consider its use when appropriate, and supporting prescribers in learning how to best use it. Furthermore, new and innovative multidisciplinary team strategies, clozapine clinics, and centers of excellence may provide much-needed support and infrastructure to help promote and manage this challenging agent effectively 58-62…”
Clozapine is an antipsychotic that exhibits superior efficacy and effectiveness for those with schizophrenia and other serious mental illness. However, its side-effect profile and administrative burdens present challenges to its use. In the United States, the medication is grossly underused even though it may improve outcomes and reduce costs. Current barriers to use include lack of prescriber knowledge and confidence, negative prescriber attitudes, special monitoring requirements, administrative factors, lack of clozapine on formularies, lack of support and infrastructure to use the medication within many health systems, and inadequate understanding or acknowledgement of clozapine prescribing and risks by policy makers and payers. Approaches using interprofessional models of care, which include pharmacists specializing in psychiatric care, can help meet the needs of patients receiving clozapine. This article lays out the big picture of barriers to clozapine and how psychiatric pharmacists could play a role in improving access.
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