Use of Long-Acting Injectable Antipsychotic Medication in Youth at Winnebago Mental Health Institute: A Clinical Pathway

To the Editor:

Winnebago Mental Health Institute (WMHI) is a State of Wisconsin, Department of Health Services, Division of Care and Treatment Services, facility. The most complex and challenging adult and pediatric psychiatric patients in Wisconsin are referred to WMHI. Correspondingly, medication management within this population is also complex and challenging. One of the most challenging medication management issues involves the use of long-acting injectable (LAI) antipsychotic medication in children and adolescents with severe psychiatric symptoms who are admitted to the Youth Services Unit (YSU). Of note, there is no U.S. Food and Drug Administration (FDA)-approved indication for the use of any LAI in a pediatric population. Despite a lack of published guidance regarding the use of LAIs in youth, a prescription utilization study revealed that LAIs are being administered to children and adolescents along a broad age range from 2 to 17 years old (Modesitt et al., 2018).

A workgroup of WMHI providers was recruited to develop a clinical pathway for the use of LAI in youth (see Fig. 1). The clinical pathway was based on a systematic literature review of LAI use in youth, including surveyed prescriber attitudes and FDA MedWatch postmarketing adverse event reports involving LAIs in a pediatric population (Scharko et al., in press). A retrospective chart review of YSU patients who received an LAI over a 2-year interval was accomplished. Input from a mental health consumer advocacy group, National Alliance for the Mentally Ill (NAMI) Wisconsin, was also obtained.

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FIG. 1.

YSU Clinical Pathway for the Use of Long-Acting Injectable Antipsychotic Medication. No specific LAI could be determined as more effective to any other, but aripiprazole monohydrate and aripiprazole lauroxil tended to be favored by YSU clinicians. In cases where an individual patient refuses oral antipsychotic medication, an order for involuntary administration of medication (Order-to-Treat) may be requested from a court. Because aripiprazole, paliperidone, and risperidone have no corresponding immediate release IM form, immediate release IM olanzapine was selected for occasional use as back-up because there is no significant cytochrome P450 drug–drug interaction between olanzapine administered with either aripiprazole, paliperidone, or risperidone (Marder and Davis, 2017). AIMS, Abnormal Involuntary Movement Scale; CBC, complete blood count with differential; CGI-S, Clinical Global Impressions-Severity Scale; C-SSRS, Columbia-Suicide Severity Rating Scale; EKG, electrocardiogram; HCl, hydrochloride; IM, intramuscular; LAI, long-acting injectable antipsychotic medication; TSH, thyroid-stimulating hormone; YSU, Youth Services Unit.

By expert consensus, the workgroup constructed a clinical pathway for the use of LAIs in patients aged 14 years and over with a Clinical Global Impressions-Severity (CGI-S) Scale score of 6 (severely ill) or greater, along with concern about treatment noncompliance. The components of the clinical pathway include an expanded shared decision-making process (Robinson et al., 2020) between patient and family, outpatient medication provider, and community stakeholders (county social services, juvenile justice, therapy providers); parental/guardian informed consent and patient assent (whenever possible); acute stabilization with oral antipsychotic medication; and transition to LAI antipsychotic medication. Exclusions from the pathway are age under 14 years, pregnancy, or parent/guardian declines use of an LAI.

Given the available evidence, it is clinically reasonable that the use of LAIs in patients aged 14 years and over can be helpful to target severe psychiatric symptoms (typically psychosis, mood disorder, and/or aggression with CGI-S ≥ 6) complicated by treatment noncompliance. The use of LAIs in adolescent patients aged 14 years and older could be an important treatment modality that can potentially reduce hospital readmission rates, minimize the need for police services, and help to maintain complex young patients in their community. Presented here is a clinical pathway that utilizes what is currently known about LAI use in youth and outlines a process that is consistent, attempts to set guardrails, and aims to help establish a standard of care.

The retrospective chart review and the interview with the NAMI-Wisconsin Executive Director were part of a study protocol approved by the Mendota Mental Health Institute Institutional Review Board, Madison, Wisconsin.

Methods and results details are contained in the Supplementary Data S1.