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Background: Antipsychotics carry a higher-risk profile than other psychotropic medications and may be prescribed for youth with conditions in which other first-line treatments are more appropriate. This study aimed to evaluate the population-level effect of the Safer Use of Antipsychotics in Youth (SUAY) trial, which aimed to reduce person-days of antipsychotic use among participants. Methods: We conducted an interrupted time series analysis using segmented regression to measure changes in prescribing trends of antipsychotic initiation rates pre-SUAY and post-SUAY trial at four U.S. health systems between 2013 and 2020. Results: In our overall model, adjusted for age and insurance type, antipsychotic initiation rates decreased by 0.73 (95% confidence interval [CI]: 0.30, 1.16, p = 0.002) prescriptions per 10,000 person-months before the SUAY trial. In the first quarter following the start of the trial, there was an immediate decrease in the rate of antipsychotic initiations of 6.57 (95% CI: 0.99, 12.15) prescriptions per 10,000 person-months. When comparing the posttrial period to the pretrial period, there was an increase of 1.09 (95% CI: 0.32, 1.85) prescriptions per 10,000 person-months, but the increasing rate in the posttrial period alone was not statistically significant (0.36 prescriptions per 10,000 person-months, 95% CI: -0.27, 0.99). Conclusion: The declining trend of antipsychotic initiation seen between 2013 and 2018 (pre-SUAY trial) may have naturally reached a level at which prescribing was clinically warranted and appropriate, resulting in a floor effect. The COVID-19 pandemic, which began in the final three quarters of the posttrial period, may also be related to increased antipsychotic medication initiation.

Objective: This study examined atypical antipsychotic prescribing by Food and Drug Administration (FDA) approved-use (on-label) status for adolescents before and during the COVID-19 pandemic., Methods: Retrospective data were collected from electronic health records (EHRs) of adolescents aged 10-17 years in Kaiser Permanente Northern California. New outpatient atypical antipsychotic prescription orders during 2013-2021 were evaluated. Prescriptions were categorized as on-label if linked in EHRs to autism, psychosis, bipolar disorder, or Tourette's diagnoses; otherwise, they were potentially off-label (herein, off-label). Trend analysis of monthly prescribing rates assessed slope change at pandemic onset for the cohort and by sex and age groups., Results: Among 5828 patients, 74.5% of new antipsychotic orders were off-label in 2021. Overall prescribing decreased significantly until early 2020 (slope = -0.045, P < .01) but then significantly increased through 2021 (post-March 2020 slope change = 0.211, P = .01). Off-label prescriptions increased at a similar rate during the COVID-19 time period, but on-label prescriptions did not change significantly. Males and younger adolescents (ages 10-14 years) showed significant decreases until early 2020, while females and older adolescents (ages 15-17 years) did not. Females and younger adolescents exhibited significant increases in overall and off-label prescribing rates following pandemic onset; older adolescents exhibited increases in overall prescriptions while males had no detectable changes., Conclusions: Antipsychotic prescribing declined slightly but then increased significantly following COVID-19 onset for overall and off-label prescriptions. Pandemic onset differentially impacted antipsychotic prescribing by sex and age, with overall and off-label prescribing driven by increases among female and younger adolescents., Competing Interests: Declaration of Competing Interest Dr. Costales reports grant support from the National Institute of Mental Health (T32MH125792) during the conduct of this study. Dr. Penfold reports receiving research funding to his institution from Janssen Research & Development, Otsuka Pharmaceuticals, and SAGE Therapeutics., (Copyright © 2024 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

To estimate the cost of implementing a clinical program designed to support safer use of antipsychotics in children and adolescents (youth) age 3-17 years at the time of initiating an antipsychotic medication. We calculate the costs of implementing a psychiatric consultation and navigation program for youth prescribed antipsychotic medications across 4 health systems, which included an electronic health record (EHR) decision support tool, consultation with a child and adolescent psychiatrist, and up to 6 months of behavioral health care navigation, as well as telemental health for patients (n = 348). Cost data were collected for both start-up and ongoing intervention phases and are estimated over a 1-year period. Data sources included study records and time-in-motion reports, analyzed from a health system perspective. Costs included both labor and nonlabor costs (2019 US dollars). The average total start-up and ongoing costs per health system were $34,007 and $185,174, respectively. The average total cost per patient was $2,128. The highest average ongoing labor cost components were telemental health ($901 per patient), followed by child and adolescent psychiatrist consultation ($659), and the lowest cost component was primary care/behavioral health provider time to review/respond to the EHR decision support tool and case consultation ($24). For health systems considering programs to promote safer and targeted use of antipsychotics among youth, this study provides estimates of the full start-up and ongoing costs of an EHR decision support tool, psychiatric consultation service, and psychotherapeutic services for patients and families.Trial registration: Clinicaltrials.gov, NCT03448575., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To develop a new approach to prescribing guidelines as part of a pragmatic trial, Safer Use of Antipsychotics in Youth (SUAY; ClinicalTrials.gov Identifier: NCT03448575), which supports prescribers in delivering high-quality mental health care to youths., Method: A nominal group technique was used to identify first- to nth-line treatments for target symptoms and potential diagnoses. The panel included US pediatricians, child and adolescent psychiatrists, and psychopharmacology experts. Meeting materials included information about Medicaid review programs, systematic reviews, prescribing guidelines, and a description of the pragmatic trial. Afterward, a series of 4 webinar discussions were held to achieve consensus on recommendations., Results: The panel unanimously agreed that the guideline should focus on target symptoms rather than diagnoses. Guidance included recommendations for first- to nth-line treatment of target mental health symptoms, environmental factors to be addressed, possible underlying diagnoses that should first be considered and ruled out, and general considerations for pharmacological and therapeutic treatments., Conclusion: Prescribing guidelines are often ignored because they do not incorporate the real-world availability of first-line psychosocial treatments, comorbid conditions, and clinical complexity. Our approach addresses some of these concerns. If the approach proves successful in our ongoing pragmatic trial, Safer Use of Antipsychotics in Youth (SUAY), it may serve as a model to state Medicaid programs and health systems to support clinicians in delivering high-quality mental health care to youths., Clinical Trial Registration Information: Safer Use of Antipsychotics in Youth; http://clinicaltrials.gov/; NCT03448575., (Copyright © 2021 American Academy of Child & Adolescent Psychiatry. All rights reserved.)

Objectives: Antipsychotic prescribing in children and adolescents increased sharply beginning in the 1990s, but recent reports among Medicaid enrollees suggest declining trends. However, few studies have included both commercially and publicly insured patients or focused on trends in new antipsychotic medications in children without documented psychotic disorders or other indicated conditions. The objective of the study was to report trends in new antipsychotic prescribing for pediatric patients (age 3-17 years) in a large children's health care system. Methods: Data were abstracted from electronic medical records (January 1, 2013 to December 31, 2017). New antipsychotic medication orders were defined as antipsychotic orders for patients without an order in the 180 days prior. Patients were excluded if the order was initiated in an emergency department or inpatient setting; they were diagnosed with psychotic disorder, mania, autism spectrum disorder, or intellectual disability; or the order was for prochlorperazine. The crude rate of new antipsychotic prescribing is reported quarterly with Poisson 95% confidence intervals in the total sample and by demographic subgroups (child vs. adolescent, female vs. male, public vs. private insurance, and white vs. nonwhite). Results: Antipsychotic orders decreased from 54.9 prescriptions per 10,000 person months in the first quarter of 2013 to 34.1 per 10,000 person months in the last quarter of 2017. Rates of antipsychotic prescribing were significantly higher for adolescents compared with children, patients who were commercially insured compared with Medicaid insured, and at most time points for white compared with non-white patients. However, prescribing rates did not differ significantly based on gender. Conclusions: Antipsychotic prescribing declined for both commercially and Medicaid-insured children in a pediatric hospital-based system, although white and commercially insured patients were more likely to be prescribed antipsychotics. More attention may be needed for reducing potentially avoidable prescribing of antipsychotics in previously understudied subgroups, such as commercially insured patients. Clinical Trial Registration Number: NCT03448575.

Introduction: There are no published procedural or safety guidelines for home-based telemental health (TMH) therapy with youth, despite the unique challenges and risks of providing services to this population outside of a traditional clinic setting. We developed clinical, logistical, and safety procedures for home-based TMH with youth in the context of a large clinical trial., Methods: A Targeted Approach to Safer Use of Antipsychotics in Youth (SUAY) study identifies youth ages 3-17 who are prescribed second-generation antipsychotic medication for non-psychotic disorders within large healthcare systems. Prescribing physicians receive psychopharmacology consultation. Patients receive a "navigator" to coordinate treatments and access to TMH if they do not have a local therapist. We optimized access by allowing TMH sessions to take place in the family's home, while providing guidelines for privacy, safety, and in-session crises., Results: Clinical issues included providing flexibility in the treatment modality and engaging families. Logistical issues included remote consenting for treatment and troubleshooting technological problems. Safety issues included crisis and safety planning with the youth and family before and during treatment., Discussion: The provision of home-based TMH therapy for youth requires adaptations to existing TMH procedural and safety guidelines to optimize clinical care, technology coordination, and safety. Trial registration number and trial register: Clinicaltrials.gov: NCT03448575.

Background: Programs such as the Pediatric Access Line in Washington state have shown decreases in antipsychotic medication use by youth with non-psychotic disorders. Program outcomes have been studied with observational designs. This manuscript describes the protocol for Targeted and Safer Use of Antipsychotics in Youth (SUAY), a randomized controlled trial of psychiatrist review of prescriptions and facilitated access to psychosocial care. The aim of the intervention is to reduce the number of person-days of antipsychotic use among participants., Methods: Recruitment occurs at 4 health systems. Targeted enrollment is 800 youth aged 3-17 years. Clinicians are block randomized to intervention versus usual care prior to the study. Youth are nested within the arm of the prescribing clinician. Clinicians in the intervention group receive an EHR-based best practice alert with options to expedite access to psychosocial care and all medication orders are reviewed by a child and adolescent psychiatrist with feedback provided to the prescriber. The primary outcome is person-days of antipsychotic medication use in the 6 months following the initial order. All randomized individuals contribute data regardless of their level of participation (including declining all services)., Discussion: The trial has been approved by the institutional review boards at each of the 4 sites. The intervention has 4 novel design features including automated recruitment using a best practice alert, psychiatrist medication order review and consultation, telephone navigation to psychosocial care, and telemental health visits. Recruitment began in March of 2018 and will be completed in June 2020. Follow-up will be completed December 31, 2020., Trial Registration: Clinicaltrials.gov, NCT03448575., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Guidelines recommend against prescribing antipsychotics without an indication, yet prescription rates remain undesirably high for youths. Information technology can facilitate guideline-based prescribing, but little is known about providers' needs. The Safer Use of Antipsychotics in Youth project is implementing an algorithm-based workflow for peer consultation, care navigation, and expedited psychotherapy access. To optimize workflow for a multisite trial, we engaged providers for input., Methods: Guided by human-centered design, we interviewed 15 providers from Kaiser Permanente Washington and Nationwide Children's Hospital about their prescribing barriers and workflow preferences. We identified qualitative themes on barriers affecting implementation and design opportunities to optimize workflow., Results: Providers expressed two major barriers: potential disruptions to clinical practice and threats to professional autonomy. Three design opportunities emerged: à la carte orders, passive review of orders, and consultation self-acknowledgment., Conclusions: Human-centered design offers an innovative approach to improve guideline-based prescribing with optimizations that are grounded in providers' needs.

Objective: To identify space-time clusters of changes in prescribing aripiprazole for bipolar disorder among providers in the VA., Data Sources: VA administrative data from 2002 to 2010 were used to identify prescriptions of aripiprazole for bipolar disorder. Prescriber characteristics were obtained using the Personnel and Accounting Integrated Database., Study Design: We conducted a retrospective space-time cluster analysis using the space-time permutation statistic., Data Extraction Methods: All VA service users with a diagnosis of bipolar disorder were included in the patient population. Individuals with any schizophrenia spectrum diagnoses were excluded. We also identified all clinicians who wrote a prescription for any bipolar disorder medication., Principal Findings: The study population included 32,630 prescribers. Of these, 8,643 wrote qualifying prescriptions. We identified three clusters of aripiprazole prescribing centered in Massachusetts, Ohio, and the Pacific Northwest. Clusters were associated with prescribing by VA-employed (vs. contracted) prescribers. Nurses with prescribing privileges were more likely to make a prescription for aripiprazole in cluster locations compared with psychiatrists. Primary care physicians were less likely., Conclusions: Early prescribing of aripiprazole for bipolar disorder clustered geographically and was associated with prescriber subgroups. These methods support prospective surveillance of practice changes and identification of associated health system characteristics., (© Health Research and Educational Trust.)

Objective: To learn if a quality of care Medicaid child psychiatric consultation service implemented in three different steps was linked to changes in statewide child antipsychotic utilization., Data Sources/study Setting: Washington State child psychiatry consultation program primary data and Medicaid pharmacy division antipsychotic utilization secondary data from July 1, 2006, through December 31, 2013., Study Design: Observational study in which consult program data were analyzed with a time series analysis of statewide antipsychotic utilization., Data Collection/extraction Methods: All consultation program database information involving antipsychotics was compared to Medicaid pharmacy division database information involving antipsychotic utilization., Principal Findings: Washington State's total child Medicaid antipsychotic utilization fell from 0.51 to 0.25 percent. The monthly prevalence of use fell by a mean of 0.022 per thousand per month following the initiation of elective consults (p = .004), by 0.065 following the initiation of age/dose triggered mandatory reviews (p < .001), then by another 0.022 following the initiation of two or more concurrent antipsychotic mandatory reviews (p = .001). High-dose antipsychotic use fell by 57.8 percent in children 6- to 12-year old and fell by 52.1 percent in teens., Conclusions: Statewide antipsychotic prescribing for Medicaid clients fell significantly at different rates following each implementation step of a multilevel consultation and best-practice education service., (© Health Research and Educational Trust.)

Introduction: Knowledge of the factors affecting the adoption of new medications can enhance mental health care and guide quality improvement and policy development. Food and Drug Administration indications for treating bipolar disorder with several second-generation antipsychotics (SGAs) in the 2000s represent an opportunity to identify factors that impact the spread of a then-innovative treatment through a new population., Methods: Analysis of Department of Veterans Affairs administrative data identified the population of 170,811 veterans diagnosed with bipolar disorder from 2003 to 2010. We analyzed time trends and predictors of antimanic choice (SGA vs other) among the 40,512 outpatients with bipolar disorder who initiated their first VA outpatient antimanic prescription, using multinomial logistic regression in month-by-month analyses. We conducted classwise analyses and investigated prespecified predictors among specific agents., Results: In classwise analyses, SGAs supplanted lithium, valproate, and carbamazepine/oxcarbazepine as the most commonly initiated antimanics by 2007. Psychosis, but not other indices of severity, predicted SGA initiation. Demographic analyses did not identify substantial disparities in initiation of SGAs. Drug-specific analyses revealed some consideration of medical comorbidities in choosing among specific antimanic agents, although effect sizes were small. Most patients initiating an antimanic had received an antidepressant in the previous year., Discussion: Second-generation antipsychotics quickly became the frontline antimanic treatment for bipolar disorder, although antidepressants most commonly predated antimanic prescriptions. Second-generation antipsychotics were used for a broad range of patients rather than being restricted to a severely ill subpopulation. The modest association of antimanic choice with relevant medical comorbidities suggests that continued attention to quality prescribing practices is warranted.

Background: Several second generation antipsychotics (SGAs) received FDA approval for bipolar disorder in the 2000s. Although efficacious, they have been costly and may cause significant side effects. Little is known about the factors associated with prescribers' decisions to initiate SGA prescriptions for this condition., Methods: We gathered administrative data from the Department of Veterans Affairs on 170,713 patients with bipolar disorder between fiscal years 2003-2010. Patients without a prior history of taking SGAs were considered eligible for SGA initiation during the study (n =126,556). Generalized estimating equations identified demographic, clinical, and comorbidity variables associated with initiation of an SGA prescription on a month-by-month basis., Results: While the number of patients with bipolar disorder using SGAs nearly doubled between 2003 and 2010, analyses controlling for patient characteristics and the rise in the bipolar population revealed a 1.2% annual decline in SGA initiation during this period. Most medical comorbidities were only modestly associated with overall SGA initiation, although significant differences emerged among individual SGAs. Several markers of patient severity predicted SGA initiation, including previous hospitalizations, psychotic features, and a history of other antimanic prescriptions; these severity markers became less firmly linked to SGA initiation over time. Providers in the South were somewhat more likely to initiate SGA treatment., Conclusions: The number of veterans with bipolar disorder prescribed SGAs is rising steadily, but this increase appears primarily driven by a corresponding increase in the bipolar population. Month-by-month analyses revealed that higher illness severity predicted SGA initiation, but that this association may be weakening over time.

Recent reports of antipsychotic medication use in pediatric populations describe large increases in rates of use. Much interest in the increasing use has focused on potentially inappropriate prescribing for non-Food and Drug Administration-approved uses and use amongst youth with no mental health diagnosis. Different studies of antipsychotic use have used different time periods, geographic and insurance populations of youth, and aggregations of diagnoses. We review recent estimates of use and comment on the similarities and dissimilarities in rates of use. We also report new data obtained on 11 health maintenance organizations that are members of the Mental Health Research Network in order to update and extend the knowledge base on use by diagnostic indication. Results indicate that most use in pediatric populations is for disruptive behaviors and not psychotic disorders. Differences in estimates are likely a function of differences in methodology; however, there is remarkable consistency in estimates of use by diagnosis.

Objectives: The objectives of this study were to ascertain the relative importance of scientific "approval" versus U.S. Food and Drug Administration (FDA) regulatory approval regarding changes in aripiprazole prescribing rates for treating bipolar disorder and to identify system-level covariates associated with faster regional uptake of aripiprazole., Methods: Medication use data for 2002–2009 were obtained from the Veterans Health Administration (VHA) National Psychosis Registry for 106,547 patients with diagnoses of bipolar disorder, aggregated at the level of the Veterans Integrated Service Network (VISN). VISN-level independent variables were obtained from several VHA organizational databases. Interrupted time-series analysis was used to examine changes in rates of prescribing aripiprazole, and logistic regression was used to model above- versus below-median growth in aripiprazole prescribing across VISNs., Results: Three inflections were observed, corresponding to the publication of two positive studies and FDA approval of aripiprazole for the treatment of bipolar mania. No significant VISN-level policy, administrative, or staffing predictors of the growth rate in aripiprazole prescribing were identified. Exploratory analyses showed that access to care may play a role in uptake, whereas competing demands, such as substance abuse treatment needs, may retard adoption., Conclusions: Early published evidence may have a strong impact on practice for low-barrier innovations, such as newly marketed medications or changes in indication for approved medications. Regional targeting of prescriber behavior interventions may maximize efficiency in efforts to change prescribing; further delineation of factors associated with regional heterogeneity in prescribing would support such efforts.

Objective: To assess whether the risk of incident diabetes was increased with the use of second-generation antipsychotics (SGAs) in a large diverse cohort of children., Methods: A retrospective study was conducted by using the administrative databases of 3 health plans participating in the Health Maintenance Organization Research Network. Children 5 to 18 years of age who initiated SGA therapy between January 2001 and December 2008 and 2 comparison groups, namely, nonusers of psychotropic drugs and users of antidepressant medications, were identified. Diagnoses from inpatient and outpatient records, pharmacy dispensings, and outpatient laboratory results were used to identify incident cases of diabetes., Results: The crude incidence rate of diabetes for the SGA-exposed cohort was 3.23 cases per 1000 person-years (95% confidence interval [CI]: 1.67-5.65), compared with 0.76 cases per 1000 person-years (95% CI: 0.49-1.12) among nonusers of psychotropic medications and 1.86 cases per 1000 person-years (95% CI: 1.12-2.90) among antidepressant users. The risk of incident diabetes was significantly increased among SGA users (unadjusted incidence rate ratio: 4.24 [95% CI: 1.95-8.72]) in comparison with nonusers of psychotropic medications but was not significantly increased in comparison with antidepressant medication users (unadjusted incidence rate ratio: 1.74 [95% CI: 0.77-3.78])., Conclusions: Although we found a potentially fourfold increased rate of diabetes among children exposed to SGAs, the findings were inconsistent and depended on the comparison group and the outcome definition.

Objective: The uptake of new antipsychotic medications among children has not been studied adequately. Although ziprasidone received Food and Drug Administration approval for the treatment of psychotic disorders among children in June 2009, it first became available for off-label use by children in 2001 and presented an excellent case study for off-label market entry. The objective of this study was to determine the pattern of initiation and switching for off-label use of ziprasidone among Michigan children who were insured by Medicaid in the first year that ziprasidone was available., Methods: We conducted a retrospective study by using Michigan Medicaid data for patients who were aged <21 years and had 2 years of continuous enrollment and at least 1 prescription for ziprasidone in the first year the medication was available. The main outcome measures were proportion of children prescribed ziprasidone as their first antipsychotic, with evidence of treatment resistance, and by a psychiatrist., Results: In the first year, 292 individuals who met criteria were prescribed ziprasidone. Approximately 53% had a diagnosis of psychosis. Explosive personality disorder and oppositional defiant disorder were the next most common diagnoses. For 33% of individuals, this was the first antipsychotic medication. Only 12% of individuals showed evidence of treatment resistance to other antipsychotic medications before switching to ziprasidone., Conclusions: During the period when ziprasidone had no approved pediatric usages, a small percentage of patients who were prescribed ziprasidone showed evidence of treatment resistance, the primary expected indication. Some prescribing for ziprasidone in the first year in this population could be considered inappropriate considering what was known about the safety and efficacy of ziprasidone in children and adolescents at the time. "Fail first" and prior authorization policies may be appropriate in the first year a medication is available so as to protect children from potential serious harm.

Objective: The purpose of this study was to examine the diffusion of olanzapine to urban and rural children insured by Medicaid in Michigan by identifying prescribing clusters through surveillance of claims records., Methods: Prescription claims records for all antipsychotic medications for 3,567 children insured by Medicaid in Michigan from 1996 through 1998 were examined through the state Medicaid database. There were 29,069 pediatric prescriptions for antipsychotic medications; 2949 were for olanzapine (576 children, 510 providers). These data were linked to the Area Resource File, Provider Enrollment File, and Rural-Urban Commuting Area codes. Patient and provider locations were geocoded by ZIP code. Mixed logistic regression analysis was performed to determine the probability of a child's being prescribed olanzapine given certain community, patient, and provider characteristics. Spatial clusters were identified through the local Moron's L statistic and empirical Bayes standardized incidence rates., Results: Rural children were more likely than urban children to be prescribed olanzapine (odds ratio [OR], 1.29; P < 0.001). There were significant differences by age and sex, with older children and girls more likely than younger children and boys to be prescribed olanzapine (OR, 1.30 and 1.37, respectively; both, P < 0.001). At the county level, the number of pediatricians per primary care physician reduced the likelihood of a child's being prescribed olanzapine (OR, 0.88; P = 0.039). The effect of the number of available mental health professionals was not significant. The global Moran's L statistic was U indicating moderate clustering of the use of olanzapine., Conclusion: Graphic surveillance data may be useful for studying the delivery and use of health cue services. Further research is needed to determine how this method can be used strategically to facilitate or impede the diffusion of new medications.