The use of second-generation antipsychotics (SGAs) in children and adolescents has increased amidst the concern for adverse effects (AEs) on overall health. The use of SGAs increases the risk for weight gain, elevated glucose, insulin resistance, hyperlipidemia, and development of type 2 diabetes mellitus.1,2 Despite these concerns, there has been a slow uptake performing recommended monitoring.3-6 To our knowledge, few studies have examined metabolic monitoring in pediatric patients receiving an SGA, most of which were conducted in Medicaid patients.6 As Medicaid beneficiaries are expected to be financially poorer, have a poorer health profile, and receive care in a fragmented system of services compared with the commercially insured, it is important to understand metabolic monitoring practices in non-Medicaid patient populations. The purpose of this study was to evaluate metabolic monitoring practices for commercially insured pediatric patients newly initiated to take an SGA and identify metabolic AEs associated with short-term use.
This was a retrospective analysis of commercially insured pediatric patients newly initiated to take an SGA at Kaiser Permanente Colorado between January 1, 2002, and June 30, 2011. Information from the study was obtained from queries of the Kaiser Permanente Colorado administrative databases. Patients were younger than 18 years of age, with a new ambulatory SGA purchase (ie, none in the previous 180 days), continuously enrolled 180 days before and after the index date, and received a supply for 60 days or more during the 180-day period post-SGA purchase. This study was approved by the Kaiser Permanente Colorado institutional review board. Informed consent for participation was waived owing to the retrospective nature of this study.
The primary outcome was the rate of metabolic monitoring performed at baseline and follow-up. Metabolic monitoring included fasting triglyceride, fasting blood glucose, blood pressure, and weight measurement obtained during the 84 days prior to and 14 days after the index date (baseline) and 84 days after the latter of index or baseline monitoring date (follow-up).2 The Cochran-Armitage Trend Test was used to assess the trend in yearly monitoring rates. Metabolic AEs were defined as weight gain of more than 7%, blood pressure greater than 120/80 mm Hg, triglyceride level 110 mg/dL or greater, or fasting blood glucose level greater than 100 mg/dL during follow-up (to convert glucose to millimoles per liter, multiply by 0.0555; triglycerides to millimoles per liter, multiply by 0.0113).
Of the 1023 pediatric patients included (Table 1), only 1 (0.1%) received all baseline and follow-up monitoring (Table 2). The proportion of patients with at least 1 monitoring increased from 2002 to 2011 (baseline, 50.5% to 60.5%; P < .001 and follow-up, 45.1% to 55.3%; P = .005). At least 1 AE was identified in 130 of 538 patients (24.2%) with any follow-up monitoring. The most frequent AEs were weight gain and elevated triglyceride level.
Table 1. Baseline Characteristics of a Commercially Insured Pediatric Population Receiving SGA
Table 2. Overall and Individual Metabolic Monitoring Measures and Adverse Effect Rates in 1023 Patients
In our retrospective analysis of more than 1000 commercially insured pediatric patients newly initiated to take an SGA, we identified that patients rarely received both recommended baseline and follow-up monitoring. Despite this low rate of monitoring, we identified a metabolic AE in 13% of all patients during follow-up.
Receipt of any metabolic monitoring increased modestly over our study period and may have reflected increased awareness of SGA risks by physicians and families. However, monitoring increases were not in proportion to the recognized risk for type 2 diabetes mellitus evident in youth after 1 year of SGA exposure.1
Our low rates of follow-up monitoring for glucose (11.8%) and lipid (9.8%) levels are numerically lower than those reported in Medicaid pediatric patients (31.6% and 13.4%, respectively).6 However, we used a more narrowly defined time frame for follow-up (ie, 84 days vs 180 days). Nevertheless, our results suggest that monitoring performance may not be influenced by an integrated health care environment.
Our study was limited by the retrospective data collection from a single health plan that only examined short-term rates of metabolic AEs and did not capture nonadherence to monitoring orders. However, the rate of AEs we observed supports the importance of metabolic monitoring and the need to identify specific barriers to metabolic monitoring in all health care environments.
Corresponding Author: Thomas Delate, PhD, MS, Kaiser Permanente Colorado, 16601 E Centretech Pkwy, Aurora, CO 80011 (firstname.lastname@example.org).
Published Online: May 5, 2014. doi:10.1001/jamapediatrics.2014.224.
Author Contributions: Drs Delate and Kauffman had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: All authors.
Acquisition, analysis, or interpretation of data: Delate, Kauffman, Botts, Gaughan.
Drafting of the manuscript: Delate, Kauffman, Wong.
Critical revision of the manuscript for important intellectual content: Delate, Kauffman, Botts, Gaughan.
Statistical analysis: Delate, Kauffman.
Obtained funding: Delate, Kauffman.
Administrative, technical, or material support: Kauffman.
Study supervision: Delate, Botts.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was funded primarily by the Kaiser Permanente Colorado Pharmacy Department. Additional funding was provided by a Pharmacy Ambulatory Care Practice & Research Network seed grant from the American College of Clinical Pharmacy.
Role of the Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Previous Presentations: This study was presented in part at the Western States Conference; May 15, 2013; San Diego, California; and at the College of Psychiatric and Neurologic Pharmacists Annual Meeting; April 22, 2013; Colorado Springs, Colorado.
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