Julie Magno Zito

Psychotropic Medication Patterns Among Youth in Foster Care

CONTEXT. Studies have revealed that youth in foster care covered by Medicaid insurance receive psychotropic medication at a rate >3 times that of Medicaid-insured youth who qualify by low family income. Systematic data on patterns of medication treatment, particularly concomitant drugs, for youth in foster care are limited. OBJECTIVE. The purpose of this work was to describe and quantify patterns of psychotropic monotherapy and concomitant therapy prescribed to a randomly selected, 1-month sample of youth in foster care who had been receiving psychotropic medication. METHODS. Medicaid data were accessed for a July 2004 random sample of 472 medicated youth in foster care aged 0 through 19 years from a southwestern US state. Psychotropic medication treatment data were identified by concomitant pattern, frequency, medication class, subclass, and drug entity and were analyzed in relation to age group; gender; race or ethnicity; International Classification of Diseases, Ninth Revision, psychiatric diagnosis; and physician specialty. RESULTS. Of the foster children who had been dispensed psychotropic medication, 41.3% received ≥3 different classes of these drugs during July 2004, and 15.9% received ≥4 different classes. The most frequently used medications were antidepressants (56.8%), attention-deficit/hyperactivity disorder drugs (55.9%), and antipsychotic agents (53.2%). The use of specific psychotropic medication classes varied little by diagnostic grouping. Psychiatrists prescribed 93% of the psychotropic medication dispensed to youth in foster care. The use of ≥2 drugs within the same psychotropic medication class was noted in 22.2% of those who were given prescribed drugs concomitantly. CONCLUSIONS. Concomitant psychotropic medication treatment is frequent for youth in foster care and lacks substantive evidence as to its effectiveness and safety.

Parental perceptions and satisfaction with stimulant medication for attention-deficit hyperactivity disorder.

&NA; Few reports have documented parental perceptions of stimulants for attention‐deficit hyperactivity disorder (ADHD), despite the recent increased use of stimulants among youths. Of 302 parents recruited from six pediatric primary care clinics, 84% completed a survey of their knowledge, attitudes, and satisfaction with the medication their child was taking for ADHD. Two thirds of the parents believed that sugar and diet affect hyperactivity. Although few parents believed that stimulants could lead to drug abuse, 55% initially were hesitant to use medication on the basis of information in the lay press, and 38% believed that too many children receive medication for ADHD. Parents were more satisfied with the behavioral and academic improvement relative to improvement in their childs self‐esteem. Attitudes were positively correlated with satisfaction and were more positive among white than nonwhite parents. The findings highlight parental misconceptions and reservations about ADHD medication treatment that require clarification as to whether race/ethnicity, income, and social status influence their views and use of treatments. J Dev Behav Pediatr 24:155‐162, 2003. Index terms: attention‐deficit hyperactivity disorder, attitudes, satisfaction, stimulant medications, survey research.

Utilization of Pharmacologic Treatment in Youths with Attention Deficit/Hyperactivity Disorder in Medicaid Database:

Background: Little is known about longitudinal changes in drug utilization in attention-deficit/hyperactivity disorder (ADHD). Objective: To describe longitudinal trends in ADHD drug utilization and explore demographic differences among youths eligible for a large Southern state Medicaid program. Methods: A cross-sectional and longitudinal analysis of 10 years of claims data for all Medicaid beneficiaries younger than 20 years of age with 6 months or more of continuous insurance (N = 2,131,953) was conducted. Annual prevalence, incidence, and persistence in ADHD medication use (stimulants and atomoxetine) were estimated based on pharmacy claims and clinician-reported ADHD diagnosis. Results: ADHD prevalence increased 1.70-fold (95% CI 1.67 to 1.73) from 3.10% (21,904 of 705,573 beneficiaries) in fiscal year 1995–1996 to 5.27% (41,661 of 790,338) in 2003–2004, paralleled by a 1.84-fold (95% CI 1.81 to 1.87) increase in drug use to 4.63%. In 2003–2004, 0.69% of youths were diagnosed and newly started on drugs, reflecting a 1.38-fold (95% CI 1.33 to 1.43) increase over 1995–1996. One in five white males between the ages of 10 and 14 years (19.24%; 95% CI 18.81 to 19.67) received ADHD medication in 2003–2004. Males continued to be more likely diagnosed and treated than females (prevalence ratio [PR] in 2003–2004 = 2.96:95% CI 2.90 to 3.03 vs 3.82; 95% CI 3.69 to 3.96 in 1995–1996), as were whites when compared with Hispanics (PR in 2003–2004 = 2.65; 95% CI 2.57 to 2.73 vs 3.78; 95% CI 3.57 to 3.99 in 1995–1996) and blacks (PR in 2003–2004 = 1.81; 95% CI 1.76 to 1.85 vs 2.00; 95% CI 1.93 to 2.07 in 1995–1996). The most common starting age throughout the study period was 5–9 years, with 2.45% (95% CI 2.37 to 2.52) new ADHD drug users in 2003–2004, but largest increases in prevalence were observed in adolescents 15–19 years of age, with 2.47% (95% CI 2.38 to 2.55) in 2003–2004 compared with 0.45% (95% CI 0.41 to 0.49) in 1995–1996. Medication persistence varied, with only 49.9% (95% CI 49.4 to 50.5) of new users receiving drugs after 1 year, with yet another 17.2% (95% CI 16.4 to 18.0) continuing for 5 years or more. Conclusions: ADHD drug utilization continues to increase due to steady increases in diagnosis and chronic use of the drugs over several years. While racial, ethnic, and sex differences persist, the age distribution of drug users has shifted toward older children. These findings emphasize the need for studies that analyze determinants of treatment as well as outcomes, both benefits and risks, associated with long-term medication use.

Cardiac Safety of Central Nervous System Stimulants in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

OBJECTIVES. Case reports have raised concerns about the risk of cardiac events associated with central nervous system stimulants for the treatment of attention-deficit/hyperactivity disorder. PATIENTS AND METHODS. This was a retrospective cohort study that used 10 years (July 1994 to June 2004) of Florida Medicaid claims data cross-linked to Vital Statistics Death Registry data. The cohort was composed of all youth 3 to 20 years old who were newly diagnosed with attention-deficit/hyperactivity disorder. Each month of follow-up was classified according to stimulant claims (methylphenidate, amphetamines, and pemoline) as current use (active stimulant claim), former use (time after periods of current use), or nonuse (time preceding the first stimulant claim, including follow-up of youth who were never exposed to stimulants). The studys end points were (1) cardiac death, (2) first hospital admission for cardiac causes or (3) first emergency department visit for cardiac causes. Risks were compared with time-dependent Cox regression analysis adjusting for various cardiac risk factors. RESULTS. During 124932 person-years of observation (n = 55383), 73 youth died, 5 because of cardiac causes. No cardiac death occurred during 42612 person-years of stimulant use. Hospital admissions for cardiac cause occurred for 27 children (8 during stimulant use, 11 during 35671 person-years of former use, and 8 during 46649 person-years of nonuse); and 1091 children visited the emergency department for cardiac causes (8.7 per 1000 person-years). Current stimulant use was associated with a 20% increase in the hazard for emergency department visits when compared with nonuse. No increased risk was found for periods of former use when compared with nonuse. CONCLUSIONS. Incidence rates of cardiac events requiring hospitalization were small and similar to national background rates. Stimulants were associated with an increase in cardiac emergency department visits. More evidence is needed that addresses the long-term risk/benefit of the various treatment options and the effect of other cardiac risk factors and comedications.

Clinical and treatment characteristics of children with attention-deficit/hyperactivity disorder in psychiatric practice

OBJECTIVE To capture information about the clinical characteristics of, and treatments for, children with attention-deficit/hyperactivity disorder (ADHD) in psychiatric practice. METHOD A mailed, self-administered questionnaire was sent to 81 practicing psychiatrists for them to complete on the next three consecutive patients aged 14 years and younger with ADHD seen during the 12-day study period. Information collected included the sociodemographic, clinical, and treatment characteristics of sampled patients. RESULTS Patients in the study were predominantly white (85%), male (78%), and between 10 and 14 years old (58%). The most common ADHD subtype was combined/predominantly hyperactive (86%); 31% had no other comorbidity. Ninety-seven percent were receiving medications, with 49% receiving two or more. The single most common medication reported was methylphenidate (51% of patients) followed by clonidine (20%). Psychotropics other than psychostimulants were used in a majority of patients (55%). CONCLUSIONS Psychiatrists, and child and adolescent psychiatrists in particular, see a more severely impaired and complex group of patients than would be expected of primary care providers. The treatment patterns of psychiatrists for these patients do not reflect the simpler treatments usually studied in clinical trials.

Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

The review presents pediatric adverse drug events from a historical perspective and focuses on selected safety issues associated with off-label use of medications for the psychiatric treatment of youth. Clinical monitoring procedures for major psychotropic drug classes are reviewed. Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring.

Impact of the 2004 Food and Drug Administration pediatric suicidality warning on antidepressant and psychotherapy treatment for new-onset depression.

Objective:To assess the national impact of the March 2004 Food and Drug Administration (FDA) antidepressant suicidality warning on the outpatient treatment of new-onset depression in youth. Method:A repeated measures, longitudinal design in a cohort of youth diagnosed with new-onset depression was used to assess pre- and post-FDA warning effects. US commercial insurance enrollees in the i3 INNOVUS database from January 2003 through December 2006 were examined. The study population included youth 2- to 17-years old with a new-onset depression diagnosis from July 2003 through June 2006 (N = 40,309). The main independent variables were the warning period (post- vs. pre-FDA warning) and age group (children vs. adolescents). The main outcome measures were youth with antidepressant dispensings and psychotherapy visits measured in 30-day intervals across 36 months following a new-onset diagnosis of any depressive disorder (N = 40,309) and specifically major depressive disorder (MDD) (N = 11,532). Results:Compared to youth with a new-onset diagnosis of depression in the pre-FDA warning period, youth with new-onset diagnosis of depression during the postwarning period had (1) A significantly lower likelihood of antidepressant use: (odds ratio [OR] = 0.85 [0.81–0.89]); When youth with the diagnosis of depression were separated into those with MDD and those with less severe depression diagnoses, only the latter had a significant postwarning antidepressant decline. (2) A significant increase in the odds of a psychotherapy visit (children, OR = 1.31 [1.23–1.40]; adolescents OR = 1.19 [1.15–1.24]). Conclusions:The FDA suicidality warning was associated with an overall decrease in antidepressant treatment for youth with a clinician-reported diagnosis of depression, but not for those with MDD. Also, following the warning, psychotherapy without medication increased.

Cardiovascular safety of central nervous system stimulants in children and adolescents: population based cohort study.

Objectives To evaluate the cardiac safety of central nervous system stimulants in children and adolescents. Design Population based retrospective cohort study. Setting Automated healthcare claims data from 1 219 847 children and young people eligible for 28 state Medicaid programmes from 1999 to 2006 linked to the Social Security Death Master File and the National Death Index. Participants Children and young people age 3-18 entered the cohort at the first diagnosis of a mental health condition commonly treated with stimulants (such as attention-deficit/hyperactivity disorder) after a minimum period of six months’ eligibility and were followed until loss of eligibility, their 19th birthday, admission to hospital for longer than 30 days, or death. Exclusion criteria included transplant recipients, receipt of dialysis, or claims indicating substance misuse. We retained high risk groups with similar use of stimulants as low risk children (such as children with congenital heart disease). Sociodemographic characteristics, cardiac risk factors, and psychiatric diagnoses obtained from before the index period were summarised with a propensity score. We used discrete survival analysis to estimate the relative risk for periods of stimulant use and non-use, adjusted for propensity score and antipsychotic use for the full cohort and the high risk and low risk groups. Main outcome measures Composite endpoint of stroke, acute myocardial infarction, or sudden cardiac death; a secondary composite endpoint added ventricular arrhythmia Results A total of 66 (95 including ventricular arrhythmia) events occurred during 2 321 311 years of follow-up. The odds ratio adjusted for propensity score and antipsychotic use for current versus no stimulant use was 0.62 (95% confidence interval 0.27 to 1.44), with a corresponding adjusted incidence rate of 2.2 and 3.5 per 100 000 patient years for current stimulant and non-use, respectively. Twenty six events occurred in high risk patients (incidence rate 63 per 100 000 patient years) with an odds ratio of 1.02 (0.28 to 3.69). Odds ratios for the secondary endpoint were similar to those for the primary endpoint (0.74, 0.38 to 1.46). Conclusions Treatment of children with central nervous stimulants is not significantly associated with an increase in the short term risk of severe cardiac events. Analyses cannot be generalised to children with long term use of stimulants. Furthermore, long term effects of slight increases in heart rate or blood pressure are unknown.

Trends and patterns of antidepressant use in children and adolescents from five western countries, 2005-2012

Following the FDA black box warning in 2004, substantial reductions in antidepressant (ATD) use were observed within 2 years in children and adolescents in several countries. However, whether these reductions were sustained is not known. The objective of this study was to assess more recent trends in ATD use in youth (0-19 years) for the calendar years 2005/6-2012 using data extracted from regional or national databases of Denmark, Germany, the Netherlands, the United Kingdom (UK), and the United States (US). In a repeated cross-sectional design, the annual prevalence of ATD use was calculated and stratified by age, sex, and according to subclass and specific drug. Across the years, the prevalence of ATD use increased from 1.3% to 1.6% in the US data (+26.1%); 0.7% to 1.1% in the UK data (+54.4%); 0.6% to 1.0% in Denmark data (+60.5%); 0.5% to 0.6% in the Netherlands data (+17.6%); and 0.3% to 0.5% in Germany data (+49.2%). The relative growth was greatest for 15-19 year olds in Denmark, Germany and UK cohorts, and for 10-14 year olds in Netherlands and US cohorts. While SSRIs were the most commonly used ATDs, particularly in Denmark (81.8% of all ATDs), Germany and the UK still displayed notable proportions of tricyclic antidepressant use (23.0% and 19.5%, respectively). Despite the sudden decline in ATD use in the wake of government warnings, this trend did not persist, and by contrast, in recent years, ATD use in children and adolescents has increased substantially in youth cohorts from five Western countries.

Services and prevention: Pharmacoepidemiology of antidepressant use

Between 1988 and 1994, data from 3 large sites revealed a 3-5 fold increase in the prevalence of antidepressant (ATD) treatment for U.S. youths aged 2-19 years. In 1994, the ATD prevalence for youths of this age ranged from 13 per 1000 (in the HMO) to 18 per 1000 (in 2 state Medicaid systems). Males predominated in the 10-14-year-olds treated with ATDs, whereas females predominated among 15-19-year-olds. Caucasians were more than twice as likely to receive ATD therapy than their African-American counterparts. Primary care providers were the major source of ATD prescriptions for youths. The leading diagnoses in primary care were ADHD followed by depression, whereas the diagnostic order was reversed for youths who received psychiatric services. This review provides details concerning these patterns and trends in ATD treatment of youths from community-based clinical data sources. In addition, the role of these data in an expanded, comprehensive psychotropic knowledge base is discussed. Finally, the implications of an expanded knowledge base for ATD treatments are discussed in regard to generating research questions on effectiveness and safety and to improve treatment consensus within a public-health perspective.