Recent child pharmacoepidemiological findings.
Explore the source record for details and available documents.
Child↗
Biomedical subjects
J M Zito
Publications and source records attributed to J M Zito.
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.
Adolescent↗
Antidepressant treatment in children and adolescents: bridging the gap between efficacy and effectiveness.
This review of antidepressant treatments in children and adolescents emphasizes the gap between efficacy data derived from randomized clinical trials (RCTs) and the limited effectiveness data from community-based practices. Part one is a brief review of data from randomized, double-blind clinical trials to assess the evidence base for the major approved indications for antidepressants in youths. Part two reviews information gaps in the evidence from RCTs. Part three discusses nonexperimental evidence of the use of antidepressants, including surveys of prescription sales, physician surveys, and population-based data. Part four presents a comprehensive model for assessing the use of antidepressants in youths in the community. The model aims to answer a range of public health-oriented questions and is intended to improve treating physicians' and clinical care providers' ability to manage medications for optimal patient benefit. Suggestions are made for engaging health service providers, health insurers, academicians, advocates, and the government in building the necessary infrastructure to make effectiveness as vital as efficacy to the model of drug therapy evaluation.
Adolescent↗
Pemoline hepatotoxicity and postmarketing surveillance.
OBJECTIVE: To review the numerous reports of hepatotoxic adverse drug reactions (ADRs) ascribed to pemoline that were sent to the U.S. Food and Drug Administration (FDA) between 1975 and 1996 and to describe the medical community's lack of awareness of these reports. METHOD: All ADR reports from 1975 through 1996 wherein pemoline was the suspect agent were obtained from the FDA MedWatch Internet site, and some details of nine pemoline-related deaths in youths were obtained directly from the FDA. The published literature on this subject was fully reviewed. RESULTS: (1) In premarketing clinical trials with pemoline in the early 1970s, hepatic abnormalities were noted in enzyme levels (1%-3% of youths receiving maintenance treatment), during rechallenges (6 of 6), and in biopsies (2 of 2). (2) Between 1975 and 1989, 12 cases of jaundice and 6 deaths in youths ascribed to pemoline hepatotoxicity were reported to the FDA. (3) The first medical literature report of a serious ADR ascribed to pemoline was in a 1989 letter to the editor. (4) Physicians generally only became aware of serious pemoline hepatotoxicity in December 1996. (5) Pemoline use increased until 1997. CONCLUSION: Limitations in postmarketing surveillance and public reporting in the United States, particularly in the 1980s, largely accounted for delays in an appropriate response to pemoline hepatotoxicity.
Adolescent↗
Psychotropic medication in children: a study from the Netherlands.
OBJECTIVE: Although there is a global concern about the increased use of psychotropic agents in children, most research literature originates in the United States and is based on figures from the first half of the 1990s. Also, few studies document the use of various types of psychotropic agents. The objective of this study was to investigate the use of psychotropic medication in children in the Netherlands and to determine whether this corresponds with previously reported figures from the United States. METHODS: A drug utilization study based on computerized pharmacy dispensing records was conducted from 1995 to 1999 for children aged 0 to 19 years in the north of the Netherlands. RESULTS: Stimulants were the most widely used psychotropic agents among 0- to 19-year-olds (prevalence: 7.4/1000 in 1999), followed by hypnotics/anxiolytics (6.9/1000) and antidepressants (4.4/1000). Prevalence rates of stimulants increased from 1.5/1000 in 1995 to 7.4/1000 in 1999. Incidence rates, proportion of girls, and duration of stimulant treatment increased as well. Changes in prevalence rates of other psychotropic agents were much smaller than those of stimulants. Finally, the vast majority of children who were treated with psychotropic agents used only 1 agent at a time. CONCLUSION: The prevalence of stimulant use in the Netherlands is much lower than reported previously (28/1000 children in 1995) from the United States, and differences also existed with regard to the use of other psychotropic agents and combinations of psychotropic agents. However, the increase in Dutch stimulant use agrees with the previously reported 2.5-fold increase in the United States and shows that the increased use of stimulants is not limited to the United States.
Adolescent↗
Mental health services for youths in foster care and disabled youths.
OBJECTIVES: This study assessed whether mental health services for youths differ with respect to medical assistance aid category. METHODS: Computerized claims for 15,507 youths with Medicaid insurance in a populous county of a mid-Atlantic state were used to establish population-based prevalence estimates of mental disorders and psychotherapeutic treatments during 1996. RESULTS: An analysis of service claims revealed that the prevalence of mental disorders among youths enrolled in foster care (57%) was twice that of youths receiving Supplemental Security Income (SSI; 26%) and nearly 15 times that of other youths receiving other types of aid (4%). Rates of mental health service use were pronounced among foster care youths aged 6 to 14 years. Attention deficit/hyperactivity disorder, depression, and developmental disorders were the most prevalent disorders. Stimulants, antidepressants, and anticonvulsants were the most prevalent medications. CONCLUSIONS: Youths enrolled in foster care and youths receiving SSI use far more mental health services than do youths in other aid categories. Additional research should evaluate the complexity and outcomes of mental health services for youths in foster care.
Adolescent↗
Trends in the prescribing of psychotropic medications to preschoolers.
CONTEXT: Recent reports on the use of psychotropic medications for preschool-aged children with behavioral and emotional disorders warrant further examination of trends in the type and extent of drug therapy and sociodemographic correlates. OBJECTIVES: To determine the prevalence of psychotropic medication use in preschool-aged youths and to show utilization trends across a 5-year span. DESIGN: Ambulatory care prescription records from 2 state Medicaid programs and a salaried group-model health maintenance organization (HMO) were used to perform a population-based analysis of three 1-year cross-sectional data sets (for the years 1991, 1993, and 1995). SETTING AND PARTICIPANTS: From 1991 to 1995, the number of enrollees aged 2 through 4 years in a Midwestern state Medicaid (MWM) program ranged from 146,369 to 158,060; in a mid-Atlantic state Medicaid (MAM) program, from 34,842 to 54,237; and in an HMO setting in the Northwest, from 19,107 to 19,322. MAIN OUTCOME MEASURES: Total, age-specific, and gender-specific utilization prevalences per 1000 enrollees for 3 major psychotropic drug classes (stimulants, antidepressants, and neuroleptics) and 2 leading psychotherapeutic medications (methylphenidate and clonidine); rates of increased use of these drugs from 1991 to 1995, compared across the 3 sites. RESULTS: The 1995 rank order of total prevalence in preschoolers (per 1000) in the MWM program was: stimulants (12.3), 90% of which represents methylphenidate (11.1); antidepressants (3.2); clonidine (2.3); and neuroleptics (0.9). A similar rank order was observed for the MAM program, while the HMO had nearly 3 times more clonidine than antidepressant use (1.9 vs 0.7). Sizable increases in prevalence were noted between 1991 and 1995 across the 3 sites for clonidine, stimulants, and antidepressants, while neuroleptic use increased only slightly. Methylphenidate prevalence in 2- through 4-year-olds increased at each site: MWM, 3-fold; MAM, 1.7-fold; and HMO, 3.1-fold. Decreases occurred in the relative proportions of previously dominant psychotherapeutic agents in the stimulant and antidepressant classes, while increases occurred for newer, less established agents. CONCLUSIONS: In all 3 data sources, psychotropic medications prescribed for preschoolers increased dramatically between 1991 and 1995. The predominance of medications with off-label (unlabeled) indications calls for prospective community-based, multidimensional outcome studies.
Attention Deficit Disorder with Hyperactivity↗
Psychotherapeutic medication patterns for youths with attention-deficit/hyperactivity disorder.
OBJECTIVES: (1) To describe temporal patterns of office visits for attention-deficit/hyperactivity disorder (ADHD) and stimulant treatment for 5- to 14-year-old US youths; (2) to compare youth visits for ADHD with and without melication according to patient demographics, physician specialty, reimbursement source, and comorbid diagnoses; and (3) to compare office visits for youths with ADHD in relation to common medication patterns (stimulants alone, stimulants with other psychotherapeutic medication, and nonstimulant psychotherapeutic medications alone). DESIGN: Survey based on a national probability sample of office-based physicians in the United States. SETTING: Physician offices. PARTICIPANTS: A systematically sampled group of office-based physicians. MAIN OUTCOME MEASURES: National estimates of office visits for ADHD and psychotherapeutic drug visits for ADHD for each year and for a combined 8-year period. RESULTS: Youth visits for ADHD as a percentage of total physician visits had a 90% increase, from 1.9% in 1989 to 3.6% in 1996. Stimulant therapy within ADHD youth visits rose from 62.6% in 1989 to 76.6% in 1996. While the majority of non-ADHD youth visits were conducted by primary care physicians, one third of ADHD youth visits were managed by psychiatry and neurology specialists. Health maintenance organization insurance was the reimbursement source for 17.9% of non-ADHD youth visits but only 11.7% of ADHD youth visits. Complex medication therapy was more likely to be prescribed by psychiatrists and less likely to be related to visits with health maintenance organization reimbursement. CONCLUSIONS: National survey estimates in the 1990s confirm the substantial increase in visits for youths diagnosed as having ADHD, with more than three quarters of these visits associated with psychotherapeutic medication treatment. Physician specialty and reimbursement source variables identify distinct patient populations with a gradient in psychotherapeutic medication patterns from single-drug standard (stimulant) therapy to complex multidrug treatment regimens for which evidence-based scientific information is lacking.
Adolescent↗
Novel antipsychotic medications in the treatment of children and adolescents.
Explore the source record for details and available documents.
Adolescent↗
Hypothesis testing: is clozapine's superior efficacy dependent on moderate D2 receptor occupancy?
BACKGROUND: How clozapine exerts superior antipsychotic efficacy in treatment-resistant schizophrenia is not known. Moderate (rather than "full") occupancy of D2 postsynaptic receptors may be crucial, perhaps by achieving a more effective D1/D2 or serotonin-2a/D2 ratio. The objective of this study was to test the moderate occupancy hypothesis of clozapine's superior efficacy. METHODS: Data from the New York effectiveness of clozapine study were used to compare 6-week clozapine treatment results in patients discontinuing oral neuroleptic medication with similar patients discontinuing long-acting depot neuroleptic. The latter group is assured "full" D2 occupancy during the 6-week clozapine treatment. RESULTS: If moderate occupancy is crucial for superior efficacy, the oral discontinuation group should manifest more improvement. Both groups showed the 6-week improvement expected with clozapine therapeutics [31% and 29% reduction in Brief Psychiatric Rating Scale (BPRS) scores in the depot and oral groups, respectively]. An analysis of covariance (for baseline BPRS) revealed no difference in change scores (df = 1,100; F = 0.17; p = ns). CONCLUSIONS: The reduced D2 occupancy hypothesis is rejected.
Antipsychotic Agents↗
Antidepressant prescribing practices of outpatient psychiatrists.
BACKGROUND: The authors examined recent changes in the number and proportion of patients prescribed antidepressants by psychiatrists in outpatient private practice and characterized antidepressant prescription patterns by patient age, sex, race, payment source, and clinical diagnosis. METHODS: The authors analyzed physician-reported data from the 1985 and 1993-1994 National Ambulatory Medical Care Survey, focusing on visits to physicians specializing in psychiatry. Logistic regressions were used to examine associations between survey year and antidepressant prescription, adjusting for the presence of other variables. RESULTS: The proportion of outpatient psychiatric visits in which an antidepressant was prescribed increased from 23.1% (95% confidence interval [CI], 19.7%-26.5%) in 1985 to 48.6% (95% CI, 47.5%-49.7%) in 1993-1994. After controlling for several patient variables, psychiatric patients were approximately 2.3 (95% CI, 1.8-2.9) times more likely to receive an antidepressant in 1993-1994 than in 1985. In 1993-1994, selective serotonin reuptake inhibitors accounted for approximately half of the psychiatric visits with an antidepressant prescription. Increases in the rate of antidepressant prescription were particularly evident for children and young adults; whites; new patients; and patients with adjustment disorders, personality disorders, depression not otherwise specified or dysthymia, and some anxiety disorders. CONCLUSIONS: During the late 1980s and early 1990s, there was a significant increase in the prescription of antidepressants by office-based psychiatrists. This increase was greatest for patients with less severe psychiatric disorders.
Adjustment Disorders↗
Pharmacoeconomics of the new antipsychotics for the treatment of schizophrenia.
Inevitably, the greater availability of more costly antipsychotic medications has resulted in attempts to regulate the use of these agents. Early objections over the cost of treatment with clozapine or risperidone have in part been mollified by preliminary statistics on the cost effectiveness of these agents. However, this issue is complex and requires careful consideration of pharmacoeconomic principles in the development and clinical distribution of novel antipsychotics. Future cost-effectiveness studies need to consider a balance of public and private perspectives. These studies should be conducted in several settings, preferably also within the context of broader, multimodal treatment intervention strategies.
Antipsychotic Agents↗
Prevalence variations in psychotropic treatment of children.
This study was undertaken to clarify several aspects of the estimation of prevalence of three commonly use pediatric psychotropic agents, namely, methylphenidate, desipramine, and imipramine. The study aims are threefold: (1) to show the variability of drug prevalence by comparing estimates from three data sources; (2) to show the misleading impression that can be created by reporting drug prevalence estimates based on counts of prescriptions rather than persons; (3) to show the utility of gender-by-age-specific prevalence of drug use as a marker for diagnosis. Two data sources that yield population-based prescription estimates were available: 1991 Medicaid administrative claims data for prescriptions from a mid-Atlantic state and 1991 prescription records of the northwest region of Kaiser Permanente, a staff-model health maintenance organization (HMO). Another source of data consists of the 1991 National Ambulatory Medical Care Survey, which records medication information reported during physician office visits. Data analysis consists of quantitative estimates of (1) drug prevalence from each source; (2) the ratio of prescription claims to persons; and (3) the proportion of drug use according to age and gender. Methylphenidate and desipramine prevalence had a twofold greater use among state Medicaid enrollees compared with HMO enrollees. Average claims-to-person ratios of 5:1 suggest better accuracy using persons with medication rather than prescription counts. Gender-by-age-specific prevalence rates showed that 75% of the drug use for desipramine among those less than 15 years old was found among males, whereas 75% of the desipramine use among those 15 or older was found among females, suggesting its use for the treatment of attention deficit-hyperactivity disorder among young males and for depression among older females. The variability of community physician decision making in pediatric psychopharmacology is better understood by observing drug prevalence rates from different settings. National sampling efforts should be undertaken to verify regional and setting-specific prevalence findings and to learn the reasons for their fluctuation.
Adult↗
Racial disparity in psychotropic medications prescribed for youths with Medicaid insurance in Maryland.
DESIGN: A retrospective analysis was conducted using state Medicaid prescription drug reimbursement claims for youths aged 5 through 14 years according to the race of the recipients of psychotropic and medical drugs. METHOD: A person-based data set was created from Medicaid administrative data for fiscal year 1991 from the state of Maryland to yield the following: (1) estimates of prevalence of prescription recipients per 100 eligible enrollees; (2) relative prescription use ratios according to race (African-American versus Caucasian); and (3) the interrelation of race and geographic region on prescription prevalence. RESULTS: Five major findings were observed: (1) African-American youths with Medicaid insurance aged 5 through 14 were less than half (39% to 52%) as likely to have been prescribed psychotropic medications as Caucasian youths with Medicaid insurance; (2) the relative difference for nonpsychotropic medication classes was much less pronounced: African-American youths were prescribed nonpsychotropic medications at a rate 60% to 87% of the Caucasian youths' rate; (3) the stimulants (essentially methylphenidate) had the most disparate African-American/Caucasian ratio (1:2.5); (4) the racial disparity for psychotropics was not altered by partial (noncontinuous enrollment) eligibility status; and (5) although geographic variation reduced the racial disparity, the substantial racial difference (1:2.0) remained. CONCLUSION: Compared with Caucasians, African-American youths aged 5 through 14 with Medicaid insurance coverage showed a distinctly lower rate of treatment with psychopharmacological agents.
Adolescent↗
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.
Adolescent↗
Sources of data for pharmacoepidemiological studies of child and adolescent psychiatric disorders.
In view of the dramatic shift to managed care models for United States health care delivery, reliable information on the prevalence and variations in psychopharmacological drug therapies for youth in community practice settings is essential. Pharmacoepidemiology, the study of medication use in large populations, aims to accomplish that challenging task. This article offers child psychopharmacologists a brief introduction to data sources for pharmacoepidemiology. Knowledge of these data sources combined with epidemiological methods for data analysis is a beginning step to assess the psychotropic medication prescribing patterns of community physicians. This review is organized in the following sequence: (1) characteristics of the "usual practice environment" according to setting, patient population, and physician characteristics; (2) validity issues related to data sources and their potential for outcomes research; (3) data sources divided into primary and secondary types that are described in terms of their features, advantages, and limitations, followed by examples of selected applied studies using such information; (4) procedures for analyzing secondary data; (5) data analytic and longitudinal approaches; and (6) access, confidentiality, and funding. A goal for future investigators in this emerging field is to develop applied research that is clinically sophisticated, methodologically sound, and public health-minded.
Adolescent↗
Direct-to-consumer prescription drug advertising.
Explore the source record for details and available documents.
Advertising↗
Methylphenidate patterns among Medicaid youths.
Treatment of attentional disorders in America has increased dramatically in recent years. This trend is accounted for partly by lengthening the duration of treatment into adulthood for some individuals as well as by increased treatment among girls. Beyond these factors, the role of economic status, race, and geographic region to explain the variation in methylphenidate use is not well understood. Computerized administrative data were used to explore the influence of several sociodemographic factors on the prevalence of methylphenidate use. The data source consisted of Maryland Medicaid prescription drug reimbursement claims data for FY1991 for children ages 5 to 14 years. In effect, the study was restricted to a sample of patients with limited income. The study aims included (1) measuring gender-, age-, race-, and region-specific methylphenidate prevalence for this restricted income population; (2) comparing the Caucasian:African-American (C:A-A) ratio for methylphenidate with the C:A-A ratio for several drug therapies having non-psychotropic uses, specifically the anti-asthma drug, theophylline, and antibiotics for infections; and (3) estimating the average daily dose of methylphenidate from prescription claims data. Total drug-specific prevalence among the 5-14 year olds was 2.2 percent for methylphenidate while age-specific prevalence varied from 0.4 percent (5 year olds) to 3.4 percent (9 year olds). The gender ratio was 3.7:1 (M:F), confirming the increasing trend for girls to receive this medication. Substantial variation across eight defined regions of the state was observed. Racial differences were pronounced: African-Americans were 2.5 times less likely to receive methylphenidate than Caucasian youths. As hypothesized, non-psychotropic drug use was distinctly different from psychotropic drug use in terms of race: theophylline was 1.5 times more likely to be found for African-Americans than Caucasians, whereas antibiotic prescriptions were 1.5 times more likely to be prescribed to Caucasian youths. Average daily dose of methylphenidate was estimated to be 18.7 +/- 10.4 mg for 5-9 year olds and 26.8 +/- 14.0 mg for 10-14 year olds. This brief report confirms the typically lower rate among African-American Medicaid youths for most prescription drugs. The dramatic racial disparity for the psychotropic agent methylphenidate is a new and compelling finding which should be verified among other economic groups. Diagnostic, referral, and cultural bias should be ruled out as possible explanations for the observed differences.
Adolescent↗