Literature Reviews and Assessments
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH) has established mechanisms to gather existing information on the use of drugs in children and the types of conditions experienced in children that require pharmacotherapy. During the last few years, NICHD has awarded a series of contracts to gather information about pediatric conditions, including data on morbidity and hospitalizations in pediatric populations, frequency of outpatient medication use, and data describing inpatient frequency-of-use. Contractors were asked to conduct systematic literature reviews and meta-analyses to provide summary information and assessments of existing data in support of the Best Pharmaceuticals for Children Act (BPCA), and to decrease the possibility that unnecessary studies are conducted in children.
One of the goals of BPCA is to make data available to the general public. As new information is gathered, NICHD will make data available on this Web site. NICHD's goal is to help educate practitioners and to expedite modifications in usage of drugs in children.
In-Patient Medications
Contractor: Nemours Foundation
Project Title: The Prevalence of Inpatient Pediatrics Prescribed and Administered Medications - An Analysis of the Experience of the Alfred I. duPont Hospital for Children
The purpose of this project is to demonstrate the prevalence of inpatient pediatric medication prescription and administration. During a four-year period, it was determined that over 32,484 pediatric patients and 1,774,543 dosages were included in the analysis and studied in various demographic categories (gender, race, age, and year). The source data came from a large pediatric hospital (Alfred I. duPont Hospital for Children).
Out-Patient Medications
Contractor: Express Scripts
Project Title: Privately Insured Patient Information
Contractor: University of Maryland Medicaid Analysis
Project Title: Publicly Supported Patient Information
Frequency of Medication Use
Contractor: Westat
Project Title: Frequency of Medication Use in Children: Comprehensive Data Analysis and Report
The purpose of this requirement is to develop national estimates of frequency of medication use in children by age group, sex, and race/ethnicity. The goal is to develop national estimates for frequencies of prescription drugs used by children. The estimates will be person-based and expressed as prevalence of the denominator population using a prescription within a given year. Overall national usage estimates need to incorporate information from databases referring to insured children, children enrolled in Health Maintenance Organizations (HMOs), Medicaid-covered children, and uninsured children. The final summary estimates and confidence intervals will be published in a document to inform the BPCA drug prioritization process and meet the requirements of BPCA for incorporating frequency of use information into the prioritization process.
Frequency of Conditions
Performed by: Agency for Healthcare Research and Quality (AHRQ)
Project Title: The Analysis of Hospital Inpatient Data for Children Using the Healthcare Cost and Utilization Project (HCUP) Kids; Inpatient Database (KID).
Contractor: Research Triangle Institute (RTI) International
Project Title: Mortality, Hospitalizations, and Medical Conditions in Children: Descriptive Epidemiology, Data Analysis, and Report
The goal of this project is to assemble information about the most frequently occurring medical conditions in the pediatric population in order to ensure that BPCA has the greatest potential for providing a public health benefit in the pediatric population, and to provide information for patient enrollment and design of clinical trials. NICHD seeks to identify and analyze sources of data describing the incidence and prevalence of medical conditions treated by prescription drugs and affecting children's health. A final deliverable of this project will be an annual report summarizing the rates of these conditions and trends in rates of these conditions.
Literature Assessments
Contractors: MetaWorks and CCS Associates
Project Title: Requirement Entitled "Systematic Literature Summaries, Assessments, Syntheses, and Meta-Analyses in Support of the BPCA"
NICHD seeks to conduct assessments of the available literature and systematic reviews of the literature on scientific questions related to implementation of BPCA. Reviews will center primarily on prescription medications used by the pediatric populations, but may also include topics related to the conduct of clinical trials in pediatric populations (e.g., a systematic review of the literature regarding consent processes in pediatric clinical trials).
The purpose of this project is to analyze questions, which can be addressed by meta-analysis, and address areas where meta-analysis can be used to inform the labeling process. NICHD hopes to initiate further meta-analyses to answer specific questions regarding pharmacokinetics and pharmacodynamics, efficacy, and safety of prescription drugs in pediatric populations.
NICHD hopes to acquire a searchable database, comprised from the literature of case reports, case series, observational studies, and clinical trials for off-patent drugs used by the pediatric population, which can be updated on an annual basis.