A B S T R A C TOBJECTIVES: To describe the frequency of off-label drug use in 2014 as defined by the Food and Drug Administration (FDA)-approved age ranges in patients #18 years of age, to determine the rate of off-label drug use in 2014 by drug classification, and to compare current off-label medication usage rates with historical rates.METHODS: This is a retrospective cohort study of an administrative database containing inpatient resource use data from January 1, 2014, to December 31, 2014. Patients #18 years of age receiving 1 of 76 selected commonly prescribed medications are included. Off-label drug use is defined as use in a patient younger than the lower limit of the FDA-approved age range for any indication or dosage form of that drug. RESULTS:At least 1 drug was prescribed off label in 779 270 of 2 773 770 (28.1%) patient visits during the study period. Younger age, longer hospital stays, and mortality were associated with higher rates of off-label medication prescription. Off-label usage of certain medications differed between care settings. Rates of off-label medication use were higher in observational (45.5%), inpatient (53.9%), and ambulatory (54.2%) settings. CONCLUSIONS:Although off-label drug use at major US pediatric hospitals is declining, 1 out of every 4 medications is not in accordance with FDA label indications for patient age. There exists substantial variation in off-label drug use among drug categories and encounter types. Although many commonly prescribed medications are FDA-approved for use in subpopulations of pediatric patients, studies of their safety, efficacy, pharmacokinetics, and optimal dosing are ongoing.
Objective: The objective was to identify key questions for emergency medicine (EM)-based adolescent sexual and reproductive health and to develop an evidence-based research agenda. Methods:We recruited national content experts to serve as advisory group members and used a modified Delphi technique to develop consensus around actionable research questions related to EM-based adolescent reproductive and sexual health care. Author subgroups conducted literature reviews and developed the initial list of research questions, which were iteratively refined with advisory members. External stakeholders then independently rated each item for its importance in expanding the evidence base (1 = not important to 5 = very important) via electronic survey.Results: Our final list of 24 research questions included items that intersected all sexual and reproductive health topics as well as questions specific to human immunodeficiency virus/sexually transmitted infections (HIV/STIs), pregnancy prevention, confidentiality/consent, public health, and barriers and facilitators to care. External stakeholders rated items related to HIV/STI, cost-effectiveness, brief intervention for sexual risk reduction, and implementation and dissemination as most important. Conclusions:We identified critical questions to inform EM-based adolescent sexual and reproductive health research. Because evidence-based care has potential to improve health outcomes while reducing costs associated with HIV/STI and unintended pregnancy, funders and researchers should consider increasing attention to these key questions.A lthough preventable, sexually transmitted infections (STIs), human immunodeficiency virus (HIV) infection, and unintended pregnancy are significant and costly public health problems in the United States that disproportionately impact adolescents, especially racial and ethnic minorities and those From the
Study Objective-Nearly 20 million adolescents receive emergency department (ED) care each year, many of whom have untreated reproductive health issues. ED visits represent an opportunity to provide appropriate care, however ED physician reproductive healthcare practices and capabilities in the United States have not been described. We sought to characterize pediatric ED director's individual practice and ED system resources for providing adolescent reproductive healthcare. Design, Setting, Participants, and Intervention-We invited pediatric ED division and/or medical directors nationally to participate in an anonymous, online survey. Main Outcome Measures-Outcomes included ED directors' personal practice regarding providing adolescent patients reproductive healthcare, and their ED's resources and standard practice regarding screening adolescents for sexually transmitted infections (STIs) and other reproductive health concerns.
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