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Off-label prescribing to children in the United States outpatient setting
Alicia T F Bazzano1, Rita Mangione-Smith, Matthias Schonlau
1UCLA School of Public Health, Department of Health Services, University of California, Los Angeles, Los Angeles, California 90095, USA.
Insights
Off-label prescribing is common in pediatric outpatient visits, affecting most children, especially those under six and seen by specialists. This highlights a need for more pediatric drug research and clearer labeling for safer clinical practice.
Area of Science:
- Pediatric Pharmacology
- Clinical Pharmacy Practice
- Health Services Research
Background:
- Off-label prescribing, using medications outside their approved indications or age groups, is prevalent in pediatric care.
- Existing studies and labeling updates have not significantly reduced this practice in outpatient settings.
Purpose of the Study:
- To quantify the frequency of off-label prescribing in US pediatric outpatient visits.
- To investigate the association of drug class, patient age, and physician specialty with off-label prescribing patterns.
Main Methods:
- Analysis of data from the National Ambulatory Medical Care Surveys (NAMCS) from 2001-2004, including 7901 pediatric outpatient visits with prescriptions.
- Comparison of prescribed medication use against FDA-approved age and indications.
- Multivariate logistic regression to identify factors influencing off-label prescribing probabilities.
Main Results:
- Off-label prescribing occurred in 62% of pediatric outpatient visits.
- High rates of off-label use were observed across medication classes: cardiovascular-renal (96%), pain (86%), gastrointestinal (80%), pulmonary (67%), and dermatologic (67%).
- Off-label prescribing was more probable in younger children (<6 years, particularly <1 year) and visits to specialists compared to general pediatricians.
Conclusions:
- The majority of pediatric outpatient visits involve off-label medication use, spanning all major drug categories.
- Younger children and those treated by specialists are more likely to receive off-label prescriptions.
- Further research on outcomes, causes, and appropriateness of off-label prescribing is crucial, alongside improved dissemination of pediatric drug information.
Objective:
The aim of this study was to determine the frequency of off-label prescribing to children at United States outpatient visits and to determine how drug class, patient age, and physician specialty relate to off-label prescribing.
Methods:
Data from the 2001 through 2004 National Ambulatory Medical Care Surveys (NAMCS) consisted of a sample of 7901 outpatient visits by children aged 0 through 17 years in which prescriptions were given, representative of an estimated 312 million visits. We compared FDA-approved age and indication to the child's age and diagnoses. We used multivariate logistic regression to determine adjusted differences in probabilities of off-label prescribing.
Results:
Sixty-two percent of outpatient pediatric visits included off-label prescribing. Approximately 96% of cardiovascular-renal, 86% of pain, 80% of gastrointestinal, and 67% of pulmonary and dermatologic medication prescriptions were off label. Visits by children aged <6 years had a higher probability of off-label prescribing (P < .01), especially visits by children aged <1 year (74% adjusted probability). Visits to specialists also involved a significantly increased probability (68% vs 59% for general pediatricians, P < .01) of off-label prescribing.
Conclusions:
Despite recent studies and labeling changes of pediatric medications, the majority of pediatric outpatient visits involve off-label prescribing across all medication categories. Off-label prescribing is more frequent for younger children and those receiving care from specialist pediatricians. Increased dissemination of pediatric studies and label information may be helpful to guide clinical practice. Further research should be prioritized for the medications most commonly prescribed off label and to determine outcomes, causes, and appropriateness of off-label prescribing to children.
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