Journal of the American Osteopathic Association
Objective: To determine the use of nonapproved medications (safety and effectiveness in pediatric patients have not been established) for children prescribed at outpatient physician visits.
Background: The National Ambulatory Medical Care Survey (NAMCS) is a nationwide periodic survey of non–federally employed office-based physicians primarily engaged in patient care activities. The NAMCS provides information on selected patient visits including data on patient demographics, reasons for visit, physician diagnoses, clinical services provided, and medications ordered. Up to 6 medications could be recorded for each visit. The number of pediatric outpatient visits sampled between 1993 and 2000 ranged from 3000 to 6000 each year.
Methods: NAMCS data were analyzed for the period 1993–2000 for all children ≤18 years of age. Medications were abstracted from the drug codes listed for each visit. For the top 200 drugs recorded, we examined the indications and usage of the drug for pediatric patients according to the 2001 Physicians' Desk Reference. The rate of nonapproved medication use was estimated according to the top 200 medications recorded. Information on the use on nonapproved medications according to medical disease and physician specialty was also examined. Weighted data were used for all analysis.
Results: For the years 1993–2000, there were an estimated 158 million pediatric outpatient visits each year to physicians in the United States. Medication was prescribed at 64.2% of pediatric visits. Of the top 200 medications prescribed to children during this time period, 8% (16/200) of these medications had not been established as safe and effective in pediatric patients. The most common prescribed nonapproved medications included Paxil®, Wellbutrin®, Vicodin®, Benzac®, and Risperdal®. The most common disorders for which nonapproved medications were prescribed included dermatological and psychiatric disorders. Dermatologists, family practitioners, psychiatrists, and pediatricians prescribed the most nonapproved medications as compared to other specialties.
Conclusion: Of the top medications prescribed to children on an outpatient basis in the United States, 8% have not been shown to be safe and effective in pediatric patients. The majority of these medications are prescribed for dermatological and psychiatric disorders and likely represents the limited availability of effective medical therapies for children with these disorders.
Morton KM, Willsie SK, Lynch JK. Outpatient Prescribing Practices for Nonapproved Drugs in Children. Journal of the American Osteopathic Association. 2005; 105(1). doi: 10.7556/jaoa.2005.105.1.24.