RT Journal
A1 Shah SS, Hall M, Slonim AD
T1 MAking progress for how medicines are used in children—reply
JF Archives of Pediatrics & Adolescent Medicine
JO Archives of Pediatrics & Adolescent Medicine
YR 2007
FD September 1
VO 161
IS 9
SP 916
OP 917
DO 10.1001/archpedi.161.9.916-b
UL http://dx.doi.org/10.1001/archpedi.161.9.916-b
AB 
In our study, off-label use of 90 drugs in patients from 31 geographically heterogeneous tertiary care children's hospitals accounted for more than $250 million.1 Almost 80% of children discharged from a participating hospital received at least 1 drug off-label. This high-level of off-label use likely underestimates the true magnitude of the problem, because we based our definition of off-label drug use solely on age criteria. Prescribing these medications for unapproved indications also constitutes off-label use; the specific indications could not be determined using our data. As Drs Taylor-Zapata and Mattison emphasize, many of the evaluated medications are off patent. Whereas exclusivity programs have resulted in increases in pediatric research from the prescription drug industry,2 the study of off-patent drugs for use in children poses an even greater challenge. We are pleased that our manuscript has helped to underscore the importance of continued evaluation of new and off-patent medications in children.