["Off-label" prescribing of drugs in the ambulatory care of children and adolescents].
OBJECTIVE
Hospitalised children receive up to 90 % of their drug prescriptions without ("unlicensed use") or outside ("off-label use") the terms of their product license. As no data are available for pediatric outpatients in Germany, we determined "off-label" use in a representative cohort of children and adolescents.


METHODS
We analyzed 1.74 million prescriptions, written from January 1 st through March 31 st, 1999, to 455 661 children and adolescents aged 0 to 16 years by 6886 specialists in pediatric, general or internal medicine. All prescriptions were covered by the public health insurance, Allgemeine Ortskrankenkasse, (AOK) Baden-Wuerttemberg. License status of 1 592 006 identifiable prescriptions comprising more than 10 000 differently branded drugs was determined in 5 age groups and in different groups of the Anatomical Therapeutical Chemical Classification (ATC). As reference documents for licensing status we used the "Fachinformation" (summary of product characteristics), the "Rote" and "Gelbe" Liste, respectively.


RESULTS
13.2 %, i. e. 210 528 of the 1.59 million prescriptions, were "off-label". 75 % of these "off-label" prescriptions were due to a lack of information on pediatric use in the summary of product characteristics. The highest "off-label" fractions were found in drugs topically used in eyes and ears (78.6 %), dermatological (57.9 %), cardiovascular drugs (55.2 %), drugs für musculoskeletal (45.2 %) and urogenital disorders (48.5 %) and antidepressants (36.6 %).


CONCLUSIONS
"Off-label" prescribing in outpatient children is less frequent than in pediatric inpatients. Considering the high absolute number of prescriptions however, 13.2 % cannot be neglected. Doctors prescribing drugs for children and adolescents should be aware of their actual licensing status because of its medical and legal consequences.
Bücheler
R
R
Abteilung Klinische Pharmakologie, Institut für Pharmakologie und Toxikologie, Universitätsklinikum Tübingen, Germany.
Meisner
C
C
Kalchthaler
B
B
Mohr
H
H
Schröder
H
H
Mörike
K
K
Schwoerer
P
P
Schwab
M
M
Gleiter
C H
CH
D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004348:Drug Labeling; D011307:Drug Prescriptions; D005194:Family Practice; D005858:Germany; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007348:Insurance, Health; D007388:Internal Medicine; D010045:Outpatients; D010372:Pediatrics