V. Gavrilov et al., Unlicensed and off-label medication use in a general pediatrics ambulatoryhospital unit in Israel, ISR MED ASS, 2(8), 2000, pp. 595-597
Background: Many medications used for children have not undergone evaluatio
n to assure acceptable standards for optimal dose, safety and efficacy. As
a result, the majority of children admitted to hospital wards receive medic
ations outside the terms of their license (off-label) or medications that a
re not specifically licensed for use in children (unlicensed). The extent o
f unlicensed and off-label medication use in ambulatory children is unknown
.
Objective: To determine the extent of unlicensed and off-label medication u
se in a general pediatrics ambulatory hospital unit in Israel.
Patients and Methods: We conducted a retrospective analysis of the medical
records of 132 outpatient children treated in the General Pediatrics Ambula
tory Unit of the Soroka Medical Center, Beer Sheva, in November-December 19
98.
Results: The children's ages ranged from 1 month to 18 years (mean +/- SD 5
0 +/- 58 months). Of the 222 prescriptions given to these children, one-thi
rd were unlicensed (8%) or unlabeled (26%). Different dose and age were the
most common categories of off-label medication use. All 18 cases of unlice
nsed use were due to modification of licensed drugs (tablets were crushed t
o prepare suspensions). Altogether, 42% of children received medicines that
were off-label and/or unlicensed.
Conclusions: More off-label than unlicensed medications were used. Further
investigations are required to establish the extent of unproved drug use in
both hospitalized and ambulatory pediatric patients in Israel. Recommendat
ions recently issued by the Ministry of Health's National Council for Child
Health and Pediatrics constitute a first step in the Israeli contribution
to the international effort demanding testing of medications for children.