Unapproved and Off-Label Use of Drugs in a Children's Hospital

To the Editor: Treatment of children may be difficult because of a shortage of properly formulated or approved drugs. 1 In the Netherlands and elsewhere, many drugs are not approved for use in children, and some drugs are often used outside the terms of the product's approval (off-label use). We studied the unapproved and off-label use of drugs in a children's hospital in which the hospital pharmacy, unlike pharmacies in many other European countries, is allowed to prepare “homemade” formulations and to modify commercial preparations in order to suit the needs of children. During a five-week period, we classified the use . . .