Editors' view Off-label and unlicensed prescribing for children: have we made any progress?

摘要

Unlicensed drugs are those that do not have marketing authorization. Off-label use is prescribing outside the terms of the product licence, for example in a different indication, age group, dose or route to that which is approved by the regulatory authority. In 1999, Collier wrote an editorial for the Journal, in which he considered the problems raised by off-label and unlicensed prescrib-ing for children. He concluded that "the current wide-spread use of products outside [licensed] conditions disadvantages children and is unacceptable".