ABSTRACT
This chapter presents the guidelines for off-label prescribing: a drug license applies to the activities of the pharmaceutical company, not the doctor's prescribing practice; and the cost of testing new uses and routes means that they are unlikely to be tested by pharmaceutical companies to gain a license. The key to safe off-label prescribing and administration of drugs is to keep risks to a minimum. Some basic rules will reduce the risks to the prescriber and person administering the preparation. Basic rules for off-label prescribing: the drug or preparation should: be licensed for other uses and routes; and be well known and studied; the reasons for use should not be trivial; and in the case of new, or little used, uses and routes, the details should be documented and consent obtained from the patient.
