Off licence and off label prescribing in children: litigation fears for physicians

Abstract

So-called "off label" and unlicensed prescribing refers to the use of medicines outside of the indications for which they are licensed by national regulatory bodies. Off label prescribing is quite common in children, as most drugs are developed only on the basis of trials with adults. Nevertheless, physicians and hospitals can be wary of using medicines in this way for fear of litigation if adverse events occur. Given this unsatisfactory state of affairs, regulatory bodies are beginning to request robust data from pharmaceutical companies with regard to the use of their products in children. In the meantime, off label prescribing remains acceptable if there is no suitable alternative and physicians are confident that they are using agents in accordance with the body of respected medical opinion.