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

Correspondence to:
Correspondence to:
Professor P Hill
Department of Psychological Medicine, Great Ormond Street Hospital for Children, Great Ormond Street, London WC1N 3JH, UK; prof{at}17wimpole.com

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.

Abbreviations: EMEA, European Medicines Agency; FDA, Food and Drug Administration; MHRA, Medicines and Healthcare products Regulatory Agency

Relevant Article

Introduction

P Hill
Arch. Dis. Child. 2005 90: i1. [Extract] [Full Text] [PDF]

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				J Bua, I L'Erario, E Barbi, and F Marchetti When off-label is a good practice: the example of paracetamol and salbutamol Arch. Dis. Child., June 1, 2008; 93(6): 546 - 547. [Full Text] [PDF]