OFF-LABEL DRUG USE IN CHILDHOOD ASTHMA

Off-label prescribing means unlabelled or unapproved prescribing of a registered medicine for a use that is not included in the product information, such as for a different indication, age, dose or dosing regimen, or via a different route. An unregistered or unlicensed medicine in South Africa is one that has not been assessed or approved by the Medicines Control Council (MCC). Off-label prescribing is relatively common in children, and many anti-asthmatic drugs are used off-label, particularly in young children. Off-label prescribing is not illegal and is not necessarily wrong. It is a reflection of inadequate paediatric clinical trials. The main problems with off-label prescribing are the higher rate of adverse events and ethical issues such as benefit/harm risks and the need for informed consent. The MCC should facilitate the registration of drugs for paediatric use, and should both enforce and encourage drug trials for medicines for children.