n Stellenbosch Law Review = Stellenbosch Regstydskrif - Regsimplikasies van die gebruik van medikasie

Volume 20, Issue 2
  • ISSN : 1016-4359
  • E-ISSN: 1996-2193



This article discusses the legal and ethical implications of the off-label use of medication. "Offlabel" means that a drug is not used in the manner for which it has been registered and which is indicated in its labeling. This does not necessarily imply that using the drug in this way is ineffective, improper or unsafe. Off-label use represents a widespread and important part of legitimate and sometimes even essential clinical practice. However, the off-label use of medication obviously increases risks to both the patient and the medical practitioner, which necessitates caution. Examples of off-label use are provided and the South African regulatory framework is compared to that of the USA. Legal implications such as the circumstances in which the off-label use of medication will be negligent, as well as the matter of informed consent in regard to off-label use, are discussed. Finally, the article deals with the issue whether information about the off-label use of medication should be supplied to medical practitioners. In South Africa no guidelines on the off-label use of medication are supplied to medical practitioners, and it is concluded that it is imperative that they are provided with increased assistance and balanced, objective information. An amendment of current legislation is suggested.

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