Abstract
The term “off-label drug use” refers to drugs that have not yet acquired “approved” status or drugs that have acquired “approved” status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996 and the common law, which require that off-label drug use is of an acceptable standard, that the patient should be fully informed, and that the patient should give informed consent. Off-label drug use is an important issue because the current law provides medical practitioners very wide discretionary power, without providing clarification for what is required of the practitioner in exercising his or her discretion in prescribing off-label. This paper discusses possible solutions to this issue, for example, establishing protocol for off-label use, an electronic database of off-label use, and the amendment of legal provisions.
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Notes
Although, the fact that the Medicines Act allows for off-label use might suggest to a practitioner that the benefits outweigh the risks.
The electronic database would need to record both positive and negative experiences to ensure optimum gain and efficiency from the database. It is noted that practitioners may be reluctant to record negative experiences due to fear of opening him- or herself up to liability, and this will need to be addressed upon implementation of the database.
See, for example, 45/Nur05/19P, http://www.hpdt.org.nz/portals/0/nur0519pfindings.pdf.
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Acknowledgements
The author would like to thank Dr. Debra Wilson, senior lecturer in law at the University of Canterbury, New Zealand, and Dr. Trevor Cook, registered medical practitioner, Christchurch, New Zealand.
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Cook, R.J. Off-Label Drug Use as a Consent and Health Regulation Issue in New Zealand. Bioethical Inquiry 12, 251–258 (2015). https://doi.org/10.1007/s11673-014-9568-6
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DOI: https://doi.org/10.1007/s11673-014-9568-6