Published: 12 December 2013

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Reminder: Unapproved Medicines and the Code of Rights

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Prescriber Update 34(4): 47
December 2013

Prescribers are reminded that while the Medicines Act 1981 allows for the use of unapproved medicines in New Zealand, the Code of Rights applies.

The Medicines Act and unapproved medicines

Prescribers may be aware that Section 25 of the Medicines Act permits practitioners to prescribe any medicine for a particular patient in their care. This includes the use of approved or unapproved medicines.

In addition, Section 29 of the Medicines Act enables a New Zealand company/pharmacy to legally obtain and supply an unapproved medicine to a patient when authorised by a prescriber (reporting requirements apply).

Prescribers are reminded that unapproved medicines prescribed and supplied in New Zealand are not regulated by Medsafe. As a result, Medsafe has not assessed the quality, safety and efficacy of the medicine or the information provided with the product.

Medicines prescribed under Section 29 of the Medicines Act do not usually have a data sheet published on the Medsafe website and sometimes information can be hard to find. The New Zealand Formulary is a valuable resource that provides information about approved and some unapproved medicines (www.nzf.org.nz).

The Code of Rights

The Code of Rights, published by the Health and Disability Commissioner, establishes the rights of consumers and the obligations and duties of providers to comply with the Code.

The Code of Rights states that the consumer has the right to treatment of an appropriate ethical and professional standard, and the provider has the responsibility to ensure treatment, whether approved or unapproved meets this standard.

Importantly, the consumer has the right to be fully informed. If the use of a medicine is unapproved, the consumer should be advised and the provider should be frank about the standard of support for the use and any safety concerns.

Right 6 of the Code of Rights specifies that every consumer, on request, has the right to receive a written summary of the information provided.

Informed consent can be written or verbal. Written consent is generally required in situations where:

• there is minimal evidence to support the use of the medicine
• the evidence of the efficacy or safety of the medicine used in this manner is equivocal
• the use is part of a clinical trial.

Further information about the use of unapproved medicines, including example scenarios, can be found on the Medsafe website (www.medsafe.govt.nz/profs/RIss/unapp.asp).

Further information about the Code of Rights can be found on the Health and Disability Commissioner website (www.hdc.org.nz/the-act--code/the-code-of-rights).