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AgVetLink March 2004 - Special Issue for Veterinarians: Page 4

Prescription of Tylan and Zinc Bacitracin

With the changes to PAR I status for these antibiotics, all growth promotion claims were removed. In conjunction with this some dose rates were changed to those supported for therapeutic use. A recent ACVM audit indicated that even though these antibiotics were being prescribed in some cases the dose rates were consistent with use for growth promotion.

Veterinarians should be aware that continued prescribing at levels below label dose rates is off-label and subject to the Code of Practice for Discretionary Use of Human and Veterinary Medicines by Registered Veterinarians, which is recognised under the ACVM Act. The veterinary evaluation required would allow these drugs to be used at lower dose rates for treatment of other species or diseases but only when the dose rate and duration can be justified to achieve a therapeutic outcome.

Where prescription products have been used for growth promotion, prescribing veterinarians must re-evaluate the dose and use against the approved claims. If the use is off-label the prescribing must conform with applicable ACVM standards or approved codes of practice.

Veterinary discretionary use and compounding activities

As some of you will be aware, the ACVM Group has recently conducted a ‘slice of life’ audit focusing on the issues of veterinary discretionary use and veterinary compounding activities. The Group has conducted several audits of this nature over the past months in an attempt to assess the ‘state of play’.

While gross breaches in current legislation are likely to lead to enforcement action, the primary purpose of the audits is to establish where the Group needs to focus its educational arm. Preliminary indications are that, although veterinarians do not seem to have a high level of understanding of their responsibilities in these two areas, many are still getting it ‘mostly right’ by applying the principles of good veterinary practice.

This document discusses the current regulatory situation with respect to veterinary discretionary use.

When is it OK for discretionary use of veterinary medicines in veterinary practice?

One of the most important things for all veterinarians to know is that discretionary or ‘off-label’ use of veterinary medicines is not the automatic right of registered veterinarians. Only the ACVM Group has the authority to approve veterinary medicines to be used in any way other than those stated on the label. This approval takes the form of a condition placed on the registration of each veterinary medicine for which discretionary use is approved.

The condition reads: 

The product may be used at the discretion of a registered veterinarian when acting in accordance with any

• applicable code of practice approved under section 28 of the ACVM Act; and
• on animals under the direct care of that veterinarian

unless that use is specifically prohibited in the current registration.

Conditions can be found on the ACVM website ( www.nzfsa.govt.nz/acvm ).

The use of human medicines and compounded medicines is permitted by a Regulation exempting use by veterinarians subject to an approved code of practice.

At present the applicable code of practice for a veterinarian in general practice is the Code of Practice for the Discretionary Use of Human and Veterinary Medicines by Registered Veterinarians. This code may be found in the Veterinary Council of New Zealand handbook and on their website.

Any veterinarian using human medicines, compounded medicines or veterinary medicines in a discretionary manner in the treatment of an animal must do so only with full knowledge of the requirements of the applicable code. Veterinarians should note that the minimum withholding period of 60 days (section C, A4) is out of date. Veterinarians should refer to the default WHPs set by the ACVM Group (see article on page 5).

The ACVM Group recognises that for the vast majority of veterinary medicines, there are many legitimate off-label uses and it is not our intention to prevent a well-established and usually self-regulated behaviour. However, on occasion, to manage the risks prescribed under the ACVM Act it may be necessary for a veterinary medicine to be used only according to label directions.

When is it NOT OK for discretionary use of veterinary medicines in veterinary practice?

Where discretionary use is not

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