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Agvetlink Special Issue for Veterinarians March 2005

‘DO NOT USE’ Statements

The utilisation of ‘Do not use’ statements on veterinary medicine labels has had a chequered past in New Zealand.  Most of the time, the statement was used because there was a lack of information to support that the use was acceptable from an animal welfare and/or residue perspective, not because a prohibition of use was found to be necessary.

The ACVM Group has made a determined move away from the inappropriate utilisation of ‘Do not use’ statements under the risk-based requirements of the ACVM Act.  Disallowing a use on the basis of insufficient information to enable formal approval of a claim is considered contrary to the principles of risk management.  Rather, the opportunity is provided for any veterinarian to use a veterinary medicine in a discretionary manner providing he/she conducts the necessary and appropriate analysis to ensure all ACVM Act risks resulting from the use are managed.

However, others do not share the ACVM Group’s philosophy.  In consequence, ‘Do not use’ statements appear on the labels of veterinary medicines registered in New Zealand for a variety of reasons, for example:

1.  Other regulatory agencies have requested inclusion of the statement.

2.  The product registrant wishes the statement included (often for liability reasons).

3.  There is an established reason for the warning.

4.  The statement was on old labels and has never been removed.

It has not always been possible to tell why the statement is on the label.

New approach

As products have been updated to the provisions of the ACVM Act, all ‘Do not use’ statements that were employed in the absence of residue data have been replaced by withholding periods (default, allocated or assessed) or more helpful wording. 

 Registrants who have insisted on retaining ‘Do not use’ statements have been required to include justification for the warning somewhere on the product label. If a prohibition on use is considered necessary by the ACVM Group to manage the risks under the ACVM Act, it will be prefixed by words to the effect of ‘It is a legal requirement that…’ (e.g. EU banned substances). 

 Warnings considered reflective of good practice (e.g. appropriate use of NSAIDs) are unlikely to be prefixed, but sufficient information will be included to provide users with the ability to conduct the necessary risk-benefit evaluation.

Australian requirements

Unfortunately, statements required by the APVMA that are included on harmonised labelling are unable to be changed, specified as applying to Australia only or placed in context because of Australian requirements.  For example, the APVMA Labelling Code requires that products registered for use in companion animals only carry the label statement ‘DO NOT USE in food-producing species’.  This statement does not necessarily apply in New Zealand.

If a product label contains any prohibition that requires clarification, veterinarians are encouraged to contact the registrant or the ACVM Group.