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Recent changes in the regulatory control of antimicrobial products

The ACVM Group has completed the review of antimicrobial products in line with the September 1999 report of the expert panel to MAF and the Animal Remedies Board. There were two main conclusions from the report:

• Growth promotion is not an appropriate use for an antimicrobial substance that is used for thetreatment of infections in humans; and

• While the development of resistance is possible (and proven in some cases), there was insufficient information to confirm that the problem was being exacerbated by the veterinary use of particular antimicrobials.

In the initial study it was found that present practices are not conducive to providing the information that would clarify the resistance situation in New Zealand. A few antibiotic products were not under any professional supervision at all, and those were predominantly registered for use as growth promotants. Other products were under professional supervision, but the licensing conditions did not encourage the gathering of information that would contribute to our understanding of the problem. Actual data on prescribing and use practices, and prevalence of resistance was virtually non-existent.

In light of the review, licences are being changed:

• to limit the antimicrobial  substances that can be used for growth promotion; and

• to introduce graded regulatory control of antimicrobial products, along with a requirement for reporting of some products.

Growth promotion claims for any antibiotic considered important in the treatment of infection in humans will no longer be approved. Licensees of such products have been advised accordingly. At the same time it has been confirmed that certain antimicrobial substances are not relevant to the problem of antibiotic resistance in humans. These are the ionophores, quinoxalines, flavophospholipols and avilamycin. Products containing these antimicrobial substances may still make growth promotion claims, but users should note that this use may still encourage the development of resistance in animal pathogens.

Graded regulatory control for antimicrobial products

Antibiotic products will be classed into the following:

• over-the-counter; and
• prescription animal remedy (PAR) class 1, groups 1 through 4.

Over-the-counter

Coincidentally, most of the products that can still be used for growth promotion can also still be sold over-the- counter. These may also have disease treatment and prevention uses as well but, in all cases, they are not relevant to antibiotic resistance developing in humans. Any antibiotic that is relevant and that is presently classed as an over-the-counter product will be reclassified as a prescription animal remedy. This mean that some common antibiotic products, such as injectable procain penicillin, will not be able to be purchased without a veterinary prescription.

For antibiotics that must be sold and used only under the prescription of a veterinarian, there will be increasingly stringent conditions imposed on veterinarians to manage the resistance problem and contribute to the overall understanding of the problem. In the past the conditions on all PAR1 products were the same. Now a graduated scale of regulatory obligations for antibiotics classed as PAR1 has been introduced.

The majority of products (group 1) will have conditions that are basically the same as they were in the past. There will be no specific reference to antibiotic resistance and no increase in the statutory obligations on veterinarians.

However, there are some antibiotic substances (group 2) that are considered to require more stringent management of the resistance problem. The antibiotics in this group (e.g. enrofloxacin and orbifloxacin) are identified as essential for use in humans and are known to cause resistance to develop in bacteria. They will still be classed as PAR1 but their use will be limited to therapeutic purposes under circumstances in which the prescribing veterinarian is satisfied that the antibiotic is likely to be the only effective treatment.

Growth promotion will be a prohibited use with no veterinary discretion to prescribe for that purpose. [to next page]

AVMAC and ILG meetings

The dates for meetings in 2002 have been confirmed.

See the Forums section of the ACVM website for details of members and the notes from meetings or the proposed agendas. The  meeting dates for this year are:

Thursday 21 February 2002
Thursday 23 May 2002
Thursday 22 August 2002
Thursday 21 November 2002