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AgVetLink June 2003

SPECIAL ISSUE FOR VETERINARIANS

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Slice of life audits and ‘proactive compliance’

In the past the level of compliance activity in the Animal Remedies Act area was not high, but this is changing markedly with the ACVM Act.

The ACVM Group has been working with the NZFSA Compliance and Investigation Group (CIG)* on a number of ‘slice of life’ audits.

Audits

Over the last few months CIG has undertaken an extensive audit looking at the supply chain for antibiotic products as a follow up to the changes made in the conditions on product registration. This audit concentrated on an ‘ingredient’ product that went through the animal feed chain into the intensive farming industries, and one ‘finished dose’ product. All facets of the process from importing and manufacturing, wholesaling, prescribing, dispensing and using were covered. Initial indications from the audit are that there is a real need for raising awareness of responsibilities under the ACVM Act.

A similar audit looking at the use of human medicines by veterinarians to measure compliance with Appendix 1 of the Code of Professional Conduct is planned. (Appendix 1 is The New Zealand Veterinary Association Code of Practice for the Discretionary Use of Human and Veterinary Medicines by Registered Veterinarians, which has been approved under section 28 of the ACVM Act.) A number of future audits are planned.

These will cover the border and the importation of products, and compounding of veterinary medicines by veterinarians. When the standards for trading, prescribing and promoting PAR products are finalised, a series of audits will be undertaken (see below).

Purpose

These audits are not being taken primarily for the purpose of identifying and prosecuting non-compliances. They are intended as an overarching indicator or the effectiveness of regulation under the ACVM Act. We expect that we will find some areas where there is too much regulatory control and others where there needs to be more, or where we need to look for different mechanisms to be effective. In the main, they will target the areas where we need to work harder on education.

Positive compliance

However, we will follow up on any serious non-compliances that are found. As a minimum response, we will re-visit people or premises where we identify non-compliances and audit them against the appropriate standards. We intend to have a positive compliance programme that will check for ongoing compliance over a period of time.

Costs

While the ‘slice of life’ activity is random and cost recovered from the compliance portions of product registration and annual fees, any positive compliance activity will be cost recovered directly from the parties being audited. The fees for this are regulated and are charged out at $121.50 per hour (inclusive of GST) plus the cost of disbursements, such as travel.

PARs

Once we have finalised the standards covering PAR trading and dispensing, it is likely that we will undertake 4 to 6 ‘slice of life’ audits over the next 18 to 24 months in order to work out what level of ongoing verification programme is needed. We expect that the initial audits will show a higher level of non-compliance than will be the case later in the process, especially given the positive compliance activities planned.

The New Zealand Veterinary Association has indicated that it will be developing codes of practice in the area of dispensing. We expect these will assist greatly, and they are a welcomed addition to the already approved code of practice covering prescribing.

* CIG Group Director Geoff Allen has a team of auditors and investigators working with him to ensure compliance with NZFSA administered legislation and to investigate allegations of non-compliance.

 

Veterinary Council of New Zealand

The NZFSA and the ACVM Group have had initial discussions with the Veterinary Council of New Zealand (VCNZ) to discuss ways of working together on compliance related issues.

Veterinarians are a key group of risk managers for the ACVM Group and for NZFSA in a wider context. The mechanisms for ensuring compliance with the Code of Professional Conduct are critical to NZFSA processes and, as two regulatory bodies, it makes sense to align our activities in order to be as effective as possible.

The strategies that we hope to develop include a range of activities from education and raising awareness to discipline and prosecution in the most serious cases. It is probable that the parties will develop a Memorandum of Understanding to outline any agreement made, and that we will have a number of operational agreements covering day to day activities. At this stage we have agreed to meet on a regular basis to progress the issues in front of us.