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AgVetLink: Number 58, October 2006

Review of PAR Traders

Background

A reality check of prescription animal remedy (PAR) traders was performed as part of the ACVM Compliance Strategy in June 2006. This check provides part of the picture that would give international trading partners assurance that NZFSA is managing the risks associated with trading in PAR products. The rest of the picture is provided by the GMP approval of manufacturers of these kinds of products and the entry audit non-veterinarian traders undergo prior to their approval as traders (see page 12).

The purpose of the review was to determine the level of understanding and compliance by PAR traders with the ACVM Act and other relevant legislation, the ACVM Standard for Prescription Animal Remedy Veterinary Medicines, codes of practice and other standards. The scope of the review was limited to registered veterinarians who were deemed as approved traders under the ACVM Standard due to their professional training and experience. Five dairy, three sheep and beef, two equine and two companion animal practices were selected at random. The selection process was weighted to ensure areas where high volumes of PAR trading occur (where issues relating to food safety and risk to trade might occur) were represented. In each clinic, interviews were held with the person responsible for the operation of the documented quality system.

Summary of findings

Quality system

All practices reviewed had a documented quality system typically supported by customised computer software. These computer programmes aided the control of the authorisation of the PAR supply for anticipated use, especially in dairy practices. The authorisations sighted were valid for 12 months, which is not in compliance with the registered code of practice for prescribing.

Two practices allowed lay staff to action immediate sale of PAR products to authorised clients in the specific circumstances where veterinary authorisations to that client had time expired, or allocated quantities of PAR products purchased had been exceeded. The procedures did require the veterinarian to follow up the sale at some later, unspecified time, and furnish a retrospective prescription/authorisation.

In four practices there was no evidence of a regular review of the Quality System to ensure it was in compliance with the Standard and the Guidance document.

All staff interviewed seemed to be conversant in the requirements of the Standard but there were not always records of their training or sign off of competence.

The practice of allowing lay staff to sell PAR products, even in specified circumstances, is a critical non-compliance to the Standard and with the conditions of registration of PAR products.

Transportation

In general, specific procedures for the safe and secure transportation of PAR products were not available but good distribution records were maintained. Transportation to the end user is typically by clinic sale directly to the client, or via farm sale from the veterinarian’s vehicle. There are situations in isolated areas where transport is via a third party, either by the client’s designated agent, courier or rural post. Delivery of PAR products to letter boxes or local general stores or garages by rural post, would be considered adequately safe or secure for ACVM purposes if they were packaged inconspicuously as to their contents. Procedures should be developed instructing staff how to ensure safe transport in these particular circumstances. PAR transport between clinics within a practice was generally by traceable courier or by clinic vehicle.

Receipt and storage

In general the quality systems did not contain specific written procedures to cover this requirement. However, all clinics did provide verbal instructions and staff appeared to be well informed and experienced in the safe and secure receipt and storage of PAR products. In all but one circumstance the PAR drugs were kept out of view and/or in locked areas as per the requirements. The cited incident was remedied immediately it was identified.

Dispensing

Generally there are well developed systems for dispensing of PAR products. However, labels containing a minimum of the prescribing veterinarian’s name and contact information were not applied to the dispensed product in all circumstances, e.g. when dispensing from the veterinarian’s car. In one farm dispensary, expired PAR products, and a significant number of used needles and syringes were observed.

The failure to label dispensed products with contact details of the prescribing veterinarian is a critical non-compliance with the standard. It is unacceptable that disposal of used equipment and expired products is not being managed appropriately by the end user.

Training

The level of training was dependent on the size of the practice both in terms of staff and volume of PAR products traded. Training needs to be ongoing to ensure any changes in the Standard are captured. The lack of records as evidence of staff training was a common observation made during the review. This is considered a non-compliance.

Documentation

In general all practices visited had documents and records available for their activities and transactions relating to PAR products. Two practices did not have the current Standard and Guidance document at the time of the visit, but there were experienced veterinarians who had independently developed systems for controlling the use and sale of all traded veterinary medicines. The ACVM documents were provided at a later time. The finding that a number of practices were not aware of the ACVM Standard is considered a critical non-compliance.

Auditor’s recommendations

The auditor made the following recommendations for the ACVM Group, the Veterinary Council of New Zealand (VCNZ) and the New Zealand Veterinary Association (NZVA):

VCNZ and NZVA only

That consideration be given to amend the current Code of Practice for Registered Veterinarians Writing Prescriptions for Prescription Medicines and Prescription Animal Remedies to extend the current 6 month limitation on prescription supply to 12 months. This is particularly applicable to authorisations where the product is held in anticipation of a need, e.g. dry cow therapy for dairy farmers.

ACVM Group only

That consideration be given to include, at the next ‘slice of life’ review, interviews with authorised clients who buy, hold and use PAR products to determine the effectiveness of the instructions and training provided by the veterinarians. This will provide a picture of the end user’s compliance level to the Standard.

That more information be provided to ensure the correct use of the terms ‘authorisation’ and ‘repeat prescription’. During this review, it seemed they were being used interchangeably, thus resulting in loss of correct meaning.

Auditor’s summary

The findings of this review provide assurance that registered veterinarians are, in general, trading PAR products in compliance to the ACVM Standard. A number of observations made were considered critical non-compliances but they were isolated to individual practices and were not considered systemic.

Both VCNZ and NZVA have been provided with an analysis of all observations made during this review. Their assistance should be sought to develop a strategy to improve the level of compliance to the Standard. This could take the form of workshops or professional advice provided through VCNZ and NZVA channels. It is then proposed that a second sample of veterinary practices is selected for an audit to determine if compliance has improved. Veterinarians should be reminded that objective evidence (i.e. records) is required to verify their compliance with the Standard. Without this information, NZFSA is not able to provide the necessary assurance to international trading partners.

The ACVM Group’s next step is to consider and respond to the auditor’s recommendations.