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AgVetLink: Number 59, December 2006

The Use of Veterinary Medicines in Research, Testing and Teaching Organisations in New Zealand

Background

The ACVM Group recently commissioned a ‘slice of life’ or ‘reality check review’ to assess the level of compliance to relevant conditions under the ACVM Act by research, testing and teaching organisations (RTTOs) when they are using veterinary medicines to manage experimental animals. This review also ascertained the level of awareness of relevant approved codes of practice and ACVM standards, and if these were being used to develop operational procedures to ensure compliance with the conditions of registration (or the conditions of exemption) for the veterinary medicines used.

Six randomly selected institutions involved in the purchase, storage, dispensing, training and use of registered veterinary medicines or unregistered veterinary and human medicines requiring veterinary overview in experimental animals were visited as part of this review.

Results

Only one major university RTTO and one commercial RTTO satisfied the reviewer regarding compliance with the requirements of the legislation. The review identified several areas where common best practice was not being achieved.

Staff

RTTOs need to ensure that the prescribing veterinarian is provided with adequate staff and resources (dependent on the size and complexity of the organisation) to ensure training of non- veterinary staff (and students if appropriate) in the legislation and the correct use of prescriptions.

Several RTTOs either employed a part- time local practicing veterinarian or had part-time permanent staff; two had unfilled vacancies for a permanent veterinary position.

Training

The RTTOs reviewed showed a large variation in the availability, standard and recording of training. Similarly, there was inconsistent recognition of staff competency.

Training must be available for new staff or students prior to them becoming involved in the use of drugs on animals. One location provided full-time ‘online’ training and competency assessment. At other locations training sessions were held infrequently.

Untrained or inadequately trained staff were found to be involved in the use or control of PAR Class II drugs at three locations.

At two locations there was evidence of the use of Twink and erasing in the drug control register. This meant that the register could not be audited as required.

At one location the procedure stated that the Drug Control Officer was to sight and verify the accuracy of each Principal Investigator’s drug use registers prior to dispensing further PAR Class II drugs. This was not occurring and PAR Class II drugs were being re-dispensed without drug register checks.

At a second location drugs that had been prescribed by more than one veterinarian were stored together and there were no staff training records available. It was not possible to identify which veterinarian had prescribed which drugs because the drugs were not identified with the prescribing veterinarian’s details. Therefore, it was impossible to trace which veterinarian was responsible for the instructions and training of non- veterinary staff for their particular use.

Audits

There was inconsistent adherence to the stated frequencies that each organisation stipulated for internal and external audits. This inconsistency and, in several cases, lack of any audits compromises the RTTO’s ability to be an efficient self regulator in the management of ACVM Act requirements.

At some locations drug stores had significant quantities of expired PAR Class II drugs. There was also inadequate security of PAR Class I and II drugs at two locations. In these instances, drugs were stored in open cupboards and were freely accessible.

There was also a lack of uniformity in the recording of drug usage. At several locations drug control registers were generic pocket notebooks, pages were not numbered and mandatory columns were either non existent or, if partially present, were hand drawn.

Summary

This review highlighted several areas where compliance with the legislation was not being achieved. However, where deficiencies were highlighted and brought to the attention of the responsible personnel, there was a universal commitment to correct procedures and ensure compliance with the ACVM Act.

There are significant risks with the use of prescription veterinary medicines within the RTTO environment. The prescribing veterinarian must rely heavily on robust internal systems to provide assurance that use of prescription medicines is compliant. A prescribing veterinarian may have numerous RTTO staff and students, often at isolated sites, using PAR Class I and, more importantly, PAR II medicines without direct physical veterinary supervision.

Locations that did not have a full-time veterinarian or where there was a current vacancy were under-resourced for their relative size and complexity, resulting in non-compliances with the code of practice and the ACVM standard.