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AgVetLink June 2005

SPECIAL FEATURE: PAR Management at the University of Otago

When asked to picture the use of veterinary medicines (VM) in the mind’s eye, visions of cows, sheep, cats and dogs are most likely brought to mind.  An image not often conjured is the use of prescription animal remedies (PARs) and human medicines within the numerous research, testing and teaching organisations throughout New Zealand.

Historically, these substances have been in common use on animals within these organisations by non-veterinarians, without appreciable veterinarian supervision. It is now expected, and legally required, that within institutional settings all PAR and human medicine use on animals will be under the supervision of a registered veterinarian.  The introduction of the ACVM Act has enabled effective risk management tools such as codes of practice to be developed to ensure the continued and controlled access to medicines within institutional settings where veterinarian presence may be limited. 

Frontrunner

The University of Otago has been one of the frontrunners in this area and since the approval of the Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing and Teaching Organisations (sponsored by The Royal Society of New Zealand) it has developed a comprehensive system of VM management based on the requirements of the Code.

John Schofield, the Director of Animal Welfare and the sole registered veterinarian on campus, has been the driving force behind the project.  He detailed the critical elements of the PAR system as the following. 

“To ensure a reasonable level of security and control, orders for PARs and human medicines are processed centrally through the Animal Welfare Office (AWO). All orders must be linked to a study protocol that has Animal Ethics Committee approval. Researchers will soon be able to request veterinary and human medicines on-line. For each approved AEC protocol an Institutional Drug Administration Order, or IDAO, is prepared by the AWO. This document is a comprehensive summary that includes the drugs, dose rates, animals, location of storage and use, and the training and experience of the personnel who will administer these medicines. In effect, the document is ‘the mother of all prescriptions’ by virtue of its complexity. This prescription is signed by the veterinarian, confirming the use of specified medicines for a particular research study. A mechanism has been developed to deal with any changes to the script that may be required from time to time. 

Because the University of Otago operates three research animal facilities, it has appointed a Drug Control Officer (DCO) at each facility to assist with the management of veterinary and human medicines. Each DCO is the local agent for the veterinarian and, working together, they provide ongoing support and guidance for researchers who have to come to terms with the legislative changes now in force. We worked closely with our local Ministry of Health MedSafe officials in the development of this programme, and their input has simplified auditing procedures. 

A customised logbook, the controlled drugs register (CDR), has been printed and issued to  research laboratories. Drug safes have been provided where necessary. These measures, along with visits by the DCO, have promoted compliance with the legislative requirements and helped users cope with a new level of bureaucracy. The goal is to have a uniform and standard system of drug control throughout the institution.”

Progressive implementation

The new system has been progressively implemented over the last 15 months following a development period of three years. PAR Roadshows were held to advise and consult with the research community prior to implementation of the Code.    Effective communication with researchers has been established through the ‘in-person’ visits by the DCO. This has assisted a reasonably smooth transition to the new system.  In addition, the control measures put in place have been so effective that University staff members attempting to circumvent the system and purchase drugs themselves have been unable to do so.

“The drug wholesaler involved was commended for prompt action and willingness to assist the university establish this drug control programme.”

Benefits

As well as significantly improving the control of medicines used in the management of experimental animals, there have been some additional benefits.

“The legislation clearly places the responsibility for the assessment of appropriate medicine use with the registered veterinarian, rather than with the AEC or the researcher. This is a significant change and provides the opportunity, almost on a daily basis, for the veterinarian to suggest best practice techniques and new drug regimes to researchers who might otherwise resort to less satisfactory historical methods.”

“Many researchers have enthusiastically embraced the new drug control programme as it has exposed them to new anaesthetic options that have facilitated research manipulations and improved animal welfare.”

Support

The implementation of this programme has been possible only with the full support of the University and the dedicated team working with John. 

”The University of Otago identified the management of veterinary and human medicines as a potential risk that required appropriate funding and resources to ensure compliance with the ACVM Act while at the same time ensuring that scientists were not disadvantaged by bureaucracy and could continue with their  research.” 

Now that the system has been in operation for some time, John notes that “once researchers understood that the AWO had no intention of limiting their access to drugs, but rather intended to supply, according to the script, reasonable quantities, the scientists’ concerns have diminished.”

Continuing development

John and his team are continuing to develop resources to facilitate an increased knowledge of VM use in laboratory animals amongst University staff and students. The AWO was awarded a grant to develop an on-line training programme using Blackboard™, which is a course management software programme that also integrates online communication software. 

“The use of Macromedia Flash™, allows for highly interactive and engaging content on what may be regarded as a dull and difficult subject. A series of case studies focuses on practical applications of anaesthetics, analgesics and antibiotics. In addition to best practice recommendations, these case studies also explore the misuse of these agents as observed during site visits in the past.”  

ACVM Group comment

ACVM Group staff members were given the opportunity to view the system on a recent visit to Dunedin.  The opinion of those present was that the system in place not only achieves, but exceeds the minimal requirements for adequate VM management as specified in the ACVM- approved Code of Practice. 

The ACVM Group intends to include an assessment of New Zealand research, testing and teaching organisational systems as one of the 2005-2006 ‘slice of life’ reviews.  If all organisations are found to have systems as comprehensive as that established for the University of Otago, the review is likely to conclude that any immediate ACVM Group intervention is unnecessary.