AVA Submission on the NSW Medicines, Poisons and Therapeutic Goods Bill 2022

Thank you for reconsidering the deadline and accepting the Australian Veterinary Association (AVA) feedback today on the draft Medicines, Poisons and Therapeutic Goods Bill 2022 (MPTG).

The AVA is the only national association representing veterinarians in Australia. Founded in 1921, the AVA today represents 8500 members working in all areas of animal science, health and welfare.

It critical for veterinary considerations be included in the review of the draft MPTG Bill as the profession is a significant user of scheduled medications. There are a number of significant differences between veterinary practice and human medical practice that could readily be recognised in this Bill. The AVA has reviewed the Consultation Draft Bill and Discussion Paper and recognises it as a particularly well drafted and comprehensive Bill.

However due to the short timeframe of only becoming aware of this draft Bill on Thursday we were unable to conduct a comprehensive consultation to inform a formal submission or undertake our usual internal review and approval processes. However please see below our informal comments on the MPTG Bill.

INTRODUCTION
The main aim of the Act is protection of public health. However, the main objective of veterinary practice is animal welfare. The NSW Veterinary Code of Conduct states as a basic principle of veterinary conduct is ‘a primary concern for animal welfare’. We request that the Objects of Act 1(a) be modified to Include ‘...health and safety of the public and animal welfare’

The structure of the veterinary profession has changed markedly since the Poisons and Therapeutic Goods Act was enacted. These changes may influence the supply of scheduled medications. One significant change is the increased range of veterinary practices which now include:

• General practice veterinary where there is a single licence holder for the practice. This practice may operate as a hospital (as defined by Veterinary Practices legislation) and may offer after hours emergency services.
• Corporate veterinary practice where the licence holder is a corporate body and which can cover a number of individual veterinary practices. After hour emergency services may be offered.
• Emergency Critical Care Practices which offer after hour emergency services and specialist emergency services for other veterinary practices (contracted or other business arrangements). These practices operate similarly to an emergency department in a public hospital.
• Mobile veterinary practices that may be associated with an existing ‘bricks and mortar’ practice or may operate as an independent veterinary hospital (currently usually associated with an animal charity such as RSPCA, Animal Welfare League or a wildlife charity). The mobile hospitals can travel to remote areas of NSW and would be similar to remote medical practices.

Several veterinary practices may have the same licence holder, similar in operational structure to pharmacies with a common owner. The transfer or more correctly resupply of restricted substances to the veterinary practices should be treated the same as the proposal for pharmacies with a similar ownership structure (exempted from definition of wholesaling). 

Veterinarians from practices with different licence holders can supply agents such as tick antiserum in emergencies, usually as a ‘one off' event and should not be considered wholesaling. These transfers currently occur through written authorities under Veterinary Practice legislation.

Cl 127 Clinical Advisory Committee
We request that a practicing veterinary practitioner be included in membership of this Clinical Advisory Committee under Cl 127

GENERAL COMMENTS
Veterinary practice has changed considerably since the first act, and substantially in the last 10 years.

There are now more than 700 veterinary hospitals in NSW. Amongst these are specialist practices and emergency practices. Having readily available access to veterinary medicines for emergency use is increasingly important. Amongst the emergency medicines will be many that are not registered by the APVMA but require compounding by a suitably qualified and experienced pharmacist. Having access to such a pharmacist is a growing need and such relationships between veterinary hospital and compounding pharmacist has parallels to the relationship between human hospitals and related pharmacies.

In most situations it is more appropriate that the compounded medicine be supplied by the pharmacist to the prescribing veterinarian in order that the veterinarian can provide the appropriate instructions on use to the client, often requiring a demonstration of administration of the medicine.

Veterinarians provide service to clients in remote areas much as medical practitioners do. Similar arrangements in the supply of medicines should apply to veterinarians as they do to medical practitioners (for example Section 54 (viii)) where medical clinic may be replaced by a suitably trained person.

With respect to Section 47 of the Bill – the USP contains a number of monographs for veterinary medicines that are not present in the BP(Vet) and should be considered a source of relevant monographs.

DICTIONARY
Stock Medicine: it is not clear that the definition of stock medicine provided accommodates all therapeutic uses of veterinary medicines in the myriad species attended to by veterinarians – ie food animals pluscompanion animals, wildlife species, zoo animals etc. Could the definition be checked? A veterinary equivalent of ‘therapeutic goods’ may be appropriate.

DISCUSSION PAPER
5.1.1. Wholesale supply of Schedule 7 substances: there are a number of veterinary medicines available as S7 products, for example, semduramicin, selenium, chlorfenvinphos and ivermectin. While agreeing that the supply of S7 products may require certain restrictions, there are a small number of S7 products that are used therapeutically.

Question 4: veterinarians should be able to obtain compounded medicines from pharmacists for supply to their clients (for example, emergency use situations) without this being considered wholesaling.

9.1. Regulatory Advisory Committee: It is not clear if Avcare Limited is included as the animal pharmaceutical representative body. If so, Avcare has been replaced by Animal Medicines Australia. As the organisation has changed its name on a number of occasions, and as there is more than one representative body (one for large companies and one for smaller companies that mainly manufacture generics) it may be preferable to refer to (something like) ‘representative organisation of animal pharmaceutical manufacturers’.

Final Sentence: “Importantly, in the exercise of functions under the Bill, the protection of the health and safety of the public is the paramount consideration.” It is not completely clear how the Bill operates with respect to animals (ie all non-human animal species).

COMMENT ON PROPOSED CHANGE TO POISON AND THERAPEUTIC REGULATION CLAUSE 65A
Wholesale supply of restricted substances to non-veterinarians for sedation and pain relief medication in animals has been proposed as an amendment of the current Poison and Therapeutic regulation clause 65A under the draft Animal Welfare Bill. This would allow non veterinarians to use and obtain S4 substances such tiletamine/ zolazepam (a combination product), acepromazine, detomidine, medetomidine and xylazine without the critically important benefits derived from veterinary supervision that provide animal assessment prior to administration, and supervision of access – and furthermore, without supply of antidotes or reversing agents (for example, atipamezole). Sedation and pain relief medication can pose a risk to animal health and safety, possible human safety from unpredictable animal responses and a potential for drug abuse from tiletamine/ zolazepam and other agents. Such changes may be sought in future legislation.

Please don’t hesitate to contact us if you would like to discuss any of the AVA comments provided above. Additionally, the AVA requests we are consulted early in the development of the regulations when they become available.