Veterinary Prescribing and Compounding Rights Working Group National Harmonisation Proposal
National harmonisation of minimum veterinary prescribing and compounding regulatory requirements for veterinary practitioners – Treatment of Livestock
Scope and Purpose
The scope of the discussion paper includes a proposed model for general veterinary chemical product controls, associated record keeping, labelling and advice note requirements and controls on how chemicals can be authorised for use by veterinary practitioners.
The discussion paper does not include a proposal for reforms to off-label controls for non-veterinarians.A Veterinary Chemical Product Off-label Working Group is to be established to develop a proposal for harmonising these controls.
The purpose of this discussion paper is to request feedback on particular aspects of the proposed national model for the harmonisation of veterinary prescribing and compounding requirements for veterinary practitioners, in relation to treatment of livestock. The details of the proposed regulatory requirements can be found in the table “Proposed Regulatory Requirements for Supply and Use of Veterinary Chemical Products”.
The feedback received will assist the development of recommendations by the Veterinary Prescribing and Compounding Rights Working Group (Working Group).
A number of questions have been included with this paper to guide feedback. Please send feedback to the Harmonisation of Agvet Chemicals Control of Use Task Group Secretariat at , 2pm 8 June 2018.
Background
The 2008 Productivity Commission report on the regulation of chemicals and plastics identified variable regulatory requirements for users of agricultural and veterinary (Agvet) chemicals between jurisdictions as an impediment to businesses operating across jurisdictional borders.
The Council of Australian Governments (COAG) agreed to develop a single national framework to improve the efficiency and effectiveness of the regulation of agvet chemicals.
Following extensive policy discussions and consultation with stakeholders, a regulatory model was developed which contained harmonised models for licensing and training, access to agvet chemicals and a national produce monitoring program.
The access to agvet chemicals model was split into separate models for agricultural chemicals and veterinary chemical products, with the veterinary chemical product reforms focusing on veterinary prescribing and compounding rights.
Currently, controls over the use of veterinary chemical products vary between states and territories. However, all jurisdictions:
(a)allow veterinary practitioners to use/authorise off-label use in Major FoodorTrade Species where animals are under the care of the veterinary practitioner (the veterinary practitioner carries some liability for their action).
(b)restrict use by non-veterinarians to following the label directions for Major Foodor Trade Species.
Unlike agricultural chemical users, veterinary practitioners are able to compound their own veterinary chemical products, use and prescribe unregistered veterinary chemical products without the requirement to have the product registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA), although restrictions apply.
Veterinary practitioner prescribing and compounding rights are justified so as to ensure the protection of animal health and welfare. However, the use of compounded and unregisteredproducts,and registered products off label,may result in non-compliant residues in Food or Trade Species which may jeopardise trade in animal products.Additionally, veterinary practitionerswho compound veterinary chemical products avoid national assessment and registration requirements which are an essential part of the risk management approach to veterinary chemical product use in Australia.
The Working Group was tasked with the specific objective to develop a detailed proposal for the implementation of the COAG Agvet Chemical Reform for the veterinary compounding and prescribing rights,A Single National Framework for the Regulation of Agricultural Chemicals and Veterinary Chemicals.
The proposed framework allowsveterinary practitioners to exercise professional judgement where appropriate to treat animals in their care with minimal risk to trade, public health and the environment. It outlines a harmonised system that allows veterinary practitioners to compound and supply a veterinary chemical product subject to certain conditions; prescribe an extension of label uses for prescription and non–prescription products; use or prescribe the use of unregistered products for Food or Trade Species in limited circumstances.
The proposed frameworkwas developed in line with the following parameters:
- Refine and increase the level of harmonisation between jurisdictions, rather than review veterinary prescribing and compounding rights from first principles
- Manage unacceptable risks to human health, trade and the environment while enabling the protection of animal health and welfare, with the off-label supply or use of registered veterinary chemical products, or the supply or use of unregistered chemicals including compounded products
- Ensure compounding rights and use of unregistered veterinary chemical products do not deter registration of new veterinary chemical products, the use of existing registered veterinary chemical products, or the use of the APVMA minor use permit system.
In the process of harmonising the regulatory requirements for supply and use of veterinary chemical products, the Working Group initially compared current state/territory legislation and identified differences between them.Where differences were identified, the Working Group attempted to reach agreement on a harmonised approach. In some cases this was relatively straightforward but for others, agreement could not readily be achieved. In these situations, a minimum level for harmonisation was agreed, with the proviso that states/territories could have additional controls if necessary. Agreement could not be reached on a number of issues because they were outside the scope of the project.
Proposed Regulatory Requirements for Supply and Use of Veterinary Chemical Products
Definitions
1)Agricultural chemicalis defined in the Agvet Code as a substance or mixture of substances that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:
a)destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing; or
b)destroying a plant; or
c)modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity; or
d)modifying an effect of another agricultural chemical product; or
e)attracting a pest for the purpose of destroying it.
2)Agvet Codeunderpins the functions of the APVMA
3)APVMA means the Australian Pesticides and Veterinary Medicines Authority
4)Human Health Productsare medicines regulated by the Therapeutic Goods Administration.
5)Major FoodandMajor Trade Species mean at least cattle, sheep, pigs and chickens (Gallus domesticus).
6)Pharmacologically equivalent veterinary chemical productis a veterinary chemical product that is registered under Part 2 or permitted under Part 7 of the Agvet Code by the Australian Pesticides and Veterinary Medicines Authority for the proposed use.
7)SCARM Principles means the principles on harmonisation of veterinary “Right to Prescribe’ and Veterinary Control of Use agreed to by the Standing Committee on Agriculture and Resource Management (SCARM) in 1999.
8)Under the direct care of a veterinary practitionerwhen treating Food or Trade Species with unregistered veterinary chemical products, agricultural chemicals or contrary to a restraint or ‘DO NOT’ statement or other prohibition, means animals that have been clinically examined by a veterinary practitionerfor the purpose of treating the relevant condition at that time.
9)Unregistered veterinary chemical productmeans a chemical product that has not been registered as a veterinary chemical product by the Australian Pesticides and Veterinary Medicines Authority and includes compounded and human health products.
10)Veterinary chemical productis defined in the Agvet Code as a substance or mixture of substances that is represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:
a)Preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or
b)Curing or alleviating an injury suffered by the animal; or
c)Modifying the physiology of the animal:
i)so as to alter its natural development, productivity, quality or reproductive capacity; or
ii)so as to make it more manageable; or
d)Modifying the effect of another veterinary chemical product.
A veterinary chemical product includes:
a)a vitamin, a mineral substance, or an additive used for a purpose mentioned in point 3 (a), (b), (c) or (d); but contrary to the definition in the Agvet Code, also includes
b)substance or mixture of substances that is:
i)prepared by a pharmacist in accordance with the instructions of a veterinary practitioner; or
ii)prepared by a veterinary practitioner; in the course of the practice, by the person preparing the substance or mixture of substances, of his or her profession as permitted by or under a law of this jurisdiction.
11)Withholding Period, in relation to the use of a chemical product, means the minimum period that needs to elapse between:
a)the last use of the product in relation to a crop, pasture or animal; and
b)the harvesting or cutting of, or the grazing of animals on, the crop or pasture, the shearing or slaughtering of the animal, or the collection of milk or eggs from the animal for human consumption, as the case may be; in order to ensure that the product’s residues fall to or below the maximum limit that the APVMA permits.
General veterinary chemical product controls
12)A person must identify animals to be treated in a way that is sufficient to identify the animal for the length of the treatment and withholding period.
13)It is an offence to provide veterinary advice that results in violative residues in Food or Trade Species.
14)Notice of any withholding period (WHP) that has not expired in treated animals must be provided to a purchaser.
15)Food or Trade Species must be treated according to the registered label unless authorised through written instruction by a veterinary practitioner or where the off-label use is not prohibited by the jurisdiction2.
16)Where veterinary chemical products are included in stock food, suppliers must notify (intending) buyers of stock food if that stock food has been treated with a veterinary chemical product, including the product name and the withholding period applicable to animals which may be fed on the stock food.
Controls on use under authorisation by a veterinary practitioner (Authorisation means use, prescribe, order, supply or recommend for use)
17)Off-label use of a registered product is permitted except in the following circumstances:
i)Use of products contrary to a RESTRAINT statement on the product label is not permitted, except in 1specified circumstances.
ii)Use of products contrary to a DO NOT statement (not under a RESTRAINT) is not permitted, except in 1specified circumstances.
18)Treating Food or Trade Species with a registered veterinary chemical product that is not registered for the purpose is not permitted, except in 1specified circumstances.
19)Treating Food or Trade Species with a registered agricultural chemical product is not permitted, except in 1specified circumstances.
20)Treating Food or Trade Species with unregistered products is not permitted except in 1specified circumstances and must not be used where a pharmacologically equivalent veterinary chemical product is currently registered.
21)Treating Food or Trade Species with a veterinary chemical product by injection is not allowed unless the label gives instructions for use by injection, except in 1specified circumstances.
22)Unregistered veterinary chemical products are not permitted to be supplied to veterinary practitioners except as allowed by a wholesaler’s licence.
1’Specified circumstances’ refer to where a veterinary practitioner may be permitted to authorise use of a veterinary chemical product but further consideration is required to set parameters to address the associated risks. In some jurisdictions a ‘specified’ circumstance is use of a veterinary chemical product in a single animal only.
2Restrictions on off-label use by non-veterinarians varies between jurisdictions. A separate proposal for harmonising these controls is under development. This will include general conditions of allowed variations to on-label use instructions.
Labels and Advice Note Requirements for Veterinary Practitioners
23)These requirements apply in parallel with State and Territory medicines and poisons legislation for substances included in the schedules of the Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons).
Note: references to ‘animal’ includes ‘animals’.
24)These requirements apply to veterinary practitioners recommending, supplying, using or prescribing a veterinary chemical product used for the treatment of a Food or Trade Species that:
i)contains a substance that is included in Schedule 4 (Prescription Only Medicine/Prescription Animal Remedy) of the Poisons Standard; or
ii)is an unregistered veterinary chemical product (includes compounded, agricultural chemicals and human health products); or
iii)is a registered veterinary chemical product used, prescribed, supplied or recommended for use not in accordance with the instructions on an APVMA approved label or an APVMA permit; or
iv)is a registered veterinary chemical product sold without a label approved by the APVMA (e.g repackaged/split products).
Labels and Advice Notes - Prepared and Provided by a Veterinary Practitioner
25)A label must be attached to each container of the product supplied and labelled in accordance with the medicines and poisons legislation in each state/territory.
26)Additional information contained in an advice note is required to manage risks associated with treatment of a Food or Trade Species under the direction of a veterinary practitioner. At the discretion of the veterinary practitioner, this information may be included on the label.
27)An advice note must always be provided at the time of supply to the animal owner or person in charge of the animal before treatment of the animal with the product commences or at the time of the initial treatment.
28)Veterinary practitioner must ensure that the owner or person in charge of any animal treated, are advised in writing that lawful advice notes or dispensing labels override any product label directions where these differ.
29)The advice note provided by a veterinary practitioner must include the following particulars:
i)the name, business name, address and telephone number of the veterinary practitioner
ii)sufficient details to identify the particular animal to be treated
iii)the name and contact details of the person who has custody or care of the animal
iv)the directions for treating the animal with the product including the dosage, frequency of the dose, treatment period and route of administration
v)the withholding period for the species of animal to be treated or, if no such period applies, the statement "Nil withholding period required”
vi)in the case of a registered veterinary chemical product, the trade name of the product and/or product number
vii)in the case of a product other than a registered veterinary chemical product the name of the active constituent, the form and the concentration of the active constituent
viii)the date the product was supplied or used
ix)the batch number of the product and its expiry date (if known).
Withholding Periods
30)Withholding Period must be included to manage risks to health and trade posed by residues. A label or advice note provided by a veterinary practitioner must specify a withholding period no less than the period which is appropriate in order to ensure that the product’s residues fall to or below the maximum limit that the APVMA permits.
31)Veterinary practitioners must be able to demonstrate that all reasonable steps have been taken to setting an appropriate withholding period for veterinary chemical use that manages the associated risks.
32)A veterinary practitioner must record the reasoning for any withholding period for an unregistered veterinary chemical product (including compounded and human health products), or a registered veterinary chemical product used not in accordance with the label instructions. The reasoning must include the applicable Maximum Residue Limits for the commodities relevant to the species being treated, reference to any data considered and any scientific information relied upon. All treatments containing the active constituent that are used, or recommended to be used, on an animal must be taken into account.
Veterinary Practitioner Records
33)A veterinary practitioner must make records within 24 hours and keep records for at least two years following the use, recommendation, prescription, or order of any veterinary chemical product.
34)The record must either be a copy of the advice note or the information required for an advice note.
Requirements for Users of Veterinary Chemical Products
35)A user of a veterinary chemical product must make a record of all treatments of veterinary chemical products administered to Food or Trade Species. Records for veterinary chemical products administered must include:
i)Name and contact details of the person who used the chemical
ii)Date the animal(s) was first treated and the date of subsequent treatments
iii)Sufficient details to identify the particular animals treated
iv)Trade name of the product
v)Batch number
vi)Dose and route of administration
vii)The relevant Withholding Period (WHP)
36)If the treatment was recommended by a veterinary practitioner a copy of the advice note must also be kept and may form part or all of the required treatment record.
37)Records made for the purpose of complying with Quality Assurance programs may form part or all of the required treatment record.
38)Users must cause a record to be made within 48 hours of use.
39)Records must be kept for a minimum of two years from the date of use and must be provided to an authorised officer upon request.
Identification
40)The user of a veterinary chemical product must ensure that any Food or Trade Species and its location is sufficiently identified to be able to comply with the relevant withholding or re-treatment periods.
Discussion
When registered products are used according to the instructions on the approved label, they are supported by the registration authority’s (APVMA) risk assessment from data provided by the company that sought registration of the product. This data must address the following risks:
- Efficacy
- Animal health and welfare
- The environment
- Occupational health
- Public Health, including residues in the food chain and Antimicrobial Resistance (AMR)
- Trade
By contrast, a veterinary practitioner authorising the use of off-label or unregistered products may have limited access and capability to assess data on residue depletion, toxic metabolites, environmental impact associated with excretion of the product and its metabolites in urine, faeces and milk, although there is usually data indicating the product is efficacious.