Urgent Action Required: Defend Veterinary Practice in Response to Proposed Changes to the NSW Medicine, Poisons and Therapeutic Goods Regulation

Addendum

Please note, the AVA provides the following positions and guidelines on compounding:

• AVA Policy – Veterinary use of compounded pharmaceuticals
• AVA Guidelines – for the preparation and use of compounded pharmaceuticals
• AVA response to the review of the guidelines for compounding of medicines

There are seven important key issues within the proposed regulations that need to be amended to reflect the current high standards of veterinary practice.

The grey boxes are extracts from the exposure draft of NSW Medicines, Poisons and Therapeutic Goods Regulation 2023, with the key issues summarised below and suggested information to include in your submission.

Proposed Section 11: Wholesale supply by pharmacists to authorised practitioners

(1) For the Act, section 14(a), wholesale supply of a Schedule 4 or 8 substance by a pharmacist to an authorised practitioner for emergency use is authorised if the supply is in accordance with a written order of the authorised practitioner.

(2) This section does not apply to the following Schedule 4 or 8 substances—

(a) for all authorised practitioners—a Schedule 4 or 8 substance that is not a registered good, and

(b) for a veterinary practitioner—a Schedule 4 or 8 substance that is not registered under the Commonwealth Agvet Codes.

(3) The pharmacist must keep a record of Schedule 4 or 8 substances wholesale supplied under this section.

Maximum penalty—Tier 6 penalty.

The problem with this proposed section: If this proposed section is adopted as-is, it will result in veterinarians no longer having compounded emergency medicines on the shelf.

The AVA is proposing a solution to this: that Section 11 should include an exemption for pharmacies that comply with the APVMA code of Good Manufacturing Practice. This will assist us to keep access to compounded emergency medicines.

In putting your individual submission, you may want to include:

• Why is having emergency stock on the shelf important to you?
• What are examples of the emergency stock you find essential in order to provide high quality veterinary care?
• What would be the consequences of not having immediate access to emergency stock?

Proposed Section 35: Restriction on non-wholesale supply of certain Schedule 4 and 8 substances

(2) A veterinary practitioner must not non-wholesale supply the following—

(a) a compounded Schedule 4D substance for non-topical use,

(b) a compounded Schedule 8 substance,

(c) dexamfetamine or lisdexamfetamine,

(d) N,ɑ-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine.

Maximum penalty—Tier 6 penalty

The problem with this proposed section: The nature of veterinary practice is unpredictable by providing care to a wide range of animals with varying medication and dosage needs. For example, vets may treat companion animals, large animals, wildlife, birds and exotics. There are numerous species for which suitable registered drugs are not available to meet their treatment needs, and as a result types of veterinary practice (eg bird medicine, exotics) are heavily reliant on compounded medicines.  This proposed regulatory provision could delay access and compromise patient care, and as a result, animal welfare.

The AVA are concerned the Regulatory Impact Statement (RIS) for the proposed regulation listed examples of scheduled 4D substances are focused on human impacts and are not applicable for veterinary uses. It remains unclear the rationale and intention for this section.

Whilst the AVA understand the NSW Ministry of Health (MoH) are trying to address the problem of diversion of S8 substances to the criminal supply, the proposed changes will be impractical for veterinary practice.

The proposed changes will change the way veterinarians treat animals and the MoH needs greater understanding of the potential unintended consequences the proposed regulation will have on veterinary practice.

The AVA recommends the MoH seek a balance between increased oversight of veterinary practice and best practice for veterinarians.

Proposed Section 38: Restriction on issue of prescriptions for certain Schedule 4 and 8 substances

(2) A veterinary practitioner must not issue a prescription for the following—

(a) a compounded Schedule 4D substance for non-topical use,

(b) a compounded Schedule 8 substance,

(c) dexamfetamine, lisdexamfetamine or methylphenidate,

(d) N,ɑ-dimethyl-3,4-(methylenedioxy)phenylethylamine (MDMA) or psilocybine.

(4) Subsections (1) and (2)(a) and (b) do not apply to a person who issues the prescription in accordance with an approval or approval exemption.

The problem:  A number of Schedule 4D products may be needed as compounded products when registered products are not suitable or available. For example, diazepam, doxapram or pregabalin may be needed clinically and available only by prescription for a compounded product.

In addition, especially for unusual or exotic pets of low bodyweight where very low doses are indicated (eg birds, reptiles) or a large animal requiring high dosage, it may be necessary to compound a Schedule 8 product for use in pain management or sedation. There are numerous species for which suitable registered drugs are not available to meet their treatment needs, and as a result, many types of veterinary practice (eg bird medicine, exotics) are heavily reliant on compounded medicines.  Restricting access in the way proposed will result in poor animal health and welfare outcomes.

Proposed Section 77 (2): Approvals required for activities involving Schedule 8 substances—the Act, s 69(1)

(2) A veterinary practitioner must not supply, administer or issue a prescription for a compounded Schedule 8 substance without an approval.

The problem: As in section 38 above and especially for unusual or exotic pets of low bodyweight where very low doses are indicated, or a large animal requiring high dosage, it may be necessary to compound a Schedule 8 product for use in pain management or sedation.

Proposed Section 79 (1): Compounding of Schedule 4D and 8 substances

(1) For the Act, section 55(1), a medical practitioner, dentist or veterinary practitioner must not compound a Schedule 4D substance for non-topical use or a Schedule 8 substance unless the person is acting in accordance with an authority granted by the Health Secretary under section 80.

Maximum penalty—Tier 6 penalty

The problem: Schedule 8 products commonly used by veterinarians include buprenorphine, butorphanol, ketamine, methadone, and morphine. Compounding includes reconstitution or manipulation of commercial products that may require the addition of one or more ingredients.

If you combine any Schedule 8 substance with one or more other constituents, or if you manipulate a commercial product (for example, you might dilute the product to ensure more accurate dosing) then under the proposed regulation that will no longer be allowed without a specific authority from the Health Secretary – usually provided for a single patient.

AVA is proposing that veterinarians are exempt from this regulation.

In putting your individual submission, you may want to include:

• How commonly do you compound Schedule 8 products?
• Which manipulations or combinations (ie compounding) are most commonly prepared and used in your practice?
• What would be the impact on animal health, animal welfare or public health if you can no longer compound these products?

Proposed Section 109: Storage requirements for Schedule 8 substances in other places

(1) A person in possession of a Schedule 8 substance to which section 107 or 108 does not apply must ensure the Schedule 8 substance is stored in accordance with this section.

Maximum penalty—Tier 6 penalty.

(2) The substance must be stored—

(a) apart from all other goods, and

(b) in a dedicated room or receptacle.

(3) The dedicated room or receptacle must be kept securely locked when not in immediate use.

(4) A receptacle must—

(a) be securely attached to a part of the premises, and

(b) not be accessible by members of the public.

(5) Storage must comply with the medication storage standards, including in relation to the receptacle.

(6) An authorised practitioner or a paramedic complies with this section by keeping a substance, kept for emergency use, in a bag that is in a room or a vehicle that is kept locked when not occupied by the person.

(7) This section does not apply to a person in possession of a Schedule 8 substance if the substance was lawfully supplied to the person from an authorised practitioner or pharmacist.

This proposed regulation would require the storage of Schedule 8 substances apart from all other goods in a dedicated secure room or receptacle.

Currently, the S4D product pentobarbital needs to be stored in a locked receptacle, and it is practical to keep it in the S8 safe.  The proposed section 109 would require storage of Schedule 8 substances separately from locked storage of pentobarbitone.

AVA is proposing that S4D and Schedule 8 substances could be stored together in the same secure receptacle or safe.

Proposed Section 152: Sterile compounded preparations—the Act, s 55

(1) A person compounding a sterile compounded preparation must comply with the requirements specified in Compounded medicines and good manufacturing practice (GMP), Guide to the interpretation of the PIC/S Guide to GMP for compounded medicinal products, published by the Therapeutic Goods Administration.

Maximum penalty—Tier 6 penalty.

(2) This section does not apply to a person compounding a substance—

(a) at a public health entity, for the purposes of the treatment of a patient at the public health entity, or

(b) at a private health facility, for the purposes of the treatment of a patient at the private health facility.

(3) A reference to a private health facility in subsection (2)(b) does not include a pharmacy at a private health facility.

(4) In this section— sterile compounded preparation has the same meaning as in the Act, section 55.

This proposed regulation will require in-practice sterile compounding of products for injection or for ophthalmic use to be undertaken in compliance with the TGA code of Good Manufacturing Practice – a standard that no veterinary practice and most animal health companies do not (and unlikely could) comply with.

AVA is seeking exemption of veterinarians compounding a substance for injection or ophthalmic use during the treatment of an animal patient.

In putting your individual submission, you may want to include:

• How often do you compound (ie manipulate or combine) products for injection or ophthalmic use?
• What impact on animal health and welfare or public health would result from the inability to compound these preparations?