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4 Final decisions on proposed amendments to the current Poisons Standard under regulation 2ZCZU
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4.1 Final decision in relation to bupivacaine
Pursuant to regulation 42ZCZU of the Regulations, a Delegate of the Secretary has made a final decision to amend the current Poisons Standard in relation to bupivacaine as follows:
Schedule 5 - Amend Entry
BUPIVACAINE in aqueous gel preparations containing 0.5 per cent or less of bupivacaine, for the dermal spray-on administration to the wounds of animals
post-surgical wounds associated with 'mulesing' of sheep; tail docking and castration of lambs; or castration and disbudding/dehorning in calves.
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to bupivacaine;
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018);
- The Scheduling handbook: Guidance for amending the Poisons Standard; and
- Australian Animal Welfare Standards and Guidelines.
Reasons for the final decision (including findings on material questions of fact)
In determining, that this matter will be a delegate-only decision I have taken into account the information provided in the application from the Applicant (APVMA), and the matters outlined under Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework (2018). In particular I note that:
- The proposed amendment to the Poisons Standard entry for bupivacaine, from its limited indication for the “‘mulesing' of sheep; tail docking and castration of lambs; or castration and disbudding/dehorning in calves”, to the more expansive indication for the “dermal spray-on administration to the wounds of animals”, increases potential benefits to the farming and veterinary industry from the broader use of the substance. The exposure of humans to bupivacaine-containing preparations to the active constituent is expected to be no greater than currently approved uses. The regulator (APVMA) has concluded that the human health risk posed by the product is acceptable according to the criteria stipulated in Section 5A of the Agricultural and Veterinary Chemicals Code Act (1994) (52E(1)(a)).
The purpose and extent for which the substance is to be used has been adequately outlined by the Applicant. I have taken into account that surgical procedures and treatment of significant injuries are adequately covered in the Australian Animal Welfare Standards and Guidelines. These standards provide animal age-related and developmental stage-related standards and guidance on when a non-veterinarian can and cannot perform such procedures (52E(1)(b)).
- I have taken into account the broader uses of bupivacaine and note that it is currently used for therapeutic uses in humans. I find that my decision would not affect such use in humans because the amendment will continue to limit use to animals when in aqueous gel preparations for dermal spray-on administration (52E(1)(b)).
- There has been no substantive change in the information available regarding the toxicity of the substance since it was last considered for Scheduling that would warrant a change to its Scheduling Classification in Schedule 5 in the Poisons Standard based on the criteria set out in the SPF (2018) under the scheduling factors for Schedule 5 substances (52E(1)(c)).
- The packaging of the preparation containing the substance will not change as a result of its broader use in animals. However, the Applicant has demonstrated that appropriate risk mitigation measures, including labelling, will be put in place should the proposed product containing the substance be registered for use in Australia. As a result, no additional measures are required in the Poisons Standard. The proposed amended entry for the substance in the Poisons Standard will not affect bupivacaine-containing ingredients listed under the ARTG (52E(1)(d)).
- The potential for misuse or abuse of the substance is unchanged from previous considerations (52E(1)(e)).
Therefore, based on the information provided in the application, I have decided to amend the current Poisons Standard in the manner set out in the application. The proposed amendment was not referred to an expert advisory committee.
Date of effect of the decision
1 February 2021