4.4. Final decision in relation to polyacrylamide
4. Final decisions (without interim decision) made pursuant to regulation 2ZCZU
4.4. Final decision in relation to polyacrylamide
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 polyacrylamide as follows:
Schedule 4 - Amend Entry
POLYACRYLAMIDE in preparations for injection or implantation:
- for tissue augmentation; or
- for cosmetic use
Date of effect of the decision
1 February 2020.
Reasons for the final decision (including findings on material questions of fact)
The proposed amendment was not referred to an expert advisory committee.
I have decided to amend the current Poisons Standard in the manner set out in the application.
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 (SPF, 2018). In particular, I note that:
- The proposed change to the Poisons Standard entry for polyacrylamide is limited to the current entry under Schedule 4. The proposed change is at the request of the veterinary medicines regulator (APVMA) for a registration application currently under its consideration, for a product designed for the intra-articular administration to horses for the treatment of non-infectious inflammation of joints. The Applicant (APVMA) has indicated that the use of the substance may be beneficial in the treatment of lameness in horses and is anticipated to improve the welfare of treated animals. The increased use of polyacrylamide in the community does pose an increased risk of exposure to the substance, but this is limited to accidental self-injection by veterinarians in the course of treating animals with product(s) containing the substance. I am satisfied that the risks from accidental self-injection/needle stick injury are relatively low on the basis that the maximum volume that could be self-injected would be expected to be the maximum volume of the ready-to-use syringe (2mL) and that systemic effects from the toxic impurities are expected at higher doses and longer duration of exposure. This risk is considered no greater than the current use of polyacrylamide in preparations for injection or implantation in human subjects. No exposure to the public is anticipated following use. Furthermore, these risks have been adequately addressed by the veterinary medicines regulator (APVMA) in its application (52E(1)(a)).
- The purposes and extent for which the substance is to be used has been adequately outlined by Applicant. The current application to Scheduling indicates that the veterinary medicines regulator is considering the registration application for a product designed specifically for the treatment of lameness in horses. I have considered that future veterinary medicine preparations containing the substance could also be used for similar indications in other animal species. This is not considered to increase the risk significantly to humans from exposure to the substance, and therefore further risk mitigation measures through the Poisons Standard are not considered necessary (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, which would warrant a change to its Scheduling Classification in Schedule 4 of the Poisons Standard based on the criteria set out under the scheduling factors for Schedule 4 substances in the SPF (2018). The diagnosis, management or monitoring of lameness in horses is such that it requires veterinary intervention before the substance is used. Furthermore, it is noted that the substance is currently available for use in various human therapeutic products, including listed medicines (52E(1)(c)).
- The dosage, formulation, labelling, packaging and presentation of the substance from its currently approved uses in humans for tissue augmentation and cosmetic use, will change as a result of its proposed use in veterinary medicines preparations. The Applicant is responsible for ensuring appropriate labelling, including: directions for use; first aid instructions; safety directions; any precaution or restraint statements and safe storage directions. The Applicant has demonstrated that appropriate risk mitigation measures 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. Further use of the substance in other veterinary medicine products will be addressed by the veterinary medicines regulator (APVMA) in any future applications to the regulator. The proposed amended entry for the substance in the Poisons Standard will not affect polyacrylamide-containing ingredients listed under the ARTG (52E(1)(d)).
- There is no information to indicate that the substance could pose a risk to humans from abuse of the substance. There is the potential for the diversion of preparations containing the substance into the human population, but listing the substance for veterinary use under Schedule 4 will subject it to the compliance obligations of the applicable Commonwealth, State and Territory jurisdictions (52E(1)(e)).
- Previous consideration by the National Drugs and Poisons Schedule Committee (NDPSC) on various occasions, affirmed the Schedule 4 classification of the substance in preparations for injection for tissue augmentation and cosmetic uses. Moreover, the NDPSC recognised that such uses would require administration and management of potential adverse effects by medical professionals. Similarly, the proposed use in veterinary medicine preparations will require appropriate diagnosis, administration and management by veterinarians. Therefore, the inclusion of veterinary medicine preparations containing polyacrylamide under Schedule 4 is deemed appropriate (52E(1)(f)).
Therefore, 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.