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3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #24, March 2020)
3.3. Interim decision in relation to pentobarbital
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Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in relation to pentobarbital as follows:
|Poisons which must be stored in a locked container to prevent unauthorised access
|PENTOBARBITAL in injectable preparations.
Proposed date of effect of the proposed amendment
1 October 2020
Reasons for the interim decision (including findings on material questions of fact)
In making this interim decision, the Delegate considered the following material:
- The scheduling proposal to amend the current Poisons Standard with respect to pentobarbital;
- Joint Meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling's advice;
- The public submissions received in response to the pre-meeting consultation;
- Section 52E of the Therapeutic Goods Act 1989, in particular (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health;
- Scheduling Policy Framework (SPF 2018);
- Scheduling handbook: Guidance for amending the Poisons Standard;
- The National Coronial Information System (NCIS) report on pentobarbital-related deaths in Australia 2000 - 2017 (pdf,792kb); and
- Specialist advice on veterinary medicine from two veterinary surgeons.
Summary of Joint ACCS-ACMS advice/recommendations to the Delegate
The reasons for the advice included:
The Committee considered that the proposal to move pentobarbital into Schedule 8 was not appropriate. The Committee recommended that the delegate, in consultation with States and Territories, consider whether appropriate controls on storage and access could be achieved by including a new entry in Appendix D. The objective would be to standardise the controls applied to the storage and access of Schedule 4 pentobarbital across the jurisdictions, acknowledging that not all jurisdictions adopt that Appendix by reference at present. A suitable outcome is that pentobarbital injection must be stored in a manner that precludes unauthorised access.
Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.
The reasons for the advice included:
- the risks and benefits of the use of a substance
- Death from misuse/suicide.
- Rapidly fatal and an attractive method promoted by suicide/voluntary euthanasia groups.
- a cheap and effective agent for humane animal euthanasia.
- the purposes for which a substance is to be used and the extent of use of a substance
- Currently marketed pentobarbital injection products are only for animal euthanasia and are widely and successfully used for this purpose, both by veterinary surgeons and by other trained and authorised persons, such as wildlife carers.
- Used widely in veterinary practice for euthanasia of animals.
- Used in the euthanasia of wild animals
- the toxicity of a substance
- Narrow therapeutic index, consistent with inclusion in Schedule 4.
- Rapid acting, causing profound central nervous system and respiratory depression and death (as little as 2g i.e. 6 mL of 325 g/L pentobarbital). Much more toxic than benzodiazepines.
- the dosage, formulation, labelling, packaging and presentation of a substance
- Risks from pentobarbital in injectable form may be different to risks associated with oral forms.
- No products listed on the ARTG for human use.
- Pentobarbital products available for animal euthanasia. Comes in large containers 500mL, however smaller pack sizes are also available.
- the potential for abuse of a substance
- Misuse for suicide reported but no evidence of abuse of injectable pentobarbital as a recreational drug.
- Oral forms, which are already Schedule 8, were previously associated with a well-defined withdrawal syndrome following prolonged use and were also quite widely used recreationally in the past.
- Potential for misuse for the purpose of suicide. Theoretically potential for recreational use however few reports of this.
- any other matters that the Secretary considers necessary to protect public health
- The current controls on storage and access should be improved and standardised across the States and Territories, to prevent unauthorised access.
- The Delegate should explore other mechanisms for achieving additional controls under a Schedule 4 entry.
- Recommend the Delegate consider an Appendix D entry, noting that not all State and Territories adopt by reference.
Reasons for interim decision
I have made an interim decision to retain the Schedule 4 entry for injectable pentobarbital. I have also decided to amend the current Poisons Standard to clarify the storage requirements for Schedule 4 injectable pentobarbital through the provision of a new Appendix D listing. The detailed reasons for my decision follow.
It is my view that a Schedule 4 classification for injectable pentobarbital is appropriate. I am not persuaded that moving injectable pentobarbital to Schedule 8 will reduce the risk of this substance being used as a method of suicide in individuals associated with the veterinary industry or by members of the general public. In coming to this decision, I had particular regard for new evidence presented since the previous consideration of pentobarbital in November 2016. These included the National Coronial Information System (NCIS) report on pentobarbital-related deaths in Australia 2000 - 2017 (which will be referred to as the 'NCIS report'), the public submissions in response to the pre-meeting consultation for the current scheduling consideration of injectable pentobarbital and the specialist advice on veterinary medicine provided by two veterinary surgeons.
I initiated the review on the scheduling of injectable pentobarbital on the recommendation of the South Australian Coroner, dated 23 October 2019, following an inquest into two deaths associated with pentobarbital (pdf,373kb). I note that the inquest was in large part devoted to exploring measures to prevent the use of pentobarbital as a method of suicide in individuals associated with the veterinary industry. I recognise that my interim decision is contrary to Coroner's recommendation. I will set out my detailed reasons below.
I want to recognise the value of human life and the critical importance of preventing suicide. It is my view that a Schedule 8 classification is unlikely to prevent access to this substance by persons who might be associated with veterinary establishments, at least as far as that method of suicide is concerned. The storage of pentobarbital injectable solution in a drug safe, required for Schedule 8 substances, is likely to preclude access by unauthorised persons. However, a Schedule 8 classification will not necessary preclude access by veterinary surgeons themselves or, in some States and Territories, by veterinary nurses, animal control officers and approved personnel in wildlife care groups. For these groups, inclusion of pentobarbital in Schedule 8 adds regulatory burden but does not necessarily have any impact on their risk of choosing to use this substance for the purpose of suicide.
I agree with the advice from the Joint ACMS-ACCS that record keeping in a Schedule 8 register is inherently less robust where bulk liquid forms of these medicines are being recorded, compared to divided doses such as tablets or ampoules. I have considered the scenario that it is unlikely that the small volume of pentobarbital required to be consumed to induce death in a human, can be missed in the commonly used 500 mL multi-dose vial. These large volume, multi-use vials are necessary to accommodate dosage volumes for small (<1 kg) to large (> 400 kg) animals, and when a number of animals must be euthanised promptly. On balance, I find that Schedule 8 restrictions on injectable pentobarbital is unlikely to prevent the use of pentobarbital as method of suicide in individuals associated with the veterinary industry.
In making my decision, I have attached significant weight to the evidence in the NCIS report, which establishes that the major source of pentobarbital used in suicides was not from veterinary establishments. The NCIS report demonstrates that the majority of the deceased were not from people working within veterinary or animal establishments or the general public acquiring pentobarbital from these establishments in Australia.
A number of possible unintended consequences would result from the inclusion of liquid pentobarbital in Schedule 8. I find that the benefit of having detailed record keeping requirements for pentobarbital and regular inventories under a Schedule 8 classification does not outweigh the need for timely access to this substance. It is my view that the added record keeping requirements and obligatory containment of pentobarbital in a drug safe when not in use, will negatively impact the ability for professionals such as: veterinary surgeons and their staff; researchers who utilise laboratory animals; government and non-government officers working with wildlife and domestic animal control; and officers managing dog health programs in remote aboriginal communities, to carry out their duties effectively and humanely. I find the specialist advice on veterinary medicine from the two veterinary surgeons to be of particular relevance on this matter. On balance, I find that the storage and record keeping requirements associated with Schedule 8 would add considerable regulatory burden for professionals using pentobarbital without any demonstrable reduction in the incidence of pentobarbital-related suicide.
I will now set out my reasons for retaining the Schedule 4 entry for injectable pentobarbital. In my reading of the available data, pentobarbital has a narrow therapeutic index and carries a significant risk of respiratory depression, even at the doses previously used therapeutically in humans. These factors are consistent with a Schedule 4 classification, which are currently in place. On balance, I am not satisfied that, misuse of pentobarbital injection for suicidal purposes, by itself, meets the Scheduling Factors under Schedule 8.
I have made a decision to include a specific requirement for the storage of injectable pentobarbital in a locked container to prevent unauthorised access. I understand that such controls are broadly in place through the provision of Section 3 of the Poisons Standard, which requires person who sells or supplies Schedule 4 (or Schedule 3) poisons to keep those poisons in a part of the premises to which the public does not have access. I recognise that the implementation of this storage requirement is inconsistent across the States and Territories insofar as it relates to injectable pentobarbital. It is my view that an Appendix D entry will clarify the specific storage requirements for injectable pentobarbital and encourage States and Territories to adopt standardised controls, without the additional burden of the record keeping requirements associated with Schedule 8. As far as veterinary premises other than veterinary hospitals is concerned, I understand that there is variation in how the storage practices within these facilities are governed across the jurisdictions. In accordance with the legislative powers of the Poisons Standard, the particulars relating to the implementation and regulation of these storage requirements to any premises, veterinary or otherwise, be it a veterinary hospital or other type of veterinary clinic is a matter for the States and Territories.
I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.
I have decided that an implementation date of 1 October 2020 is appropriate.