Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS and Joint ACMS-ACCS meetings, June 2020

Scheduling of chemicals and poisons

9 September 2020

This consultation closed on 13 October 2020.

1 Notice of interim decisions made under Regulation 42ZCZN of the Therapeutic Goods Regulations 1990

This web publication constitutes a notice for the purposes of regulation 42ZCZP of the Therapeutic Goods Regulations 1990 (the Regulations). In accordance with regulation 42ZCZP, this notice sets out:

  • the interim decisions made by a delegate of the Secretary under regulation 42ZCZN in relation to proposed amendments to the current Poisons Standard which were referred to an expert advisory committee under subdivision 3D.2 of the Regulations in June 2020;
  • the proposed date of effect of the proposed amendments (in circumstances where the interim decision proposes an amendment to the current Poisons Standard).

In accordance with regulation 42ZCZP, interested persons (including the applicant requesting the amendment) are invited to make submissions to the Secretary in relation to these interim decisions on or before 13 October 2020.

We have changed the way to make submissions.

Submissions now should be provided through our consultation hub. Submissions will be considered by the Delegate in making the final decision.

Please note that in accordance with subregulation 42ZCZQ(4) of the Regulations, the Secretary must publish all relevant submissions received, unless the Secretary considers the information to be confidential information.

How to respond

We have changed the way to make submissions.

Go to our consultation page to make a submission about these proposals to amend the Poisons Standard.

If you have difficulty accessing the consultation hub or uploading your submission, contact medicines.scheduling@health.gov.au and include 'Proposed Amendments to the Poisons Standard (Medicines)' or 'Proposed Amendments to the Poisons Standard (Chemicals)' in the subject line of the email.

2 Interim decision in relation to nicotine

Note that the interim decision on nicotine is not published in this notice. Publication is planned for 23 September 2020.

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

4 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25, June 2020)

3.1 Oxymetazoline

Scheduling of chemicals and poisons

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.1 Interim decision in relation to oxymetazoline

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to oxymetazoline.

Materials considered

In making this interim decision, the Delegate considered the following material:

  • The application to amend the current Poisons Standard with respect to oxymetazoline;
  • The five public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
  • The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
  • 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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate

The Committee recommended that the current scheduling of oxymetazoline remains appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:
  • Risks
    • Risks with prolonged use leading to rebound nasal congestion, particularly with treatment of congestion in relation to allergic rhinitis.
  • Benefits
    • Long history of use and the safety profile is well characterised;
    • Few other risks if taken in accordance with directions.
b - the purposes for which a substance is to be used and the extent of use of a substance:
  • Product is used for symptomatic relief of nasal congestion.
c - the toxicity of a substance:
  • Toxicity of the substance is low, if taken in accordance with the instructions on the packet;
  • Ongoing reports from NSW Poisons Information Centre on incorrect dosing.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
  • Packaged as a nasal spray for topical application, appropriate warning and use statements required on the label;
  • Pack size does not limit duration with this product (provides much more than 3 days' supply) i.e. risk mitigation through reducing pack sizes cannot be achieved.
e - the potential for abuse of a substance:
  • There is a small potential for incorrect use, as consumers may not read or understand the information on the packet;
  • Cases of non-medical use are rarely reported, but not unheard of.
f - any other matters considered necessary to protect public health:
  • Inconsistency with access controls placed on phenylephrine;
  • Concern with use for allergic rhinitis and self-selection.
Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to retain the scheduling of oxymetazoline in the current Poisons Standard. This decision is to not implement the proposal to down-schedule oxymetazoline to the general sales level. The detailed reasons for my interim decision follow.

Oxymetazoline is used for symptomatic relief of nasal congestion. In my view, access to oxymetazoline in a pharmacy allows for the provision of pharmacist advice to mitigate the risk of inappropriate use. I am concerned that access to oxymetazoline at the general sales level, without pharmacist input, will lead to adverse effects from overuse and rebound congestion from prolonged use. I have considered the scenario where consumers may be able to identify and self-manage nasal congestion, for which oxymetazoline is intended, but may confuse the symptoms with allergic rhinitis. I am concerned that oxymetazoline may be used by consumers with allergic rhinitis when there are other more appropriate medications and this may contribute to rebound congestion.

I am of the view that product packaging and labelling, in the absence of pharmacist consultation, is inadequate to mitigate the risk of inappropriate use. Taking into account that rebound congestion is not well understood by consumers, I consider that access to advice from a health professional within a pharmacy, is important to guide patient behaviour.

Based on my reading of the evidence the net public health benefit from the wider availability of oxymetazoline is limited.

I have taken into account the public submission from the NSW Poisons Information Centre (NSW PIC), which establishes that the number of calls regarding incorrect oxymetazoline dosing had been constant in recent years. The NSW PIC were concerned that wider access, through unscheduled oxymetazoline, could increase the incidence of dosing errors. In making my decision to retain the current scheduling of oxymetazoline, the safety issues raised by the NSW PIC were a minor consideration, relative to my concerns of inappropriate use, set out above.

I have considered the claims in the public submissions that access controls on oxymetazoline in Australia are more restrictive than similar overseas regulators. Oxymetazoline is available as 'general sale' in UK, Canada, New Zealand and USA. However, there are other differences in the way medicines are regulated overseas that influence safety and access to health professional advice. Overseas classification for medicines are not always directly equivalent to Australia as some other countries do not have two pharmacy schedules. In practice, general sales in other countries is not the equivalent of being sold in supermarkets.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

3.2 Eletriptan

Scheduling of chemicals and poisons

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.2 Interim decision in relation to eletriptan

Note

New text is shown as green, larger font, with a horizontal line above it.

Interim decision

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 eletriptan as follows:

Schedule 4 - Amend Entry

ELETRIPTAN except when included in Schedule 3.

Schedule 3 - New Entry

ELETRIPTAN for oral use in tablets containing 40 mg or less per tablet and when in a pack containing not more than 2 dosage units for the acute relief of migraine in patients who have a stable, well-established pattern of symptoms.

Appendix H - New Entry

ELETRIPTAN

Index - Amend Entry

ELETRIPTAN

Schedule 4
Schedule 3
Appendix H

Materials considered

In making this interim decision, the Delegate considered the following material:

  • The application to amend the current Poisons Standard with respect to eletriptan;
  • The two public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
  • The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
  • 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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate

The Committee recommended that the scheduling of eletriptan be down-scheduled from Schedule 4 to Schedule 3 and to create an Appendix H entry in the current Poisons Standard.

The Committee also recommended an implementation date of 1 February 2021.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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 (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:
  • Risks
    • Frequent use may result in medication overuse headache;
    • Possible cerebral vascular side effects associated with eletriptan as well as cardiovascular events;
    • Dizziness and drowsiness;
    • Risk concerning potential delay in seeking medical advice.
  • Benefits
    • Eletriptan provides effective treatment of acute migraine with or without aura;
    • Established safety profile when used as directed;
    • Timely access for patients with confirmed migraine diagnosis may improve patient outcomes.
b - the purposes for which a substance is to be used and the extent of use of a substance:
  • Acute treatment of migraine headache with a stable well established pattern of migraine symptoms with or without aura.
c - the toxicity of a substance:
  • Contraindications to use:
    • Hypertension;
    • Established coronary artery disease (including ischaemic heart disease (IHD));
    • Signs and symptoms of IHD or Prinzmetal's angina;
    • History of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
    • Peripheral vascular disease;
    • Basilar or hemiplegic migraine or 'atypical' headache;
    • Using another triptan;
    • Used an ergotamine type medication within 24 hours;
    • Serious cardiac events, including some that have been fatal, have occurred following the use of other 5HT1 agonists;
    • Interaction risk if used within 48 hours of treatment with the following potent CYP3A4 inhibitors: ketoconazole, itraconazole, erythromycin, clarithromycin, amprenavir, ritonavir, indinavir, saquinavir, nelfinavir and nefazodone (specific to eletriptan).
  • Adverse effects are typically mild in intensity and transient.
  • Most common adverse effects dizziness, drowsiness and chest symptoms.
  • Safety and efficacy not established in people <17 or > 65.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
  • The recommended initial dose is 40 mg.
  • The maximum single dose is 80 mg.
  • The maximum daily dose should not exceed 160 mg.
  • If a second dose is required, it should not be taken within 2 hours of the initial dose.
  • The proposed Schedule 3 entry is for oral use in tablets containing 40mg or less per tablet and when in a pack containing not more than 2 dosage units.
e - the potential for abuse of a substance:
  • NIL.
f - any other matters considered necessary to protect public health:
  • Risk reduction can be further mitigated by pharmacist counselling and verification of diagnosis by a medical practitioner if required.
  • Consideration of sufficient time for information to be developed by February 2021.
Reasons for the interim decision (including findings on material questions of fact)

I have made a decision to down-schedule eletriptan from Schedule 4 to Schedule 3 with a new Appendix H listing in the current Poisons Standard.

I have decided to include a pack size limit in the new Schedule 3 entry to mitigate the risks of medication overuse headache, unintentional and intentional overdose. I have made the Schedule 3 entry indication specific on the grounds that eletriptan is not effective for other types of headache. I note that this decision is consistent with the recent decisions to down-schedule sumatriptan, zolmitriptan, rizatriptan.

I find that the eletriptan satisfies the Schedule 3 scheduling factors on the basis that the risk profile of eletriptan is well defined and the risk factors for adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist. I am satisfied that the risk of adverse events, including cardiovascular events, can be minimised through pharmacist-consumer consultation. Pharmacists will exercise profession judgment on the migraine pattern of the presenting patient and if necessary, refer the patient for verification of diagnosis by a medical practitioner. Eletriptan is most effective when taken as soon as possible following onset of a migraine. I am of the view that down-scheduling of eletriptan to Schedule 3 would improve timely access for patients with migraine and therefore improve patient outcomes.

I consider the recent decisions to down-schedule sumatriptan, zolmitriptan, rizatriptan to Schedule 3 to be relevant to my deliberations on the basis that there is a therapeutic class effect associated with “triptans” or 5HT1 agonists. I have not identified any significant differences in eletriptan compared to sumatriptan, zolmitriptan, rizatriptan which would signal for it not to be down-scheduled to Schedule 3. I have considered that there is no evidence that any triptan is safer than another, although the response to each agent can vary considerably between patients. The same individual may also respond quite differently to different triptans. I have taken into account that unlike sumatriptan, zolmitriptan and rizatriptan, eletriptan is not a substrate of MAO-A, which in my view, is in favour eletriptan being made available in addition to other the triptans, especially in patients taking monoamine oxidase inhibitors (MAOIs).

I note that a number of peak heath organisations, including the Pharmacy Guild of Australia, Pharmaceutical Society of Australia and the Australian Medical Association were in support of a decision to down-schedule eletriptan to Schedule 3 of the Poisons Standard.

Having considered the matters set out in the guidelines for advertisements for medicines containing Schedule 3 substances, I am satisfied that there are no foreseeable potential impacts on public health that would preclude advertising eletriptan directly to consumers through the provision of an Appendix H listing.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (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 (f) any other matters considered necessary to protect public health.

Proposed implementation date

1 February 2021

3.3 Clotrimazole

Scheduling of chemicals and poisons

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.3 Interim decision in relation to clotrimazole

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to clotrimazole.

Materials considered

In making this interim decision, the Delegate considered the following material:

  • The application to amend the current Poisons Standard with respect to clotrimazole;
  • The seven public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
  • The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
  • 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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate

The Committee recommended that the current scheduling of clotrimazole in the Poisons Standard remains appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:
  • Risks
    • Well established safety profile with few risks from use.
  • Benefits
    • Effective treatment of vulvovaginal candidiasis caused by Candida albicans.
b - the purposes for which a substance is to be used and the extent of use of a substance:
  • For the treatment of vulvovaginal candidiasis caused by Candida albicans (clotrimazole 1% for vaginal use).
c - the toxicity of a substance:
  • Clotrimazole is an imidazole derivative that has low levels of systemic absorption from vaginal administration.
  • It is extensively metabolised in the liver to inactive compounds. No carcinogenicity or mutagenicity was observed in animal studies.
  • Vaginal clotrimazole is generally well tolerated with the main reported adverse reactions being local irritation (e.g. burning, erythema). Hypersensitivity/allergic reactions are rare.
  • Vaginal clotrimazole is considered safe to use in pregnancy (a 1-week course) and in breastfeeding.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
  • Clotrimazole 10mg/ml (1%) cream to be applied once daily for 6 days.
  • Warning statements are already required for clotrimazole vaginal preparations. The effectiveness of the proposed packaging warning statement 'For women who have previously been diagnosed with vaginal thrush' is unclear given there is evidence that consumers do not read the package information and that reading the label does not improve the accuracy of self-diagnosis.
e - the potential for abuse of a substance:
  • There is no evidence of dependence or abuse of clotrimazole vaginal preparations, however misuse due to misdiagnosis is probable.
f - any other matters considered necessary to protect public health:
  • Repeated studies and clinical experience demonstrate that self-diagnosis is inaccurate. Self-misdiagnosis cannot be addressed by labelling, packaging, and the provision of other information alone.
  • Use may delay diagnoses so does not meet Scheduling factors for Schedule 2.
Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision not to amend the current Poisons Standard in relation to the clotrimazole, specifically not to down-scheduling clotrimazole in vaginal preparations from Schedule 3 to Schedule 2. The reasons for my decision are set out below.

It is my view that pharmacist intervention, currently in place, is the critical mitigating factor to ensure the quality use of clotrimazole 1% in preparations for vaginal use. Increased consumer availability as a Schedule 2 medicine would remove the opportunity for direct pharmacist consultation and increase the potential for harm to consumers.

In 2018, I made a final decision not to amend the current scheduling of clotrimazole, with the major risks identified as inaccurate self-diagnosis and delayed treatment if the product is used for vaginal infections not caused by Candida albicans. These previous concerns regarding misdiagnosis and delayed treatment where an individual self-diagnoses and self-selects a treatment for vaginal symptoms remain unchanged.

I disagree with the views expressed by the applicant, that clotrimazole meets the Schedule 2 Scheduling Factors outlined in the Scheduling Policy Framework 2018 (SPF 2018). Schedule 2 medicines are for minor ailments or symptoms that can easily be self-diagnosed by consumers and are unlikely to be confused with other more serious diseases or conditions. The TAFT project conducted by Tenni et al (2005) about treatment of vulvovaginal candidiasis (VVC) concluded that 'women who self-diagnose VVC do so poorly' and that 'approximately two thirds of patients who self-diagnose vaginal candidiasis are incorrect'[1] . Another qualitative Australian study of bacterial vaginosis (BV) conducted by Bilardi et al (2016) found that individuals who experienced BV for the first time treated themselves for VVC and 'consequently did not seek medical assistance for up to a few weeks after symptoms first presented, however, sought treatment sooner with subsequent episodes'[2].

I further find that the quality use of clotrimazole cannot be achieved by labelling, packaging and/or the provision of other information alone. The proposed warning statement 'For women who have previously been diagnosed with vaginal thrush' does not mitigate the risk of inaccurate self-diagnosis and subsequent delay in appropriate treatment.

Based on my assessment, I find that the net benefit associated with access to clotrimazole 1% in preparations for vaginal use as a Schedule 2 medicine is limited to convenience for consumers. Whilst clotrimazole 1% in preparations for vaginal use has a favourable safety profile, there is no compelling evidence to suggest that current access is inadequate. In my view, the benefit of convenience does not sufficiently outweigh the risk of harm associated with clotrimazole use set out above.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the 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 of a substance; (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.


Footnotes

3.4 Sildenafil

Scheduling of chemicals and poisons

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.4 Interim decision in relation to sildenafil

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to sildenafil.

Materials considered

In making this interim decision, the Delegate considered the following material:

  • The application to amend the current Poisons Standard with respect to sildenafil;
  • The five public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
  • The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
  • 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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate

The Committee recommended that the scheduling of sildenafil in the Poisons Standard remains appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:
  • Risks
    • Potential for incorrect diagnosis of erectile dysfunction (ED) by pharmacists. CVD risk and contraindications, adverse effects, misuse.
    • Adverse events - the most serious of which are non-arteritic ischaemic optic neuropathy (NAION), priapism and interactions with nitrates and other drugs.
    • Common adverse events include headache and flushing.
    • Risk of lack of ongoing medical monitoring (under the current proposal).
  • Benefits
    • Effective treatment of ED.
b - the purposes for which a substance is to be used and the extent of use of a substance:
  • Intended for use in men with ED aged 18 years or over, to assist in treatment of ED.
  • ED affects up to 50% of men aged 40 to 70 years.
c - the toxicity of a substance:
  • Sildenafil has a wide therapeutic index.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
  • No Schedule 3 product at present.
e - the potential for abuse of a substance:
  • Some evidence of off-label use (in the context of recreational substance use) and sourcing through internet purchases outside the medical system.
f - any other matters considered necessary to protect public health:
  • All men with ED need thorough medical evaluation for its cause and ongoing monitoring.
  • ED may be a symptom of more serious underlying conditions, which require ongoing medical monitoring (in addition to medical diagnosis).
  • Sildenafil meets Schedule 4 factors, requiring medical intervention for monitoring of the condition.
Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision not to amend the current Poisons Standard in relation sildenafil, specifally not to down-schedule certain preparations of sildenafil from Schedule 4 to Schedule 3. My view is that the current scheduling of sildenafil is appropriate. The reasons for my decision are set out below.

Sildenafil is approved for the treatment of ED. ED can be a symptom of underlying conditions, which require medical practitioner diagnosis, ongoing monitoring and treatment. Having considered the Scheduling Policy Framework 2018 (SPF 2018), I find that the requirement for medical practitioner intervention is consistent with the Scheduling Factors under a Schedule 4 classification.

Sildenafil had been considered for down scheduling on two previous occasions, in 2017 and 2018. On both occasions, I found that sildenafil did not meet the Schedule 3 scheduling factors and that proposed education and checklist material was insufficient to mitigate the risk of down scheduling. In my view, the applicant has not presented, and I have not found, any new compelling clinical evidence to support the inclusion of sildenafil in Schedule 3.

I have considered the proposed risk mitigation strategies outlined in the Appendix M entry put forward by the applicant and found it did not systematically assess the risks associated with sildenafil use. I acknowledge that while pharmacists would not be making an initial decision as to whether treatment with sildenafil should be initiated. However, I have strong concerns that if down-scheduled there there is a risk of repeat supply without medical intervention and lack of follow up. I find that the potential for harm in the absence of medical practitioner oversight carries more weight than the benefit of increased patient access.

I have considered the views expressed in the public submissions and those of the applicant, suggesting that down-scheduling sildenafil to Schedule 3 would create ease of access, increase awareness of ED and enable early engagement with the healthcare system. However, no data has been provided to substantiate these claims or clearly articulate how these benefits would apply to men's health in general.

Having considered the need for medical practitioner oversight and the risks to consumers with the lack of patient follow up in a pharmacy setting, I am of the firm view that the current scheduling of sildenafil under Schedule 4 is appropriate.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the 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 of a substance; (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.

3.5 Ibuprofen

Scheduling of chemicals and poisons

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.5 Interim decision in relation to ibuprofen

Note

New text is shown as green, larger font, with a horizontal line above it.

Interim decision

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 ibuprofen as follows:

Schedule 2 - Amend Entry

IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:

  1. in liquid preparations when sold in the manufacturer's original pack containing 8 g or less of ibuprofen; or
  2. in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
    1. as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
    2. packed in blister or strip packaging or in a container with a child-resistant closure;
    3. in a primary pack containing not more than 25 dosage units;
    4. compliant with the requirements of the Required Advisory Statements for Medicine Labels;
    5. not labelled for the treatment of children 6 years of age or less; and
    6. not labelled for the treatment of children under 12 years of age when combined with phenylephrine.
  3. in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units, when labelled:
    1. not for the treatment of children under 12 years of age.
Materials considered

In making this interim decision, the Delegate considered the following material:

  • The application to amend to amend the current Poisons Standard with respect to ibuprofen;
  • The eight public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
  • The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
  • 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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate

The Committee recommended that the current Schedule 2 entry for ibuprofen in the Poisons Standard be amended as follows:

Schedule 2 - Amend Entry

IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:

  1. in liquid preparations when sold in the manufacturer's original pack containing 8 g or less of ibuprofen; or
  2. in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
    1. as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
    2. packed in blister or strip packaging or in a container with a child-resistant closure;
    3. in a primary pack containing not more than 25 dosage units;
    4. compliant with the requirements of the Required Advisory Statements for Medicine Labels;
    5. not labelled for the treatment of children 6 years of age or less; and
    6. not labelled for the treatment of children under 12 years of age when combined with phenylephrine.
  3. in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units, when labelled:
    1. not for the treatment of children under 12 years of age.

The Committee also recommended an implementation date of 1 February 2021.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:
  • Risks
    • Increased risk to the elderly, those with cardiovascular disease, renal disease and asthma and a rare incidence of hypersensitivity reactions and liver damage.
    • It should not be taken in children younger than 12 years, or by women in the first three months of pregnancy.
    • Increased risk of GI bleeding in persons who have a past history of gastric bleeding, stomach ulcers or prolonged use of ibuprofen.
    • It should not be taken by those who have an allergy to aspirin or NSAIDs.
    • The risks are consistent with other already unscheduled and S2 ibuprofen products.
  • Benefits
    • Relief of pain and fever.
    • Ibuprofen is well tolerated with an excellent safety profile at these dosages.
    • Only a single tablet is required to be taken.
b - the purposes for which a substance is to be used and the extent of use of a substance:
  • Short term treatment for the relief of mild to moderate pain and fever associated with colds and flu, headaches, back pain, muscular aches and pain, dental related pain, arthritis, primary dysmenorrhoea, and other inflammatory conditions.
c - the toxicity of a substance:
  • Minimal toxicity at recommended dosage.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
  • 400mg tablets in an immediate release formulation in a pack of 12 dosage units.
  • Labelled with 'DOUBLE STRENTH'.
  • RASML Warning labelling is appropriate.
  • The small size of the pack at 12 tablets is consistent with short-term use and is a significant mitigation for concern around excessive doses.
  • Risk around dose confusion mitigated by labelling.
e - the potential for abuse of a substance:
  • Low.
f - any other matters considered necessary to protect public health:
  • Change the wording of the proposed scheduling entry to exclude the modified release formulation. The experience with modified release products is limited.
  • Ibuprofen modified release does not have the same safety profile as immediate release formulations, is designed to manage persistent pain and is not recommended to be included for down scheduling.
  • Committee recommends that that the term 'strong pain' would not be appropriate to use in advertising or labelling and that labelling should be closely looked at to mitigate risks.
  • The potential for confusion with multiple products makes labelling and education through advertising important for risk mitigation.
  • Targeted consumer education campaign around the new dosage regime and need for consumers to read the label is recommended.
Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to amend the Schedule 2 entry for ibuprofen in the Poisons Standard. The reasons for my decision are set out below.

It is my view that the net benefits of broadening the availability of immediate release ibuprofen with restrictions placed on age, dosage form and pack size, combined with warning labels, outweighs the potential risks associated with improper use.

I have made the decision to limit the new entry to immediate release formulations, as modified release ibuprofen has limited clinical experience and a very different use profile. Ibuprofen modified release is designed to help manage recurrent or chronic pain and therefore requires pharmacist intervention to ensure the quality use of the medicine. For this reason, modified release ibuprofen should remain in Schedule 3 and has been excluded from this amendment.

I have determined that ibuprofen at this dosage level and pack restriction, meets the Schedule 2 Scheduling Factors outlined in the Scheduling Policy Framework (SPF) 2018. I took into account that ibuprofen has a wide therapeutic index and the risk from harm from overdose is minimal. I consider the risk profile of ibuprofen to be superior to that of other nonsteroidal anti-inflammatory drugs (NSAIDs) and compared to combination paracetamol+ibuprofen formulations currently available in Schedule 2. I have considered that very large doses of ibuprofen are required for moderate to severe toxicity (>/= 400mg/kg or 28 g for a 70 kg person) and that a 400 mg 12-dosage pack contains only 4.8 g ibuprofen. There is unlikely to be any increased safety risk when taken according to directions, noting the availability of 20 g ibuprofen in the 100 pack of 200 mg tabs (with a maximum dose of 1200mg/day) is currently available under Schedule 2.

I have considered the views expressed in the public submissions and acknowledge that there is concerns regarding the established pain relief culture of taking two tablets, which may lead to the risk of double-dosing. However, I am of the view that this risk is not unique to double strength ibuprofen. It is my understanding that products with double strength formulations have been available under Schedule 2 for many years. I also consider that the pack restrictions mitigate any significant risk. If a consumer took double the recommended dose (i.e. 800 mg/day) they would take a non-toxic dose and consume the supply in 1.5 days.

I am satisfied that the Schedule 2 criteria have been met and the quality use of 400 mg ibuprofen immediate release can be achieved through appropriate labelling, packaging and provision of professional advice when necessary, mitigating risks associated with incorrect dosing.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the 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 of a substance; (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.

Proposed implementation date

1 February 2021

3.6 Cumyl-pegaclone

Scheduling of chemicals and poisons

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.6 Interim decision in relation to cumyl-pegaclone

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Interim decision

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 cumyl-pegaclone as follows:

Schedule 9 - New Entry

2,5-DIHYDRO-2-(1-METHYL-1-PHENYLETHYL)-5-PENTYL-1H-PYRIDO[4,3-B]INDOL-1-ONE (SGT-151)

Index - New Entry

2,5-DIHYDRO-2-(1-METHYL-1-PHENYLETHYL)-5-PENTYL-1H-PYRIDO[4,3-B]INDOL-1-ONE (SGT-151)
cross reference: SGT-151, CUMYL-PEGACLONE.

Schedule 9

Materials considered

In making this interim decision, the Delegate considered the following material:

  • The proposal to amend the current Poisons Standard with respect to cumyl-pegaclone;
  • The three public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
  • The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
  • 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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate

The Committee recommended that that cumyl-pegaclone be entered in Schedule 9 of the Poisons Standard as follows:

Schedule 9 - New Entry

2,5-DIHYDRO-2-(1-METHYL-1-PHENYLETHYL)-5-PENTYL-1H-PYRIDO[4,3-B]INDOL-1-ONE (CUMYL-PEGACLONE) (SGT-151)

Index - New Entry

2,5-DIHYDRO-2-(1-METHYL-1-PHENYLETHYL)-5-PENTYL-1H-PYRIDO[4,3-B]INDOL-1-ONE (CUMYL-PEGACLONE) (SGT-151)

Schedule 9

The Committee also recommended an implementation date of 1 February 2021.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:
  • Risks
    • Cumyl-pegaclone has no therapeutic benefits established through clinical trials or research.
  • Benefits
    • Use of cumyl pegaclone is associated with serious medical and psychiatric effects, including hallucinations, delusions, irritability, paranoia as well as elevated blood pressure, chest pain, vomiting.
b - the purposes for which a substance is to be used and the extent of use of a substance:
  • No current human therapeutic use, or uses in industrial, agricultural, or cosmetic products.
  • Current use is in the context of non-medical substance use.
c - the toxicity of a substance:
  • Described by clinicians as consistent with "serotonin toxicity".
  • Cumyl-pegaclone is a potent full agonist of the cannabinoid CB1 and CB2 receptors. Cannabinoid receptor binding affinity and efficacy for the cannabinoid receptors CB1 and CB2 suggest that the formation of a γ‐carboline core leads to a more potent compound when compared to the corresponding indole core structures.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
  • No approved product currently marketed.
e - the potential for abuse of a substance:
  • Established potential for abuse. It has been synthesised for its psychoactive properties and recreational drug use. Tolerance to effects and withdrawal symptoms have been reported.
f - any other matters considered necessary to protect public health:
  • Whilst cumyl-pegaclone is captured by the group entry for synthetic cannabinomimetics, specific listing will remove any ambiguity surrounding the scheduling of this substance.
  • Evidence of harms in Australia have been documented.
Reasons for the interim decision (including findings on material questions of fact)

I have made an interim decision to amend the current Poisons Standard and create a new Schedule 9 entry for cumyl-pegaclone. The reasons for my decision are set out below.

Cumyl pegaclone is a synthetic cannabinoid (SC) and new psychoactive substance (NPS) that is currently captured by the Schedule 9 entry for synthetic cannabinomimetics. Cumyl-pegaclone has a gamma-carboline core structure that is different from other synthetic cannabinomimetics, and for this reason, I have made a decision to create a specific Schedule 9 entry to provide clarity that the substance is prohibited. It is my view that this decision will also remove ambiguity in any prosecutions for possession and sale of the substance.

I have determined that cumyl-pegaclone meets the Schedule 9 Scheduling Factors in the Scheduling Policy Framework (SPF) 2018. I took into account that cumyl-pegaclone has no established medical, industrial, agricultural or cosmetic uses and as a synthetic cannabinoid it can cause psychoagitation, cardiovascular effects, sedation and intoxication. I am satisfied that a high level of control is required through prohibition of manufacture, possession, sale or use to prevent abuse, misuse or diversion into illicit activities.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the 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 of a substance; (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.

Proposed implementation date

1 February 2021

4.1 Cannabidiol (private application) and cannabidiol (delegate initiated)

Scheduling of chemicals and poisons

4 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25, June 2020)

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4.1 Interim decision in relation to cannabidiol (private application) and cannabidiol (delegate initiated)

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendments to cannabadiol made the following interim decisions:

  • in relation to the proposed amendment in the private scheduling application, made an interim decision not to amend the current Poisons Standard to exclude cannabadiol from scheduling and allow its general sale.
  • in relation to the proposed delegate-initiated amendment, made an interim decision to amend the current Poisons Standard to down schedule cannabadiol to allow greater access through a new Schedule 3 entry in accordance with specified requirements and with additional supply requirements specified in Appendix M to allow it to be provided by a pharmacist.

The proposed Poisons Standard entry in relation to cannabidiol is as follows:

Schedule 4 - Amend Entry

CANNABIDIOL in preparations for therapeutic use where:

  1. cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and
  2. any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2 per cent or less of the total cannabinoid content of the preparation;

    except when included in Schedule 3.

Schedule 3 - New Entry

CANNABIDIOL in oral, oral mucosal and sublingual formulations preparations for therapeutic use when:

  1. the cannabidiol is either plant derived, or when synthetic only contains the (-) CBD enantiomer; and
  2. the maximum recommended daily dose is 60 mg or less of cannabidiol; and
  3. in packs containing not more than 30 days' supply; and
  4. cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation; and
  5. any cannabinoids, other than cannabidiol, must be only those naturally found in cannabis and comprise 2 per cent or less of the total cannabinoid content of the preparation; and
  6. for adults aged 18 years and over; and
  7. packed in blister or strip packaging or in a container fitted with a child-resistant closure.

Appendix F, Part 3 - New Entry

POISONS (other than agricultural and veterinary chemicals) TO BE LABELLED WITH WARNING STATEMENTS OR SAFETY DIRECTIONS

POISON WARNING STATEMENTS SAFETY DIRECTION
CANNABIDIOL when included in Schedule 3. 67, 111

67: Do not use if pregnant or likely to become pregnant.

111: Do not use if breastfeeding or plan to breastfeed.

Appendix M - New entry

ADDITIONAL CONTROLS OR SUPPLY REQUIREMENTS FOR POISONS INCLUDED IN SCHEDULE 3 TO ALLOW THEM TO BE PROVIDED BY A PHARMACIST

POISON CONDITION OF SUPPLY
CANNABADIOL Supply is limited to medicines that are entered on the Australian Register of Therapeutic Goods (ARTG).
Materials considered

In making these interim decisions, the Delegate considered the following material:

Summary of Joint ACMS-ACCS advice to the Delegate

Due to the significant overlap between the private scheduling application and the delegate-initiated amendment, the Committee considered these proposals together.

The Committee recommended that the current scheduling of cannabidiol remains appropriate. The majority of the members on the Committee were not persuaded that there is currently sufficient evidence to relax the access controls on cannabidiol, derived from plants or synthetically produced, to the general sales levels or that cannabidiol meets the scheduling factors for Schedule 3.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included (a) the 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 of a substance; (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:

a - the risks and benefits of the use of a substance:
  • Risks

    The Committee identified the following risks:

    • CBD, being an inhibitor of CYP3A4, CYP2D6, CYP2C19, CYP2C9 and P-glycoprotein, is likely to have interactions with many pharmaceuticals available for human use. Pharmacodynamic interactions with drugs that cause CNS depression (opioids, benzodiazepines, antipsychotics, gabapentinoids, sedating antihistamines), are likely.
    • CBD can have adverse reactions including somnolence, decreased appetite, diarrhoea, fatigue and liver dysfunction.
    • The current lack of approved indications would prevent a pharmacist being able to determine appropriate supply.
    • The Committee noted the potential for use, outside of that legally permitted by the Poisons Standard, particularly in children/adolescents, if CBD were to be available as a Schedule 3 medicine.
  • Benefits
    • The Committee noted that it was difficult to assess the benefits in the absence of an approved product or clearly defined indications.
    • The Committee noted that the TGA Safety Review concluded that doses up to 60 mg/day may potentially be used safely in adults.
b - the purposes for which a substance is to be used and the extent of use of a substance:
  • The Committee noted that currently there are no registered CBD products in Australia and unapproved CBD products are accessed via the Special Access Scheme (SAS).
  • The pre-meeting public submissions put forward a wide range of conditions for which CBD could be used, of which some were consistent with a Schedule 4 listing and some may be appropriate under a Schedule 3 classification.
c - the toxicity of a substance:
  • The Committee agreed that CBD toxicity is likely to be lower at low doses.
  • The Committee identified that there is potential to increase risk of toxicity from other drugs through inhibition of their metabolism/efflux.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
  • The Committee noted there is no registered product available in Australia, however overseas experience indicates a broad range of presentations including orally, topically, via inhalation and vaporisation.
e - the potential for abuse of a substance:
  • The Committee acknowledged that CBD has low abuse potential at low doses.
  • There is a possible risk of overuse or misuse of low dose CBD for inappropriate indications including the treatment of children.
f - any other matters considered necessary to protect public health:
  • In the absence of an Australian registered product, the Committee considered that down scheduling may not be effective at improving consumer access to low dose CBD, simultaneously noting that down-scheduling may encourage sponsors to apply for registration.
  • The safety and quality of a pharmacist compounded CBD product would be difficult to ensure or enforce. There was also concern that without a defined indication and guidance, compounding pharmacies may have difficulty ensuring that dispensing was consistent with the Schedule 3 factors.
  • The Committee raised concerns regarding the use of low dose CBD in pregnancy or lactation advising that the risks are unknown as these aspects were not reviewed in the TGA safety report.
Reasons for the interim decisions (including findings on material questions of fact)

I have made interim decisions, firstly not to exempt CBD from inclusion in the Poisons Standard and, secondly, to facilitate greater access to cannabidiol (CBD) by down-scheduling it from Schedule 4 to Schedule 3 of the Poisons Standard, subject to a number of criteria being satisfied.

The two interim decisions are represented collectively in one proposed amendment to the Poisons Standard.

The aforementioned criteria required to be satisfied are as follows:

  • restrictions on the preparation and dose, dosage form, pack size, age and limiting supply to Australian registered products
  • a requirement for a child-resistant closure unless the product is packed in blister or strip packaging
  • creation of an Appendix F listing to include a requirement for specific warning statements on the labelling of CBD-containing Schedule 3 products available to the public
  • exclusion of a medicine including CBD from Appendix H, that is those medicines are excluded from being advertised directly to consumers
  • creation of an Appendix M listing to limit supply to medicines including CBD which are entered on the Australian Register of Therapeutic Goods.

However, as part of my interim decisions, I am seeking additional advice from the November meeting of the Joint ACMS-ACCS, on the following criteria that I have incorporated:

  • An Appendix M entry to limit supply to medicines entered in the Australian Register of Therapeutic Goods (ARTG);
  • Dose restrictions;
  • Age restrictions; and
  • Advertising restrictions.

With criteria in place to limit supply to ARTG registered products, I am of the the view that CBD meets the Schedule 3 Scheduling Factors as outlined in the SPF 2018 as follows:

  • the medicine is substantially safe with pharmacist intervention to ensure the quality use of the medicine. There may be potential for harm if used inappropriately.
  • the use of the medicine is not expected to produce dependency.
  • the risk profile of the medicine is well defined (at the proposed dose). The risk factors for adverse effects, interactions and contraindications are known, identifiable and manageable by a pharmacist (when in preparations for therapeutic use and packaged in containers with child-resistant closures.)

The detailed reasons for my decision follow.

Having considered the proposal to exempt CBD from scheduling in the private application and the findings of the expert evaluation, I am not satisfied that CBD can be supplied at the general sales level, with reasonable safety, and without any access to health professional advice. The external evaluation report found that whilst CBD has low toxicity, adverse events and drug interactions are possible. On that basis, it is my firm view that CBD is unsuitable for general sales. It is my view that consumers would not be able to identify and self-manage the conditions for which CBD would be most commonly used without guidance from a health professional. Due to uncertainty of adverse effects, the effects of longer term use and the potential for drug interactions, I find that the risks cannot be managed with packaging and labelling in the absence of pharmacist advice. I note that there was unanimous agreement, among the Joint ACMS-ACCS #25 members, in their advice on this matter, that CBD did not meet the criteria for 'reasonable safety' as defined in the Scheduling Policy Handbook.

I have considered the concerns raised by the Joint ACMS-ACCS #25 in down-scheduling CBD from Schedule 4 to Schedule 3. I understand that in the absence of a registered product or a specific indication, it is difficult to assess the risks and benefits of over the counter (OTC) use. Accordingly, I have applied criteria in the entry in Schedule 3 as earlier noted as well as new entries in Appendices F and M that would address these issues. I have also excluded medicines including CBD from an entry in Appendix H, that is from being advertised directly to consumers.

I note the concerns raised in the external evaluation report over the paucity of evidence of efficacy for many of the indications for which there is public demand. However, the restrictions that I have applied in Appendix M should appropriately manage these concerns.

Furthermore, in accordance with the availability of poisons as outlined in the Poisons Standard, the inclusion of a poison in a Schedule indicates the degree of control required if it is marketed. It does not indicate that:

  • the poison is available; nor
  • the poison has been approved or is efficacious for any use that may be specified in a Schedule; nor
  • any obligation for registration of a therapeutic good containing that poison is negated.

I note that if a CBD product were to be registered as a Schedule 3 medicine, an application for product registration would include a full submission to support its intended use, including data relating to the efficacy for any indications for the product. The TGA product evaluation process would include assessment as to whether the proposed use was consistent with a Schedule 3 listing (i.e. self-diagnosable or requiring pharmacist intervention to monitor safe use following initial medical diagnosis).

I have decided to limit the proposed Schedule 3 entry to oral, oral mucosal and sublingual formulations. In making this decision I have attached weight to the findings of the TGA Review on the safety of low dose cannabidiol. The report establishes that doses up to 60 mg/day may have a suitable safety profile and possible clinical utility when used via the oral route, in the management of some conditions that do not require medical practitioner oversight. I am of the view that this is a necessary limitation to protect public safety, based on the current available evidence.

I have identified the risk of accidental exposure to children particularly for liquid formulations containing CBD. On that basis, I have decided to introduce a requirement in the Schedule 3 entry for the inclusion of child resistant closures, unless the product is packed in blister or strip packaging.

The Scheduling Policy Framework (SPF 2018) provides that the advertising of medicines containing Schedule 3 substances should be permitted unless there is reason not to. In order for these medicines to be lawfully advertised, they need to be included in Appendix H of the Poisons Standard. Having considered the matters set out in the Guidelines for advertisements for medicines containing Schedule 3 substances, I have considered the potential impact on public health in accordance with the questions noted as relevant to the delegate's considerations in those Guidelines. In particular, I have had regard to the potential for drug-drug interactions the risk of occurring of which may be increased by advertising. I also consider that increased patient education is required to ensure safe use and that patient choice could therefore be adversely influenced if CBD products were to be advertised. I have not taken into account any other additional factors Accordingly, I have decided not to list CBD in Appendix H.

I have also decided to include a new Appendix M entry for CBD, which would restrict the supply of CBD to medicines entered on the Australian Register of Therapeutic Goods (ARTG). This will ensure that only products that have been approved for a specific indication appropriate under a Schedule 3 listing, will be available without a prescription. I note the Committees' advice that the safety and quality of a compounded CBD product is difficult to ensure and enforce. It is my view that this measure will enable pharmacists to make informed decisions to supply CBD in line with Schedule 3 factors and in accordance with professional practice standards.

I note that the TGA Review on the safety of low dose cannabidiol did not assess the use of CBD during pregnancy and lactation. For this reason, I have decided to include a new entry in Appendix F, that is a requirement for warnings against the use of Schedule 3 CBD in pregnancy and breastfeeding.

I have had regard to the 5409 public submissions received in the pre-meeting consultation and the diversity of views expressed in these submissions. There was a large volume of submissions from individuals as part of a campaign. The majority of these submissions (approx. 52%) supported an alternative proposal set out in the campaign and just under half (46%) agreed with the private application, while a small number (approx. 2.5%) agreed with the delegates proposal. Of the 109 non campaign submissions, 80% of submission supported the down scheduling of CBD in some form. Many proposed a new solution and alternative means to increase accessibility while still balancing public safety.

I will consider the Committees' advice and the submissions received in response to my interim decision, before coming to a final decision on the scheduling of CBD.

Proposed implementation date

1 June 2021

4.2 Isothiazolinones, methylisothiazolinone and methylchloroisothiazolinones

Scheduling of chemicals and poisons

4 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25, June 2020)

4.2 Interim decision in relation to isothiazolinones, methylisothiazolinone and methylchloroisothiazolinones

Interim decision

A Delegate of the Secretary has made a decision to defer the interim decision for isothiazolinones, methylisothiazolinone and methylchloroisothiazolinones, until June 2021. This is to allow for further consideration of appropriate cut-offs and for consultation with key stakeholders that will be affected by any change in the scheduling of these substances. The Joint ACMS-ACCS #25 was in support of this decision.