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

Scheduling of chemicals and poisons

10 June 2020

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1.5. Selective Serotonin Reuptake Inhibitors (SSRI)

Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #29 March 2020)

1.5. Interim decision in relation to Selective Serotonin Reuptake Inhibitors (SSRI)

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 include a Selective Serotonin Reuptake Inhibitors (SSRI) group entry.

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 a Selective Serotonin Reuptake Inhibitors (SSRI) group entry;
  • Advisory Committee on Medicines 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) 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;
  • Scheduling handbook: Guidance for amending the Poisons Standard; and
  • Scheduling Policy Framework (SPF 2018).

Summary of ACMS advice/recommendations to the Delegate

The Committee did not recommend a SSRI class entry.

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:

  1. the risks and benefits of the use of a substance
    • Risks:
      • SSRIs exert secondary physiological effects on the body due to their effects on various neurotransmitter receptors, and depending on the individual agent, slightly different adverse event profiles are produced.
      • Some adverse effects are serious and severe, and some are frequent. These may include sexual dysfunction, suicide risk, decreased appetite, dry mouth, headache, nausea, agitation, cardiac disturbances.
      • SSRIs can interact with other drugs and reduce their efficacy, cause adverse effects, or cause dangerous reactions such as serotonin syndrome.
      • Abrupt cessation of SSRI medicines can cause a withdrawal syndrome.
    • Benefits:
      • Effective treatment for depressive disorders with a better safety profile compared to many other treatments.
      • SSRI medicines can effectively treat serious mental health conditions.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • SSRI medicines are used to treat health conditions such as depression, anxiety and eating disorders, the safe treatment of which requires the supervision of a medical practitioner, which is achieved by including SSRI medicines in Schedule 4.
    • Due to their relative safety compared to other antidepressants, SSRIs are commonly used.
  3. the toxicity of a substance
    • Medical intervention needed due to drug interactions and increased risk of adverse effects, including serotonin syndrome.
    • Abrupt cessation of treatment with SSRIs can lead to withdrawal / discontinuation syndrome.
    • In overdose, SSRI are rarely fatal. The risk of toxicity and death is higher if taken with other drugs or alcohol.
  4. the dosage, formulation, labelling, packaging and presentation of a substance
    • Many products registered on the ARTG - all are Schedule 4.
  5. the potential for abuse of a substance
    • SSRIs are not demonstrated to have a dependence liability.
  6. any other matters that the Secretary considers necessary to protect public health
    • A class SSRI entry may not capture intended substance and/ or may create ambiguity in the scheduling.

Reasons for interim decision

I have made an interim decision not to amend the current Poisons Standard in relation to the proposal to include a Selective Serotonin Reuptake Inhibitors (SSRI) group entry. My detailed reasons follow.

It is my view that as a legislative instrument it is important that the Poisons Standard is specific and unambiguous. I find it problematic that the group entry, as proposed, is ambiguous in its intended capture. I have considered a scenario where a substance that satisfies the risk profile for Schedule 4 may not be captured by the proposed group entry. I have also considered an alternative scenario whereby lower risk substances may be inadvertently captured by the group entry. In addition, the group entry, as proposed, is likely to create uncertainty with respect to herbal extracts with potentially SSRI-like action e.g. St John's Wort.

In making my decision, I considered whether there is an urgent public health concern that would warrant the need for an SSRI group entry. I have not identified compelling evidence that establishes the provision of an SSRI group entry is required to be in place to protect health.

I agree with the Committee's finding that the relevant provisions of section 52E 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 that the Secretary considers necessary to protect public health.

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