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Final scheduling decisions and reasons: NCEs and Appendix H

Part A - Final decisions on matters not referred to an expert advisory committee

12 December 2018

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1.1. Appendix H

1. Delegate-only decisions on Schedule 3 substances to be added to Appendix H of the Poisons Standard

1.1. Appendix H

Delegate's final decision
Final decision:

The delegate's final decision is to amend Appendix H of the Poisons Standard as follows:

Appendix H - New entries:

ADRENALINE

CICLOPIROX

CLOBETASONE

FAMCICLOVIR

FLUORIDES

GLUCAGON

ISOCONAZOLE

KETOPROFEN

LEVONORGESTREL

NALOXONE

OXICONAZOLE

PARACETAMOL

PODOPHYLLOTOXIN

PODOPHYLLUM EMODI (podophyllin)

PODOPHYLLUM PELTATUM (podophyllin)

SALICYLIC ACID

TIOCONAZOLE

TRIAMCINOLONE

Index - Amend Entries

ADRENALINE

Schedule 4

Schedule 3

Appendix H

CICLOPIROX

Schedule 4

Schedule 3

Schedule 2

Appendix H

CLOBETASONE

Schedule 4

Schedule 3

Appendix F, Part 3

Appendix H

FAMCICLOVIR

Schedule 4

Schedule 3

Appendix H

FLUORIDES

cross reference: SILICOFLUORIDES

Schedule 6

Schedule 5

Schedule 4

Schedule 3

Schedule 2

Appendix E, Part 2

Appendix F, Part 3

Appendix H

GLUCAGON

Schedule 3

Appendix G

Appendix H

ISOCONAZOLE

Schedule 6

Schedule 4

Schedule 3

Schedule 2

Appendix H

KETOPROFEN

Schedule 4

Schedule 3

Appendix H

LEVONORGESTREL

Schedule 4

Schedule 3

Appendix H

NALOXONE

Schedule 4

Schedule 3

Appendix H

OXICONAZOLE

Schedule 4

Schedule 3

Schedule 2

Appendix H

PARACETAMOL

cross reference: ASPIRIN, IBUPROFEN, METOCLOPRAMIDE, SALICYLAMIDE, CAFFEINE

Schedule 4

Schedule 3

Schedule 2

Appendix F, Part 3

Appendix H

PODOPHYLLOTOXIN

cross reference: PODOPHYLLIN

Schedule 4

Schedule 3

Schedule 2

Appendix F, Part 3

Appendix H

PODOPHYLLUM EMODI (podophyllin)

cross reference: PODOPHYLLIN

Schedule 4

Schedule 3

Schedule 2

Appendix F, Part 3

Appendix H

PODOPHYLLUM PELTATUM (podophyllin)

cross reference: PODOPHYLLIN

Schedule 4

Schedule 3

Schedule 2

Appendix F, Part 3

Appendix H

SALICYLIC ACID

cross reference: CHOLINE SALICYLATE

Schedule 3

Appendix H

TIOCONAZOLE

Schedule 4

Schedule 3

Schedule 2

Appendix H

TRIAMCINOLONE

Schedule 4

Schedule 3

Schedule 2

Appendix F, Part 3, Part 2

Appendix H

Proposed implementation date:

1 February 2019

Reasons:
  • There is no potential for abuse, inappropriate use and/or diversion that may be exacerbated by advertising.
  • There are no potential interactions with the substances (drug-drug, drug-food) that require increased patient education to ensure safe use and therefore patient choice could be adversely influenced by advertising.
  • There are no additional risks associated with the dosage form that may impact on safe use that may be exacerbated by advertising.
  • There is no other information that may be relevant, for example the substance has sedating properties, or there are safer alternatives available and therefore patient choice could be adversely influenced by advertising.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:

  • The outcome of the Appendix H review;
  • Consideration of the submissions in response to the public consultation and feedback from stakeholder workshops;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (2018) stating that Schedule 3 substances will be include in Appendix H unless it is determined that advertising is not appropriate for a particular substance; and
  • 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.
Decision:

The delegate has also decided to refer the following substances to the ACMS for further advice:

  • Glyceryl trinitrate
  • Isosorbide dinitrate
Scheduling proposal and reasons for proposal

Advertisements to the public for therapeutic goods must not contain any reference to a substance included in Schedule 3 of the Poisons Standard[1], unless the substance is also listed in Appendix H of the Poisons Standard.[2]

Up until 2018, substances in Schedule 3 were not included in Appendix H, unless an adequate justification was presented as to the reasons for including the substance in Appendix H. Currently there are only 19 of 85 Schedule 3 substances included in Appendix H. As mentioned, the current Scheduling Policy Framework (2018) states that Schedule 3 substances will be included in Appendix H unless it is determined that advertising is not appropriate for a particular substance.

To facilitate the transition of substances to Appendix H, it was agreed that the current Schedule 3 substances would be considered via consultation, and specific rescheduling applications from individual stakeholders would not be required.

A consultation paper inviting comments on proposals to add a number of Schedule 3 substances to Appendix H of the Poisons Standard was published on the TGA website on 4 June 2018, and closed on 9 July 2018. This consultation was the culmination of input from stakeholders at targeted consultation activities held at the TGA in February and March of 2018, and led to the development of draft Guidelines for advertisements for medicines containing Schedule 3 Substances.


Footnotes

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