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Consultation: Proposed amendments to the Poisons Standard - ACMS and Joint ACCS/ACMS meetings, November 2019

Invitation to comment

19 September 2019

This consultation closed on 17 October 2019.

Scheduling amendments referred to expert advisory committee

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on scheduling proposals referred to the November 2019 meetings of the Advisory Committee on Medicines Scheduling (ACMS #28) and the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #23).

Submissions must be received by close of business 17 October 2019. See How to respond.

1. Proposed amendments referred for scheduling advice to ACMS #28

1.1 Mometasone

CAS Number

105102-22-5

Alternative names

IUPAC: (1R,2R,3aS,3bS,9aS,9bR,10S,11aS)-9b-chloro-1-(2-chloroacetyl)-1,10-dihydroxy-2,9a,11a-trimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one

Applicant

Private Applicant

Current scheduling

Mometasone is currently in Schedules 2 and 4 of the Poisons Standard as follows:

Schedule 4

MOMETASONE except when included in Schedule 2.

Schedule 2

MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.

Index

MOMETASONE

Schedule 4
Schedule 2

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Schedule 4 - Amend Entry

MOMETASONE except when included in Schedule 2 or 3.

Schedule 3 - New Entry

MOMETASONE as the only therapeutically active substance in preparations for dermal use containing 0.1 percent or less of MOMETASONE in packs containing 15g or less except when included in Schedule 2.

Schedule 2 - Amend entry

MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the and when packed in a primary pack containing 200 actuations or less, for the short term prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years and over.

APPENDIX M - New Entry

MOMETASONE

The medicine (mometasone) should only be supplied if the patient has had a formal diagnosis by a medical practitioner (or periodic review of the condition) within the last 6 months and specifically recommended mometasone. This is to be determined by a patient questionnaire.

Specific pharmacist training on the provision of this medicine is required.

Index - Amend Entry

MOMETASONE

Schedule 4
Schedule 3
Schedule 2
Appendix M

Consideration of whether a new Appendix H entry for mometasone is appropriate, should Schedule 3 be considered appropriate, as the Scheduling Policy Framework provides that Schedule 3 medicines will be included in Appendix H unless determined that there are reasons for not permitting the advertising of a particular substance. The proposed Appendix H entry is as follows:

APPENDIX H - New Entry

MOMETASONE

1.2. Zolmitriptan

CAS Number

139264-17-8

Alternative names

(S)-4-[[3- [2-(dimethylamino)ethyl] -1H-indol-5-yl]methyl] -2-Oxazolidinone

Applicant

Private Applicant

Current scheduling

Zolimtriptan is currently in Schedule 4 of the Poisons Standard as follows:

Schedule 4

ZOLMITRIPTAN

Index

ZOLMITRIPTAN

Schedule 4

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Schedule 4 - Amend Entry

ZOLMITRIPTAN except when included in Schedule 3.

Schedule 3 - New Entry

ZOLMITRIPTAN for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when in tablets containing 2.5 milligrams or less per tablet and when sold in a pack containing not more than 2 tablets.

Appendix H - New Entry

ZOLMITRIPTAN

Appendix M - New Entry

ZOLMITRIPTAN - to be dispensed by a registered pharmacist who has assessed a patient's symptoms to be consistent with an acute, episodic migraine attack; and that assessment and supply is consistent with expected professional standards of practice and specifically related clinical support tools and resources; and that a history of migraine or acute migraine treatment has ideally been verified e.g. via the patient's My Health Record, or through previous prescribing/dispensing.

The pharmacist will record the supply of this medicine in their dispensary software, and include the patient's name, address, date of birth and gender. The pharmacist will label product with patient's name and directions for use and date of supply. The pharmacist will upload a record of supply to the patient's My Health Record.

Index - Amend Entry

ZOLMITRIPTAN

Schedule 4
Schedule 3
Appendix H
Appendix M

Key uses/expected use

Medicines

Reasons for proposal

  • Down-scheduling will provide safe and timely access to zolmitriptan for people suffering acute, episodic migraine.

1.3. Sumatriptan

CAS Number

Sumatriptan: 103628-46-2

Sumatriptan succinate: 103628-48-4

Alternative names

3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methane sulphonamide; 1-{3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide

Applicant

Private Applicant

Current scheduling

Sumatriptan is currently in Schedule 4 of the Poisons Standard as follows:

Schedule 4

SUMATRIPTAN

Index

SUMATRIPTAN

Schedule 4

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Schedule 4 - Amend Entry

SUMATRIPTAN except when included in Schedule 3.

Schedule 3 - New Entry

SUMATRIPTAN for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms when in tablets containing 50 milligrams or less per tablet and when sold in a pack containing not more than 2 tablets.

Appendix H - New Entry

SUMATRIPTAN

Appendix M - New Entry

SUMATRIPTAN - to be dispensed by a registered pharmacist who has assessed a patient's symptoms to be consistent with an acute, episodic migraine attack; and that assessment and supply is consistent with expected professional standards of practice and specifically related clinical support tools and resources; and that a history of migraine or acute migraine treatment has ideally been verified e.g. via the patient's My Health Record, or through previous prescribing/dispensing.

The pharmacist will record the supply of this medicine in their dispensary software, and include the patient's name, address, date of birth and gender. The pharmacist will label product with patient's name and directions for use and date of supply. The pharmacist will upload a record of supply to the patient's My Health Record.

Index - Amend Entry

SUMATRIPTAN

Schedule 4
Schedule 3
Appendix H
Appendix M

Key uses/expected use

Medicines

Reasons for proposal

  • Down-scheduling will provide safe and timely access to sumatriptan for people suffering acute, episodic migraine.

2. Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #23

2.1. Caffeine

CAS Number

58-08-2 (anhydrous)

Alternative names

1,3,7-Trimethylpurine-2,6(3H,1H)-dione; 1,3,7-Trimethylxanthine; 7-Methyltheophylline

Applicant

The Commonwealth Department of Health

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Schedule 6 - New Entry

CAFFEINE (CAS No. 58-08-2) except:

  1. when included in Schedule 4; or
  2. in divided preparations for internal human therapeutic use when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
  3. in undivided preparations for internal human therapeutic use with a concentration of 4 per cent or less of total caffeine and when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
  4. in preparations for external use; or
  5. in other preparations with a concentration of 4 percent or less of caffeine.

Schedule 4 - New Entry

CAFFEINE (CAS No. 58-08-2) for internal human therapeutic use except:

  1. in divided preparations when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine; or
  2. in undivided preparations with a concentration of 4 per cent or less of caffeine and when labelled with a maximum recommended daily dose of no greater than 600 milligrams of total caffeine.

Key uses/expected use

Medicines, veterinary, food and cosmetic.

Reasons for proposal

  • The dietary ingestion of caffeine has led to it being the most widely consumed psychoactive compound worldwide (Cappelletti et al., 2018).[1] Caffeine powder is readily available for sale and consumption on the Australian market via the internet and numerous pure or highly concentrated (>98%) caffeine powders have been advertised for sale online either on Australian websites or international websites that are available to the Australian public.
  • A recent fatality associated with inadvertent caffeine overdose suggests the current availability of pure or highly-concentrated caffeine powder presents a risk of poisoning.
  • Appropriate labelling and control of all concentrated caffeine products would reduce the risk of inadvertent overdose.
  • The toxicity of orally administered caffeine in rats is within the AHMAC Scheduling policy framework for Schedule 6. Potentially fatal doses (reported at 5 g) are easily exceeded with the availability of pure or highly-concentrated caffeine products and intentional ingestion of such products will be reduced if labelled as a POISON.
  • The Australian Regulatory Guidelines for OTC Medicines (ARGOM)and the Therapeutic Goods (Permissible Ingredients) Determination specify appropriate restrictions for internal caffeine within the low risk framework of listed medicines and OTC medicines. Internal human therapeutic use outside of these restrictions should be considered for prescription-only scheduling.
  • It should be noted that this proposal is not intended to schedule caffeine that occurs naturally in foods (such as coffee, tea and cocoa) or items that are covered by a Food Standard Code.

Footnotes


How to respond

Submissions must:

Submissions might also include:

  • suggested improvements; and/or
  • an assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

What will happen

All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments will be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment on 6 February 2020.

Privacy and your personal information

  • The TGA collects your personal information in this submission in order to:
    • Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • Help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the coversheet, see How to respond above).
  • Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE' and highlighted in grey.
  • Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to medicines.scheduling@health.gov.au or chemicals.scheduling@health.gov.au.