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Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Invitation to comment

30 August 2018

This consultation closed on 31 October 2018.

Invitation for public submissions

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary decides to refer a proposed amendment to the current Poisons Standard to an expert advisory committee pursuant to regulation 42ZCZJ of the Regulations.

Details of the proposed amendment which a delegate of the Secretary has referred to the Advisory Committee on Medicines Scheduling (ACMS)'s meeting in March 2019 (ACMS # 26) are set out below.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions to be made in relation to the proposed amendment on or before close of business on 31 October 2018 (first closing date). See the section below titled: How to make a submission.

1. Details of proposed amendment referred to ACMS #26

Paracetamol (modified release)

Paracetamol (modified release)

CAS Number:

103-90-2

Alternative names

N-(4-hydroxyphenyl)acetamide (IUPAC); 4'-hydroxyacetanilide; 4-acetamidophenol, N-acetyl-4-aminophenol; N-acetyl-p-aminophenol (APAP); acetaminophen

Applicant

This proposed amendment has been initiated by a delegate of the Secretary of the Department of Health.

Current scheduling

Paracetamol is listed in Schedules 2, 3 and 4 of the Poisons Standard as follows:

Schedule 4

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 30 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection.

Schedule 3

PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2.

Schedule 2

PARACETAMOL for therapeutic use:

  1. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
  2. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
  3. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  4. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
  5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  6. in other preparations except:
    1. when included in Schedule 3 or 4; or
    2. in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
      2. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      3. not labelled for the treatment of children 6 years of age or less, and
      4. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaifenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. packed in blister or strip packaging or in a container with a child-resistant closure,
      2. in a primary pack containing not more than 20 tablets or capsules,
      3. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      4. not labelled for the treatment of children 6 years of age or less, and
      5. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaifenesin.

It is also included under the entry PARACETAMOL in Appendix F with the following statements:

Appendix F, Part 3

PARACETAMOL

Warning Statements: 97 (Adults: Keep to the recommended dose. Don't take this medicine for longer than a few days at a time unless advised to by a doctor) AND/OR 98 (Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor), 99 (If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage), 100 (Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist).

Proposed scheduling

The delegate of the Secretary proposes to:

  • amend the terminology in the Poisons Standard from 'slow release' paracetamol to 'modified release 'paracetamol; and
  • up-schedule modified release tablets or capsules containing less than or equal to 665 mg of paracetamol from Schedule 2 to Schedule 3 of the current Poisons Standard, as follows:

    Schedule 4 - Proposed Amended Entry

    PARACETAMOL:

    1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
    2. when combined with ibuprofen in a primary pack containing more than 30 dosage units;
    3. in slow release modified release tablets or capsules containing more than 665 mg paracetamol;
    4. in non-slow modified release tablets or capsules containing more than 500 mg paracetamol;
    5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
    6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
    7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
    8. for injection.

    Schedule 3 - Proposed Amended Entry

    PARACETAMOL:

    1. when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or
    2. in modified release tablets or capsules containing less than or equal to 665 mg of paracetamol.
Key uses / expected use

Modified Release paracetamol is approved for the following indications:

  • Effective relief from persistent pain for up to 8 hours.
  • Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache.
  • Provides effective temporary relief of pain and discomfort associated with: headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures.
  • Reduces fever.
Reasons for proposal
  • The current term 'slow release' in the Poisons Standard does not correctly describe the pharmacological action of this formulation of paracetamol and 'modified release' is the correct terminology and is used in all the product information.
  • The TGA has conducted a review of the safety of modified release (MR) paracetamol in Australia, and sought the advice of the Advisory Committee on Medicines, following a decision by the European Medicines Agency (EMA) to suspend marketing of MR paracetamol products in the European Union (EU). The EMA's decision was based on an increased risk of death or serious liver injury in people who overdose either deliberately or accidentally on MR paracetamol compared to IR paracetamol. The increased risk arose because of the unpredictable levels and duration of paracetamol in the blood following an overdose with MR paracetamol.
  • The antidote used to treat paracetamol overdose is short-acting but MR paracetamol products may continue to increase blood levels of paracetamol after the effects of the antidote have worn off. In many cases doctors treating an overdose are not aware which formulation of paracetamol has been taken. The higher strength of MR paracetamol and the large pack size increase the risks. An Australian study has confirmed that MR paracetamol is less safe when involved in an overdose.
  • Modified release (MR) paracetamol appears to provide little benefit over standard immediate release (IR) paracetamol other than less frequent dosing.
  • The complex and unpredictable pharmacokinetic profile of MR paracetamol following an overdose means that the continued availability of MR paracetamol in pack sizes of 96 caplets as a Schedule 2 medicine poses an unacceptable to risk to the Australian population.
  • International regulators including the European Medicines Agency and New Zealand's Medsafe have taken action on this issue with the EMA suspending the sale of MR paracetamol in EU member countries altogether.
  • Up-scheduling MR paracetamol to Schedule 3 will provide an opportunity for pharmacists to counsel patients on the importance of not exceeding a dose of 6 tablets per day, whilst still preserving OTC access to these products.

NOTE

This proposal would still allow modified release paracetamol products to be available in a pharmacy, however would require pharmacist involvement.

No other paracetamol products are proposed to be rescheduled. See also (Q&A page)

How to make a submission

The expert advisory committee must consider all public submissions received by the first closing date which:

  • are relevant to the proposed amendment; and
  • address a matter mentioned in section 52E of the Therapeutic Goods Act 1989 (Act).

Accordingly, to ensure that your submission is considered, your submission should:

  • be relevant to the proposed amendment (and/or address a matter mentioned in section 52E of the Act); and
  • be sent by the first closing date to for substances referred to the ACMS or Joint ACMS-ACCS, or for substances referred to the ACCS. (Please include 'Proposed Amendments to the Poisons Standard (Medicines/Chemicals)' in the subject line of the email);

Ideally, your submission should:

  • be accompanied by a completed TGA Consultation submission coversheet;
  • be no more than 3 pages;
  • include any suggested improvements to the proposed amendment; and/or
  • include 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.

Publication of submissions received on or before the first closing date

Pursuant to regulation 42ZCZL(3) and (4), the Secretary will publish all public submissions received on or before the first closing date on the TGA's webpage titled: Public submissions on scheduling matters.

The Secretary will not, however, publish any information that the Secretary considers to be confidential information.

Accordingly, in order to assist the Secretary to make this assessment, please:

  • complete a TGA Consultation submission coversheet
  • highlight any text within the body of your submission that you want to remain confidential in grey and mark as 'IN CONFIDENCE'.

Further information about how TGA considers information which might be personal or sensitive in nature is set out below in the section titled Privacy and your personal information.

What will happen next

After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment. The Secretary will then, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.

Interim decisions will be published on the TGA website: Scheduling delegate's interim decisions & invitations for further comment

Privacy and your personal information

The Therapeutic Goods Administration (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, when making your submission, you consent to the publication of this information. If at any point in time, you change your mind and wish for your personal information to be redacted then please contact the Scheduling Secretariat at so that the public submissions can be updated accordingly.

The TGA will not publish information it considers confidential, including yours/other individuals' personal information (unless you/they have consented to publication or it is required by law) or commercially sensitive information. Also, the TGA will not publish information that could be considered advertising or marketing (e.g. logos or slogans associated with products), information about any alleged unlawful activity or that may be defamatory or offensive.

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.

For general privacy information, please go to the TGA's webpage on Privacy. The TGA is part of the Department of Health and the link includes a link to the Department's privacy policy and contact information if you have a query or concerns about a privacy matter.

Enquiries

Any questions relating to submissions should be directed by email to (for substances referred to the ACMS or Joint ACCS-ACMS) or (for substances referred to the ACCS).