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Interim decisions and invitation for further comment on substances referred to the March 2019 ACMS/ACCS meetings

Scheduling of chemicals and poisons

6 June 2019

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1.5. Interim decision in relation to paracetamol (modified release)

1 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #26, March 2019)

1.5. Interim decision in relation to paracetamol (modified release)

Interim decision:

For the reasons set out below, a delegate of the Secretary has, in relation to the proposed amendment, made an interim decision under regulation 42ZCZN to amend the current Poisons Standard in relation to paracetamol (modified release) 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 release 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 665 mg or less paracetamol.

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 caffeine, 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 caffeine, 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 caffeine, 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 caffeine, phenylephrine and/or guaifenesin.

Appendix F, Part 3

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.)

Appendix H

PARACETAMOL

Index

PARACETAMOL

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

Schedule 4

Schedule 3

Schedule 2

Appendix F, Part 3

Appendix H

Proposed date of effect of the proposed amendment: 1 October 2019
Reasons for the interim decision (including findings on material questions of fact):

I agree with the committee's finding that the relevant matters of section 52E of the Therapeutic Goods Act 1989 included (a) 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; (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.

In my view, the relevant parts of the SPF, 2018 are the Scheduling Factors for Schedules 4, 3 and 2.

Reasons for interim decision:

I have made the decision to up-schedule paracetamol in modified release (MR) tablets or capsules containing 665 mg or less of paracetamol to Schedule 3. This will enable MR paracetamol-containing products to be available to the public from a pharmacist, without a prescription, for the reasons set out below.

In making my decision, I have taken into account the arguments made in the public submissions in opposition of the proposed up-scheduling of MR paracetamol including that, but not limited to;

  • Australian overdose rates appear to be lower than those overseas;
  • there will be disadvantage to those who use MR paracetamol at the moment for the management of osteoarthritis; and
  • up-scheduling could divert people to opioids or other medicines.

Among other things I find that the complex and unpredictable pharmacokinetic profile of MR paracetamol following an overdose poses an unacceptable risk to the Australian population and that my concerns regarding the potential for abuse outweigh the arguments to retain the Schedule 2 entry.

I consider that MR paracetamol is substantially safe with pharmacist advice available to ensure quality use under a Schedule 3 classification. My view is that there is the potential for harm if it is used inappropriately, and on balance, I find that up-scheduling MR paracetamol products to Schedule 3 would allow for additional pharmacist oversight while retaining public access.

In making my decision I considered that the Scheduling Factor 2 for inclusion in Schedule 2 states that, 'The use of the medicine is substantially safe for short term treatment and the potential for harm from inappropriate use is low.' I considered the compelling body of evidence, including data from the European Medicines Agency, that there is an increased risk of death or serious liver injury in people who overdose either deliberately or accidentally on MR paracetamol compared to immediate release paracetamol. In my deliberations I have given substantial weight to the evidence that the increased risk associated with MR paracetamol use, is linked to unpredictable levels and duration of paracetamol in the blood following an overdose with MR paracetamol. I have considered the view that treatment protocols in Australia may be more effective than the EU from which these data are based. Nonetheless I consider that there is insufficient evidence to show that treatment protocols sufficiently mitigate the risks associated with MR paracetamol use in Australia. In making my decision I have had regard for the higher strength of MR, unpredictable pharmacokinetics, potential pharmacobezoar[1] and that large pack size increase the risks associated with overdose with MR paracetamol. I have decided that there is reasonable evidence that the potential for harm from inappropriate use of MR Paracetamol is not low and that the Scheduling Factors for Schedule 2 are not met.

Having considered the evidence for harm, my view is that greater direct involvement of pharmacists in the sale of MR paracetamol if it were included in Schedule 3 may prevent unintentional overdose through consumer education. Up-scheduling is likely to reduce the risk of either inadvertent overdose (through consumers not understanding that the products are intended for a specific chronic condition, have a lower limit of number of tablets per day and do not exert their full effect as soon after dosing as immediate release paracetamol) and the more common deliberate overdose due to greater oversight of sales. Pharmacists would be able to exert some control over purchase for suspected problematic or inappropriate use.

I have made a decision that a pack size constraint is not required to support the proposed Schedule 3 entry. At the time of making my decision I considered that the increased involvement of pharmacists in sales may be effective in educating consumers and in providing a barrier to access for intentional self-harm.

I have considered the evidence that 'modified release' is the current correct pharmacokinetic term used in the Product Information for these products, and I find that the use of 'slow release' in the current Poisons Standard does not correctly describe the pharmacological action of this formulation of paracetamol. For the reasons referred to above, I have decided that the 'slow release' descriptor should be replaced with 'modified release' as proposed.

I also concur with the committee's reasons under each matter relating to section 52E.


Footnotes

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