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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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1.8. Flurbiprofen

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

1.8. Interim decision in relation to flurbiprofen

Note

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Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment to broaden the availability of flurbiprofen, made an interim decision to amend the current Poisons Standard as follows:

Schedule 4 - Amend Entry

FLURBIPROFEN except when included in or expressly excluded from Schedule 2.

Schedule 2 - Amend Entry

FLURBIPROFEN in preparations for topical oral use when:

  1. in divided preparations containing 10 mg or less of flurbiprofen per dosage unit except when:
    1. for the treatment of adults and children over 12 years of age; and
    2. in a primary pack containing not more than 16 dosage units.
  2. in undivided preparations containing 0.25 percent or less or 10 mg or less per dose of flurbiprofen.

Index

FLURBIPROFEN

Schedule 4
Schedule 2

Proposed date of effect of the proposed amendment

1 October 2020

Reasons for the interim decision (including findings on material questions of fact)

In making this interim decision, the Delegate considered the following material:

Summary of ACMS advice/recommendations to the Delegate

The Committee recommended that amendments to the current Schedule 4 and Schedule 2 entries for flurbiprofen in the Poisons Standard as follows:

Schedule 4 - Amend Entry

FLURBIPROFEN except when included in or expressly excluded from Schedule 2.

Schedule 2 - Amend Entry

FLURBIPROFEN in preparations for topical oral use when:

  1. in divided preparations containing 10 mg or less of flurbiprofen per dosage unit except when:
    1. for the treatment of adults and children over 12 years of age; and
    2. in a primary pack containing not more than 16 dosage units.
  2. in undivided preparations containing 0.25 percent or less or 10 mg or less per dose of flurbiprofen.

Index

FLURBIPROFEN

Schedule 4
Schedule 2

The Committee also recommended an implementation date of 1 October 2020.

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; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the advice included:

  1. the risks and benefits of the use of a substance
    • The Schedule 2 exemption for flurbiprofen meets the Scheduling Handbook's criteria for 'reasonable safety' criteria.
    • Benefits:
      • Equivalent or better risk/benefit profile than systemic oral analgesics/anti-inflammatories which may be used for the same purpose.
      • Clinically meaningful pain relief provided by flurbiprofen lozenges
      • Flurbiprofen demonstrated superiority over demulcent only lozenges (non-medicated) for self-medication of sore throat.
    • Risks:
      • Is classified a Category B2 medication for pregnancy.
      • Risk of idiosyncratic reaction is very rare.
      • Should not be used by children < 12 years.
      • Same risk profile as all NSAIDs (but systemic exposure much less):
        • Risk in those with asthma, allergies to NSAIDs or aspirin.
        • Risk in those with heart failure, kidney disease, liver disease, peptic ulcer.
        • Interaction with certain medications (anti-hypertensives, methotrexate, anticoagulants).
      • Risk of concomitant use of oral NSAIDs.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • Indication is for the relief of pain, swelling and inflammation of a severe sore throat.
  3. the toxicity of a substance
    • The toxicity of flurbiprofen is considered very low: there is very low buccal systemic absorption, 10% of approved oral dose of same medication.
  4. the dosage, formulation, labelling, packaging and presentation of a substance
    • Lozenge formulation.
    • 8.75mg lozenges in a blister pack of 16.
    • Risk warnings on the packaging.
  5. the potential for abuse of a substance
    • NIL
  6. any other matters that the Secretary considers necessary to protect public health
    • NIL

Reasons for interim decision

I have made an interim decision to amend the Schedule 2 and Schedule 4 entries for flurbiprofen in the Poison Standard. The reasons for my decision are set out below.

In my opinion, the net benefits of broadening the availability of flurbiprofen to the general sale level with restrictions placed on age and dosage form combined with warning labels outweighs the potential risks associated with improper use.

In coming to this decision, I considered that flurbiprofen lozenges have the potential to improve the self-management of sore throats. I also took into account that pain relief associated with flurbiprofen use has been confirmed in a number of randomised controlled clinical trials in the literature, which demonstrate meaningful pain relief and better pain control than demulcents. I am satisfied that the risks associated with the potent Nonsteroidal anti-inflammatory drugs (NSAID) activity of flurbiprofen can be mitigated by its preparation as a lozenge, which has very low buccal systemic absorption. I accept the evidence that the low bioavailability of the lozenge preparation will minimise the known drug interactions and contraindications.

It is my view that the abuse potential of flurbiprofen lozenges is small based on my assessment of the accounts of misuse, intentional misuse and intentional overdose in the Worldwide Reckitt Benckiser Periodic Safety Update Report (PSUR) data and in the data presented in a public submission from the NSW Poisons Information Centre. On the balance of evidence, I am satisfied that there is a net benefit to public health in greater access to flurbiprofen at the general sales level.

I have decided to include a pack size limit of sixteen dosage units. My assessment is that this pack size limit amounts to two days' supply if the maximum of eight tablets per day is consumed. I understand this pack size to be in line with the Therapeutic Guidelines for Management of Acute Pharyngitis/Tonsillitis in Australia. I note that similar products available at the general sales levels currently have larger pack size limits in place e.g. unscheduled oral ibuprofen is available in twenty-four units (four days) and paracetamol in twenty units (two and a half days).

I made a decision to include specific warning label against the use of flurbiprofen in children less than twelve years of age to mitigate the risk of inappropriate use. My decision to include a mandatory warning label is consistent with the request from the public submissions from the NSW Poisons Information Centre and Australian Medical Association.

Taking into account the restrictions on age and dosage form described above, I am satisfied that flurbiprofen lozenges are able to be supplied at the general sales level, with reasonable safety, without any access to health professional advice. It is my view that the criteria for 'reasonable safety' as set out in the Scheduling Handbook are satisfied.

I have made a decision to not allow the supply of flurbiprofen throat sprays at the general sales level. I have not identified compelling data to establish this preparation could be supplied at the general sales level with reasonable safety.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are 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; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

Implementation date

I have decided the appropriate implementation date is 1 October 2020.

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