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Scheduling delegate's final decisions, June 2016

Scheduling of medicines and poisons

23 June 2016

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2.2 Ketoprofen

Part A - Final decisions on matters referred to an expert advisory committee

2. Scheduling proposals referred to the March 2016 meeting of the Advisory Committee on Medicines Scheduling (ACMS#17)

2.2 Ketoprofen

Delegate's scheduling proposal

Proposal to amend the scheduling of ketoprofen to include divided preparations for oral use containing 200 mg or less of ketoprofen per dosage unit in Schedule 3.

Applicant's application and scheduling proposal

To amend the scheduling of ketoprofen to include divided preparations for oral use containing 200 mg or less of ketoprofen per dosage unit in Schedule 3.

The reasons for the request are:

  • The doses that are able to alleviate or cure tenosynovitis are larger than those currently available through Schedule 3; and
  • Ketoprofen is able to be ordered through UK, USA or Spanish websites at 50 mg or 100 mg of ketoprofen per dosage unit.
Substance summary

Ketoprofen, a propionic acid derivative, is non-steroidal anti-inflammatory drug (NSAID) and has been marketed for the treatment of rheumatoid arthritis and osteoarthritis in various forms (standard release capsules, sustained release capsules, suppositories and topical gels).

Current scheduling status

KETOPROFEN is currently listed in Schedules 3 and 4.

Scheduling history

Ketoprofen has been available in Australia since 1981 in orally administered dose forms.

In 1999, the National Drugs and Poisons Schedule Committee decided to harmonise with New Zealand in regard to oral and dermal preparations of ketoprofen - creating the Schedule 3 entry for 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units.

Pre-meeting public submissions

Two submissions were received. Both submissions opposed the proposal due to increased risks of gastrointestinal and cardiovascular adverse effects compared to other NSAIDs available over the counter (i.e. ibuprofen, diclofenac and naproxen).

The public submissions are available at Public submissions on scheduling matters.

Summary of ACMS advice to the delegate

The Committee advised that the current scheduling of ketoprofen remains appropriate.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: 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; and d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the advice comprised the following:

  • Risks include increased gastrointestinal and cardiovascular adverse effects compared to other NSAIDs available over the counter (i.e. ibuprofen, diclofenac and naproxen).
  • Ketoprofen is not recommended for use while breastfeeding and there is increased risk of adverse effects in the elderly.
  • Ketoprofen is registered for use in the treatment of rheumatoid arthritis and osteoarthritis.
  • Common toxicity issues related to the substance include: nausea, dyspepsia, GI ulceration/bleeding, raised liver enzymes, diarrhoea, headache, dizziness, salt retention and hypertension.
  • The substance is available in 200 mg controlled release oral capsules and 100 mg suppositories.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors19;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is that the current scheduling of ketoprofen remains appropriate.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; and d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the decision comprised the following:

  • Risks include increased gastrointestinal and cardiovascular adverse effects compared to other NSAIDs available over the counter (i.e. ibuprofen, diclofenac and naproxen).
  • Ketoprofen is not recommended for use while breastfeeding and there is increased risk of adverse effects in the elderly.
  • Ketoprofen is registered for use in the treatment of rheumatoid arthritis and osteoarthritis.
  • Common toxicity issues related to the substance include: nausea, dyspepsia, GI ulceration/bleeding, raised liver enzymes, diarrhoea, headache, dizziness, salt retention and hypertension.
  • The substance is available in 200 mg controlled release oral capsules and 100 mg suppositories.
Public submissions on the interim decision

No submissions were received.

Delegate's final decision

The delegate has confirmed the interim decision as no evidence has been received to alter the interim decision. The delegate has confirmed that the final decision and reasons are in keeping with those for the interim decision.


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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