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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2016
Scheduling medicines and poisons
Part A - Interim decisions on scheduling proposals referred to an advisory committee (March 2016)
3. Advisory Committee on Medicines Scheduling (ACMS#17)
Referred 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 applicant's reasons for the request were:
- 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.
Specific issues/questions raised by the delegate
The delegate asked the committee the following questions:
- Is a dosage unit of 200 mg ketoprofen appropriate for Schedule 3?
- If so, how many units should be allowed to be in a pack for Schedule 3?
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).
KETOPROFEN is currently listed in Schedules 3 and 4.
KETOPROFEN in divided preparations for oral use containing 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units.
- in preparations for dermal use; or
- when included in Schedule 3.
Relevant scheduling history
Ketoprofen has been available in Australia since 1981 in orally administered dose forms.
In 1999, the Committee decided to harmonise with New Zealand in regard to oral ketoprofen preparations, 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.
Public pre-meeting 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).
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 recommendations comprised the following:
- 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
The delegate considered the following in regards to this proposal:
- Scheduling proposal;
- Public submissions received;
- ACMS advice;
- Section 52E of the Therapeutic Goods Act 1989;
- Scheduling factors19;
- Other relevant information.
Delegate's interim decision
The delegate has considered and agrees with the advice and reasons of the ACMS, that the current scheduling of ketoprofen remains appropriate.
The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (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; (d) the dosage, formulation, labelling, packaging and presentation of a substance.