You are here

Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, February 2016

Scheduling medicines and poisons

3 February 2016

Book pagination

2.2 Naproxen

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

2. Scheduling proposals referred to the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS#16)

2.2 Naproxen

Scheduling proposal

The medicines scheduling delegate has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):

  • Include Naproxen in Appendix H.
Substance summary

The applicant has provided the following information regarding Naproxen:

Naproxen, a propionic acid derivative, is a non-steroidal anti-inflammatory drug (NSAID). Naproxen is used in musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis including juvenile idiopathic arthritis. It is also used in dysmenorrhoea, headache including migraine, postoperative pain, soft-tissue disorders, acute gout, and to reduce fever. Naproxen is usually given orally as the free acid or as the sodium salt (550 mg of naproxen sodium is equivalent to about 500 mg of naproxen).

Scheduling status

NAPROXEN is currently listed in Schedules 2, 3 and 4, and in Appendix F.

Schedule 2

NAPROXEN in divided preparations containing 250 mg or less of naproxen per dosage unit in packs of 30 or less dosage units.

Schedule 3

NAPROXEN in a modified release dosage form of 600 mg of naproxen or less per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.

Schedule 4

NAPROXEN except when included in Schedule 3 or in Schedule 2.

Scheduling history
Advisory Committee on Medicines Scheduling (ACMS): March 2014

Delegate decision: July 2014

The ACMS considered a proposal to include naproxen in Schedule 2 in a modified release (extended release) dosage form containing 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units, when labelled not for treatment of children under 12 years of age. The ACMS recommended, and the delegate confirmed, that those modified release naproxen preparations should be included in Schedule 3. The ACMS also recommended that the SUSMP Appendix F warnings current at that time for naproxen should apply to the new Schedule 3 dosage form for naproxen. The implementation date for the delegate’s decision was 1 October 2014.

Advisory Committee on Medicines Scheduling (ACMS): November 2014

Delegate decision: March 2015

The ACMS considered a proposal to include naproxen (when in Schedule 3) in Appendix H. The ACMS recommended, and the delegate confirmed, that the current scheduling of naproxen remained appropriate. Reasons for the delegate's March 2015 decision included that: Schedule 2 naproxen products can be advertised to consumers and there does not appear to be any additional benefit in advertising modified release naproxen; concern that advertising Schedule 3 products might encourage consumers to request the modified release product when conventional lower dose product might be more appropriate; and that modified release naproxen had only recently been included in Schedule 3, and there were no Schedule 3 naproxen products on the ARTG and consequently no experience with their marketing/use in Australia.

Pre-meeting public submissions

Four public submissions were received.

The main points of the supporting decisions were:

  • Schedule 2 naproxen has been available for 20 years, during which related products have been advertised. This has not lead to inappropriate use or misuse by consumers.
  • As the Schedule 3 entry is for a once per day dosage form, the public would benefit from knowing that there is a pain relief option with an easy to follow dosage regimen.
  • There is a lower daily dose of naproxen with the Schedule 3 product.
  • The availability of a pharmacist at point of sale means consumers will be made aware verbally, in addition to product labelling, of the single dose of the product.
  • The advice from the pharmacist, together with appropriate warning statements on labelling and the availability of the CMI will help ensure that consumers have the information they need to manage the use of this product for the short term relief of pain.
  • Schedule 3 pack size limit provides for continuous therapy for over two weeks. This supports the need for intervention by pharmacists to ensure modified-release naproxen can be used safely and optimally.
  • Diclofenac, another non-steroidal anti-inflammatory medicine which has similar pharmacological properties and risk profile, has been listed on Appendix H since August 2001.

The main point of the opposing submission was:

  • No new data is available in the published literature to revert the prior decision. The reasons for the prior rejections in relation to naproxen remain relevant and should be given due consideration in any decisions relating to the current application.
ACMS advice to the delegate

The ACMS recommended that naproxen should be listed in Appendix H.

The committee recommended an implementation date of 1 June 2016.

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; 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.

The reasons for the recommendation comprised the following:

  • There is a public health benefit to advertising and there will not be inappropriate use.
  • The recommendation is consistent with diclofenac’s Appendix H inclusion.
Delegate's considerations

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 factors17;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is to include Naproxen in Appendix H.

The proposed implementation date is 1 June 2016.

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; and c) the toxicity of the substance.

The reasons for the recommendation comprised the following:

  • Public health benefit to advertising and that there will not be inappropriate use.
  • Public health benefit to advertising and that there will not be inappropriate use.
  • Public health benefit to advertising and that there will not be inappropriate use.
Schedule entry
Appendix H - New entry

Footnotes

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

Book pagination