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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 Schedule 2 naproxen entry to exclude naproxen (i.e. make it available for sale outside pharmacy) when containing 200 mg or less of naproxen per dosage unit in packs of 12 or less dosage units when not labelled for the treatment of children under 12 years of age.
The applicant's reasons for the request were:
- The proposal to amend the current Schedule 2 naproxen entry to exclude naproxen 200 mg solid oral dosage forms in a limited few days' supply. This would be packaged and labelled with restrictions and conditions that are consistent, if not more conservative, than the current unscheduled OTC ibuprofen preparations.
- Local and global post-marketing experiences, overseas regulatory status in comparable markets (such as Canada and the USA), as well as various published safety data, help support the approval for an open-sale supply of naproxen in Australia. This indicates no greater health risk to the public than the current S2 scheduling for naproxen and/or the scheduling exemption for ibuprofen, when compared with the proposed amendment.
- The open-sale of naproxen would provide consumers with a wider access to, and added option for, self-medicate for mild to moderate conditions including body aches, muscle and period pain.
Specific questions raised by the delegate
The delegate asked the committee the following questions:
- Is it appropriate for naproxen 200 mg dosage units to be unscheduled?
- If so what is an appropriate pack size?
Naproxen is an arylpropionic acid derivative related to the arylacetic acid class of medicines. It has analgesic, anti-inflammatory and antipyretic properties. It is unrelated to salicylates and the corticosteroid hormones. Naproxen therapeutic indications include treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis; symptomatic treatment of primary dysmenorrhoea and relief of acute and/or chronic pain states in which there is an inflammatory component as well as an analgesic in acute migraine attack.
Naproxen is a non-selective non-steroidal anti-inflammatory drug (NSAID) inhibiting both COX-1 and COX-2 and it exhibits a pharmacologic profile similar to other compounds in the NSAID class, such as ibuprofen. Naproxen has been widely used as a prescription and OTC medicine for many years, and its safety profile has been well-characterised.
NAPROXEN is currently listed in Schedules 2, 3 and 4, and in Appendix F. The delegate in March 2016 decided that from 1 June 2016, naproxen will also be in Schedule H.
NAPROXEN in divided preparations containing 250 mg or less of naproxen per dosage unit in packs of 30 or less dosage units.
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.
NAPROXEN except when included in Schedule 3 or in Schedule 2.
101: Don't use [this product/name of the product]:
If you have a stomach ulcer.
In the last 3 months of pregnancy. [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea.]
f you are allergic to (name of substance) or anti-inflammatory medicines.
104: Unless a doctor has told you to, don't use [this product/name of the product]:
For more than a few days at a time.
With other medicines containing (name of substance) or other anti-inflammatory medicines.
If you have asthma.
If you are pregnant. [This statement may be omitted in preparations used exclusively for the treatment of dysmenorrhoea.]
Relevant scheduling history
A detailed history of scheduling of naproxen can be found on the TGA website.
Naproxen was first included in Schedule 4 of the Poisons Standard in June 1982.
In February 1983, the Poisons Scheduling Committee agreed to reschedule naproxen from Schedule 4 to Schedule 3 when supplied in packs of 12 tablets for the treatment of the symptoms of dysmenorrhea.
In August 1989, a new Schedule 2 entry for naproxen was supported by the Scheduling Committee when labelled for the treatment of spasmodic dysmenorrhoea in packs of 12 or less on the grounds that it did not present an apparent public health hazard.
In November 1998, the NDPSC amended the Schedule 2 entry for naproxen to allow preparations containing 250 mg or less per dosage unit in packs of 20 or less dosage units.
In November 1999, the NDPSC rescheduled the Schedule 3 entry to Schedule 2 on the basis that the safety data was similar to that of other NSAIDs already listed in Schedule 2. An Appendix F warning was linked to the Schedule 2 entry.
In August 2001, the committee considered a proposal to exempt naproxen when in 250 mg or less per dosage unit, in packs of 24 or less dosage units, for the short-term analgesic therapy of dysmenorrhoea. The committee decided that the Schedule 2 entry remained appropriate given concerns around lack of evidence regarding safety and the need to access advice and counselling.
In May 2005 warning statements 101 and 104 were included in Appendix F.
In March 2014 (delegate decision July 2014), the ACMS considered a proposal to include naproxen in Schedule 2 in a new 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 advised, and the delegate decided, that those modified release naproxen preparations should be included in Schedule 3. The ACMS also advised that the existing Appendix F warnings for naproxen should apply to the new Schedule 3 dosage form for naproxen. This was implemented on 1 October 2014.
In November 2014, the ACMS rejected a proposal to include naproxen (when in Schedule 3, which covers only modified release naproxen) in Appendix H, citing 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.
In November 2015, the ACMS advised, and the delegate agreed, to include naproxen in Appendix H. The implementation date is 1 June 2016.
Public pre-meeting submissions
Three submissions were received. Of these, one submission supported the proposal. Main points:
- Comparable products (ibuprofen, paracetamol and aspirin) are exempt from scheduling when in small packs and has a well-established safety profile.
- Consumer would benefit.
The other two submissions opposed the proposal. Main points:
- ACMS considered a similar proposal in November 2014 (to include naproxen in Appendix H) and concluded the current scheduling is appropriate, due to the gastrointestinal risk being greater than ibuprofen. [Note: naproxen is in Appendix H as of 1 June 2016]
- There would be an increased risk to consumers with cardiovascular complications, particularly elderly consumers.
- Greater emphasis should be placed on communicating to consumers the relevant risk factors and the need to limit dose and duration of treatment.
Summary of ACMS advice to the delegate
The committee advised that the current scheduling of naproxen 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; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.
The reasons for the recommendations comprised the following:
- Naproxen carries a higher risk of gastrointestinal toxicity than ibuprofen. The risk of cardiovascular toxicity associated with use of OTC naproxen is likely to be the same as that for OTC ibuprofen.
- Use of medicines for the relief of pain is common. A greater risk of gastrointestinal toxicity associated with the use of naproxen is likely to be significant if the use of naproxen increased as a result of it being available as an unscheduled medicine.
- No consumer experience in Australia for OTC naproxen except for use in period pain
- There is evidence that administration with naproxen results in an increased incidence of serious upper gastrointestinal toxicity when compared with other NSAIDs
- The individual dose unit strength of the naproxen in the submission is different from that currently available, creating possible confusion amongst consumers.
- Availability of naproxen as an unscheduled medicine is unlikely to provide a greater consumer health benefit when compared with use of ibuprofen as an unscheduled medicine or naproxen as a Schedule 2 medicine. If unscheduled ibuprofen is inadequate for pain relief it is preferable that the consumer access health professional advice regarding the appropriate pain management.
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 factors20;
- 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 naproxen 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; and (f) any other matters that the Secretary considers necessary to protect public health.