3.1 Oxymetazoline

3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)

3.1 Interim decision in relation to oxymetazoline

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision not to amend the current Poisons Standard in relation to oxymetazoline.

Materials considered

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

• The application to amend the current Poisons Standard with respect to oxymetazoline;
• The five public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
• The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
• Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
• The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
• The Scheduling handbook: Guidance for amending the Poisons Standard.

Summary of ACMS advice to the Delegate

The Committee recommended that the current scheduling of oxymetazoline remains appropriate.

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 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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.

The reasons for the advice included:

a - the risks and benefits of the use of a substance:

• Risks
  • Risks with prolonged use leading to rebound nasal congestion, particularly with treatment of congestion in relation to allergic rhinitis.
• Benefits
  • Long history of use and the safety profile is well characterised;
  • Few other risks if taken in accordance with directions.

b - the purposes for which a substance is to be used and the extent of use of a substance:

• Product is used for symptomatic relief of nasal congestion.

c - the toxicity of a substance:

• Toxicity of the substance is low, if taken in accordance with the instructions on the packet;
• Ongoing reports from NSW Poisons Information Centre on incorrect dosing.

d - the dosage, formulation, labelling, packaging and presentation of a substance:

• Packaged as a nasal spray for topical application, appropriate warning and use statements required on the label;
• Pack size does not limit duration with this product (provides much more than 3 days' supply) i.e. risk mitigation through reducing pack sizes cannot be achieved.

e - the potential for abuse of a substance:

• There is a small potential for incorrect use, as consumers may not read or understand the information on the packet;
• Cases of non-medical use are rarely reported, but not unheard of.

f - any other matters considered necessary to protect public health:

• Inconsistency with access controls placed on phenylephrine;
• Concern with use for allergic rhinitis and self-selection.

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

I have made an interim decision to retain the scheduling of oxymetazoline in the current Poisons Standard. This decision is to not implement the proposal to down-schedule oxymetazoline to the general sales level. The detailed reasons for my interim decision follow.

Oxymetazoline is used for symptomatic relief of nasal congestion. In my view, access to oxymetazoline in a pharmacy allows for the provision of pharmacist advice to mitigate the risk of inappropriate use. I am concerned that access to oxymetazoline at the general sales level, without pharmacist input, will lead to adverse effects from overuse and rebound congestion from prolonged use. I have considered the scenario where consumers may be able to identify and self-manage nasal congestion, for which oxymetazoline is intended, but may confuse the symptoms with allergic rhinitis. I am concerned that oxymetazoline may be used by consumers with allergic rhinitis when there are other more appropriate medications and this may contribute to rebound congestion.

I am of the view that product packaging and labelling, in the absence of pharmacist consultation, is inadequate to mitigate the risk of inappropriate use. Taking into account that rebound congestion is not well understood by consumers, I consider that access to advice from a health professional within a pharmacy, is important to guide patient behaviour.

Based on my reading of the evidence the net public health benefit from the wider availability of oxymetazoline is limited.

I have taken into account the public submission from the NSW Poisons Information Centre (NSW PIC), which establishes that the number of calls regarding incorrect oxymetazoline dosing had been constant in recent years. The NSW PIC were concerned that wider access, through unscheduled oxymetazoline, could increase the incidence of dosing errors. In making my decision to retain the current scheduling of oxymetazoline, the safety issues raised by the NSW PIC were a minor consideration, relative to my concerns of inappropriate use, set out above.

I have considered the claims in the public submissions that access controls on oxymetazoline in Australia are more restrictive than similar overseas regulators. Oxymetazoline is available as 'general sale' in UK, Canada, New Zealand and USA. However, there are other differences in the way medicines are regulated overseas that influence safety and access to health professional advice. Overseas classification for medicines are not always directly equivalent to Australia as some other countries do not have two pharmacy schedules. In practice, general sales in other countries is not the equivalent of being sold in supermarkets.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health.