1.6. Ranitidine

1 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #29 March 2020)

1.6. Interim decision in relation to ranitidine

Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment to increase the pack sizes available for general sale and in pharmacies for ranitidine, made an interim decision not to amend the current Poisons Standard.

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

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

• The application to amend the current Poisons Standard with respect to ranitidine;
• Advisory Committee on Medicines Scheduling's advice;
• The public submissions received in response to the pre-meeting consultation;
• Section 52E 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;
• Scheduling handbook: Guidance for amending the Poisons Standard; and
• Scheduling Policy Framework (SPF 2018).

Summary of ACMS advice/recommendations to the Delegate

The Committee recommended that the scheduling of ranitidine in the Poisons Standard 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 purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; and (e) the potential for abuse of a substance.

The reasons for the advice included:

1. the risks and benefits of the use of a substance
   • Risks:
     • Masking symptoms of more serious underlying conditions such as gastric cancer, undiagnosed peptic ulcer or gastro-oesophageal reflux.
     • Increased availability in general sale and Schedule 2 may prolong potential treatment periods without advice from a healthcare professional.
   • Benefits:
     • Effective relief of symptoms of gastro-oesophageal reflux; and
     • Ease of access and convenience with larger pack sizes.
2. the purposes for which a substance is to be used and the extent of use of a substance
   • Relief of symptoms of gastro-oesophageal reflux.
3. the toxicity of a substance
   • Risk profile is well defined.
   • The potential for harm from inappropriate use is low.
4. the dosage, formulation, labelling, packaging and presentation of a substance
   • The proposed pack size is not consistent with short term treatment.
   • Ranitidine is currently listed in Schedules 2 and 4, with an exemption to allow general sales of small quantities of both 150mg (7 dosage units) and 300 mg (14 dosage units) tablets.
5. the potential for abuse of a substance
   • Low/minimal.
   • Potential for long term inappropriate use with larger pack sizes.
6. any other matters that the Secretary considers necessary to protect public health
   • NIL.

Reasons for interim decision

I have made an interim decision not to amend the current Poisons Standard in relation ranitidine. My view is that the current scheduling of ranitidine is appropriate. The detailed reasons for my decision follow.

It is my view that pharmacist intervention, currently in place, is the critical mitigating factor to ensure the quality use of ranitidine. Increased pack sizes of ranitidine available at the general sales level and Schedule 2 would remove the opportunity for pharmacist interaction and increase the potential for harm to consumers.

I have identified a number of factors, which would necessitate consumer consultation with a pharmacist to reinforce and/or expand on aspects of the safe use of ranitidine. These include, the use of the ranitidine at established therapeutic dosage levels may mask the symptoms or delay diagnosis of a serious condition or lead to sub-optimal treatment of conditions such as Gastro-oesophageal reflux disease (GORD). Pharmacist intervention is required to detect the masking of a serious disease or compromising medical management of a disease, and to deal with it appropriately.

Based on my assessment, I find that the net benefit associated with access to ranitidine at the general sales level or Schedule 2 is limited to convenience for consumers. Whilst ranitidine has a favourable safety profile, there is no compelling evidence to suggest that current access is inadequate. In my view, the benefit of convenience does not sufficiently outweigh the risk of harm associated ranitidine use set out above.

I disagree with the views expressed by the applicant that, increasing the pack size in the Schedule 2 would ensure patients have continued access to counselling for the safe use of the product. In my opinion, a larger pack size may delay medical review for more severe gastro-oesophageal disease or complications. On balance, I find that an increase in the pack size availability is inconsistent with the quality use of ranitidine.

I agree with the Committee's finding that the relevant provisions of section 52E 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.