1.2. Interim decision in relation to glyceryl trinitrate

Interim decision:

For the reasons set out below, a delegate of the Secretary has, in relation to the proposed amendment, made an interim decision under regulation 42ZCZN to amend the current Poisons Standard in relation to glyceryl trinitrate as follows:

Proposed date of effect of the proposed amendment: 1 October 2019

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

Having considered the matters set out in the Guidelines for advertisements for medicines containing Schedule 3 substances it is my view that GTN meets the criteria for advertising for the reasons set out below. While oral GTN is associated with significant adverse effects and requires caution for use, coupled with detailed advice about how to use it correctly, I have decided that adequate controls are already in place to manage these risks through the Schedule 3 listing and the need for pharmacist involvement in supply. I find that the ability to advertise this medicine should not change the medicine's risk profile and that any potential for inappropriate use will not exacerbated by advertising.

In making my decision, among other things, I relied on evidence that there is a lack of safer alternatives and that GTN has a long history in the market place as a Schedule 3 medicine. Pharmacists will be aware of the sedating potential and potential drug interactions (e.g. PDE5 - sildenafil) that require increased patient education to ensure safe use so patient choice is unlikely to be adversely influenced by advertising. Any of the risks of potential abuse or misuse are low and further limited by sublingual GTN's propensity to cause vascular headaches, therefore it is unlikely that any risks associated with the dosage form that may impact on safe use would be exacerbated by advertising.

I considered the potential benefits to public health from advertising of this medicine, in particular:

• It could potentially raise awareness amongst people who have already been diagnosed with angina and prescribed GTN, of its availability over-the-counter to enable emergency supply;
• Public awareness amongst consumers that they can obtain repeat supplies from their pharmacist may help to ensure people have effective GTN supplies in their possession at all times, without them perceiving that they need to wait to obtain a script from their doctor;
• Oral sublingual GTN tablets have a short shelf life (i.e. 3 months from the date of opening the container) and advertising these products may assist in ensuring that angina suffers have in date and active tablets;
• Advertising of topical GTN could encourage patients who have anal fissure to discuss their symptoms with a health professional, leading to better health outcomes.

I have taken into account the arguments in opposition of the proposed amendment, including that direct advertising to the public could divert patients from proper medical investigation. I find that on balance the public health benefits to be gained from inclusion of GTN in Appendix H outweigh the potential health risks, which in my view, are adequately controlled through the existing Schedule 3 listing.