Further public consultation on appropriate access and safety controls (Poisons Standard schedule) for alkyl nitrites

Prior to making a final decision on possible amendments to the Poisons Standard schedule for alkyl nitrites, the TGA decision-maker (delegate) has requested that further public consultation be undertaken. There will not be a decision announced on alkyl nitrites on 29 November 2018.

The reasons for considering amendments to the Poisons Standard for alkyl nitrites, the main component of "poppers", arise from the need to balance several factors:

• The products have significant use among a number of groups in the Australian community.
• Because many products contain prescription-only substances, such access may not be legal.
• While many people apparently use inhaled alkyl nitrite products without adverse effect, some serious health impacts have been reported in certain users from both inhalation and ingestion of alkyl nitrite containing products. These include loss of vision (maculopathies or retinal damage) and presentation in hospital emergency departments and subsequent hospitalisation due to methaemoglobinaemia. Methaemoglobinaemia is a very serious condition which results in less oxygen delivery to bodily organs resulting in chest pain, shortness of breath, altered mental state and possible permanent organ damage.
• More commonly, the alkyl nitrites can cause low blood pressure, tachycardia, dizziness, nausea and fainting, especially if the user is taking certain prescription medicines.

There is some, incomplete evidence that particular members of the family of alkyl nitrite substances may be more toxic than others.

In order to assess the possible impact of different approaches to access and safety controls on risks associated with alkyl nitrites, a discussion paper outlining these factors will be published on the TGA website on Thursday 29 November 2018. This will include discussion of a range of possible options on access controls. These range from general (unrestricted) sale, through to access in pharmacies, pharmacist only access, prescription only access or prohibited substance status, and whether it is appropriate to apply different access controls to different members of the alkyl nitrite family of substances.

Interested individuals and organisations will be invited to provide submissions in writing by 15 January 2019. The TGA also proposes to hold public meetings in Sydney and Melbourne at the end of January or early February 2019. Details on how to register your interest in these meetings will also be provided on 29 November 2018.

Background

In Australia, medicines and poisons (chemicals classified as "use with caution", "poison" or "dangerous poison") are classified into Schedules according to the level of regulatory control required over the access to (availability of) the substance to protect public health and safety. The Schedules are published in the Poisons Standard and are given legal effect through state and territory legislation. The Poisons Standard is formally referred to as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

On 12 April 2018 a scheduling amendment was proposed by the delegate of the Secretary of the Department of Health to create a new Schedule 4 (Prescription Only Medicine) group entry for alkyl nitrites, some of which have a street name of 'poppers', and amend the Appendix A listing for lubricants.

The matter was referred to the June 2018 meeting of the Advisory Committee on Medicines Scheduling (ACMS). Following the ACMS meeting, the delegate's interim decision on alkyl nitrites was published on 10 September 2018. It proposed to amend the Appendix A listing for lubricants, to move all currently scheduled alkyl nitrites from Schedule 4 to create a new Schedule 9 (Prohibited Substance) group entry for alkyl nitrites. A number of public submissions were received opposing the interim decision. On 8 November 2018, the joint meeting of the ACMS and the Advisory Committee on Chemicals Scheduling (ACCS) further considered the matter, with several presentations from interested parties given at that meeting.

Before making a final decision, the delegate must consider the matters to be taken into account in section 52E of the Therapeutic Goods Act 1989, the Scheduling Policy Framework, information obtained through public consultations and meetings, public submissions received, the advice of the advisory committees plus any additional evidence.

The matters to be taken into account by the delegate in accordance with section 52E of the Therapeutic Goods Act are:

1. the risks and benefits of the use of a substance;
2. the purposes for which a substance is to be used and the extent of use of a substance;
3. the toxicity of a substance;
4. the dosage, formulation, labelling, packaging and presentation of a substance;
5. the potential for abuse of a substance;
6. any other matters that the Secretary considers necessary to protect public health.

The Scheduling Policy Framework sets out the national policy for applying access restrictions to medicines and "poisons". Substances are scheduled according to the risk of harm and the level of access control required to protect consumers. The Scheduling Policy Framework is available at AHMAC - Scheduling policy framework for medicines and chemicals.