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Public meeting communique: Regulatory options for appropriate access and safety controls for alkyl nitrites

7 March 2019

The Therapeutic Goods Administration (TGA) recently held two public meetings to consult on regulatory options for appropriate access and safety controls for alkyl nitrites. The Sydney meeting was on 31 January 2019 and the Melbourne meeting was on 7 February 2019.

  • The Sydney meeting was conducted in partnership with the Kirby Institute and the National Drug and Alcohol Research Centre (NDARC) at the University of New South Wales (UNSW) and included presentations from the NSW Poisons Information Centre and the Australian Federation of AIDS Organisations (AFAO). Twenty nine people recorded their attendance.
  • The Melbourne meeting was co-hosted by the Australian Research Centre in Sex, Health and Society (ARCSHS) from La Trobe University, had a similar format to the Sydney meeting and included a presentation from Thorne Harbour Health (THH). Forty three people recorded their attendance.

At both meetings the speakers presented detailed information regarding alkyl nitrates, their use and the regulatory options for consideration.

Each public meeting also included small group discussions about the scheduling options set out in the TGA discussion paper. Views from both the Sydney and Melbourne meetings were similar and are summarised below.

Overall, there was strong opposition to placing all alkyl nitrites in Schedule 8, Schedule 9 or Schedule 10. Banning the use of alkyl nitrites was considered not acceptable as their use was said to help reduce harms such as anal injury and possible blood-borne disease transmission during anal sex. Participants also considered that a ban could lead people to purchase these substances through unregulated, and possibly illegal, sources. However, it was suggested that Schedule 9 may be appropriate for isopropyl nitrite, which is thought to be associated with rare but serious retinal maculopathy that can lead to temporary or permanent vision impairment or loss. Most participants supported better packaging, labelling and education as options to help prevent harm, in preference to regulation through scheduling.

Participants made it clear that any changes that would make alkyl nitrites unavailable from adult shops or sex on premises venues would make life more difficult for members of the LGBTQI community. It was recognised that many of the scheduling options would mean that a medicinal product containing an alkyl nitrite would have to be developed and registered with the TGA. There was a strong concern about whether or not any company would choose to register a product, how long such a process might take and what the cost implications for users would be. There was also a concern that even if these substances were available as medicines in Schedule 2, 3 or 4 via a pharmacy, people may choose to purchase them online from sites outside Australia in preference to purchasing them in person.

In Sydney, Schedule 3 (Pharmacist Only Medicine) was the preferred option. This was supported for a variety of reasons including access to safe products and the ability to receive professional advice and educational material through discussion with a pharmacist. Some support was voiced for Schedule 4 (Prescription Only Medicine) and Schedule 2 (Pharmacy Medicine). However, Schedule 4 was generally thought to present a barrier in terms of patient-doctor communication and disclosure of personal circumstances. In addition, some participants felt that availability on the shelves of a pharmacy (Schedule 2) may not offer appropriate safety controls. Based on the scheduling factors, attendees recognised that alkyl nitrites would not be able to be unscheduled.

In Melbourne, the general consensus was for alkyl nitrites to be put in Schedule 2, making them easily accessible on pharmacy shelves, with appropriate packaging, labelling and instructions. Melbourne participants did not agree that Schedule 3 was the most appropriate, due to the requirement to disclose information about personal circumstances to a pharmacist in a very public setting. Schedule 3 was thought to have an advantage over Schedule 4, as it would mean that users could share a substance with a partner without doing anything illegal. Schedule 4 was not supported due to barriers to access such as the need to obtain a prescription, increased pressures on general practitioners and costs associated with medical visits. There was a strong view that alkyl nitrites should be unscheduled until a medicinal product is registered and a mechanism other than scheduling should be employed to control access. Licensing at a state and territory level for certain adult-only shops and sex-on-premises venues, with appropriate education, was one suggested mechanism to make these products easily available.

At both public meetings, discussions covered issues outside the required considerations for scheduling (Section 52E of the Therapeutic Goods Act 1989 and the Scheduling Policy Framework>). Concerns included that restricting access to alkyl nitrites may perpetuate stigma and fear and may impact users' mental health. Attendees felt that public health education about how to use alkyl nitrites should be increased in order to improve the safety of the community in general.

The Advisory Committees on Medicines and Chemicals Scheduling will be provided with feedback from these public consultations at their March 2019 meeting. Publication of a final decision is anticipated in June 2019.

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Speakers and presentations

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Sydney presentations

Melbourne presentations