The TGA sought comments from interested parties on a discussion paper outlining different approaches to access and safety controls for alkyl nitrites in order to inform a decision on how best to control potential risks to public health and safety.
Options for access range from general (unrestricted) sale, through to access in pharmacies, pharmacist only access, prescription only access or prohibited substance status. It may be appropriate for access controls to vary for between members of the alkyl nitrite family of substances. We are interested in hearing your views.
Document released for consultation on Friday 30 November 2018.
Interested parties should respond by close of business Tuesday 15 January 2019.
Feedback will be released following consideration of submissions. (See 'What will happen').
The TGA also proposes to hold public meetings in Sydney and Melbourne at the end of January or early February 2019 to facilitate further stakeholder input into the discussion about possible approaches to access and safety controls for alkyl nitrites. Further details will be advised in December 2018. See more via TGA
Public submissions on regulatory options for appropriate access and safety controls for alkyl nitrites
Submission: AIDS Action Council of the ACT
REGULATORY OPTIONS FOR APPROPRIATE ACCESS AND SAFETY CONTROLS FOR ALKYL NITRITES - SEEKING PUBLIC FEEDBACK The Therapeutic Goods Administration’s (TGA) interim decision to reschedule alkyl nitrates from a prescribed medicine to a prohibited substance is opposed by the AIDS Action Council of the ACT (the Council). The consequence of this decision could mean members of the LGBTIQ community will be liable for prosecution or legal penalties if found using or in possession of these substances. Therefore, the Council does not endorse the listing of alkyl nitrates in Schedule 9 of the Poisons Standard for the following reasons:
The Interim Decision has been based on inadequate facts and anecdotal evidence which do not satisfactorily meet the conventional standards of evidence required to justify this type of decision;
The harmfulness and possibility of misuse has been exaggerated;
Specialists from the Alcohol and Other Drugs sector have not been invited to contribute their input;
Stakeholders most affected by this decision have not been consulted or engaged in the decision making process; and
An already marginalised community will face substantial harm by criminalising their use of alkyl nitrates. Alkyl nitrates have been used within the LGBTIQ community since the 70s for recreational and sexual activities. In particular, they have been predominately used by gay and bisexual men, and sex workers to aid in safe and satisfying anal sex. Alkyl nitrates assist in relaxing the sphincter muscles decreasing the likelihood of anal tears or fissures, and lower the chance of condom breakage. As such, these substances have a legitimate and therapeutic benefit, as defined by the TGA. Read the full submission here