1. Question
Can nitrates be added to a different schedule to allow scripting from sexual health practitioners?
Answer
Currently, the following substances are in schedule 4 of the Poisons Standard, making them prescription only medicines: amyl nitrite, butyl nitrite, isoamyl nitrite, isobutyl nitrite and octyl nitrite. A sexual health doctor (or any other medical practitioner) can write a prescription for products containing these substances. Thus they should only be made available by a pharmacist on prescription and cannot legally be sold under the counter in retail outlets or online.
However, at present there are no products containing these substances registered by the TGA, however it is legal to obtain them on prescription via a compounding pharmacy, or through personal importation for up to 3 months use with a prescription.
2. Question
Would you consider listing as a schedule 5 drug rather the 9?
Answer
Alkyl nitrites can't be scheduled as household/industrial chemical substances because they have a human therapeutic use and this use is not permitted under the Industrial Chemicals (Notification and Assessment) Act 1989. There appears to be no genuine household/industrial use in Australia. As a result, Schedule 5 (Caution) and Schedule 6 (Poison) schedules, which are used for industrial, agricultural and veterinary chemicals, cannot be used to enable label warnings or packaging changes.
Poisons for therapeutic use (medicines) are mostly included in Schedules 2, 3, 4 and 8 of the Poisons Standard.
3. Questions
What does the available evidence tell us about the prevalence of adverse reactions to the recreational use of poppers?
What, if any, data collection procedures are in place to measure negative health impacts from poppers?
What actual negative health impacts have occurred in Australia from the use of poppers?
Poppers have a very practical use in the gay community when engaging in anal sex, in addition to lubricant and condoms. Poppers reduce pain and discomfort in the receptive partner - and greatly reduce the chance of physical damage occurring. This is especially true for younger gay men. The removal of legal access to poppers would have significant negative health outcomes, both mental and physical, on this population. What weighting has been given to balancing out the positive health outcomes of poppers usage verses the negative outcomes?
The removal of legal access to poppers would lead to an increase in the illegal supply of poppers with the associated risks that come from an unregulated black market without proper quality controls. How does this situation increase health outcomes?
Answers
The data on prevalence of adverse events associated with the recreational use of poppers tells us that many people using inhaled alkyl nitrite containing products do so without reporting harm.
However, there have been some very serious health impacts reported including:
- Rare loss of vision (maculopathies or retinal damage) even after a single use
- Hospital emergencies due to methaemoglobinaemia (loss of oxygen delivery to bodily organs)
- Interactions with certain medicines affecting blood pressure and existing medical conditions can worsen adverse events
The user base is wider than the LGBTIQ community - so there are more 'less experienced' poppers users, and therefore increased harms due to the lack of labelling of products to describe safe use plus no requirement for packaging to have child-proof caps or other caps to prevent ingestion (but not inhibit inhalation).
Further data will be presented at the public meetings planned for 31 January and 7 February. Data will include adverse events reported following alkyl nitrite use - an analysis of Australian Poisons Information Centre and NSW Health data.
4. Questions
- From the TGA website, 'Toxicity includes tachycardia, hypotension, headache, flushing, dizziness, nausea, and syncope. Co-use with phosphodiesterase type 5 (PDE-5) inhibitors can lead to severe hypotension.' What is the rate of toxicity? If inhaled, how common are these symptoms?
- From the TGA website, 'Increased risk of cardiovascular harm when used in conjunction with other vasodilators.' What is the increase here? How often is amyl nitrate used in conjunction with other vasodilators in Australia? What evidence is available to shed light on this question?
- The Delegate's reported a recent increase in the use of amyl nitrites for recreational purposes and this was based on the Australian Trends In Ecstasy and Related Drug Markets 2016: Findings from the Ecstasy and Related Drugs Reporting System (EDRS) report. This report involved 795 participants and compared usage across two years: 2015 and 2016. Is there any evidence in addition to this study to indicate an increase in recreational usage of amyl nitrites in Australia?
- From the TGA website, 'Inhalation of alkyl nitrites can lead to methaemoglobinaemia and even death, with significantly increased risk if ingested. Methaemoglobinaemia is potentially life threatening if not treated appropriately.' Where is the evidence of the incidence of alkyl nitrite related methaemoglobinaemia or death in Australia?
- From the TGA website, 'Alkyl nitrites can cause chemical burns to the skin and eyes on direct contact. Other risks of alkyl nitrites include maculopathy and skin lesions.' Where is the evidence of the incidence of this occurring in Australia?
- From the TGA website, 'There is a high potential for misuse and abuse of alkyl nitrites for euphoric properties, and as sex aids due to their muscle relaxant properties.' The potential for abuse does not equate to ACTUAL abuse. What evidence is there of the rate of actual abuse?
- From the TGA website, 'The misuse and abuse of alkyl nitrites appears to be in particular sections of the community rather than widespread.' Which sections of the community appear to be misusing and abusing alkyl nitrites?
- Are you aware of any plans to classify amyl nitrite as a drug of dependence under the Drugs, Poisons and Controlled Substances Act 1981 (Vic)?
Answers 1-5
The data on prevalence of adverse events associated with the recreational use of poppers tells us that many people using inhaled alkyl nitrite containing products do so without reporting harm.
However, there have been some very serious health impacts, as described in the response to question 3.
Answers 6-7
Both statements quoted from the TGA website are referring to misuse caused by people drinking the contents of the 'popper' or excessive repeated inhalation, rather than inhaling the contents or using an alkyl nitrite in conjunction with other drugs such as sildenafil (Viagra®) or Tadalafil (Cialis®) or street drugs resulting in hospitalisation due to serious adverse events. The user base is now wider than the LGBTIQ community and the products are packaged without instructions for use, warnings or safety directions - so there are more 'less experienced' poppers users, and therefore increased harms.
Answer 8
We have no knowledge of any plans to classify amyl nitrite as a drug of dependence under the Drugs, Poisons and Controlled Substances Act 1981 (Vic).
5. Questions
If the committee decides to ban poppers how do they plan to regulate the import of poppers from overseas?
What plans does the committee have to implement harm minimisation practices for the illegally produced poppers that will immediately become available on the black market are poppers are banned in Australia?
Will sniffer dogs be used to detect poppers and if so how does the committee propose to minimise harm to the dogs being trained to sniff poppers?
Answer
The way poppers are currently supplied is not legal under state and territory law. Currently, the following substances are in schedule 4 of the Poisons Standard, making them prescription only medicines: amyl nitrite, butyl nitrite, isoamyl nitrite, isobutyl nitrite and octyl nitrite. Thus they should only be made available by a pharmacist on prescription and cannot legally be sold under the counter in retail outlets or online.
If 'poppers' are banned (placed in schedule 9 or 10) they could not be imported from overseas and would be subject to the same controls as other 'prohibited substances' (S9) and 'substances of such danger to health as to warrant prohibition of sale, supply and use' (S10).
6. Questions
Does the TGA acknowledge the therapeutic benefits of alkyl nitrites (or what is commonly referred to as 'amyl' or 'poppers') for receptive partners during sex?
Does the TGA acknowledge the history of safe, responsible use of 'poppers' by consenting adults over five decades as a sexual aid?
Does the TGA acknowledge that any restriction on the access and use of 'poppers' will unfairly target and discriminate against the LGBTIQ community in Australia?
Will the TGA assist those that wish to safely and responsibly utilise 'poppers' as a sexual aid?
Will the TGA hinder access to individuals that wish to safely and responsibly utilise 'poppers' as a sexual aid?
Answer
Currently, the following substances contained in 'poppers' are in schedule 4 of the Poisons Standard, making them prescription only medicines: amyl nitrite, butyl nitrite, isoamyl nitrite, isobutyl nitrite and octyl nitrite. Thus they should only be made available by a pharmacist on prescription.
Public submissions received in response to the delegate's interim decision have highlighted the therapeutic use of substances belonging to the alkyl nitrite family of substances by the LGBTIQ community. The ability of alkyl nitrites to relax smooth muscle, including that of the anal sphincter, is well known.
7. Questions
What is the exact evidence base that the decision is being made on?
- I would like the TGA to define, with citation to current legislation, the definition of what constitutes a "psychoactive substance"? (Federal).
- I would like the TGA to point out the relevant, conclusive evidence that they have used in their preliminary determination to ban alkyl nitrates and related substances.
- I would like the TGA to point out or disclose, in case study or otherwise, relevant evidence showing the apparent harmfulness of the use of alkyl nitrates.
- I would like to understand why the TGA would push to ban alkyl nitrates, given a similar push in the UK rightfully failed to succeed based on a number of reasons; insufficient evidence or harm being one of them.
- Given anal sex practises of the gay community in particular, and the relation to alkyl nitrates use; I would like to hear the defence from the TGA of the following; given that there is a clear discrimination against the minority that is the gay community, how can the TGA prove they are not targeting this minority in their efforts to ban the use of alkyl nitrates.
Answers
Alkyl nitrites are not considered psychoactive substances under Australian Law. The psychoactive use proposal in the UK (that was not proceeded with) related to psychoactive substance law.
Following publication of the delegate's interim decision on alkyl nitrites in September 2018, over 40 public submissions were received. On 8 November 2018, at a joint meeting of the Advisory Committee on Medicine Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS), further consideration was given to the scheduling of alkyl nitrites, with several presentations from external parties given at that meeting. Following this meeting the delegate considered the advice from ACMS and ACCS, the presentations made at the joint meeting and the public submissions received, and decided that further public consultation was warranted before making a final decision.
When making a final decision on the scheduling of a substance, the delegate must consider the matters to be taken into account under 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 on Medicines and Chemicals Scheduling, plus any additional evidence that is considered relevant.
8. Questions
How does this proposed change fit in with the Australian government's commitment to harm minimisation when it will create a black market for an illicit drug and push consumers to access products that are illegal or to develop new drugs that are possibly dangerous to circumvent this policy?
Has the TGA considered the ample evidence and history where governments have made certain drugs illegal and this action has led to increased harm to users and society in general? Why does the TGA think this time the outcome will be different?
Answer
Scheduling is not a decision made by the Minister or Ministers. It is a decision made by a delegate of the Secretary of the Department of Health in order to protect public health.
When making a final decision on the scheduling of a substance, the delegate must consider the matters to be taken into account under 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 on Medicines and Chemicals Scheduling, plus any additional evidence that is considered relevant.
9. Question
The use of Amyl Nitrate to assist people (particularly gay men) in having safer and more pleasurable anal sex is well documented. By aiding in relaxing muscles, this prevents tearing, bleeding and reduces the risk of HIV contraction. In this context, amyl nitrate is a harm reduction tool. How can making this harm reduction tool unavailable to our community, by pushing its use underground into an unregulated market, be justified?
Answer
Currently, amyl nitrite is in schedule 4 of the Poisons Standard, making it a prescription only medicine. Thus it should only be made available by a pharmacist on prescription and cannot legally be sold under the counter in retail outlets or online.
The purpose of the consultation and public meetings is to identify possible mechanisms for the legal supply of products containing these substances but in a safe manner.
10. Questions
I've used Poppers for years (I'm 83yrs old) and I have never suffered any adverse health effects. I use Poppers as a muscle relaxant. So my question is.
Why do we need the TGA to now attempt to apply ANY restrictions on our use of Poppers (Amyl Nitrite)?
The TGA has not offered ANY good reasons from a health point of view. The TGA has quoted one or two very rare cases of possible health issues which were inconclusive and very selective. There are many substances and supplements which may cause a health issue, the list is long, but we don't ban them all! They are used intelligently by us all as adults!
In fact I'd go so far as to say, the TGA is responding to a very selective point of view of the Right wing religious organisations or individuals who wish to impose their religious nonsense on all of us! These beliefs are man-made restrictions and have nothing to do with any so called deity or dreamed up god! So I'll repeat my question?
With insufficient justification, why do we need the TGA to now attempt to apply ANY restrictions on our use of Poppers (Amyl Nitrite)?
Answer
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 and amend the Appendix A listing for lubricants. Reasons for the proposal are available here: Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS
The Scheduling Policy Framework and criteria for scheduling are in section 52E of the Therapeutic Goods Act 1989. There is no ability for the application of these laws to be influenced by particular religious or political views.
When making a final decision on the scheduling of a substance, the delegate must consider the matters to be taken into account under 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 on Medicines and Chemicals Scheduling, plus any additional evidence that is considered relevant.
11. Questions
Was the proposal to place alkyl nitrites in Schedule 9 and above based on an internal understanding of the substances as illicit drugs with no therapeutic application?
When did the TGA learn of the therapeutic use of alkyl nitrites and their importance in the LGBTIQ community?
In the case of a ban on alkyl nitrites, what does the TGA predict or suggest that people use to enable comfortable and safe receptive anal sex?
Answer
Public submissions received in response to the delegate's interim decision have highlighted the therapeutic use of substances belonging to the alkyl nitrite family of substances by the LGBTIQ community. The ability of alkyl nitrites to relax smooth muscle, including that of the anal sphincter, has been known for decades.
12. Questions
Why was this review instigated?
Who is putting it forward to ban these? No need to ban them.
Will the TGA release the full details on how this process of rescheduling first came about?
Answer
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 and amend the Appendix A listing for lubricants. Reasons for the proposal are available at: Consultation: Proposed amendments to the Poisons Standard being referred to the June 2018 meetings of the ACCS, ACMS and Joint ACCS/ACMS
13. Question
I would like to know why I was arrested, charged and taken to court and made to pay a fine. So it is already illegal so I would like to know what this is all about. I also lost my job because I was arrested with Amyl.
Answer
The way poppers are supplied is not legal under state and territory law. Currently, amyl nitrite is in schedule 4 of the Poisons Standard, making it a prescription only medicine. Thus it should only be made available by a pharmacist on prescription and cannot legally be sold under the counter in retail outlets or online.
14. Question
The interim decision states that "there is a high potential for misuse and abuse of alkyl nitrites for euphoric properties, and as sex aids due to their muscle relaxant properties." - I would like to know at what point and/or threshold or under which definition a 'sex aid' is defined as having 'a high potential for misuse and abuse' by the TGA.
Answer
The statement "there is a high potential for misuse and abuse of alkyl nitrites for euphoric properties" was referring to misuse caused by people drinking the contents or excessively repeatedly inhaling of the 'popper'. It is recognised that alkyl nitrites are not drugs of dependence.