Popping out


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Pharmacies to dispense product used as a sex aid following TGA ruling

The Therapeutic Goods Administrations’ scheduling committee has recommended some of a range of products currently used as sex aids and room odorisors be downscheduled for pharmacist only sale.

In its March 2019 meeting, the Advisory Committee on Medicines Scheduling (ACMS) recommended altering the scheduling of some products containing alkyl nitrites, which have the street name of ‘poppers’.

The ACMS delegate ruled that amyl nitrite now be listed in Schedule 3 when used in preparations for human therapeutic use and packaged in containers with child-resistant closures.

There is a new group Schedule 4 entry for all non-S3 and S10 alkyl nitrates, which would capture previously unscheduled substances sold as room odorisors and sex aids. 

Isopropyl nitrite and n-propyl nitrite were to move to S10 as prohibited products due to their toxicity.

The downscheduling of amyl nitrite was made because “there is some clinical experience and a more robust safety profile for this member of the alkyl nitrite family of substances given it has been used clinically to treat angina,” the delegate said.

“I am satisfied that amyl nitrite meets the Scheduling Factors for Schedule 3”.

Those reasons include:

  • The medicine is substantially safe with pharmacist intervention to ensure the quality use of
    the medicine. There may be potential for harm if used inappropriately.
  • The use of the medicine is not expected to produce dependency.
  • The risk profile of the medicine is well defined (in comparison to other members of the
    alkyl nitrite family of substances). The risk factors for adverse effects, interactions and
    contraindications are known, identifiable and manageable by a pharmacist (when in
    preparations for human therapeutic use and packaged in containers with child-resistant
    closures.)

“I have considered that additional controls over access and training to enable amyl nitrite to be
provided by a pharmacist through inclusion in Appendix M may be relevant. However, in the absence of a registered product, I have decided to not make a decision on this matter,” the delegate said.

A number of public submissions had stated that any changes which would remove alkyl nitrites from adult shops or sex on premises venues may adversely affect members of the LGBTQI community in terms of sexual health, sociocultural and psycho-social harm.

“I have taken these matters into account in my deliberations…..Taking into account the increasing instances of poisoning and toxicity I find that, on balance, it is not in the interest of public health to have alkyl nitrites unregulated such that they are freely available at adult only stores and for general sale,” the ACMS delegate said.

“It is my view that that their lawful supply under the regulatory framework for medicines, which has a number of inherent and important protections for consumers, is in the interest of promoting public health while not preventing access.

“The supply of alkyl nitrites through a qualified health practitioner would mean that there is an opportunity for counselling and education on safe use and other related public health issues”.

The decision did consider their potential benefit for relaxing smooth muscle and preventing potential tearing of the inner sphincter during receptive anal intercourse, “which I note
was the central argument put forward in the majority of public submissions in support for a less
restrictive or unrestricted access to alkyl nitrites.”

The implementation date for the change is set for 1 February 2020.

Click here for more information on the decision

 

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18 Comments

  1. pagophilus
    08/06/2019

    Legitimising recreational drug use by the community, or various subcultures within it? Giving in to pressure from special interest groups?

    Where is the Aust R commercially available amyl nitrite product? Or are compounding pharmacies now going to get a big boost to their business by compounding recreational drugs? And why not give us a detailed description on how these amyl nitrite “poppers” are used? And where do we find references on dosage, side effects, contraindications, drug interactions, precautions, pharmacokinetics, use in renal impairment etc? Which pharmacist in their right mind who cares about medication safety and quality use of medicines could dispense these products with a clear conscience? Or course those in it only for the money will have no problem, until the first coroner’s court case of a death involving the use of one of these drugs.

    Society is going downhill fast when regulatory bodies legitimise recreational drug use through such rescheduling actions.

    • Jarrod McMaugh
      08/06/2019

      How many deaths are occurring from the use of these products now?

      What is your definition of “recreational” in relation to these items?

      With regards to a commercial product, the delegate isn’t responsible for considering whether a product is available, only in the scheduling of the specific chemical(s)

      “Which pharmacist in their right mind who cares about medication safety and quality use of medicines could dispense these products with a clear conscience” – given that there is a specific therapeutic purpose for these items, which has been shown to reduce harm & risk in specific circumstances, the answer to this question is ‘all of them

      I think a valid question is response would be “which pharmacist would block the supply of this product when a clear therapeutic use has been defined in the decision handed down by the TGA delegate”

      • pagophilus
        08/06/2019

        ‘I think a valid question is response would be “which pharmacist would block the supply of this product when a clear therapeutic use has been defined in the decision handed down by the TGA delegate”‘

        There’s a subtle shift in legal language here which I believe would be open to legal challenge. In order to sell S3’s we’re supposed to establish a therapeutic need. There is no therapeutic need and you cannot realistically say that there’s a patient under our care. Recreational need is not therapeutic need.

        • Jarrod McMaugh
          08/06/2019

          TGA has established a therapeutic need.

          What recreational use are you referring to?

          • pagophilus
            08/06/2019

            TGA has established caving in to a special interest group’s recreational use. Its use may well have a public health benefit, but it’s recreational use, not therapeutic. It’s just legitimising what already happens, which is not therapeutic. The only perceived benefit is the opportunity for counselling when dispensing it. Whether that provides any benefits will be seen, but even if it doesn’t I doubt the decision will ever be reversed. Too much of a political hot potato.

          • Andrew
            09/06/2019

            I understand you’re a hospital pharmacist, in which case you’re unlikely to be called upon to personally supply poppers. It’s almost as if your indignation is based on something NOT directly related to the product.

          • pagophilus
            09/06/2019

            That something not directly related to the product doesn’t give pharmacists licence to ignore all the usual procedures relating to establishing a therapeutic need and all the other medication safety related stuff. No group gets a special pass. What, next we’ll be dispensing party drugs at music festivals in an effort to minimise harm? I can just imagine it.

          • RobS
            01/07/2019

            Lets state it plainly your opposition to this is homophobic. There are a number of products that were specifically developed and marketed as sexual aids for heterosexual sex, those products have serious side effects and can be fatal in combination with other products and that never precluded their licensing nor do you argue they should have. Poppers have a legitimate use to prevent severe discomfort and physical harm occurring for some people during homosexual intercourse. Many licensed drugs produce euphoria but their legitimate medical purpose justifies their availability despite that. There is no difference with alkyl nitrites except for the target population being homosexuals and that’s where your problem lies. In your own words they’re “caving in to special interest groups” for whom sex is recreational and not a legitimate physical and mental health issue that justifies therapeutic assistance when it is associated with discomfort and dysfunction. Your issue is with the “special interest group” not the medication.

          • pagophilus
            08/06/2019

            TGA doesn’t establish a therapeutic need. The pharmacist should establish that the patient has a therapeutic need. I don’t see either a patient nor a therapeutic need but a customer and a recreational need.

          • Jarrod McMaugh
            09/06/2019

            You keep referring to a recreational need.

            What exactly is your understanding of the purpose of using this group of agents that you keep referring to a recreational purpose for them?

          • pagophilus
            09/06/2019

            I don’t have to state the obvious. You have a brain, go and search what people do with them.

          • Jarrod McMaugh
            09/06/2019

            The reason I keep asking is that there is a criteria of use that constitutes a therapeutic purpose.

            One would expect that if a person cannot discuss their concerns in a forum that is protected (ie not your real name, subscribers only can read) then having a conversation about that therapeutic purpose (facilitating receptive anal sex by relaxing smooth muscle thereby reducing risk of injury and subsequently reducing risk of STI infection) may be a bit much to ask.

            As you asked earlier: “Which pharmacist in their right mind who cares about medication safety and quality use of medicines could dispense these products with a clear conscience” – I guess the answer is ‘those pharmacists who aren’t squeamish about asking relevant questions, and those who don’t put their own personal views ahead of the person they are assisting at any given time’

          • pagophilus
            09/06/2019

            I suppose it’s possible to put a nice spin on “Recreationally, it is used to enhance sexual experience or to experience a general sense of pleasure. The effects are felt within 30 seconds of taking the drug, and last for around 2-3 minutes.”

            I guess going by names such as poppers, liquid gold, rush, purple haze and buzz, it has been used therapeutically all these years and nobody knew until now….

          • Jarrod McMaugh
            09/06/2019

            What you’ve described is a short term recreational effect.

            It’s different to the therapeutic application for which the TGA has listed it as schedule 3.

          • pagophilus
            09/06/2019

            Which in practice has no relevance because it will make no difference to how people use it.

          • Jarrod McMaugh
            10/06/2019

            Exactly – the concerns over a “short term recreation impact” won’t affect the application of this class to the therapeutic effect (how people use it), so there should be nothing standing in the way of a pharmacist determining that therapeutic need and then providing a product with advice as we would with any other product that is OTC

  2. pagophilus
    08/06/2019

    How does this fit in with the following page from the Australian Drug Foundation?

    https://adf.org.au/drug-facts/amyl-nitrite/

    That page specifically states that there is no safe level of drug use.

    • Pablo
      09/06/2019

      I wouldn’t be comfortable dispensing any drug without knowing the safe level of drug use… Our practice should be guided by high quality evidence rather than personal testimonies alone from the long term users. We clearly need more data about amyl nitrite to identify the minimum effective dose that is safe to dispense. Without having the full drug monograph on hand and making the drug widely accessible, we can potentially do more harm than good.

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