ADHD Medication Options

Ben M made this Freedom of Information request to Advisory Committee on Prescription Medicines

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Dear Advisory Committee on Prescription Medicines,

Would it be possible to reconsider your treatment options for ADHD and be more open to a wider variety of medications prescribed for ADHD. I'm 17, was diagnosed with severe ADHD 3 years ago and the use of psychostimulants has reshaped my life for the better. The only problem is that the variety of treatments is minuscule compared to that of other countries and has left me between a rock and a hard place, unfortunately. I was first prescribed a non-stimulant medication "Strattera" which did absolutely nothing for my hyperactivity or attentiveness. Then I was prescribed Ritalin and Concerta, which somewhat helped but made me very sick. Then I was prescribed Vyvanse and Dexamphetamine which have the least side effects and is what I use to date, and effectively control my hyperactivity and concentration, but make me feel awful, almost depressed and suicidal at one point. Unfortunately, my doctor said there is no more medication that he can prescribe me, so I either deal with it or suffer the consequences. This is really unfortunate and annoying for someone like me who genuinely suffers from this condition and I can confidently say Dexamphetamine was the reason I was able to get my life back on track, stop getting into trouble and stay in school. But it's so horrible the effects it makes me feel on the inside (and yes I've tried all different mg variation, currently on 20mg Dexamphetamine/day started at 70mg Vyvanse).

I'm asking if you could consider expanding the medication options such as Adderall and Desoxyn. I've seen many people online say that Desoxyn has a different effect on all other medications, and provides increased benefits with fewer side effects of mental fogginess. Unfortunately for many things, it takes many tries before we find "the right one", but I feel the options available in Australia are more so "here's what we got now suck it up and get over it", and that is NOT how I should have to feel and is why the need for Medications such as Desoxyn and Adderall need to be approved and prescribed here in Australia, as they are in other countries around the world.

Yours faithfully,

Ben M

TGA Info,

1 Attachment

Dear Ben,

Thank you for your email to the Advisory Committee on Medicines (ACM)
requesting that they reconsider treatment options for ADHD. 

Please note that the ACM is not a decision making body. Rather, it
provides independent medical and scientific advice to the Minister for
Health and the Therapeutic Goods Administration (TGA) on issues relating
to the safety, quality and efficacy of medicines supplied in Australia.
This reply is on the committee’s behalf.

In Australia, therapeutic goods must be included on the Australian
Register of Therapeutic Goods (ARTG) before they can be sold, unless they
are specifically exempt from this requirement. As you are aware, both
Adderall and Methamphetamine are not currently on the ARTG. In order for a
prescription medicine to be included in the ARTG a ‘sponsor’ is required
to submit an application accompanied by appropriate scientific data to
support the quality, safety and efficacy of the product for its intended
use(s). The TGA then reviews the data and may seek the advice of ACM for a
recommendation regarding entry of the medicine on the ARTG. Ultimately it
is the TGA that makes a decision to approve or reject the application.

The TGA cannot compel the sponsor to make such an application to include a
medicine on the ARTG. However, Australian patients may still be able to
access certain ‘unapproved’ medicines that are not yet included in the
ARTG, such as Adderall and Methamphetamine, but are available overseas
through the Special Access Scheme (SAS).

The SAS provides arrangements for the import and/or supply of an
‘unapproved’ therapeutic good for a single patient, on a case-by-case
basis. SAS applications should be initiated by the patient’s treating
doctor. Further information about the SAS is available on the TGA website
at: [1]www.tga.gov.au/form/special-access-scheme.

I encourage you to discuss the appropriateness of seeking access to
‘unapproved’ treatments with your treating doctor(s). Alternatively, the
TGA can be contacted by phone regarding each scheme on 02 6289 4632, or by
email to [2][email address].

Yours sincerely

Regulatory Assistance Service
Regulatory Guidance, Assistance and SME Section

Regulatory Engagement, Education and Planning Branch

Phone: 1800 020 653 Fax: 02 6203 1605
Email: [3][email address]

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia

[4]www.tga.gov.au

[5]Facebook icon [6]Twitter icon [7]Youtube icon [8]Instagram
icon [9]LinkedIn icon

This response is general information given to you without prejudice; it is
not binding on the TGA and you should get your own independent legal
advice to ensure that all of the legislative requirements are met.

 

 

References

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Posty left an annotation ()

This is a thoughtful and useful response to a request that is not an FOI request.