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New restrictions on prescribing ivermectin for COVID-19

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Dear Department of Health,

Today my pharmacist advised me that they were unable to fulfil my script for Ivermectin issues on Sept 10 due to the TGA's New restrictions on prescribing ivermectin for COVID-19 issued the same day.

The update from Sept 10, states that the TGA is acting on the advice of the Advisory Committee for Medicines Scheduling (ACMS).

I would like to request a copy of the information that this advice from the ACMS was based on. Specifically, I would like to request a copy of the ACMS' review into ivermectin including references to any scientific papers used in this review

The update from Sept 10, also claims that the 3 - 4 fold increase in dispensing of ivermectin prescriptions in recent months is leading to national and local shortages for those who need the medicine for scabies and parasite infections.

My prescribing doctor informed me that the pharmacist compounding my prescription has recently taken delivery of a large amount of Ivermectin and has plenty in stock.

I would therefore challenge the claim that there are local shortages of this drug and would like to request the evidence that this claim is based on.

Yours faithfully,

Daniel

TGA FOI, Department of Health

4 Attachments

Dear Daniel

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act).

"I would like to request a copy of the information that this advice from
the ACMS was based on. Specifically, I would like to request a copy of the
ACMS' review into ivermectin including references to any scientific papers
used in this review

The update from Sept 10, also claims that the 3 - 4 fold increase in
dispensing of ivermectin prescriptions in recent months is leading to
national and local shortages for those who need the medicine for scabies
and parasite infections.

My prescribing doctor informed me that the pharmacist compounding my
prescription has recently taken delivery of a large amount of Ivermectin
and has plenty in stock.

I would therefore challenge the claim that there are local shortages of
this drug and would like to request the evidence that this claim is based
on."

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 13 October 2021.

However, where there is requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension.

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 

 1. Personal/Third party Information

Documents containing personal/third party information, (e.g. the names and
contact details of any individuals, or any information that could
reasonably identify an individual) may require the Department to consult
with the identified individuals or parties. This consultation is likely to
add to the time taken to process your request, and potentially increase
the charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal/third party information in the documents (e.g. names,
contact details, addresses) relating to:

o third parties; and
o Commonwealth staff (please note that unless you advise otherwise, we
will assume that you do not seek access to personal information of
Commonwealth employees below Senior Executive Service level).

 

If you are not seeking access to any personal/third party information, you
can simply reply: 'no personal/third party information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal/third party information you require.

 

 2. Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

We look forward to hearing from you by COB Thursday 7 October 2021.

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4][IMG][5][IMG][6][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. mailto:[email address]
3. http://www.tga.gov.au/
4. https://www.facebook.com/TGAgovau/
5. https://twitter.com/TGAgovau
6. https://www.youtube.com/channel/UCem9INJ...

TGA FOI, Department of Health

6 Attachments

Dear Daniel

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being 27 October 2021.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

Karen

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...

TGA FOI, Department of Health

5 Attachments

Dear Daniel,

 

I refer to the TGA’s request consultation letter (attached) that was sent
to you on 13 October 2021.

 

As noted in paragraph 26 of our letter, and, in accordance with subsection
24AB(7) of the FOI Act, as we have not received any correspondence from
you within the 14 days as stipulated in the letter, your request is now
taken to have been withdrawn.

 

Regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

 

 

From: TGA FOI <[email address]>
Sent: Wednesday, 13 October 2021 4:21 PM
To: '[FOI #7855 email]'
<[FOI #7855 email]>
Cc: TGA FOI <[email address]>
Subject: Request consultation - FOI 3077 [SEC=OFFICIAL]

 

Dear Daniel

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being 27 October 2021.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

Karen

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [6][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [7]www.tga.gov.au

 

[8][IMG][9][IMG][10][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. mailto:[email address]
7. http://www.tga.gov.au/
8. https://www.facebook.com/TGAgovau/
9. https://twitter.com/TGAgovau
10. https://www.youtube.com/channel/UCem9INJ...

We don't know whether the most recent response to this request contains information or not – if you are Daniel please sign in and let everyone know.