Response 623370519

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Your details

4. Where are you or your organisation based?

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New Zealand
Australia
Other

5. Which of the below options best describes you in the context of this consultation?

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Healthcare professional
Member of the public
Sponsor
Manufacturer
Supplier
Importer
Government
Researcher
Professional body
Industry organisation
Consumer organisation
Institution (eg, university, hospital)
Regulatory affairs consultant
Laboratory professional
Other

Publishing submissions and Official Information Act 1982 requests

6. Do you give us permission to publish your submission?

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(Required)
Yes. You may publish this submission, including my personal details (name, organisation)
Yes. You may publish this submission but only after removing my personal details (name, organisation)
No. Do not publish this submission

Proposed warning and advisory statement for opioids

8. Should the package labelling for opioid medicines include a warning and advisory statement relating to the harm of abuse, misuse, and dependence?

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Yes
No

9. Which of the proposed statements should be including on the package labelling for opioid medicines?

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[Name of opioid] is an addictive substance
Use of this medicine has the risks of overdose and dependence
Contains opioid
None of the above

10. Do you agree with the proposed conditions for opioid medicines: ‘For all classifications, including prescription, and all uses’?

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Yes
No
If no, please suggest alternative conditions
I believe that the proposed warning statement should not apply to opioids when combined with anaesthetics. These combination products are administered by healthcare professionals in a hospital setting and are not generally dispensed directly to patients. Patients would therefore be unlikely to see the warning statement.

The labelling of Redacted text products include the statement 'Recommended for use under Specialist direction'.

Opioids when combined with anaesthetics were excluded from the TGA Opioid Reforms.

11. Do you agree with the proposed implementation timeframe of 12 months following the update of the Label Statements Database on the Medsafe website?

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Yes
No

12. Do you have any other comments?

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Yes
No