Published: 27 July 2022

Consultations

Outcome of the consultation on the proposed warning and advisory statements relating to the harm of opioid abuse

• Summary
• About the consultation
• Submissions received
• Outcome
• Implementation date
• Enquiries

Summary

• Medsafe sought comments on plans to introduce new labelling requirements for medicines containing opioids.
• 41 responses to the consultation were received.
• Download the Consultation outcome document to view the consultation feedback, Medsafe’s response and the finalised warning and advisory statements:
  Proposed warning and advisory statements relating to harm of opioid abuse – Consultation outcome (PDF, 271 KB, 18 pages)
• The implementation date for the new statements will be 1 March 2024.

About the consultation

This Medsafe consultation proposed new warning and advisory statements for opioid medicines. The proposed statement arose from a recommendation of the Medicines Adverse Reactions Committee to minimise opioid misuse, abuse and dependence.

The consultation opened on 16 February 2022 and closed on 4 April 2022.

More information about the consultation.

Submissions received

There were 41 responses to the consultation. Respondents included members of the public, healthcare professionals, industry, and professional bodies. Most respondents were supportive of the new warning and advisory statements.

You can view the submissions that we have permission to publish.

Medsafe would like to thank all those who took the time to respond to the consultation and provided comments.

Outcome

The information below is only a brief summary of the consultation outcomes. For the full consultation feedback and Medsafe’s response, please download the consultation outcome document.

• Proposed warning and advisory statements relating to harm of opioid abuse – Consultation outcome (PDF, 271 KB, 18 pages)

Based on respondent feedback, we have made some changes to our initial proposed statement – see the consultation outcome document for details.

Key outcomes are as follows.

• The new warning and advisory statement “Use of this medicine has the risk of overdose and dependence” will be added to the Label Statements Database.
• The currently required statement for prescription codeine products is superseded by the new statement. The entry for over-the-counter codeine products will be removed from the Label Statements Database.
• The new statement does not apply to opioid medicines indicated solely for anaesthetic use or postoperative or obstetric analgesia, or for opioid dependence.

Implementation date

The proposed implementation date for the new warning and advisory statements was 12 months following the update of the Label Statements Database. However, based on feedback from industry, the implementation date has been revised to 18 months.

The Label Statements Database will be updated on 1 September 2022. Medicines released for supply in New Zealand after 1 March 2024 must have updated package labels that include the new warning and advisory statement. However, we encourage sponsors to update their labels before this date, if feasible.

We expect that all New Medicine Applications will comply with the updated labelling requirements unless we have agreed to alternative arrangements proposed by the sponsor.

Enquiries

Any questions relating to this consultation should be emailed to: medsafeapplications@health.govt.nz.