Proposed warning and advisory statement relating to the harm of opioid abuse, misuse, and dependence

Closed 4 Apr 2022

Opened 16 Feb 2022

Overview

This Medsafe consultation proposes a new warning and advisory statement for the opioid class of medicines. The statement would be included in the Label Statements Database (LSD), which lists the warning and advisory statements that are required on medicines and related products package labels.

Opioid medicines are prescription medicines used to relieve moderate to severe acute pain and can also be used in palliative care. Most opioid medicines are also classified as controlled drugs, with restrictions on prescribing and supply.

Internationally there has been an increasing trend in opioid-associated harm due to abuse, misuse, and dependence. Harm associated with opioid use is comparatively lower in New Zealand. However, evidence exists of opioid abuse, misuse, and dependence in New Zealand.

In June 2021, the Medicines Adverse Reactions Committee recommended that the LSD should be updated to include a warning and advisory statement for all opioid medicines. The Committee noted that most medicines are repackaged from the manufacturer’s original pack to dispensing packs, and that dispensing packs are not required to include LSD statements on the label. However, the Committee still considered it helpful to have a warning statement on the manufacturer’s pack in cases where manufacturer packs are dispensed to patients. The minutes of the meeting can be found here.

The LSD already has a warning for codeine that must be on the package labels for any codeine containing medicine:

  • Codeine is an addictive substance

Table 1 below shows the proposed conditions, statement options and required by (implementation) date for the opioid medicine warning and advisory statement.

Table 1: Opioid warning and advisory statement: proposed conditions, statement options and required by date

Medicine/Group/Class Conditions Statement Required by
Opioids
Examples include:
  • Alfentanil
    Buprenorphine
    Codeine
    Dihydrocodeine
    Fentanyl
    Methadone
    Morphine
    Oxycodone
    Pethidine
    Remifentanil
    Tramadol
For all classifications, including prescription, and all uses
  • [name of opioid] is an addictive substance
    [or]
  • Use of this medicine has the risks of overdose and dependence
    [or]
  • Contains opioid
12 months from when the Label Statements Database is updated

 

Medsafe is seeking your comments on:

  • whether the package labelling for opioids should include a warning and advisory statement relating to the harm of abuse, misuse, and dependence
  • the preferred statement option (see Table 1)
  • the proposed conditions and required by (implementation) date (see Table 1).

Note that if this proposed statement is added to the Label Statements Database, words of a similar meaning to the statement may be used and individual statements may be combined, provided the intent is not changed.

To assist in the analysis of submissions, Medsafe will only accept submissions made through this consultation website. However, the full consultation document is attached below as a PDF, and it can be viewed online, downloaded and/or printed.

What happens next

All comments will be considered. Once the analysis of submissions is complete, the Label Statements Database may be updated.

We will publish the outcome on the Outcome of Consultations web page on the Medsafe website.

To subscribe to an automatic email notification of the website updates, please register here.

Audiences

  • Members of the public
  • Health sector
  • Disability sector
  • Ministry staff
  • Mental health and addiction services
  • Pharmaceutical companies
  • Service providers

Interests

  • Therapeutic products