Manatū Hauora is publishing the results of our engagement on opioid prescribing regulations. We have received a good amount of feedback, including written submissions from prescribers, dispensers, service users, and consumer groups, as well as several health organisations. These will help us to review the controls and safeguards, including regulations, for prescribing opioids to ensure they are fit for the purposes of both managing the risk of inappropriate prescribing and ensuring there is adequate access to opioids for people who need them.
In December 2022, the Misuse of Drugs Amendment Regulations 2022 (the amendments) made several changes to controlled drug prescribing regulations. One of the changes allowed Class B controlled drugs to be prescribed for up to 3 months with up to 1 month dispensing, when prescribed electronically through the New Zealand ePrescription Service (NZePS) by any prescriber with authority to prescribe such drugs. This change was intended to improve access to Class B controlled drugs, including ADHD medicines, for people with ADHD and chronic conditions. The increase in the maximum amount was intended to provide more flexibility for practitioners to prescribe appropriate amounts of drugs for their patients.
In response to concerns that were raised after the amendments were made and Pharmac considering making changes to the Pharmaceutical Schedule to align with the regulatory changes, Manatū Hauora set up a working group to help review the current controls to see if they were fit for the purposes of both managing the risk of opioid misuse and ensuring appropriate patient access. The working group helped Manatū Hauora develop several proposals that were then tested with stakeholders.
The review found that while the changes were appropriate for ADHD medicines, there were gaps in existing controls for opioids. At this stage, there are no plans to change the prescribing regulations to ADHD medicines – the maximum prescribing limits for ADHD medicines will remain at three months.
The engagement also found that current regulations did not adequately balance the risks of harm against the benefits of access to opioids for those who need them. Clinicians raised concerns that the current 3-month prescription limit might increase the quantity of opioids being prescribed and could increase the risk of opioids being accessed inappropriately. There was also concern that clinical guidance and best practice might not always be followed, and that prescription limits help monitor and identify unusual practice.
Further changes to opioid prescribing limits will require new Amendment Regulations and the associated Cabinet decisions. The Minister will be talking to her colleagues about what changes are necessary and when they can be made.
In the interim, there are a number of safeguards in place to manage the risk of opioid use. These include regulations that set out who can prescribe these medicines, monitoring of prescribing practices, clinical guidance that determines appropriate practices, professional sanctions where inappropriate prescribing occurs and Pharmac’s Pharmaceutical Schedule, which provides subsidisation criteria that limits the amount of Class B opioids that may be dispensed at one time.
