Published: 1 May 2020

Medicines

COVID-19 - Potential shortage of fentanyl injection – use of unapproved product

 

Medsafe has become aware that, due to the current international supply situation arising from the COVID-19 pandemic, there may be a shortage of approved fentanyl injection in New Zealand.

Current situation
Supply of unapproved fentanyl injection by section 29
Medsafe advice
More information

Current situation

PHARMAC and the suppliers have been working to manage the fentanyl injection supply situation. However, some unapproved fentanyl injection product may need to be supplied under section 29 of the Medicines Act 1981.

Medsafe is also in contact with PHARMAC and the suppliers regarding whether unapproved products may be eligible for an abbreviated approval under section 23 of the Medicines Act 1981. If this is possible, Medsafe will expedite the approval process to avoid any disruption caused by supplying unapproved product under section 29.

Note that the situation is very fluid and may become out of date quickly. Medsafe will update this advice as needed.

Supply of unapproved fentanyl injection by section 29

Section 29 allows the supply of an unapproved product by an importer or manufacturer, to a medical practitioner (often with a pharmacy as an intermediary). Before supplying by section 29, the importer or manufacturer in New Zealand must receive the following information:

• medical practitioner’s name
• patient’s name
• product description
• the place of supply
• date of supply.

Section 29 is an exemption to the usual requirement for a product to be approved under section 20 of the Medicines Act 1981 and only applies to medical practitioners.

Medsafe advice

Using an unapproved fentanyl injection product that has been supplied under section 29 may cause difficulties for health care services. Medsafe provides the following advice, should this situation eventuate.

• It is accepted that, in this case, supplies of fentanyl injection may be made to health services before details about patients and the use of the product become known. The section 29 details must be provided retrospectively to the supplier, and as it is the supplier’s responsibility to collect these details, the supplier should check that the purchaser agrees to provide the details retrospectively before supply is made.
• Fentanyl is classified as a controlled drug. Because the details required for supply by section 29 are the same as those required for a controlled drug, health services may be able to submit those details to the fentanyl supplier.
• Under the Medicines Act 1981, only medical practitioners can prescribe unapproved fentanyl. It may be advisable to reserve approved fentanyl stock for prescribing by other prescribers.
• As Medsafe has not assessed an unapproved product, the quality, safety and efficacy of the product cannot be assured. This information should be part of the patient informed consent process. Note that assurance of the quality, safety and efficacy of an unapproved product may depend on whether it has been approved by a respected overseas regulator.

More information

Further Medsafe advice on prescribing unapproved medicines
Medicines Act 1981