Pharmaceutical supplier API has notified Te Pātaka Whaioranga – Pharmac that they have closed their Auckland manufacturing plant and are withdrawing from the New Zealand market. This was not a decision Pharmac had control over – this was a commercial decision by API. API supplied around 21 funded medications in New Zealand, including dexamfetamine 5 mg tablets.
It is expected that stock of the API brand of dexamfetamine to begin running out during August 2022, and people will need to change brands to continue with their treatment. A brand change for this medicine is not ideal. However, the Pharmac clinical experts have advised that ongoing supply of dexamfetamine is essential.
Pharmac is working to secure long-term supply of dexamfetamine sulfate 5 mg tablets. Pharmac will keep you updated about this, but in the meantime, listing a short-term supply of Aspen’s brand of dexamfetamine 5 mg tablets on the Pharmaceutical Schedule from 1 August 2022.
This brand of dexamfetamine has the same active ingredient and strength but it not currently approved by Medsafe for use in New Zealand.
The Aspen brand of dexamfetamine sulfate 5 mg tablets is not currently approved by Medsafe for use in New Zealand. It will need to be prescribed and supplied under section 29 of the Medicines Act 1981.
Section 29 of the Medicines Act allows for medicines that are not Medsafe approved to be prescribed and supplied to people. The medicine must be prescribed by someone registered with the Medical Council of New Zealand. This is also a requirement for dexamfetamine prescribing under the Misuse of Drugs Regulations 1977.
Pharmac know supplying a medicine under section 29 is not ideal. In this case, however, this was the only way for Pharmac to ensure people could continue to access appropriate treatment.
Pharmac has encouraged Aspen to get in touch with Medsafe about seeking the necessary consents for this brand. However, this process takes time, and we are advised that approval may not be granted before supply of this brand commences.
The medicine notices section of the Pharmac website will be kept up to date as more information about this brand change becomes available.