Dexamfetamine 5 mg: Brand change

Brand change Active

From August 2022 the brand of dexamfetamine will be changing. The new brand will look different, but the tablets have the same active ingredient.

5 August 2022: Brand change leaflet added

Alternative brand listed

From early August 2022, the brand of dexamfetamine will change from the ‘PSM’ brand to the Aspen brand so people can continue taking this medicine. 

Schedule listing for dexamfetamine(external link)

Aspen’s brand of dexamfetamine is not currently Medsafe approved. This means that it will need to be prescribed and supplied in line with section 29 of the Medicines Act 1981. While not approved in New Zealand, this brand is approved and used in Australia. 

Prescribing and supplying an unapproved medicine

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 – such as, a doctor.  

We know supplying a medicine under section 29 is not ideal. In this case, however, It will allow patients to have continued access to appropriate treatment. 

We apologise for any inconvenience this might cause. 

Advice for prescribing under section 29 – BPAC website(external link)

Prescriber and pharmacist requirements for section 29 medicines – Medsafe website(external link)

Medsafe’s section 29 Declaration / Notification Form [DOC](external link)

What patients need to know about section 29 medicines – Health Navigator website(external link) 

Pharmac has encouraged Aspen to get in touch with Medsafe about seeking the necessary consents for this brand. We are advised that approval may not be achieved within the timeframes available.

The temporary brand looks different but works the same way

The packaging and tablets will look different, but the tablets have the same active ingredient and work in the body the same way.

A side by side comparison of the 2 brands of pills. The PSM brand are plain white tablets on both sides. The Aspen brand are also white tablets, however on one side the tablet is scored and has D and 5 etched into the tablet..
Tablets not shown to scale
The label for the Aspen product. The details of the product, name and dose, are in a green box. More consumer information is in a yellow box. In a white box it says this is a controlled drug..
Label not shown to scale

Why is this happening?

The current supplier, API, is leaving the New Zealand market. Their PSM brand of dexamfetamine is no longer being manufactured. We have sourced short term supply of the Aspen brand of dexamfetamine so people can continue to access their medicine. We are working to secure long-term supply of dexamfetamine sulfate 5 mg tablets.

Key dates

1 August 2022:  Aspen’s dexamfetamine sulfate will be listed on the Pharmaceutical Schedule (Pharmacode 2642298) 

August / September 2022: PSM brand of dexamfetamine likely to no longer be available (Pharmacode 2461374)

1 August 2023: the ‘PSM’ brand of dexamfetamine will be delisted from the Pharmaceutical Schedule 

Brand switch fee for pharmacists

We know that moving people from one brand to another can be difficult. To support this, we are covering the cost with a brand switch fee. This will be in place from 1 August 2022 to 1 November 2022.

This is the first brand change for this medicine. We know some patients, whānau or carers may have some questions to ask their pharmacists. This is an opportunity to provide some extra counselling to reassure people that Aspen’s brand of dexamfetamine works the same as the PSM brand.

More about brand switch fees

We appreciate the time you take to help people understand brand changes. We have developed a pamphlet you can download and print for patients, whānau or carers. 

Who to contact?

If you have any questions or concerns about this change, talk with your doctor, nurse or pharmacist. 

You can also get more information from us at enquiry@pharmac.govt.nz or 0800 660 050