Fluoxetine 20 mg caps: Supply issue resolved

The brand change for fluoxetine from Fluox to Arrow-Fluoxetine has occurred earlier than expected.

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5 April 2023 update

The supply issue for fluoxetine 20 mg has been resolved. Reserves of fluoxetine 20 mg have returned to normal levels.

Supply issue for Arrow-Fluoxetine

The brand change for fluoxetine hydrochloride 20 mg cap (from Fluox to Arrow-Fluoxetine) occurred earlier than expected. This created a supply issue with Arrow-Fluoxetine (Pharmacode 2450860).

This issue was caused by stock of Fluox, the previous brand, running out earlier than expected. We had anticipated Fluox would be available until 1 June 2023, when it is to be delisted.  

Supply status

The 60,000 unit delivery that arrived at the end of February has been distributed around the country. A further 60,000 unit delivery was delivered in the end of March 2023.

Affected products

There are three currently funded fluoxetine hydrochloride products.

Arrow-Fluoxetine

  • Chemical: Fluoxetine hydrochloride    
  • Presentation: 20 mg capsule
  • Supplier: Teva
  • Pharmacode: 2450860 

Fluox

  • Chemical: Fluoxetine hydrochloride    
  • Presentation: 20 mg cap
  • Supplier: Viatris 
  • Pharmacode: 2353121 

Fluox

  • Chemical: Fluoxetine hydrochloride    
  • Presentation: 20 mg tab dispersible
  • Supplier: Viatris 
  • Pharmacode: 2618575 

Schedule listing for fluoxetine(external link)

Alternative product

We secured 22,000 units of an alternative brand of fluoxetine. It was listed from 20 February 2023. It arrived in Aotearoa during the week beginning 21 February 2023. 

Chemical Formulation Brand Pack size Pharmacode Proposed price and subsidy
Fluoxetine hydrocholoride Cap 20 mg Brown & Burk 30 2653354 $2.22

The Brown and Burk brand is not Medsafe approved. It was dispensed and prescribed in line with section 29 of the Medicines Act. This brand is approved in the United Kingdom. 

UK datasheet and patient information leaflet(external link) 

For pharmacists

  • Wastage claimable
  • Rule 5.5 of the General Rules to limit dispensing quantities for this medicine (7 days’ at a time) was applied

Note that Sector Operations Group were unable to process claims for February 2023 dispensing of the above listing. Pharmacies can either:

  • submit claims in March 2023 OR
  • reclaim any rejected claims in March 2023.

Prescribing and supplying a medicine under section 29

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 – e.g., doctors. 

We know supplying a medicine under section 29 is not ideal. This is the only alternative available to ensure people can continue to access treatment. 

We apologise for any inconvenience this causes. 

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

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

Dispensing limits removed 

From 27 January 2023 until 12 March 2023, we put a 7 day dispensing limit in place. Pharmacists could only dispense a maximum of 7 days' supply at a time of fluoxetine 20 mg. Dispensing has now returned to monthly. The pharmacist must clearly annotate the prescription for fluoxetine 20 mg with:

  • the words “out of stock” or “OOS” and
  • initial the annotation in their own handwriting. 

This applied to all 3 funded presentations of fluoxetine:  

  • Arrow-Fluoxetine 20 mg capsules (2450860)
  • Fluox 20 mg capsules (2353121)
  • Fluox 20 mg dispersible tablets (2618575)

Pharmac activated rule 5.5 of the General Rules of the Schedule to limit dispensing quantities for this medicine. 

Rule 5.5 of the General Rules

Pharmacists’ discretion

Pharmacists could use their discretion to dispense more than 7 days’ supply when it’s difficult for people to get to the pharmacy. Reasons for this can include that the patient:

  • has limited physical mobility
  • lives and works a long distance from the pharmacy
  • is moving away
  • will be travelling when they need to pick up the repeat.

Please note, this does not include blister packing as a reason for dispensing more than 7 days’ supply at one time.

We appreciate that this added significant burden to pharmacists’ workload. We made these changes to preserve the remaining supply of fluoxetine. 

Pharmacists: claiming for 7-day dispensing

Te Whatu Ora/Health New Zealand updated the pharmacy claiming system to enable the change in frequency of fluoxetine dispensing during this supply issue.

If a pharmacy has had a prescription rejected due to period of supply for fluoxetine, please resubmit the prescription for payment. 

Substitution of Fluox 20mg dispersible tablets

Our clinical advisors have informed us that Fluox 20 mg dispersible tablets are an appropriate substitution for Arrow-Fluoxetine 20 mg capsules or Fluox 20 mg capsules. The dispersible tablets can also be swallowed whole like the capsules. 

During this supply shortage, pharmacists can dispense Fluox 20 mg dispersible tablets, in place of Arrow-Fluoxetine 20 mg capsules or Fluox 20 mg capsules. As supplies of the capsules are returning to normal, we would prefer that pharmacists dispense capsules when possible, for people that are usually prescribed capsules. 

If pharmacists must use tablets, process the prescription as endorsed, regardless of the Schedule criteria. 

The Online Schedule was not updated to reflect this change because of the timeframes. 

We did not make these changes lightly

We acknowledge the inconvenience that dispensing limits create for pharmacists and people taking medicine. Limiting dispensing helped distribute the limited supply of fluoxetine as fairly as possible. 

We appreciate pharmacists' vital role in responding to this issue and apologies for any inconvenience caused.  

Key dates

27 July 2022: Brand change notified as a result of our tender decision

1 January 2023: Arrow-Fluoxetine (Pharmacode 2450860) listed

27 January 2023: Dispensing limited to 7 days’ supply for all 20 mg presentations of fluoxetine

1 February 2023: Dispensing software updated to reflect these changes 

12 March 2023: Dispensing returned to normal

1 June 2023: Fluox (pharmacode 2353121) will be delisted

Who to contact

If pharmacies are having difficulty getting access to fluoxetine, we recommend they check with other wholesalers. We understand there are varying stockholdings around the country.

We understand that this supply issue will be frustrating for people who use fluoxetine 20mg. If you have concerns around your health, you can speak to your healthcare practitioner or contact one of the following helplines:

Pharmacies can subscribe to email updates for this and other supply issues

If you have questions about this supply issue, email enquiry@pharmac.govt.nz