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DHSC announces further extension of fluoxetine serious shortage protocol


By Isabel Shaw

15 Mar 2021

The Department of Health and Social Care (DHSC) has extended a serious shortage protocol (SSP) for 30mg capsules of the antidepressant fluoxetine for the second time since December.

The SSP, which was put in place on 20 October 2020, was originally due to expire last December, before being extended to 12 March – and now to 17 May.

Under the protocol, pharmacists can supply an alternative of one fluoxetine 10mg and one 20 mg capsule for every fluoxetine 30mg capsule they need to replace.

This is the seventh time a formulation of the drug has been placed under an SSP since the mechanism – aimed to mitigate the impact of medicines drug shortages – was introduced in 2019.

According to the NHS Business Services Authority, there are currently three active SSPs for fluoxetine – SSP007 for the 30mg capsules, SSP009 for 40mg capsules, and SSP005 for 10mg tablets.

The SSP for 10mg tablets has been in place for a year but is due to expire at the end of this month (31 March), as is the SSP for 40mg capsules.

‘Manufacturing issues’

The DHSC told the Pharmacist last month that fluoxetine 30mg and 40mg capsules are marketed by one company in the UK, Advanz Pharma, who it said is experiencing a ‘temporary supply issue’ with resupply of the capsules.

It added that the 10mg tablets are marketed solely by Endo Ventures Limited in the UK, with ‘resupply expected Q3 2021’.

DHSC is working with both companies to ‘expedite the next deliveries where possible’.

A spokesperson for Advanz Pharma told the Pharmacist: ‘Advanz Pharma is just one of several suppliers for this product. We have been experiencing recurrent supply shortages due to manufacturing issues.

‘Ensuring continuous supply is a key priority for us. We are working hard with our manufacturing partner and doing everything we can to minimise any impact on patients. We can confirm we are currently in stock of the 10mg presentation.’

Endo Ventures Limited did not respond to a request for comment.

Morningside Pharmaceuticals, a manufacturer of 10mg fluoxetine capsules which were briefly on an SSP in 2019, said their supply issues had also been due to a ‘manufacturing delay’.

A spokesperson said: ‘Our supply of fluoxetine 10mg has been relatively stable across the past two years, with just two months when we were out of stock due to a manufacturing delay.

‘We are aware of supply issues across the market, and have worked with the Department of Health and Social Care to support the market, and ensure that the needs of patients are met.’

‘Working closely’ with suppliers

The DHSC spokesperson said: ‘We understand the distress that medicine supply issues can cause and want to reassure patients we are doing everything we can to help them access the treatments they need.

‘We are aware of a temporary supply issue with some strengths of fluoxetine formulations due to manufacturing issues. We are working closely with the suppliers to resolve the situation as quickly as possible.

They added: ‘There are sufficient supplies of alternate formulations of fluoxetine to support the market during this time.’

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