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Consider inhaled budesonide stock levels for off-label COVID treatment

"Inhaled budesonide is the first widely available, inexpensive drug found to shorten recovery times"
"Inhaled budesonide is the first widely available, inexpensive drug found to shorten recovery times"

UK pharmacies should maintain stock levels of inhaled budesonide to meet routine use as well as fulfil off-label prescriptions for the treatment of COVID-19, NHSE&I has said.

Pharmacies will be notified of any supply issues and should continue to order supplies through their usual business routes, the UK chief medical officers (CMOs) wrote in a message published on the central alert system (CAS) yesterday (April 12).

Early treatment with inhaled budesonide has been found to shorten recovery times from COVID-19 in patients over 50 who were treated with it at home or in other community settings, according to findings from the PRINCIPLE COVID-19 clinical trial.

Inhaled budesonide was added to the trial on November 28 last year and a total of 961 patients – who were either over 50 with an underlying health condition or over 65 – were randomly selected to receive it at home.

The trial concluded that treatment  “shortens recovery time by a median of three days in patients with COVID-19 who are at higher risk of more severe illness and are treated in the community”.

Inhaled budesonide is the “first widely available, inexpensive drug found to shorten recovery times in COVID-19 patients aged over 50”, according to the PRINCIPLE trial researchers.

Advice to pharmacy teams

Pharmacy teams dispensing inhaled budesonide for the at-home treatment of COVID-19 should ensure patients or their representatives are aware of how to use the inhalers, according to the CAS alert.

They can also signpost patients to additional resources and are encouraged to “report any suspected adverse drug reactions” via the Yellow Card reporting site.

The CMOs specified that the inhaled budesonide is not being recommended as a “standard of care”, but can be used for off-label prescribing on a “case-by-case basis for symptomatic COVID-19 positive patients aged 65 and over, or aged 50 or over with co-morbidities”.

Pharmacy’s role

Professor Mahendra Patel, who is pharmacy and ethnic minorities community lead at the PRINCIPLE trial, said “it is exciting to now share the news about the use of budesonide Turbohaler for the early treatment of COVID-19 symptoms in the community”.

“This is a drug commonly used for the treatment of asthma and, in this instance, it has clearly shown to reduce the recovery time within non-hospitalised patients and helps them feel better.

“It’s really encouraging to see pharmacy playing an important role in the PRINCIPLE trial through helping to raise awareness of it UK-wide, across communities and healthcare settings,” he added.

“The PRINCIPLE trial is innovative in that it also allows to introduce new treatments, for example recently with the antiviral favipiravir. Pharmacy can continue to play a crucial role in supporting the trial and help recruiting patients from all backgrounds, including those most adversely affected.

“This creates an exciting opportunity for pharmacy to support future research in healthcare, beyond COVID-19,” Professor Patel said.

Do you regularly dispense budesonide in your pharmacy?

N O, Pharmaceutical Adviser

There are over 10 - 20 or more varieties of inhaled Budosenide. Which one to stock? Will the DoH pay for keeping these in stock? considering not many dispense these anymore. They better force the manufacturers and wholesalers to keep enough in stock for us to order for next day delivery.

Adam Hall, Community pharmacist

I will 'consider' stocking budesonide for unlicenced use when DoH set up an advanced service to do so. In other words - pay me and I'll think about it

David Moore, Locum pharmacist

Off label. Do they mean off licence?

C A, Community pharmacist

Off-label means the product has a license but is being used for in a different way or for a different reason. You can be reasonably certain of the safety if the doses are similar to those in the SPC, efficacy/value may be questionable. Reasons for Off-label prescribing can be orphan diseases, rare diseases etc, often there can be quite good local knowledge or specialist knowledge but the license holder doesn't feel its worth a clinical trial to extend the license.

As opposed to unlicensed medicines, which can vary from unlicensed formulations of licensed medicines, through medicines which are licensed in other countries, but lack a UK license, to medicines that have no licence

N O, Pharmaceutical Adviser

On a lighter note Off Licence means a place where you can buy spirits to uplift yourself after a hard fraught day ;-)

TC PA, Community pharmacist


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