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Pharmacies to 'validate' which patients get adrenaline auto-injectors

Mylan warned of supply issues with its 300 microgram EpiPen in May
Mylan warned of supply issues with its 300 microgram EpiPen in May

Pharmacies are being asked to “validate” whether patients are in urgent need of adrenaline 150 microgram auto-injectors as England faces a “critical supply issue”.

In joint guidance from the Department of Health and Social Care (DH) and NHS England published yesterday (October 16), pharmacists have been told they “must” follow its flow chart of questions – “unless there is an immediate clinical need” – to decide whether “the prescription should be fulfilled, partially fulfilled, or [the] supply delayed”.

The DH’s “dispenser validation protocol” advises conserving supplies to dispense to “children weighing 25kg or less, with the greatest short-term need”, but stresses that “all patients need to have access to a minimum of two 150 microgram adrenaline auto-injectors”.

Pharmacists are advised to delay supply to patients under 25kg who already have two or more auto-injectors – “not including at school or nursery”.

“The purpose of the validation is to ensure that every eligible patient has at least one in-date device and that a situation is avoided where some patients have two in-date devices, whilst others have none,” the DH explained.

“This can only be achieved by restricting issue of new devices until further notice,” it added.

Delays until the end of the year

Mylan has been affected by manufacturing issues of its EpiPens “for several months”, the DH said. The manufacturer initially warned of supply issues with its 300 microgram EpiPen in May.

However, the supply issues are now “most acute” for the EpiPen Junior 150 microgram device, and Mylan is “currently out of stock”. Further supplies are not expected until the end of October, the DH warned.

Manufacturers Bausch and Lomb, and ALK, are “working with their supply chains to increase supplies” of their alternative junior auto-injectors, Emerade 150 microgram and Jext 150 microgram, the DH added.

However, the extra supplies issued to UK wholesalers this week will not be “sufficient to fulfil normal demand”.

“In addition, it is anticipated that there will be a backlog of patients with prescriptions to be dispensed from August and September”, which means “there may be ongoing constraints until the end of the year”, the DH warned.

See the Pharmaceutical Services Negotiating Committee website for its advice on the patient validation protocol.

11 Comments
Question: 
How regularly do you dispense junior auto-injectors?

tushar trivedi, Locum pharmacist

PSNC is an oragnisation which is not fit for purpose to represent interest of  pharmacy. It lacks the leverage and authority to represent interest of pharmacy profession. It is an understatement to state that PSNC has again failed to understand the complexity of operation involved in following the guidance issued with no reimbursement for pharmacy. 

Mike Bereza, Community pharmacist

We should get together and make a training course for patients to teach them how to use Prefilled syringes or opening an ampoule so they do not need to rely on supply issues of Auto Injectors. It would be a simple video which the patient can watch and then ask questions in store and have the technique demonstrated to them by a fully trained pharmacist.

Leon The Apothecary, Student

Step 1) First get your Epipen...oh wait.

Benie I, Locum pharmacist

How much will you charge for the course Mike?

A B, Community pharmacist

Would be interesting to see a video of someone suffering analphylaxis opening a glass ampoule, drawing up the liquid and calmly injecting themselves.

Caroline Jones, Community pharmacist

Presumably better than nothing?

Benie I, Locum pharmacist

I'm still curious as to whether the course will be free or if Mike charges. But point well made AB.

V K P, Community pharmacist

what exisiting resources? the resources are not in surplus to take on extra tasks which should not be passed on to the pharmacy in the first place. this is an issue created by the manufacturers and they should be facing the burden of prescription validation and all the extra processes that PSNC is passing on to the pharmacy. Get the prescribers to stop prescribing and that should cut majority of the prescription validation issue. the pharmacy contract says we have to dispense prescriptions without undue delay and not that we should question what has been prescribed and the clinical need for it. does that not fall in the remit of the prescriber??? what happens when a pharmacist does not dispense based on the flow chart and an incident occurs with a fatality. the GP will turn around and say they had issued the prescription and the parent will say that the pharmacist did not dispense the prescription. Who will then be facing the music from the regulators and where will the liability fall?

 

The fact that PSNC have issued guidance to say that this extra work should be covered by existing resources is frankly shocking. 

We should be funded to do this extra work. End of.

Dave Downham, Manager

Is exiting resources a Freudian slip?

No just a spelling mistake :)

It is frankly bonkers that PSNC put out guidance on this to tell us to do more stuff for nothing. We pay for the time PSNC spends on this and we end up worse off. We have MUGS written all over us.

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