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.