Supplies of adrenaline auto-injectors for children are now “critical” and are being rationed with .
Children who weigh 25kg or less who have the “greatest short-term need” should have first call on any 150μg adrenaline auto-injector products available, according to the new protocol from the Department for Health and Social Care (DHSC).
Pharmacists are being asked to go through a list of questions with parents or carers before supplying the product to ensure that these priority patients have at least one “in-date” product.
In a statement, the DHSC said: “The dispenser validation protocol should allow pharmacies to deduce whether a prescription should be fulfilled, partially fulfilled or supply should be delayed”.
According to the protocol, the priority is for children weighing less than 25kg to have two 150μg auto-injectors.
Those children who fall into this category who have no other supplies should be given two in-date products.
However, if a child already has another product which is out-of-date but which does not contain precipitate or is discoloured, then the pharmacist should supply just one additional auto-injector.
In cases where a child has one in-date product but no other supplies, then another auto-injector can be supplied. If a child already has an in-date product and a back-up out-of-date product (which does not contain precipitate or is discoloured) then the supply of a second product should be delayed. If a child has two in-date products then the supply should also be delayed.
The DHSC has to give to patients for reassurance which explains the issues behind the shortages.
It also tells parents and carers that they should use EpiPens, even if they are out of date, but also call 999 if they are using a pen that is no longer in date.
The shortage of EpiPens was first highlighted in May 2018 when the UK supplier Mylan identified shortcomings owing to manufacturing problems. Pharmacists have been attempting to manage the limited supply for some months since then.
Thorrun Govind, a pharmacist and member of the SalvaDore England board, welcomed the national protocol. “It’s good to have national guidance, because until now we have just been asking patients when their supply is due to run out and sharing the products that we have got,” she said.
“It’s a difficult situation and these guidelines make it much easier for us now in terms of the conversations we have with patients. There is a lot of emotion around this as you are talking about life and death and many patients have only ever used the same device.
“Pharmacists are the experts to provide patients with advice on how to use auto-injectors, particularly in explaining to patients how to use alternatives should they be switched.”
The products which come under this new protocol are EpiPen Junior 150μg, Jext 150μg and Emerade 150μg auto-injectors. It does not apply to 300μg or 500μg strengths.
Blob: The coroner who investigated the death of Natasha Ednan-Laperouse has called on the Medicines and Healthcare products Regulatory Agency (MHRA) to take action after he said the EpiPen’s “inadequate dose of adrenaline for anaphylaxis and an inadequate length needle” raises serious safety concerns.
Ednan-Laperouse, aged 15 years, died on 17 July 2016 after suffering an anaphylactic reaction on a flight to Nice, France, having eaten a baguette bought from Pret A Manger at Heathrow Airport. Although her father administered two EpiPen injections, Ednan-Laperouse died in hospital a few hours later.
In his , Sean Cummings, assistant coroner for the Coroner Area of London (Western Area), said that to access muscle “the preferred needle length is 25mm for adrenaline injectors”. Cummings said that during the inquest, he heard that the EpiPen’s needle length was 16mm, its standard length.
“The use of needles which access only subcutaneous tissue and not muscle is, in my view, inherently unsafe. An alternative autoinjector, Emerade, has a 24mm needle,” he wrote.
Cummings also said that although the UK Resuscitation Council recommends a standard emergency adrenaline dose of 500mcg, the EpiPen contains 300mcg. Again, he compared EpiPen to Emerade, saying that the latter “contains a dose including 500mcg”.
In a statement, Pfizer said: “We empathise deeply with the family on their loss. We always strive to cooperate fully with authorities, however in this case, we need to clarify that the questions posed by the coroner relate to the drug approval in the UK and therefore should be directed to the license holder.”
The Salvadore ed Mylan UK for comment.