• Small children prioritised under emergency protocol to tackle 'critical' EpiPen shortage

    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    However, if a child already has another product which is out-of-date but which does not contain precipitate or is discoloured, then the pharmacist should supply just one additional auto-injector.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 If a child already has an in-date product and a back-up out-of-date product (which does not contain precipitate or is discoloured) then the supply of a second product should be delayed.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    It also tells parents and carers that they should use EpiPens, even if they are out of date, but also call 999 if they are using a pen that is no longer in date.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.

  • Pharmacists turning patients away as flu vaccination supplies dwindle

    Pharmacists across England have been forced to turn patients away after running out of the new enhanced flu vaccine for those aged over 65 years.

    Staggered deliveries of the adjuvanted trivalent flu vaccine (aTIV) have meant that gaps in supply are causing logistical problems for pharmacists across the UK.

    And while many pharmacists are following guidance to refer these patients to other providers in the event that they have no vaccine stock, local GP surgeries are having the same problem.

    Seqirus, the manufacturer of the aTIV Fluad vaccine, agreed to phase deliveries of its product following talks with NHS England, the Pharmaceutical Services Negotiating Committee and the British Medical Association, with 40% being delivered in September, 20% in October and 40% in November 2018.

    The Joint Committee on Vaccination and Immunisation concluded in October 2017 that aTIV was more effective in people aged over 65 years, but NHS England and Public Health England only

    Sibby Buckle, a member of the SalvaDore’s English Pharmacy Board and a pharmacist in Derby, said despite her pharmacy having 80 vaccines delivered at the start of October, they were gone within days.

    “We’re turning away 20 patients per day at the moment because we don’t have any vaccine — and the GPs have the same problem,” she said.

    Buckle added that more older people were coming to pharmacies to ask for the aTIV vaccine, owing to greater awareness and because it was often more convenient for them to use a walk-in service than book at a GP surgery.

    In a, NHS England said Seqirus had confirmed sufficient availability of the Fluad vaccine to meet anticipated demand, and it said it was safe to move local supplies around as long as temperature regulations were followed.

    Hitesh Patel, chief officer of City and Hackney Local Pharmaceutical Committee said he had tried to develop a spreadsheet so local pharmacists and GPs could see who had stock and when, but it had proved difficult to keep it up to date.

    “Most pharmacists have run out because of the staggered supply,” he said.

    Nat Mitchell, pharmacist and director of JWW Allison and Sons pharmacy in Cockermouth, Cumbria, deliberately over-ordered supplies in anticipation of greater numbers of people seeking the vaccination this year, but has still been left short of supply.

    “I am getting more … so it’s not been too bad but we have had to change our system and reserve vaccine for people so they can come back,” he said.

    Despite the reports of shortages, pharmacy minister Steve Brine has claimed there was no flu vaccine shortage.

    Responding to a written parliamentary he said there was “no shortage overall”.

    In his response, Brine said NHS England wrote to community pharmacists and GPs in February 2018 to recommend they order aTIV for use in patients aged over 65 years this winter.

    He said NHS England also issued guidance in August 2018 for community pharmacies and GP surgeries to plan their flu clinics.

    MPs on the House of Commons Science and Technology have also said they have confidence in the current flu vaccination procurement system and say there is no reason for reform.

    In a into the flu vaccination service published on 16 October 2018, the committee said it was “reassured” that action has been taken to tackle shortages where they exist during this current flu season and said: “We see no reason why this arrangement should change.”

     

  • EMA to scale back work further after Christmas because of Brexit relocation

    The  as it relocates from London to Amsterdam because of Brexit.

    Announcing the introduction of the third phase of its plan to focus on core work during the run-up to Brexit, the EMA said it would have to pare down its operations even further in January 2019.

    Phase three of the  kicked in on 1 October 2018, but it said that it “anticipates that phase three will have to be complemented with additional temporary suspensions/reductions as of 1 January 2019”.

    The latest scaling back of work includes slowing down on guideline development and revision. The EMA is also expected to put non-product related working parties on hold from 1 November 2018.

     

     

An EpiPen brand adrenaline auto-injector

Small children prioritised under emergency protocol to tackle 'critical' EpiPen shortage

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.

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