Anaphylaxis Campaign

Supporting people at risk of severe allergies

DonateEMERGENCY INSTRUCTIONS

The Anaphylaxis Campaign is saddened to hear of the death of Professor Anthony J. Frew, a key leader in allergen immunotherapy

by

November 2018

The Anaphylaxis Campaign is saddened to hear of the early and unexpected death of Professor Anthony J. Frew.  Professor Frew was a key opinion leader in allergen immunotherapy, with his research focusing on air pollution and on improving the care pathways for a better and early diagnosis of patients with allergies.

Lynne Regent said: “Our heartfelt condolences go out to his family and friends at this difficult time. Professor Anthony J. Frew was a great supporter of the Anaphylaxis Campaign and will be very much missed.”

Anaphylaxis Campaign CEO attends a roundtable meeting with Secretary of State Michael Gove to discuss allergen labelling laws

by

On Monday 26th  November Lynne Regent, CEO of the Anaphylaxis Campaign attended a productive roundtable meeting with the Environment Secretary Michael Gove, the Food Minister David Rutley, specialists, industry stakeholders, academics and clinicians.

Discussion focused on the review of allergen labelling following the death of Natasha Ednan-Laperouse who died after eating a baguette from Pret a Manger at Heathrow airport in July 2016. The coroner who presided over the inquest of Natasha Ednan-Laperouse concluded that the current legislation is not adequate and requested a review.

The Anaphylaxis Campaign welcomes the review and hopes the outcomes will make eating out for food allergic consumers as manageable and safe as possible.

 

What is the legislation for a food business that makes and sells food on the same site?

At present when a food business sells prepacked food for direct sale the same regulations apply as to non-prepacked food under the EU Food Information for Consumers Regulation No. 1169/2011 commonly known as EU FIR 2014, this means food business preparing their products freshly on their premises are exempted from the obligation of labelling them with a list of ingredients including the provision of allergen information. This is because it is expected that the customer is able to speak with the person who made or packed the product to ask about ingredients. All mandatory allergen ingredients information (the 14) should be available and easily accessible for the consumer and this can be communicated through a variety of means to suit the business format of the food business operator.

Emerade® 150mg and Jext® 150mg Adrenaline Auto-Injectors validation process no longer required

by

The Pharmaceutical Services and Negotiating Committee (PSNC) has released updated information confirming that from Thursday 29th November 2018 adrenaline 150 microgram auto-injectors will no longer be subject to additional validation processes. This applies to Emerade® 150mg and Jext® 150mg.

The Department of Health and Social Care (DHSC) has stated that stock levels are now at a level where the validation protocol put in place in October, and revised earlier this month, is no longer required. Please note, EpiPen products were subject to prescription validation prior to the protocol introduced in October and this will continue as before.

The PSNC has confirmed that community pharmacy teams will, therefore, be permitted to dispense the total number of adrenaline 150microgram auto-injectors prescribed to each patient. However, whilst stock filters through the supply chain, some wholesalers may still apply a restriction to ordering levels. Pharmacy teams may wish to discuss this with their usual wholesaler. To read the full article please click here.

For further information on the availability of adrenaline auto-injectors click here to full our latest statement.

Alternatively if you have any other questions or concerns please contact our Helpline and Information team at [email protected] or call 01252 542 029 for support between Monday-Friday, 9am-5pm.

The Anaphylaxis Campaign is shocked to hear of an airline passenger going into anaphylactic shock after consuming food containing sesame seeds on-board a flight.

by

Sonia Bagga, 39, went into anaphylactic shock after eating two bites of a chicken wrap that she didn’t know contained sesame seeds while on-board a BA flight returning home in September from a family holiday in Dubai. A doctor on board recognised the symptoms and reacted quickly by finding her adrenaline auto-injector and injecting her with adrenaline.

Lynne Regent said: “We hope Sonia has recovered both physically and mentally after what must have been a horrific experience. We urge individuals to continue to ask about ingredients when being served food, regardless of location and always carry your adrenaline auto-injector’s”

The Anaphylaxis Campaign provides medically informed advice and information via our clinical panel to help educate and empower the allergic community to take responsibility for their own safety when travelling.

If you have any concerns or further questions, please contact our helpline team at [email protected] or call 01252 542 029.

What advice does the Anaphylaxis Campaign recommend to people at risk of severe allergies when travelling?

We have a whole host of information available on our website including…

Aimmune Therapeutics, Inc. Publish Promising Results of Oral Immunotherapy Trial for Peanut Allergic Patients

by

The Anaphylaxis Campaign is delighted to hear about the success of Aimmune Therapeutics, Inc. Phase 3 PALISADE trial and publication of its results in the New England Journal of Medicine.

PALISADE (Peanut Allergy oral Immunotherapy Study of AR101 for Desensitization, is an international, randomized (3:1), double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of AR101 in patients with peanut allergy. PALISADE was conducted at 66 sites in 10 countries in North America and Europe, where 496 patients ages 4–17 received either AR101 or placebo (372 AR101, 124 placebo), along with 55 adults ages 18–49, who were not part of the primary analysis.

AR101 is an oral drug that delivers peanut protein. Through a desensitisation approach, increasing doses of peanut protein were given over a 6-month period in an initial dose escalation phase, reaching a dose of 300mg. A maintenance phase proceeded this, lasting for 24 weeks with patients continually receiving this 300mg dose of peanut protein.

In the trial’s primary analysis of peanut-allergic children and adolescents ages 4–17, AR101 treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo. The increase, which was measured through a series of doses in an exit food challenge, suggests that AR101-treated patients could expect to have protection against reactions to accidental peanut exposures.

“Trials like PALISADE are crucial to the help build confidence for people living in fear of a severe reaction to allergies. Small successful steps will help towards a brighter future, not only for people with peanut allergies but hopefully for all allergies” say Anaphylaxis Campaign Chief Executive Lynne Regent.

 

To read, NEJM publication of PALISIDE results click on the following link: https://www.nejm.org/doi/full/10.1056/NEJMoa1812856

The link below is to Aimmune’s full statement:
http://ir.aimmune.com/news-releases/news-release-details/landmark-palisade-trial-ar101-published-new-england-journal

Click on the following link to read about other treatments that Aimmune Therapeutics, Inc. are developing to help protect people with food allergies: https://www.aimmune.com/pipeline/

Links to the tree Leo’s Chapters

#LeosStory: Watch. Share. Raise awareness.

Chapter 3: Watch the animation on YouTube here.

Chapter 2: Watch the animation on YouTube here.

Chapter 1: Watch the film on YouTube here.

 

The Anaphylaxis Campaign provides information and support to parents and carers of children at risk of severe allergies through our free helpline and support groups run by dedicated volunteers.

Our helpline team is on hand to answer your questions about allergies and reactions and put your mind at rest over the things concerning you. Contact 01252 542029 or email [email protected] between 9am and 5pm, Monday to Friday with your allergy problems or questions.

Mohammed Abdul Kuddus and Harun Rashid have been jailed following the death of Megan Lee

by

Today Mohammed Abdul Kuddus was jailed for two years and Harun Rashid for three years after being found guilty of manslaughter last month.

After eating takeaway food containing peanuts from the Royal Spice Indian in Hyndburn, Lancashire on Friday December 30th 2016, Megan Lee began experiencing a severe allergic reaction. She was later admitted to Royal Blackburn Hospital but sadly passed away on 1st January 2017.

The judge, Mrs Justice Yip, said she hoped “the message is heard” and that food suppliers who fail to take proper care “will face significant custodial sentences if a death results”.

Anaphylaxis Campaign Chief Executive Lynne Regent says: “Our heartfelt condolences go out to Megan’s family at this very difficult time. We will continue to work with the food industry to highlight how vital it is that people living with severe allergies are provided with food that is safe for them to eat. It is extremely important that food companies learn from this tragic incident and the implications of getting it wrong.”

The Anaphylaxis Campaign is the only UK wide charity focused on supporting those at risk of severe allergies and anaphylaxis. We provide information and support to people at risk of severe allergies, their parents and carers, the food and pharmaceutical industries as well as healthcare professionals. Furthermore, we campaign and fundraise to achieve our ultimate aim, to create a safe environment for all people at risk of severe allergies.

For information and advice on the Food Information Regulations and eating out with severe allergies, visit our website.

If you have any concerns, please contact our helpline team at [email protected] or call 01252 542029

The Anaphylaxis Campaign is pleased to promote chapter 3 of Leo’s Story’, a short peanut allergy awareness animated film.

by

Welcome to Leo’s Story Chapter 3 which brings the latest results from the pan-European APPEAL (Allergy to Peanuts impacting Emotions And Life) Study to life.  The Anaphylaxis Campaign is a member of Team APPEAL which is a large two-phase study that is investigating the psycho-social impact of peanut allergy on the person with the allergy and their family members.

Chapter 3 reveals the daily life and emotional impact this food allergy has on children, young adults and parents. Anxiety, frustration and stress are just some of the emotional impacts that people are feeling. We encourage you to view this story and share with your friends

In the UK it is estimated that around 5 – 8 % of children have a proven food allergy with up to 1 in 55 children having a peanut allergy.

#LeosStory: Watch. Share. Raise awareness.

Chapter 3: Watch the animation on YouTube here.

Chapter 2: Watch the animation on YouTube here.

Chapter 1: Watch the film on YouTube here.

The Anaphylaxis Campaign provides information and support to parents and carers of children at risk of severe allergies through our free helpline and support groups run by dedicated volunteers.

Our helpline team is on hand to answer your questions about allergies and reactions and put your mind at rest over the things concerning you. Contact 01252 542029 or email [email protected] between 9am and 5pm, Monday to Friday with your allergy problems or questions.

Mohammed Abdul Kuddus and Harun Rashid found guilty of manslaughter following the death of Megan Lee

by

Today Mohammed Abdul Kuddus and Harun Rashid have been found guilty of manslaughter after failing to discharge general health and safety duty to a person other than an employee and of contravening or failing to comply with EU provision concerning food safety and hygiene.

After eating takeaway food containing peanuts from the Royal Spice Indian in Hyndburn, Lancashire on Friday December 30th 2016, Megan began to experiencing a severe allergic reaction. She was later admitted to Royal Blackburn Hospital but sadly passed away on 1st January 2017.

Anaphylaxis Campaign Chief Executive Lynne Regent has supported Megan’s family throughout this horrific ordeal. Lynne says: “The Anaphylaxis Campaign offers its deepest sympathies to Megan’s family and friends at this difficult time. We hope that lessons can be learnt from this tragic incident. We cannot stress enough how vital it is that anyone affected by food safety issues continues to report any problems to their appropriate Trading Standards or Environmental Health Officer.”

The Anaphylaxis Campaign is the only UK wide charity focused on supporting those at risk of severe allergies and anaphylaxis. We provide information and support to people at risk of severe allergies, their parents and carers, the food and pharmaceutical industries as well as healthcare professionals. Furthermore, we campaign and fundraise to achieve our ultimate aim, to create a safe environment for all people at risk of severe allergies.

We have more information and advice about eating out when you have a food allergy on our website here.

If you have any concerns or questions, please contact our helpline team at [email protected] or call 01252 542 029.

For further information, please contact our press office via [email protected] or call 01252 893 862.

IMPORTANT: Please read our further updated statement regarding the availability of adrenaline auto-injectors in the UK

by

We are aware that many people across the UK are experiencing issues when seeking to obtain adrenaline auto-injectors (AAIs), despite having a prescription for these devices and appreciate that this can be very worrying.

The Anaphylaxis Campaign has been in contact with the Department of Health, the Medicines and Healthcare products Regulatory Agency, the pharmaceutical industry and other key stakeholders to raise these concerns. We have contacted Bausch + Lomb UK who distribute Emerade®, Mylan UK who distribute EpiPen® and ALK-Abelló who distribute Jext® for an update on the availability of their AAI devices in the UK. The statements below set out the latest position.

If you have any concerns about your prescription we advise you should speak with your GP or pharmacist, you may wish to take this statement along with you for reference.

Availability of Emerade®

Emerade® is available in three doses; 150, 300 and 500 micrograms (adrenaline tartrate). Emerade 500 micrograms solution for injection (adrenaline tartrate) can be considered for adults in the UK for over 60kg bodyweight depending on clinical judgement. Bausch + Lomb provided us with the following information on 26th September 2018:

Bausch + Lomb is committed to helping ensure that patients have access to the medicines they need, and we are working diligently to help meet increased demand for this medicine.

Over the last 7 months we have seen a large increase in demand for our products due to the supply issues with Epipen 300mcg and in recent weeks an announcement of supply constraints on Epipen 150mcg.

We are working with our manufacturing supplier to increase production and produce as many units as possible but will not be able to supply the total demand that is normally delivered by other companies. Currently there is stock of both Emerade 300 micrograms and 500 micrograms solution for injection (adrenaline tartrate) in our UK wholesalers, and stock of Emerade 150 micrograms solution for injection (adrenaline tartrate)  will be available on the 27th of September for pharmacies.

You can reach Bausch + Lomb UK customer services via +44 (0)208 781 2920.

Availability of EpiPen®

EpiPen® is prescribed in two doses. EpiPen® 0.3mg, also known as ‘Senior’, is generally prescribed for adults and children above 25kg in body weight. EpiPen Jr® 0.15mg or ‘Junior’ is generally prescribed for children between 7.5kg and 25kg body weight. Mylan provided us with the following information on 29th October 2018:

We have received the following updated statement from Mylan regarding the availability of EpiPen® 0.3mg and EpiPen® Jr 0.15mg Adrenaline Auto-Injector.

Supply Overview

Our manufacturing partner Meridian Medical Technologies, a Pfizer company, continues to experience interruptions in the production of EpiPen 0.3mg and EpiPen Jr 0.15mg Adrenaline Auto-Injectors (AAIs).

We appreciate how important it is for individuals with life-threatening allergies to have access to adrenaline auto-injectors and understand the challenges this situation continues to pose for patients.

We will continue to proactively and diligently update pharmacies, healthcare professionals and patient advocacy groups across the country regarding any changes in stock availability.

The manufacturer, Pfizer, anticipates that supply of EpiPen 0.3mg will stabilise in the fourth quarter of 2018. The supply status will be continually reviewed by the manufacturer and the Department of Health and Social Care.

Essential Facts About EpiPen®

EpiPen has been available in the UK since 1996 and has been used to provide emergency treatment to those at risk of anaphylaxis.

The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health and Social Care in the United Kingdom, is responsible for ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy. The MHRA reviewed and approved EpiPen as a fit for purpose self-administration adrenaline auto-injector device for allergic emergencies, which includes approval of the product’s needle length and dosage.

We are aware that questions have recently been raised around the needle length and strength of adrenaline contained with an EpiPen auto-injector. The Resuscitation Council (UK) guidelines for “Emergency treatment of anaphylactic reactions”. were quoted in respect of the needle length and adrenaline dose for treating anaphylactic reactions. These guidelines state that they are for healthcare providers who are expected to deal with an anaphylactic reaction whilst working in a hospital or out-ofhospital setting. They are not intended to provide guidance to patients or carers when self-administering adrenaline through AAIs.

As with all medicinal products, safety data are collected in respect of EpiPen. These data are submitted to the MHRA. These data is kept under constant review and if there was evidence data to suggest there was a concern with either the needle length or the strength of the adrenaline in EpiPen they would be reconsidered.

In conjunction with the administration of an AAI to a patient, the emergency services should be called immediately. The controller should be informed that they or the patient is suffering from anaphylaxis and their guidance followed.

Training and education of patients, carers and healthcare professionals in respect of EpiPen is of paramount importance to ensure appropriate administration. Read the user guide and visit the EpiPen website to find practical advice to using your EpiPen, including a demonstration video.

If you need any further information, please contact our Medical Information team on +44 (0)1707 853 000 or email [email protected]

Availability of EpiPen 0.3mg Adrenaline Auto-Injectors

EpiPen 0.3mg is currently available.

To help manage product availability on an ongoing basis until a steady supply resumes, pharmacies are allocated product on a prescription-only basis and can place orders for up to a maximum of two EpiPen 0.3mg Adrenaline Auto-Injectors per prescription.

Patients should present their prescription to a pharmacy who will be able to place an order for up to a maximum of two EpiPen 0.3mg Auto-Injectors per prescription.

EpiPen 0.3mg Adrenaline Auto-Injectors – Extended Use Beyond Labelled Expiry Date for Select Lots

To address supply constraints of EpiPen 0.3mg, Mylan UK has worked with the MHRA to obtain its approval to the use of nine specific lot (batch) numbers of EpiPen 0.3mg Auto-Injectors beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below.

Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 20189.

This announcement is based on a careful review by Mylan and the MHRA of data about these specific batches provided by Pfizer. We believe the extension of the use of these nine batches beyond the labelled expiry date will temporarily improve patients’ access to and use of EpiPen 0.3mg Auto- Injectors.

The affected lots, which have labelled expiry dates between July 2018 and November 2018 are listed in the table below.

Lot Labelled Expiry Date (end of the month) Extended Use by Date
(end of the month)
6FA794J 07.2018 11.2018
6FA795Y 07.2018 11.2018
7FA112F 09.2018 01.2019
7FA106B 09.2018 01.2019
7FA283B 10.2018 02.2019
7FA251D 10.2018 02.2019
7FA250B 10.2018 02.2019
7FA265C 11.2018 03.2019
7FA265B 11.2018 03.2019

Important: the extended use only applies to the lots of EpiPen 0.3mg auto-injectors listed in the table above.

The extension of the use beyond the labelled expiry date does not apply to EpiPen Jr 0.15mg auto-injectors or any EpiPen 0.3mg lot numbers not specified above. Patients must continue to adhere to the manufacturer’s expiry date labelled on any EpiPen not covered by the lot numbers
above.

Further information

  • To make sure patients can access their medicines during this supply constraint, the period that the nine specific lots of EpiPen 0.3mg (listed above) can be used has been extended by a further four months beyond the labelled expiry date on the pack.
  • You can find the lot number on the end-flap of the box and on the EpiPen itself. If you’re unsure whether your EpiPen is affected, please talk to your pharmacist.
  • This extension of use beyond the labelled expiry date is based on data showing these nine batches of EpiPen 0.3mg auto-injectors will work just as well for this period. This has been reviewed by the UK medicines regulator, MHRA. EpiPen auto-injectors should continue to be stored as labelled on the pack.
  • As with all EpiPens, patients should periodically visually inspect the adrenaline solution through the viewing window to make sure the solution is clear and colourless. If it is discoloured or contains solid particles the EpiPen should be replaced as soon as possible.
  • At the end of the extended use beyond the labelled expiry date period (the end of the month
    listed in the right column above), you will still need to obtain a new auto-injector by the usual means.
  • Please note that the information provided in this letter supersedes any other communication that you may receive from the Expiry Alert Service.

EpiPen 0.3mg Adrenaline Auto-Injector – with an expiry date of February 2019

Pfizer recently made available to Mylan a limited volume of single and twin-pack EpiPen 0.3mg Auto-Injectors that will expire in February 2019.

This supply is not subject to the current prescription validation process, as previously outlined, and will be available for pharmacists to order and hold in stock. Pharmacies wishing to order EpiPen 0.3mg Adrenaline Auto-Injectors with an expiry date of February 2019 should refer to the “Instructions for Pharmacists” section below. The product meets all required quality standards and remains valid through the last day of the month (28 February 2019).

Availability of EpiPen Jr 0.15mg Adrenaline Auto-Injector

Mylan has recently received supply of EpiPen Jr 0.15mg Adrenaline Auto-Injectors and our distribution partner, Alliance Healthcare, are in receipt of this supply, which is now available for pharmacies to order.

Pharmacies are able to place orders for up to a maximum of two EpiPen Jr 0.15mg Adrenaline Auto-Injectors per prescription and should follow the Instructions for Pharmacists when placing orders.

A reminder that the extension of the use beyond the labelled expiry date for the nine lots of EpiPen 0.3mg listed above does not apply to any EpiPen Jr 0.15mg auto-injectors or any EpiPen 0.3mg lot numbers not specified. Please continue to adhere to the manufacturer’s expiry date labelled on any EpiPen 0.3mg not covered by the lot numbers above and all EpiPen Jr 0.15mg auto-injectors.

Information for Patients

Mylan is unable to make any specific treatment recommendation to individual patients. Patients should speak to their healthcare provider for appropriate actions to be taken. However, if you have a question about your EpiPen device please contact our Medical Information team who will be able to help you: +(0) 1707 853 000 or email: [email protected]

Information for Prescribers

To support patient access to the product during this supply constraint, we are encouraging healthcare professionals to manage prescription renewals diligently. Please note, when validating the expiry date of an adrenaline auto-injector, the product expires on the last day of the month indicated. For example, if it expires in February, it remains valid (not expired) until February 28.

Instructions for Pharmacists

Pharmacies that are presented with a prescription for EpiPen 0.3mg or EpiPen Jr 0.15mg Auto-Injectors can place an order for up to a maximum of two EpiPen 0.3mg or EpiPen Jr 0.15mg Auto-Injectors per prescription. Please send anonymized prescriptions for EpiPen 0.3mg or EpiPen Jr 0.15mg Auto- Injectors to Alliance Healthcare’s prescription validation service, either by Fax (0330 332 8126) or email ([email protected]). Please include your Alliance Healthcare account number when placing your order.

Pharmacies wishing to order stock of EpiPen 0.3mg Adrenaline Auto-Injectors with an expiry date of February 2019 can do this through the usual channels. There are currently two presentations available; a single device with a pip code: pip 8133308 EPIPEN 0.3mg (EXP 02/2019) and a twin pack with a pip code: pip 8001000 EPIPEN 0.3mg (EXP 02/2019). Please ensure you specifically reference these codes when placing your order.

You can reach Mylan UK customer services via +44 (0)1707 853 100.

Availability of Jext®

Jext® is prescribed in two doses. Adults and children over 30kg are generally prescribed 300mcg. Children between 15kg and 30kg are generally prescribed 150mcg. ALK provided us with the following information on Monday 23rd 22nd October 2018:

Supply of Jext® (adrenaline as tartrate) 150 mcg and 300 mcg Adrenaline Auto-Injector

There is currently a shortage of adrenaline auto-injectors in the UK. This shortage has been caused by intermittent supply issues of the most commonly prescribed brand and is affecting most countries in Europe.  It is anticipated that supply will stabilise in the fourth quarter (October to December) of 2018.  The supply status will be continuously reviewed by the Department of Health and Social Care.

ALK is working hard to help address the situation and has significantly increased production of its Jext® 150 mcg and 300 mcg adrenaline auto-injectors at its European manufacturing facility. However, due to the time needed for manufacture and the magnitude of the current deficit, it is not possible for ALK to completely meet the shortfall in supply in the short term.

ALK is working closely with its UK distribution partner Alliance Healthcare to ensure equitable distribution of supplies but it is likely that Jext® 150 mcg and Jext® 300 mcg will not be available at all times.

Extended Use Beyond Labelled Expiry Date for Selected Lots of Jext® 150 mcg and 300 mcg Adrenaline Auto-Injectors

To further ease the situation, ALK has obtained acceptance from the UK medicines regulator, MHRA, to extend the use of specific lot (batch) numbers of Jext® 150 mcg and Jext® 300 mcg auto-injectors, beyond the labelled expiry date by four months. The affected lot numbers are listed in the table below.

Affected lots (batches) for extended use of Jext® auto-injectors

No. Strength, mcg Lot (batch) no. Labelled Expiry Date (end of the month) Extended Use by Date (end of the month)
1 150 T4933 Jul 2018 Nov 2018
2 150 T5019 Aug 2018 Dec 2018
3 150 T5132 Aug 2018 Dec 2018
4 150 T5326 Sep 2018 Jan 2019
5 150 T5407 Sep 2018 Jan 2019
6 150 T5478 Sep 2018 Jan 2019
7 150 T5669 Oct 2018 Feb 2019
8 150 T5819 Oct 2018 Feb 2019
9 150 T5940 Oct 2018 Feb 2019
10 150 T6143 Nov 2018 Mar 2019
11 150 T6399 Nov 2018 Mar 2019
12 150 T6620 Nov 2018 Mar 2019
13 150 T6930 Dec 2018 Apr 2019
14 300 T4801 Jul 2018 Nov 2018
15 300 T4857 Jul 2018 Nov 2018
16 300 T5122 Aug 2018 Dec 2018
17 300 T5327 Sep 2018 Jan 2019
18 300 T5401 Sep 2018 Jan 2019
19 300 T5468 Sep 2018 Jan 2019
20 300 T5656 Oct 2018 Feb 2019
21 300 T5779 Oct 2018 Feb 2019
22 300 T5747 Oct 2018 Feb 2019
23 300 T5798 Oct 2018 Feb 2019
24 300 T5867 Oct 2018 Feb 2019
25 300 T6074 Nov 2018 Mar 2019
26 300 T6233 Nov 2018 Mar 2019
27 300 T6366 Nov 2018 Mar 2019
28 300 T6363 Nov 2018 Mar 2019
29 300 T6554 Nov 2018 Mar 2019
30 300 T6721 Nov 2018 Mar 2019
31 300 T6635 Dec 2018 Apr 2019
32 300 T6846 Dec 2018 Apr 2019

Important: the extended use only applies to the lots of Jext® 150 mcg and Jext® 300 mcg auto-injectors listed above.  Patients can continue to use the Jext® auto-injectors of these specified lots safely until the extended use by date as stated above.

This extended use does not apply to any other lot number of Jext® auto injectors not specified. Patients must continue to adhere to the labelled expiry date on any Jext® auto injector not covered by the lot numbers above.

This extended use of 4 months beyond the labelled expiry date for the specific lots is based on supportive stability data for Jext® auto injectors and has been reviewed by the MHRA.  The Jext® auto injectors of these specific lots will continue to work safely and as intended within the allowed extended use by date.

This announcement regarding the extended use of certain batches supersedes any notification that a patient may receive via the expiry alert service from www.jext.co.uk.

Information for Patients

  • Lot numbers and labelled expiry dates are marked on the side of the box and on the autoinjector label itself.
  • The specified lots of Jext® 150 mcg and 300 mcg autoinjectors will continue to work safely over the extended use period beyond the labelled expiry date.
  • If you are unsure whether your Jext® auto injector is affected, talk to your pharmacist.
  • The Jext® auto injectors should continue to be stored as labelled on the pack.
  • Towards the end of the extended use period (the end of the month listed in the right column of the table above), a new auto injector will still need to be obtained.
  • You should continue to check periodically the viewing window in the label of your auto injector to ensure that the liquid inside is clear and colourless. Do not use the autoinjector if the liquid is discoloured.
  • You should consult your doctor or pharmacist if you have any concerns regarding this announcement. ALK cannot give specific treatment advice to patients.

If you require additional information or have any questions, please contact ALK Customer Services: 0118 903 7940.

Anaphylaxis Campaign Frequently Asked Questions

How do I check the expiry date on my AAIs?

As some of the additional stock available in the UK at present has an expiry date of October 2018, we are advising patients to check the expiry date on their Adrenaline Auto-Injectors when they receive them and not to dispose of any ‘expired’ AAI devices before they have obtained a new device.

Your AAI devices will have instructions for use printed on the outside and generally will have a shelf life of up to 18 months. The expiry date will be printed on the casing. Each of the three companies who distribute AAIs run an expiry alert service. If you register your device and expiry date with them, they will send you a reminder when it is due to expire.

Whichever devices you have been prescribed, it is important that you keep your AAIs in their original containers to prevent light exposure, do not store them above 25°C and do not freeze them. If the liquid in your AAI appears cloudy or discoloured, it should be replaced with a new device. If the liquid in the device is not cloudy or discoloured, the AAI device can still be used in an emergency.

What should I do if I have concerns about my prescription during a supply issue?

If you are worried about your prescription, we advise you to visit your GP and discuss this directly with them. If necessary, your GP can prescribe an alternative medication.

What should my pharmacist do if they are experiencing issues?

Your pharmacist should contact the supplier of your AAI through their distribution partner e.g. Alliance Healthcare, or their customer service department directly for updates regarding any issues they experience.

I have been prescribed a new brand of AAI, what should I do?

We believe your GP or pharmacist should make sure you know how to use your new brand of AAI. You should also train anyone who might be required to administer it in an emergency, such as family members and friends. You can order a trainer pen to practice with and find further help on the website relevant to the medication you carry.

An Emerade® trainer can be ordered from the Emerade® website: www.emerade-bausch.co.uk

An EpiPen® trainer can be ordered from the EpiPen® website: www.epipen.co.uk

A Jext® trainer can be ordered on the Jext website: www.jext.co.uk

I have a different question, can you help?

In recent weeks we have received a dramatic increase in inquiries to our Helpline with lots of our members and the wider allergic community expressing concern on a range of topics. Our helpline and information team have answered some of the most frequently asked questions that we have recently received. Please click here to view these.

You can reach Bausch + Lomb UK customer services via +44 (0)208 781 2920.

You can reach Mylan UK customer services via +44 (0)1707 853 100.

You can reach ALK-Abelló customer services via 0118 903 7940.

 

After the dramatic increase in inquiries to our Helpline with lots of our members and the wider allergic community expressing concern on a range of topics our Helpline Team have answered some of our frequently asked questions which you can view here.

Alternatively if you have any other questions or concerns please contact our Helpline and Information team at [email protected] or call 01252 542 029 for support between Monday-Friday, 9am-5pm.

Stephanie talks to us about how glitter has helped her educate children all about severe allergies in her bid to improve allergy awareness in schools

by

In July of 2016, Stephanie and her family made the big move from Canada to Cardiff. For anyone, moving across oceans and time zones is an adjustment but for Stephanie there was another element to consider, her son William’s severe allergies.

Stephanie’s idea of raising awareness of severe allergies and anaphylaxis in schools began when William started school in Cardiff. ‘The allergy game in Canada is completely different, in schools there was training for all staff on how to use Adrenaline Auto Injectors and children are educated about the seriousness of allergies.’ Stephanie felt that when William first started his new school there was a lack of awareness around severe allergies, with William at times being excluded from activities where his allergens may be present. Understanding that education would be the key to improving this, Stephanie sat down with William and asked if he would be happy for her to speak in schools about creating a safer environment for all children with severe allergies. ‘I’m not trying to change the world to adjust to William’s allergies but instead raising awareness and empathy.’

With an idea in place to approach local schools and do a presentation on how everyone can keep those with severe allergies safe, Stephanie approached the Anaphylaxis Campaign with her plan. From here, Stephanie, with the help of the Campaign’s Information Team, developed a PowerPoint which helped create a Schools Allergy Awareness Pack. With the presentation ready, Stephanie started contacting local schools and offered to facilitate an allergy awareness lesson. With four lessons completed and more confirmed Stephanie is well on the way to achieving her goal of educating both children and staff of the seriousness of allergies and anaphylaxis.

Stephanie has come up with creative ways of teaching these subjects and has found materials to be her greatest friend. ‘I realised I needed visual tools to engage the children. I used glitter to highlight cross contamination by getting the children to put it on their hands and then shake each other’s hand to show how allergies can travel and why it is so important to wash your hands’. This great idea along with the PowerPoint and other activities sheets has enabled the children to learn all about allergies and how they can help not only other children who may be affected by these but also their teachers. ‘When there are thirty children in the class a teacher can’t keep an eye on all of them at once, teaching children the signs and symptoms of an allergic reaction enables them to notice if their friend is looking unwell and tell the teacher who can help’.

When asked what sort of things she hears a lot, Stephanie said that the children have asked if anyone can have an allergy. Stephanie mentions how referring to celebrities who have allergies is a great answer for this and also shows how it doesn’t have to stop anyone from doing anything, it just means you have to be a bit more careful. When asked if she has seen an impact from her lessons, Stephanie mentioned how William’s best friend, who like William is just six, has been great in telling his parents that they need to know how to use his Adrenaline Auto Injector and when William is round that they should avoid eating anything with his allergens in.

It is clear from talking to Stephanie that her son William has been a great driving force in the fantastic work she has been doing. ‘I am a mum of a child with allergies trying to make the world a bit better for him, allergies are not feared in our house.’ It certainly seems that William thinks his mum is great and has told Stephanie how proud he is of her. Armed with this and an ambition to keep going, Stephanie is keen to not only carry on her work within primary schools but is also hoping to start work on a presentation that can be used in secondary schools.

When asked what she would say to other people who would like to do a similar thing, Stephanie said ‘If I can do it, anyone can. Hearing the words ‘mum I’m proud’ makes the months of work all worthwhile. Even if you go into just one school you are raising awareness of allergies to those who may not know much about them’.

We can’t thank Stephanie enough for all the amazing work she has been doing. Here at the Anaphylaxis Campaign, we think Stephanie is an inspiration and cannot wait to see her continue her fantastic work!