Anaphylaxis Campaign

Supporting people at risk of severe allergies

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Emerade Device Alert

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Thursday 11th July 2019

Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18). Pharmaswiss Ceska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.

The information below has been provided by the MHRA. Click here to visit the www.gov.uk website article.

Brief description of the problem

Bausch & Lomb UK limited has informed us of a risk of Emerade product failing to deliver a dose of adrenaline from the syringe due to blockage of the needle.

This issue was first detected in June 2018 during routine stability testing of the syringe component of Emerade, with potential to affect 1.5 in every ten thousand pens, and therefore considered a rare event. However, recent information indicates that the potential occurrence of needle blockage in batches on the market is higher than first estimated and we are therefore bringing it to the attention of patients.

The potential for units on the market to have a blockage of the needle which could lead to Emerade failing to deliver a dose when activated is now estimated to be 0.23 %, which would affect 2.3 in every thousand pens. (This estimate is based on simulated laboratory conditions without the auto-injector component which may lower the potential rate of failure to deliver.)

However, if the patient follows the existing advice to carry two in-date pens with them at all times, the risk of not being able to deliver a dose of adrenaline before the emergency services arrive is substantially reduced (from 0.23% to 0.000529%).

It should be emphasised that two pens are already recommended to be carried at all times in case the patient does not improve after the first injection which may occur for a number of reasons.

This notification of potential for needle blockage applies to Emerade devices of all strengths. It does not apply to the other marketed brands of adrenaline auto-injectors.

The Medicines and Healthcare products Regulatory Agency (MHRA) is not recalling batches of Emerade.

In the UK there are two alternative adrenaline auto-injector devices available. However, the different brands of adrenaline auto-injectors are not used in exactly the same way and therefore specific training and advice is required for each of the devices.

Furthermore, there are insufficient supplies available of alternative brands to support the removal of one brand.

The manufacturer conducted extensive investigations and has implemented corrective actions. Emerade manufactured with all the corrective processes is expected to be introduced into the market from mid-July 2019.

Updated Thursday 17th July 2919

How do I know if I have a faulty pen?

All Emerade pens currently on the market have a low risk of being defective but there is no way for the patient to tell by looking at an unused device that it is faulty. Users may be able to check if a dose of adrenaline has been delivered as expected by noting the following:

  • Before use, you can see the solution as clear and colourless in the viewing window of the pen by lifting the label.
  • If you need to use a pen and it works properly, you will see the plunger rod visible in the whole of the viewing window for the Emerade 300 mcg and 500 mcg autoinjector. The viewing window for the 150 mcg autoinjector will appear yellow from the plunger rod and spacer component of the autoinjector.
  • The plunger rod is of different colour for each strength of the Emerade autoinjector: blue for Emerade 500 mcg; green for Emerade 300 mcg and yellow for Emerade 150 mcg.
  • If it fails to activate properly, you may not see the plunger rod or the plunger rod may not ‘fill’ the whole of the viewing window as it would do normally. You may also see a yellow spacer, which is a component of the autoinjector, in the viewing window for Emerade with needle blockage. Please note however that you may still hear an audible click even it has not worked correctly.
  • It might be difficult to differentiate the viewing window for the 150 mcg Emerade pen between a successful activation (a pen without needle blockage) and unsuccessful activation (a pen with needle blockage). Therefore in all cases it is important that if you stlll feel unwell after your first injection you should administer your second pen without delay (5-15 minutes according to the patient leaflet). You should make sure you carry two devices at all times.

Pens are currently being manufactured with full corrective actions. The company has advised that Emerade manufactured with all the corrective processes will be introduced into the market from mid-July 2019. For enquiries regarding stock, please contact Bausch & Lomb Customer Services, Tel: 0208 781 2991 Email: [email protected]

Action for healthcare professionals and patients

Healthcare Professionals should contact all patients, and their carers, who have been supplied with an Emerade device to inform them of the potential defect and reinforce the advice to always carry two in-date adrenaline auto-injectors with them at all times.

This advice is provided in the approved patient information leaflet for Emerade, which should be provided to the patient or caregiver at dispensing.

Patients experiencing any problem with Emerade failing to activate should report this via the MHRA’s Yellow Card Scheme and keep the pen for further examination.

Additional advice to patients

Additional advice to reiterate to patients is to:

  • Check expiry date and replace the pen before it expires
  • Use the autoinjector at first signs of anaphylaxis
  • Call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna -fill-axis’)
  • Lie flat if possible with your legs up to keep your blood flowing
  • Use second pen if still unwell after 5-15 minutes

There is also a fact sheet with advice on the use of adrenaline auto-injectors which patients or carers are encouraged to read.

The risk of device mishandling or device failure exists with all adrenaline auto-injectors and is something that patients and carers should be aware of.

The chance of a successful outcome is increased if there is prompt administration of adrenaline at the first signs of anaphylaxis.

Even with an apparently successful response to adrenaline auto-injector administration, patients may relapse some hours later which underlines the importance that the emergency services should always be called.

Contact details for further information

For stock enquiries please contact Bausch & Lomb Customer Services:

Tel: 0208 781 2991 Email: [email protected]

For medical information enquiries please contact Lizanne Kombrink, Pharmacovigilance and Medical Information Officer:

Tel: 0208 781 5523 Email: [email protected]

 

If you have any questions, you can contact our helpline and information team at [email protected] or call 01252 542029 for support between Monday-Friday, 9am-5pm.

Prescription Charge Increase in England

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The Government has announced that the NHS prescription charge in England is set to increase by 20p to £9.00 from Monday 1st April 2019. The cost of a prescription prepayment certificate for 3 months will remain £29.10 and a prescription prepayment certificate for 12 months will remain £104.

The Anaphylaxis Campaign are part of the Prescription Charges Coalition and are campaigning to extend exemption from prescription charges to all those with long-term conditions in England. The coalition brings together over 40 organisations representing hundreds of thousands of people with numerous long-term health conditions.  We are involved as the current system, created in 1968, is unfair and very out-of-date, with some long-term conditions qualifying people for free prescriptions whilst others do not. This affects us at the Anaphylaxis Campaign because allergy often requires regular and long-term prescriptions which are not exempt from charges despite being essential to day to day quality of life and, in the case of adrenaline injectors, lifesaving.

The impact of paying for prescriptions whilst living with a long-term condition is both serious and widespread as the Prescription Charges Coalition reports show. You can read the reports here.

 

For further information on the Prescription Charges Coalition, and to get involved, visit the website: http://www.prescriptionchargescoalition.org.uk/

You can also show your support or share your experiences via Twitter at @prescriptionCC

 

If you have any questions, please contact our helpline on: 01252 542029 or [email protected]

Research – The impact of oral food challenges for food allergy on quality of life: A systematic review

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Background

Food allergy significantly impairs health related quality of life (HRQL). Currently, it is still unknown whether diagnostic interventions for food allergy improve HRQL. We aim to assess the impact of diagnostic interventions for food allergy on HRQL.

Methods

A systematic search was performed in MEDLINE, Embase, Cochrane Library, and CINAHL focused on patients with a (suspected) food allergy who underwent diagnostic interventions (ie, skin prick test, specific IgE, or oral food challenges [OFC]) and in whom HRQL was assessed. The mean difference between HRQL before and after the diagnostic intervention was calculated. A minimal clinically important difference of 0.5 was considered clinically relevant for the food allergy quality of life questionnaire.

Results

Seven of 1465 original identified publications were included in which the impact of an OFC on HRQL was investigated (total patients n = 1370). No other diagnostic interventions were investigated. Food allergy?specific parent?reported HRQL improved significantly after an OFC irrespective of the outcome in children with a suspected food allergy in two publications. The change was considered clinically relevant in one of two publications. In addition, parent?reported HRQL improved after an OFC to assess the eliciting dose in children with a confirmed food allergy. The parental burden was significantly reduced after an OFC to assess resolution of food allergy. A meta?analysis could not be performed due to the limited numbers of, and considerable heterogeneity between, eligible publications.

Conclusion

An OFC is associated with an improved food allergy specific HRQL and a reduced parental burden of food allergy.

Access the full paper here.

BSACI – Early Feeding Guidance

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The British Society for Allergy & Clinical Immunology ‘s Paediatric Allergy Group (PAG) and the Food Allergy Specialist Group (FASG) of the British Dietetic Association (BDA) have developed guidance for UK Healthcare Professionals on preventing food allergy in higher risk infants. This includes advice on the earlier introduction of potential allergenic foods into the infant diet to reduce the risk of food allergy.

This is guidance, not a guideline and is designed to provide practical advice on implementing the evidence available from the EAT, LEAP and other studies. The guidance complements the recent review and joint statement from the Scientific Advisory Committee on Nutrition (SACN) and the Committee on Toxicity of Chemicals in food, Consumer products and the Environment (cot) – “Assessing the health benefits and risks of the introduction of peanut and hen’s egg into the infant diet before six months of age in the UK, which acknowledge that targeted advice may be appropriate for infants at higher risk of developing food allergy.

The Early Feeding Guidance for Healthcare Professional can be accessed here.

A summary of the guidance can be accessed here.

North West Paediatric Allergy Network launch new online resource

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A new online resource has been developed in the North West of England to help parents, children and healthcare professionals with a range of information about children’s allergies.

The North West of England is home to seven million people or one eighth of the UK population. The region has 1.5 million children and it is estimated that one in four, or nearly 400,000, have allergic diseases.

The North West Children’s Allergy Network is coordinated by specialists in children’s allergies from around the North West region, working together with nurses, dietitians, primary care professionals and patient and carer representatives and is one of eight sites developed as part of the Royal College of Physicians’ Future Hospital Programme.

Dr John Dean, RCP Clinical Lead for Quality Improvement and Patient Safety, said:

“Having an allergy can significantly impact on both a child’s and parents’ life, but more than half of children who are thought to have an allergy to foods or medicines don’t. It’s really important that if you think a child does have an allergy that you make sure the diagnosis is right by talking to a health professional. This Network resource can provide help to all parents and children in the North West and help manage any allergy and put to rest any worries or concerns.”

Dr Peter Arkwright, North West Paediatric Allergy Network Chair, said:

“Working closely with parents has been really important in making sure the Network addresses the very real concerns that families have regarding allergies. Working alongside families allows us to ensure that we deliver healthcare which is responsive to the needs of all children and parents. The resources and information available, such as FAQs and access to healthcare professionals, helps empower patients in taking control of their allergy journey.”

Elaine Ward, Deputy Chief Executive of the Anaphylaxis Campaign, said:

“We are delighted that the North West Paediatric Allergy Network has been able to launch this new online resource to support people living with allergies, their families and healthcare professionals. As the only UK wide charity solely focused on supporting people at risk of severe allergic reactions, we believe that collaboration to encourage greater awareness and education about the risks of anaphylaxis is vital.”

The information includes FAQs for parents on allergies and detailed support on how to safely use medicine such as inhalers and adrenaline pens and is available at http://allergynorthwest.nhs.uk.

Our CEO attends House of Commons debate on ‘Allergy Awareness in Schools’

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Earlier this week on Wednesday 14th March 2018 our Chief Executive Lynne Regent was delighted to attend a House of Commons debate on ‘Allergy Awareness in Schools’.

Westminster Hall debates in the Grand Committee Room allow time for individual MPs to raise issues of importance to them through a series of Private Members’ general debates.

We are grateful for Jo Swinson MP, Member for East Dunbartonshire, who is herself at risk of anaphylaxis, for securing this time to debate this important issue which covered a wide range of topics including:

  • The need for further allergy awareness and education of children, parents and schools
  • The positive impact of the Human Medicines (Amendment) Regulations 2017 which allow schools in the UK to buy adrenaline auto-injector devices without a prescription to use in an emergency on children who are at risk of a severe allergic reaction known as anaphylaxis
  • Raising awareness more generally about allergies and anaphylaxis and the challenges in altering perceptions of allergy in the media
  • Allergy support in local communities and the role of the Department for Education and of the Department of Health and Social Care

In her speech, Jo Swinson MP paid tribute to Nicky Forrest who runs a support group for people at risk of anaphylaxis in her local area in conjunction with the Anaphylaxis Campaign, saying:

“At this point, I pay tribute to Nicky Forrest, a mum in my constituency who, in addition to all sorts of work on the parent council of a local school, runs a local support group for allergy sufferers and their parents so they can share their experiences, advise one another and campaign.”

We also would like to thank Jo for her praise of the “excellent work” done by the Anaphylaxis Campaign and other organisations to help schools “improve the work that they do”.

The Parliamentary Under-Secretary of State for Education Nadhim Zahawi MP, Member for Stratford-on-Avon concluded the debate by saying:

“We have much to be proud of in how we have moved forward to address the medical conditions of pupils in schools, but I recognise that there may be much more that we can do. I have arranged a roundtable with the Health Conditions in Schools Alliance to discuss in detail the issues that it feels still need to be addressed, to ensure that every young person has the best opportunity to reach their full potential. I am open-minded about what will hopefully be put in front of me. I will take my learning from this debate to that roundtable and ensure that we consider the issue of allergies in the round, alongside those of other medical conditions in schools.”

The Health Conditions in School Alliance is made of over 30 organisations, including the Anaphylaxis Campaign, other charities, healthcare professionals and trade unions who work collaboratively to make sure children with health conditions get the care they need in school.

Statement following the death of James Turnbull

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The Anaphylaxis Campaign was saddened to learn of the death of 15-year-old James Turnbull, who died after experiencing a severe allergic reaction earlier this year on Saturday 24th February 2018.

From the media reports we understand James took a bite out of a friend’s Chinese takeaway, not realising it contained traces of nuts, and experienced a severe type of allergic reaction known as anaphylactic shock.

Lynne Regent, Chief Executive of the Anaphylaxis Campaign, said:

“Our heartfelt condolences go out to James’ family at this difficult time. Sadly, we know teenagers and young people are a particular risk group of dying as a result of a severe allergic reaction. This is why we highlight that it is so important that people who are living with severe food allergies draw attention to these when eating out. We would also advise people with food allergy to avoid sharing food with friends without having checked the ingredients and cross-contamination risks first.”

We have more information and advice about eating out when you have 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.

Eating Out

By law, food businesses selling catered food (for example in restaurants, takeaways and hotels) are required to provide information on major allergenic ingredients, either in writing and/or orally. If information is provided orally, the food business will need to ensure that there is some sort of written signage that is clearly visible, to indicate that allergen information is available from a member of staff. Systems should also be in place to ensure that, if requested, the information given orally is supported in a recorded form to ensure consistency and accuracy.

You can find out more in our guide to eating out here.

Statement regarding the findings of the inquest of Shahida Shahid

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17th January 2018

The coroner’s inquest into the death of 18-year-old Shahida Shahid ruled yesterday a verdict of death by misadventure. Our Chief Executive was personally in attendance at the inquest in Manchester over several days to offer support to Shahida’s family.

We wish to make it clear that the Anaphylaxis Campaign are not legal experts; the primary reason we attend inquests are to offer support to families and to identify if there are specific lessons that can be learned to take forward into the work we do to support people at risk of severe allergic reactions.

Shahida was known to have eczema and an allergy to milk from an early age, later developing other allergies to egg, fish and nuts. She collapsed due to a severe allergic reaction following a visit to Almost Famous Burgers in Manchester, where she ate a chicken burger that had been marinated in buttermilk. Although a friend administered the adrenaline auto-injector that Shahida carried with her, she sadly suffered irreversible brain damage and died three days later in hospital on 12th January 2015.

Lynne Regent, Chief Executive of the Anaphylaxis Campaign, said:

“Throughout the coroner’s inquest I have been struck by the dignity of Shahida Shahid’s family, who last week were remembering the third anniversary since her death, and who have had to relive over the past few days the tragic circumstances which led to her dying.

It was clear from the evidence heard at the inquest that Shahida was an intelligent and sensible young woman, who did all the right things to minimise the risks of experiencing a severe allergic reaction, including carrying her emergency adrenaline medication, training her friends and family how to use it and informing people about her allergies.

In their conclusion, the jury raised that there was an issue of lack of communication in the restaurant in which Shahida ate. This is an important reminder to everyone within the catering industry that robust procedures need to be followed when people affected by food allergies draw attention to their needs when eating out.

We will be working with the local authority and other organisations involved in the inquest. We will also be writing to the catering companies that we work with to remind them about our best practice advice in light of the evidence we have heard.”

The role of the coroner and purpose of an inquest

We understand that the extensive media coverage of the inquest has raised several questions from our supporters about the role of the coroner and purpose of an inquest.

A coroner is appointed by a local authority and investigates deaths reported to them to find out who has died and how, when, and where they died. An inquest is a public court hearing held by the coroner to discover the facts about the circumstances of someone’s death. There are a very limited number of specific legal terms used to record cause of death, one of which is the term ‘misadventure’.

The coroner decides who should be called to give evidence as a witness. If a witness lives in England or Wales, they must attend if they are asked; if they live abroad, they do not have to attend.

An inquest is different from other types of court hearing because there is no prosecution or defence. The purpose of an inquest is to establish the relevant facts and cannot blame someone for someone’s death. The coroner or jury cannot find a person or organisation criminally responsible for someone’s death. For legal reasons, therefore, we cannot comment on certain aspects of any inquest.

The Ministry of Justice has produced a booklet called a ‘Guide to Coroner Services’ and if you are interested in the coronial process, you may find it helpful to read: https://www.gov.uk/government/publications/guide-to-coroner-services-and-coroner-investigations-a-short-guide.

Advice for people living with food allergy

By law, food businesses selling catered food (for example in restaurants, takeaways and hotels) are required to provide information on major allergenic ingredients, either in writing and/or verbally. If information is provided verbally, the food business will need to ensure that there is some sort of written signage that is clearly visible, to indicate that allergen information is available from a member of staff. Systems should also be in place to ensure that, if requested, the information given verbally is supported in a recorded form to ensure consistency and accuracy.

You can find out more in our guide to eating out for young people here: https://www.anaphylaxis.org.uk/young-people/young-people-help-a-guide-to-eating-out/.

Advice for the catering industry

We believe every member of your team needs some understanding of food allergy and its possible consequences and this should be incorporated into your staff training. Members of staff, who serve meals to customers, need to be able to offer accurate information about ingredients. If they are unsure of what is in a particular meal, there should be a procedure in place for finding out. There should be a designated person on duty during each shift that is able to answer questions about ingredients.

We have practical advice for the catering industry on our website: https://www.anaphylaxis.org.uk/corporate/corporate-protecting-allergic-customers/.

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.

Statement regarding inquest into the death of Shahida Shahid

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10th January 2018

We were very saddened to learn of the death of 18-year-old Shahida Shahid a few years ago. Our Chief Executive is currently attending the coroner’s inquest that has been taking place this week in Manchester to understand if lessons can be learned from this tragic case.

Shahida was known to have eczema and an allergy to milk from an early age, later developing other allergies to egg, fish and nuts. She collapsed due to a severe allergic reaction following a visit to Almost Famous Burgers in Manchester. Although a friend administered the adrenaline auto-injector that Shahida carried with her, she sadly suffered irreversible severe brain damage and died three days later in hospital on 12th January 2015.

Lynne Regent, Chief Executive of the Anaphylaxis Campaign, said:

“Our heartfelt condolences go out once again to Shahida’s family. The Anaphylaxis Campaign will continue to monitor this case very carefully as it progresses to understand if lessons can be learned from this tragic case.

It is vital that people living with food allergies draw attention to these when eating out and that all in the food service industry are fully trained and aware of the importance of dealing with food allergies correctly.”

The inquest began on 8th January 2018 and is expected to last at least eight days. We do not expect to release further comments until the conclusion of the inquest, when all the evidence has been heard.

By law, food businesses selling catered food (for example in restaurants, takeaways and hotels) are required to provide information on major allergenic ingredients, either in writing and/or orally. If information is provided orally, the food business will need to ensure that there is some sort of written signage that is clearly visible, to indicate that allergen information is available from a member of staff. Systems should also be in place to ensure that, if requested, the information given orally is supported in a recorded form to ensure consistency and accuracy.

You can find out more in our guide to eating out for young people 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.

Statement regarding Blackburn Magistrates’ Court hearing following the death of Megan Lee

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Yesterday two men appeared in court having been charged with manslaughter following the death of 15-year old Megan Lee on 1st January 2017.

Megan had eaten food from the Royal Spice Indian takeaway in Hyndburn, Lancashire on Friday December 30th 2016 before experiencing an apparent severe allergic reaction. She was admitted to Royal Blackburn Hospital but sadly passed away on New Year’s Day.

We understand at the brief hearing at Blackburn Magistrate’s Court on 4th January 2017, Mohammed Abdul Kuddus, 39, of Blackburn, and Harun Rashid, 38, of Rossendale, confirmed their name, age, address and nationality and were released on conditional bail.

The Magistrates have sent the case to Burnley Crown Court, where the men will appear on 7th February 2018.

Both men have been charged with manslaughter, one count of failing to discharge general health and safety duty to a person other than an employee and one count of contravening or failing to comply with EU provision concerning food safety and hygiene.

The company that owned the takeaway at the time of the incident, RS Takeaways Ltd, has also been charged with one count of failing to discharge general health and safety duty to a person other than an employee and contravening or failing to comply with EU provisions concerning food safety and hygiene. The company charges will also be heard at the crown court on the same date.

The Royal Spice Indian takeaway is now trading under new ownership.

Lynne Regent, Chief Executive of the Anaphylaxis Campaign, said:

“The Anaphylaxis Campaign will continue to monitor this case very carefully as it progresses and continue to support Megan Lee’s family who have worked with us tirelessly to raise awareness about severe allergies and anaphylaxis and have fundraised actively to support our work. It is vital 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 solely 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; and 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.