Anaphylaxis Campaign

Supporting people at risk of severe allergies

DonateEMERGENCY INSTRUCTIONS

Supply Status of Emerade Adrenaline Auto-Injectors in the UK -Statement from Bausch + Lomb

by

We have received the following statement from Bausch + Lomb regarding the supply status of AAIs:

Bausch + Lomb is committed to helping ensure that patients have access to the medicines they need, and we are working diligently to help supply the market with this critical medicine. Over the last year we have seen a large increase in demand for our products due to supply issues with other Adrenaline Auto-injectors (AAIs) and we have worked very closely with our manufacturing partners to substantially increase production across our range of Emerade 150mcg, 300mcg and 500mcg Adrenaline Auto-Injectors to help support patients.

Emerade 500mcg (Adrenaline Tartrate)

Further volumes of Emerade 500mcg (Adrenaline Tartrate) will be available in wholesalers from 18th of October and we are working with our supply chain to ensure that this is optimized to be available to patients with a valid Emerade 500mcg prescription. The next shipment will be available in November.

Emerade 300mcg (Adrenaline Tartrate)

Further supply of Emerade 300mcg (Adrenaline tartrate) will be available in wholesalers on the 18th of October, and we are working with our supply chain to ensure that this is optimized to be available to patients with a valid Emerade 300mcg prescription. The next shipment will be available in November.

Emerade 150mcg (Adrenaline Tartrate)

There is an additional supply of Emerade 150mcg (primarily a paediatric dose) which should be available in pharmacy and wholesalers on Monday 14th of October. Bausch + Lomb advise that patients should seek advice from your Health Care Practitioner on suitable alternatives should your current AAI be unavailable.

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

Supply Status of Emerade Adrenaline Auto-Injectors in the UK -Statement from Bausch + Lomb

We have received the following statement from Bausch + Lomb regarding the supply status of AAIs:

Bausch + Lomb is committed to helping ensure that patients have access to the medicines they need, and we are working diligently to help supply the market with this critical medicine. Over the last year we have seen a large increase in demand for our products due to supply issues with other Adrenaline Auto-injectors (AAIs) and we have worked very closely with our manufacturing partners to substantially increase production across our range of Emerade 150mcg, 300mcg and 500mcg Adrenaline Auto-Injectors to help support patients.

Emerade 500mcg (Adrenaline Tartrate)

Further volumes of Emerade 500mcg (Adrenaline Tartrate) will be available in wholesalers from 18th of October and we are working with our supply chain to ensure that this is optimized to be available to patients with a valid Emerade 500mcg prescription. The next shipment will be available in November.

Emerade 300mcg (Adrenaline Tartrate)

Further supply of Emerade 300mcg (Adrenaline tartrate) will be available in wholesalers on the 18th of October, and we are working with our supply chain to ensure that this is optimized to be available to patients with a valid Emerade 300mcg prescription. The next shipment will be available in November.

Emerade 150mcg (Adrenaline Tartrate)

There is an additional supply of Emerade 150mcg (primarily a paediatric dose) which should be available in pharmacy and wholesalers on Monday 14th of October. Bausch + Lomb advise that patients should seek advice from your Health Care Practitioner on suitable alternatives should your current AAI be unavailable.

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

New Allergy Labelling Rules- Update from The FSA

by

Information on the scope of the new Allergy Labelling legislation was scheduled to be published by the FSA on the 1st October 2019 but due to Industry stakeholders raising further questions concerning the new rules, the FSA have decided to defer issuing information on the scope of the new legislation in order to provide more time to examine the issues raised. This includes exploring how the legislation sits with particular business models.

The intention now is that information on prepacked for direct sale food will form part of the FSA’s planned Technical Guidance, to be published by the end of this year. This additional period of engagement will not affect the legislation, which will still apply from 1 October 2021.

 

New Allergy Labelling Rules- Update from the FSA

Information on the scope of the new Allergy Labelling legislation was scheduled to be published by the FSA on the 1st October 2019 but due to Industry stakeholders raising further questions concerning the new rules, the FSA have decided to defer issuing information on the scope of the new legislation in order to provide more time to examine the issues raised. This includes exploring how the legislation sits with particular business models.

The intention now is that information on prepacked for direct sale food will form part of the FSA’s planned Technical Guidance, to be published by the end of this year. This additional period of engagement will not affect the legislation, which will still apply from 1 October 2021.

 

MHRA Issues Device Alert for Emerade

by

Thursday 3rd October 2019

The Medicines & Healthcare products Regulatory Agency (MHRA) has received reports of Emerade pens failing to activate. This means that the needle is not released, and the injection is not delivered.

This is different from the needle blockage issue that you are likely to have been informed about previously by your healthcare professional via a drug alert. This risk is expected to be resolved in all new stock manufactured since July 2019 that will now start to be released to the market.

The cause of the activation failures is being intensively investigated but is currently unknown.

Following discussions with alternative adrenaline auto-injector suppliers there are currently sufficient supplies available to meet historic demand. However, there are insufficient surplus devices to replace all the Emerade pens that would need to be recalled. Therefore, at present, the MHRA is advising that Emerade devices should not be recalled.

The activation failures have not been traced to any particular batches of product.

The MHRA understands that you will be very concerned that the pens in your possession may be affected.

It is important to note that based on all the information to date, the majority of pens will activate as normal.

If you do need to use an Emerade pen, as a precaution you should press the pen very firmly against the thigh. If this does not result in activation, you should immediately use your second pen. Information is provided below to illustrate what a non-activated pen looks like.

If a further dose of adrenaline is needed before the emergency services arrive, additional attempts should be made to administer a pen that has failed to activate. This is because reports received suggest that a pen may activate after further attempts.

You are reminded to carry two in-date pens with you at all times.

The MHRA and Bausch and Lomb UK Limited will provide updated information to healthcare professionals and affected members of the public as soon as it becomes available.

You can help us by continuing to report any issues directly via the Yellow Card reporting tool, https://yellowcard.mhra.gov.uk

Download the free Emerade mobile app. The free Emerade mobile is available for iPhone and Android phones and includes: Instructions for Emerade, Symptoms of anaphylaxis and Video demonstrations

*Download the app now by visiting the App Store or Google Play and search for “Emerade”.

 

Click here for instructions on how to see if your Emerade auto-injector has activated

 

Reporting a problem

It is easiest and quickest to report ADRs online via the Yellow Card website –

https://yellowcard.mhra.gov.uk/ or via the Yellow Card app available from the Apple App Store or Google Play Store.

Alternatively, prepaid Yellow Cards for reporting are available:

  • by writing to FREEPOST YELLOW CARD (no other address details necessary)
  • by emailing [email protected]
  • at the back of the British National Formulary (BNF)
  • by telephoning the Commission on Human Medicines (CHM) free phone line: 0800-731-6789
  • by downloading and printing a form from the Yellow Card website (see link above)

When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates, and product brand name.

 

Contacts 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 the Pharmacovigilance and Medical Information Officer, Tel: 0208 781 5523, Email: [email protected]

Further information on Emerade including use of the app can be found at https://www.emerade-bausch.co.uk/

 

The Anaphylaxis Campaign would like to reinforce the following advice;

  • Always carry two adrenaline auto-injectors with you at all times.
  • Ensure you have registered the expiry date of your devices on the relevant manufacturers websites to give you ample warning when a new prescription is required.
  • Ensure you gain a replacement device prior to disposing of any out of date devices.
  • Always make sure you have a trainer device which can be ordered from the manufacturer’s websites for free:
  • Make sure that your family and friends are familiar with the device you have and how to use it.
  • In an emergency call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna-fill-axis’).

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

IMPORTANT UPDATE: Extended Use-by Period for Specific Lots of Jext® 150mcg and 300mcg Adrenaline Auto-Injectors

by

To support and maintain an overall adequate supply, 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 link below.

Click here to see the affected lot numbers

Important: The extended use only applies to the lots of Jext® 150 mcg and Jext® 300 mcg autoinjectors 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.

If you have any questions, you can contact our helpline team at [email protected] or call 01252 542029.

IMPORTANT UPDATE: Extended Use-by Period for Specific Lots of EpiPen® 0.3mg Adrenaline Auto-Injectors

by

Mylan UK have obtained acceptance from the MHRA to extend the use of specific lot numbers of EpiPen® 0.3mg auto-injectors, by 4 months beyond the labelled expiry date. The affected lot numbers are listed in the link below.

Click here to see the affected lot numbers

Important: The extended use only applies to the lots of EpiPen® 0.3mg auto-injectors listed above. Patients can continue to use the EpiPen® 0.3mg auto-injectors of these specified lots safely until the extended use by date as stated above. This extended use does not apply to EpiPen 0.15mg auto-injectors or any lot number of EpiPen® 0.3mg auto-injectors not specified. Patients must continue to adhere to the labelled expiry date on any EpiPen not covered by the lot numbers above.

If you have any questions, you can contact our helpline team at [email protected] or call 01252 542029.

Adrenaline Auto-Injector Supply Update – Instructions for Schools

by

The following information has been taken from Mylan’s September 2019 EpiPen® supply statement.

Click here to read the full statement

 

To support children and young adults who may be at risk of anaphylaxis whilst away from home, the Human Medicines (Amendment) Regulations 2017 allows schools, without the need for a prescription, to purchase and hold supply of adrenaline auto-injectors.

Regulations allow the purchase of a reasonable number of adrenaline auto-injectors for use on an occasional basis and as required. Schools requiring a supply of adrenaline auto-injectors to be used in emergency situations are now able to order EpiPen 0.3mg and EpiPen Jr 0.15mg through Mylan’s distributor, Alliance Healthcare.

To place your order, please provide your local pharmacy with a letter, written on your school’s headed paper and signed by the principal or headteacher. The pharmacy will then send the request to Mylan’s distribution partner, Alliance Healthcare.

Please be reminded that the purchase of EpiPen 0.3mg and EpiPen Jr 0.15mg is currently limited to two devices per order.

 

If you have any questions, you can contact our helpline team at [email protected] or call 01252 542029.

Latest Update on Adrenaline Auto-Injector Supply in the UK – September 2019

by

24th September 2019

The adrenaline auto-injectors prescribed in the UK at present are Emerade®, EpiPen® and Jext®. They are designed for self-use and that is why they are usually referred to as ‘adrenaline auto-injectors’ or ‘AAIs’. We have been in contact with the pharmaceutical companies on the latest supply status and have had the following responses;

Emerade®

3rd October: The Medicines & Healthcare products Regulatory Agency (MHRA) has received reports of Emerade pens failing to activate. This means that the needle is not released, and the injection is not delivered. Click here to read more

14/10/2019: We have received a new update from Bausch & Lomb regarding Emerade supply – click here to read

EpiPen®

EpiPen®, has experienced manufacturing challenges which has resulted in interruptions in the production of EpiPen 0.3mg and EpiPen Jr 0.15mg Adrenaline Auto-Injectors (AAIs).

To help manage product availability on an ongoing basis until a steady supply resumes, Mylan assigned a prescription validation process for EpiPen 0.3mg, meaning patients can obtain up to a maximum of two EpiPen 0.3mg AAIs per prescription. The prescription validation process has now been extended to include EpiPen Jr 0.15mg.

Click here to read the full statement

Jext®

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.

To support and maintain an overall adequate supply, 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.

Click here to read the full statement

 

The Anaphylaxis Campaign would like to reinforce the following advice;

  • Always carry two adrenaline auto-injectors with you at all times.
  • Ensure you have registered the expiry date of your devices on the relevant manufacturers websites to give you ample warning when a new prescription is required.
  • Ensure you gain a replacement device prior to disposing of any out of date devices.
  • Always make sure you have a trainer device which can be ordered from the manufacturer’s websites for free:
  • Make sure that your family and friends are familiar with the device you have and how to use it.
  • In an emergency call 999, ask for an ambulance and say anaphylaxis (pronounced as ‘anna-fill-axis’).

 

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

Pret A Manger Set to Complete National Rollout of Full Ingredient Labels

by

Move follows launch of Pret Five-Point Allergy Plan earlier this year

24 September 2019

Pret A Manger (Pret) has today announced that all 391 of its UK shops will have full ingredient labels on all freshly made products by the end of the week.

Over the last six months, Pret has carried out one of the biggest operational changes in the business’s history, introducing full ingredient labels in shops across the UK, supported by new labelling technology and a comprehensive training programme on this development for over 9,000 Team Members.

As a result of the change, all of Pret’s freshly made sandwiches, salads, baguettes and soups are now labelled on pack each day with a full list of ingredients, with the presence of any of the 14 EU declarable allergens highlighted in bold.

The roll-out follows a successful pilot in two shops in London Victoria in the wake of last year’s inquest into the death of Natasha Ednan-Laperouse in 2016.

Since November, Pret Team Members have labelled over 30 million products, using two new pieces of equipment: individual recipe cards which enable Team Members to prepare food in kitchens on site and print off a bespoke label; and new tablets to keep a record of each product that leaves the kitchen.

The initiative forms a key part of Pret’s Allergy Plan, launched in May 2019. The plan, which is designed to help every customer with allergies get the best possible information about Pret food and drink, sets out five priorities for Pret to help people with allergies. These include the launch of new menu tablets in every shop, the removal of allergens from a range of Pret products, and a commitment to produce quarterly food safety reports. Earlier this month, the Government announced that new legislation will come into force in October 2021 which requires food businesses to fully label all food pre-packed for direct sale. The changes Pret has made come two years ahead of the new policy coming into effect.

Pano Christou, Pret CEO, commented:

“When we launched the Pret Allergy Plan, we said we would learn from the past and make meaningful changes to help customers with allergies. In less than a year, we have made the biggest change to Pret kitchens in our history. Software developers have created new labelling technologies. Walls have been knocked down to provide extra space in our kitchens. Electricians have been to every shop, weaving wires through some of the oldest buildings in the UK. It has been a real team effort. I know it’s been challenging for our shops while we’ve made all these changes. I want to thank every Team Member for what they have achieved. Our task now is to keep delivering on the Pret Allergy Plan. Pret’s commitment is absolutely clear: to make sure that every customer has the information they need to make the right choice for them.”

Tanya Ednan-Laperouse, of the Natasha Allergy Research Foundation, commented:

“One year on from Natasha’s inquest, we are extremely pleased that Pret a Manger has delivered on its pledge to learn the lessons and bring meaningful change for all allergy sufferers. Pret has shown that with a strong corporate determination to do the right thing, the food industry is capable of providing the necessary full allergen and ingredient labelling to give consumers the appropriate information and choices. Their research also shows 88 per cent of the public support Natasha’s Law, making it the most important priority for food retailers and customers amid the growing epidemic of allergies in the UK. Pret has taken the lead and we urge others to follow suit and prevent families in the future from suffering as we will always do.”

Lynne Regent, Chief Executive, Anaphylaxis Campaign commented:

“Millions of people are living every day with allergies – which is why we strongly believe full ingredient labelling is a necessary step. Pret has shown through the action it has taken that full ingredient labelling is possible in busy kitchens. We hope this will serve as an encouragement for other food businesses to follow suit ahead of the legislation coming into force.”

Bruno Nobrega, Manager of one of the first Pret shops to pilot the new labels, added:

“I’m incredibly proud of my team for showing that it was possible to label every single product in our kitchens. When we first started the trial last year, I thought it would take months for us to get used to a new system. My team proved me wrong and the feedback from customers has been brilliant.”