EMERADE INJECTIONS

D R U G A L E R T
CLASS 4 MEDICINES DEFECT INFORMATION
Caution in Use – Action within 72 hours
Notification to Patient Level
Date: 11 July 2019 EL (19)A/17 Our Ref: MDR 55-06/18
___________________________________________________________________________________
Dear Healthcare Professional,
Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK
Limited)
Emerade 150 micrograms solution for injection in pre-filled
syringe
Emerade 300 micrograms solution for injection in pre-filled
syringe
Emerade 500 micrograms solution for injection in pre-filled
syringe
PL 33616/0013
PL 33616/0014
PL 33616/0015
(Adrenaline)
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. However, if the patient follows the existing advice to carry
EL (19)A/17 Page 2 of 3
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%).
* This estimate is based on simulated laboratory conditions without the auto-injector component which may
lower the potential rate of failure to deliver.
 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 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.
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 autoinjectors 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 system and keep the pen for further examination:
https://yellowcard.mhra.gov.uk/
Additional advice to reiterate to patients is:
 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
EL (19)A/17 Page 3 of 3
See https://assets.publishing.service.gov.uk/media/5b644e25ed915d377695c83d/AAI-PDFv4.
pdf for a sheet to provide to patients and carers in this discussion
 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 autoinjector administration, patients
may relapse some hours later which underlines the importance that the emergency services
should always be called.
Contacts for Further Information:
For stock enquiries please contact Bausch & Lomb Customer Services, Tel: 0208 781 2991
Email: Pharma_CS@bausch.com
For medical information enquiries please contact Lizanne Kombrink (Pharmacovigilance and Medical
Information Officer), Tel: 0208 781 5523, Email: Pharmacovigilance.UK@bausch.com
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.
NHS Regional Teams are asked to forward this to relevant clinics, general practitioners and community
pharmacists for information / action.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574

DRUG ALERT SUPPLY DISRUPTION ALERT

Page 1 of 5
Supply Disruption Alert
SDA/2019/004 Issued: 01 August 2019 at 10:30 Valid until: 30th September 2019
Emerade 500 microgram and 300 microgram adrenaline auto-injector devices
Summary
Emerade 500 microgram and 300 microgram devices, manufactured by Bausch & Lomb UK, will be experiencing a short-term disruption in supply:
• Emerade 500 microgram: is out of stock until the 28th of August.
• Emerade 300 microgram: limited supplies remain available but will be out of stock from early-mid August with further supplies expected by the end of September.
The following management plan has been developed in collaboration with NHS England, the British Society for Allergy & Clinical Immunology (BSACI), the Medicines and Healthcare Products Regulatory Agency (MHRA) and National patient groups.
Action
All health care professionals in primary, secondary or specialist healthcare services who prescribe, dispense or administer adrenaline auto-injectors (AAIs), or who advise patients and their carers, should ensure that:
1. All patients prescribed Emerade 500 microgram and 300 microgram AAIs are identified and in cases where they require replacements during the shortage period the following should be actioned:
a) Patients are reviewed to ensure their AAI prescription is still appropriate in line with existing guidance (see page 3 for further detail).
b) Patients are made aware that an AAI device can be used until the end of the month listed as expiry. Therefore, the product expires on the last day of month indicated e.g. a device labelled ‘August 2019’ does not expire until the 31st August 2019.
c) If replacement Emerade 500 microgram devices are required these should be replaced with a 300 microgram AAI device of an alternative brand and the patient should ensure they carry a minimum of 2 devices at all times. Those initially prescribed Emerade 300 microgram should have this replaced with an alternative brand in the same strength, when a new device is required. Please note, different brands of AAIs are not used in exactly the same way and therefore specific training and advice is required for each of the devices (further advice is provided on page 3).
d) Where there is no patient / clinician preference EpiPen should be considered as the first line alternative because although supplies of both the AAI alternatives (Jext and EpiPen) are currently available, supplies of Jext are unlikely to be sufficient to support a significant switch to this product.
e) Patients or carers are reminded to administer an AAI as soon as they experience symptoms of a severe allergic reaction and then call an ambulance stating they are having an “anaphylactic reaction”. Patients should administer a second auto-injector 5 mins after the initial dose, if no improvement is seen.
f) On the rare occasion, and by exception, at the clinical judgement of the prescribing clinician, that consideration is given to prescribing of a vial of adrenaline to be drawn up by the patient for self-
SDA/2019/004 Issued: 1 August 2019 at 10:30 Valid until: September 2019
MHRA Page 2 of 5
administration via the intramuscular route. It should be recognised that although this would allow administration of a dose larger than 300 mcg per injection, this will require specific training.
g) AAIs should only be prescribed and dispensed to those who truly need them, as any additional issuing to patients with sufficient supplies who are worried about the shortages could exacerbate the overall supply situation (see page 3-4 for further guidance).
h) Due to the shortage, we ask that, when renewing the adrenaline in your anaphylaxis kits, all staff are alerted to please stock ampoules (ensuring you also include dosing charts, needles and syringes) and not AAIs.
2. Prescribers should work in close collaboration with their local pharmacies to understand which AAIs are available. Prescribers and pharmacists should work together to ensure patients who are switched to an alternative device are trained appropriately and understand how to use the new AAI
Action, to be taken by
• General Practices
• Community Pharmacies
• Acute Trusts
• Community Trusts
• Mental Health Trusts
• Ambulance Trusts
Deadlines for actions
Actions initiated: 1 August 2019
Actions completed: 30 September 2019
Product details
Emerade 500 micrograms (adrenaline tartrate) solution for injection in pre-filled pen.
Emerade 300 micrograms (adrenaline tartrate) solution for injection in pre-filled pen.
Problem / background
There is a short-term supply issue affecting Emerade 500 microgram and 300 microgram AAIs. Bausch & Lomb are the sole UK supplier of Emerade devices in the UK. This is caused by manufacturing issues experienced by their Swedish manufacturing partner, relating to its production line, which has led to a temporary decrease in output.
New supplies of Emerade 500 microgram are expected by the end of August 2019 and we are working with Bausch & Lomb UK to try and improve this date.
Limited stock of Emerade 300 microgram is available. Currently, new supplies are expected by the end of September 2019.
The MHRA issued a Caution in Use drug alert on 11 July 2019 relating to a defect that has the potential to have affected Emerade pens currently on the market and may result in failure to deliver a dose of adrenaline due to needle blockage.. It is estimated that 2.3 in every 1,000 pens in circulation could be affected. 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%).
SDA/2019/004 Issued: 1 August 2019 at 10:30 Valid until: September 2019
MHRA Page 3 of 5
New stocks of Emerade (all strengths) manufactured after the 30th of June 2019 will incorporate all corrective actions taken to rectify the potential for blocked needles.
In the UK there are two alternative AAI devices available, EpiPen, supplied by Mylan and Jext, supplied by ALK. However, neither of these companies supply a 500 microgram strength AAI. Both companies manufacture 300 microgram AAI pens. Both companies are aware of the supply disruptions affecting Emerade 500microgram and 300 microgram AAIs.
Both Jext and EpiPen AAIs are currently available, however, supplies of Jext are unlikely to be sufficient to support a significant switch to this product and therefore where there is no patient / clinician preference EpiPen should be considered as the first line alternative.
The advice from national experts is, in the absence of Emerade 500 microgram, affected patients should be prescribed 300 microgram AAIs and advised to keep at least two pens with them at all times.
To ensure that patients are able to maintain access to supplies of 300 microgram devices throughout this time we have asked Mylan to continue with their prescription validation process for pharmacies to order supplies of EpiPen 300 microgram. Further details are available at: www.epipen.co.uk.
Supplies of all 150 microgram devices (Emerade, Jext and EpiPen) are unaffected and remain available in volumes to support normal demand.
Existing Guidance
This section summarises the existing guidance that the actions are based on. It is intended as an easy reference summary of the existing guidance. All prescribers should review current guidance for when to prescribe adrenaline auto-injectors for adults and children that has been developed by the Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI), and also refer to the guidance in BNF and provided by manufacturers as appropriate.
https://www.bsaci.org/Guidelines/adrenaline-auto-injector
Regulatory advice for two adrenaline auto-injectors as the norm for most patients, once a need for an AAI prescription has been confirmed, should continue to be adhered to:
https://www.gov.uk/drug-safety-update/adrenaline-auto-injectors-updated-advice-after-european-review
https://assets.publishing.service.gov.uk/media/5b644e25ed915d377695c83d/AAI-PDF-v4.pdf
All patients should be reminded that at the onset of symptoms of anaphylaxis, they should:
• Immediately use an adrenaline auto-injector device.
• Immediately call an ambulance (999) or send someone to do this. Say this is an emergency case of anaphylaxis*
*Please note- ambulances carry adrenaline 1mg/1ml (1 in 1,000) ampoules, which are not affected by the shortage
SDA/2019/004 Issued: 1 August 2019 at 10:30 Valid until: September 2019
MHRA Page 4 of 5
Consider if the initial prescription of AAIs is appropriate
Patients at risk of anaphylaxis that should be considered for long-term provision of an adrenaline auto-injector include those:
• who are allergic to high-risk allergens, for example nuts with other risk factors (such as asthma), even if the reaction was relatively mild
• who had a reaction in response to trace amounts of allergen/trigger
• who cannot easily avoid the allergen
• with continuing risk of anaphylaxis (e.g. food dependent, exercise-induced)
• with idiopathic anaphylaxis
• with significant co-factors (e.g. raised baseline serum tryptase)
The decision to prescribe requires a tailored, individual decision as part of a package of measures and is not a substitute for a referral to an allergy specialist. The decision to prescribe should be made by a clinician experienced in risk assessment in this context.
Adrenaline auto-injectors should be discontinued if the original prescription was inappropriate.
How many AAIs are required?
The majority of patients should have two AAI devices available at all times but there is existing flexibility within the prescriber information for the clinician, in exceptional cases, to prescribe one AAI, based on careful assessment of individual risk factors.
Which AAI devices can be used?
There are three adrenaline auto-injector devices available in the UK; EpiPen®, Jext® and Emerade® and all can be prescribed. The devices differ slightly in the administration technique and specific training is required for each device. The devices are not interchangeable without specific training on the device being issued to the patient. This is the responsibility of the prescriber and training may be accessed via pharmacists, practice nurses or allergy services.
The following links provide training materials for the different devices.
• EpiPen devices: http://www.epipen.co.uk/patients/epipenr-user-guide
• Jext devices: https://jext.co.uk/
• Jext 150 Training Video: https://www.medicines.org.uk/emc/product/5747/rmms
• Jext 300 Training Video: https://www.medicines.org.uk/emc/product/5748/rmms
• Emerade devices: https://www.emerade-bausch.co.uk/patient/how-to-use-emerade
• Emerade 150: https://www.medicines.org.uk/emc/product/5278/rmms
• Emerade 300: https://www.medicines.org.uk/emc/product/5280/rmms
• Emerade 500: https://www.medicines.org.uk/emc/product/5279/rmms
Adrenaline for anaphylaxis kits
• Some healthcare professionals may be holding Emerade, or other AAIs, in preference to adrenaline ampoules, to treat anaphylactic reactions; this should not be necessary.
• All healthcare professionals providing services where anaphylaxis treatment may be required, including but not exclusive to flu vaccination services, should have the competency to draw up and administer intramuscular adrenaline from ampoules with a normal syringe and needle.
Due to the shortage, we ask that, when renewing the adrenaline in your anaphylaxis kits, all staff are alerted to please stock ampoules (ensuring you also include dosing charts, needles and syringes) and not AAIs.
SDA/2019/004 Issued: 1 August 2019 at 10:30 Valid until: September 2019
MHRA Page 5 of 5
The Green Book and Resuscitation Council guidance provides additional advice to healthcare professionals on the use of adrenaline in response to anaphylaxis. Pharmacists providing vaccination services may also wish to refer to PSNC FAQs. Supplies of adrenaline ampoules are currently available and there is an expectation that healthcare professionals should use these in preference to the Emerade or similar devices.
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists; however, each organisation needs to ensure a senior clinician takes responsibility for coordinating all actions that need to be taken.
• General Practitioners
• Practice Nurses
• Chief Pharmacist
• Allergy specialists/allergy teams
• School Nursing/Medical Services
• Emergency Preparedness and Response Officer
• Medical Directors
• Pharmacists
• Paediatricians
• Paediatrics departments
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive Supply Disruption Alerts directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to the DH Supply Resilience Team, quoting reference number SDA/2019/004.
Email: supplyresiliencemd@dhsc.gov.uk

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