Allergy patients who carry Emerade 500 microgram adrenaline
auto-injector pens should contact their prescriber and seek
replacement pens of a different brand.
Healthcare professionals are being asked to contact patients who
use Emerade 500 microgram pens following notification by the
Medicines and Healthcare products Regulatory Agency (MHRA).
Patients and/or carers should return all Emerade 500 micrograms
auto-injectors to their local pharmacy once they have obtained a
prescription for, and been supplied with, an alternative brand.
The recall is due to reports of difficulty in activating the
pens, meaning the dose of adrenaline may not be delivered when
needed by a patient for a severe, acute allergic reaction
(anaphylaxis). Most of the pens will still activate, but more
force may need to be applied.
The recall of Emerade 500 microgram auto-injectors follows the
previous recalls of Emerade 150 and 300 microgram auto-injectors.
More information on the previous alerts can be found on the
following links: 150mcg
recall and 300 mcg recall.
The pens were recalled in three phases to ensure there would be
enough supplies of the alternative pens, EpiPen or Jext,
available for patients.
Alternative brands of adrenaline auto-injector (EpiPen and Jext)
are available in a maximum strength of 300 micrograms.
There are data to show that a single EpiPen (300 microgram) or
Jext (300 microgram) pen will be a suitable replacement for a
single Emerade 500 microgram pen.
This is based on recently available results from a study that
compared blood levels of adrenaline following EpiPen 300
micrograms or Jext 300 micrograms with that following Emerade 500
micrograms. Patients should always carry two pens.
A MHRA spokesperson, said:
Action has been taken to protect patients, following detection
of a fault in one component of the Emerade adrenaline
auto-injector pens.
Patients should return all Emerade 500 microgram pens to their
local pharmacy once they have a new prescription and have been
supplied with pens of an alternative brand.
It is vital that patients follow existing advice to carry two
pens with them at all times and to contact their doctor when a
replacement is due.
When switching to a different brand of adrenaline pen the
patient must ensure they are familiar with how to use the pen
as each brand is administered differently.
Given the current COVID-19 pandemic, the MHRA in line with NHS
guidance, is urging patients who need to return auto-injector
pens to minimise additional burden on healthcare professionals
and heed the advice on social distancing.
-
a patient or carer should make a telephone appointment with
their doctor to request a prescription for replacement pens
of a different brand. Unless their doctor advises otherwise,
they should not visit the GP surgery in person
-
request the prescription is sent to a pharmacy to avoid
collecting in-person from the surgery
-
if a patient and/or their household is self-isolating, ask a
friend or relative to collect the replacement pens from the
pharmacy. Some pharmacies offer a home delivery service
-
once the patient has the replacement auto-injector pens
return Emerade 500 mcg pens to the pharmacy. Some pharmacies
have drop-off boxes to facilitate distancing.
At present, healthcare professionals are unlikely to be able to
help with face to face training but there may be opportunities
for remote consultations. Patients must take particular care to
read the instructions on how to use the pen which are in the
leaflet contained in the box.
The manufacturers’ websites for each brand of pen have
information and training videos on how to use the auto-injector.
Trainer pens can be obtained from the manufacturer and patients
are strongly urged to get these so they can practise with the new
device.
If an Emerade pen does need to be used before a patient is able
to obtain an alternative pen, it should be pressed very firmly
against the thigh. If this does not result in activation, the
patient should immediately use their second pen.
