Patients, carers and healthcare professionals with kits of the
opioid overdose medicine Prenoxad Injection must visually check for the
presence of two needles inside their kit. Any kits that do not have two needles
should be returned for a replacement
A small number of
kits of Prenoxad (naloxone) 1mg/ml Solution for Injection in a pre-filled
syringe, an emergency medicine for suspected opioid overdose, may be missing
needles, which would mean that some individuals may not be able to administer
life-saving doses of this medicine in an emergency.
The Medicines and Healthcare
products Regulatory Agency (MHRA) is urging patients,
carers and healthcare professionals who have kits of Prenoxad Injection for
emergency situations to visually check the contents of their kits by holding
the front of the sealed kit against a light source to confirm that there are
two (2) needles inside their kit. If the kit does not have two needles, it should
be returned and replaced. Detailed instructions and reference images on how to
visually check the kits can be found in the MHRA
patient letter.
If it is not
possible to confirm the presence of two needle packets visually, holders of
Prenoxad Injection can open their kits without touching the pre-filled syringe (the tube with
liquid in) to confirm there
are two needles inside each kit. Once the check is
completed, the kit must be carefully closed to ensure the contents stay secure.
People can ask a healthcare professional if they are
not sure how to visually check or physically open a Prenoxad Injection
kit.
Healthcare
professionals, services providers and local teams, including those involved in
needle exchange services, have been asked by the MHRA to contact people who
have been supplied Prenoxad Injection kits to ask them to check their kits for
missing needles, and to arrange a replacement if needed.
This issue was
detected when the manufacturer received reports from France of missing needles
in kits of Prenoxad Injection. These kits normally contain 2 needles along with
the pre-filled syringe containing the active ingredient (naloxone) and the Patient Information
Leaflet. Although there are no reports to date of kits in the UK with
missing needles, the potential for a small number of kits to have fewer than
two (2) needles cannot be ruled out. There is no evidence to date that this
manufacturing error has caused any harm to patients in the UK.
Dr Alison
Cave, MHRA Chief Safety Officer, said:
“Patient safety is
always our priority. It is vitally important that you visually check the
contents of your Prenoxad Injection kit and if there are fewer than two
needles, you should return your kit and obtain a replacement. If you have been
given a kit of this medicine since 27 March 2020 and are unsure how many
needles it contains, please seek advice from the healthcare professional or
service provider who supplied this kit.
“If needed, your
healthcare professional or service provider will give you a replacement kit or
refer you to their nearest supplier. This
will usually be a drug treatment service, a community pharmacy, a needle and
syringe programme, a peer support group, or a drugs outreach worker.
“We have taken
prompt action to ensure kits with missing needles will no longer be given to
patients. There are no concerns about the medicine in these kits and other
products containing naloxone have not been affected by this manufacturing
error. Please report any issues with your Prenoxad Injection kit via the Yellow
Card scheme website.”
Prenoxad Injection
is carried by people at risk of opioid overdose, or those who know people at
risk of overdose. It is used during emergencies at home, in non-medical spaces
or in healthcare facilities for the complete or partial reversal of respiratory
depression caused by natural and synthetic opioids including methadone, and
some other opioids such as dextropropoxyphene and certain mixed analgesics:
nalbuphine and pentazocine. Prenoxad Injection may also be used for the
diagnosis of suspected severe opioid overdose.
Further information
- Detailed
instructions and reference images on how to check Prenoxad Injection kits
for missing needles are included in the MHRA
patient letter.
- Anyone
experiencing or observing someone experiencing symptoms of opioid overdose
should immediately seek medical assistance. If there is nasal naloxone or
injectable naloxone (with a needle) available, it should be administered
according to the instructions in the kit. If someone has
symptoms of an opioid overdose and is not breathing, 999 should be called
and an ambulance requested immediately. General symptoms of opioid
overdose include pinpoint pupils, loss of
consciousness, respiratory depression (breathing slows or stops),
extremely pale face that may feel clammy to the touch, bluish purple tinge
to lips or fingernails, no response to noise, cannot be awakened, unable
to speak, vomiting and/or making gurgling noises.
