5 December 2019:
ASCIA has been notified that EpiPen® Jr will not be available from 5 December 2019. See notice from Mylan Australia here. People who are newly diagnosed or who have used their last EpiPen® Jr may not be able to purchase an EpiPen® Jr device until stock arrives from the United States on 17 December or shortly thereafter. In light of this critical development ASCIA recommends that all remaining stock in pharmacies should be provided to newly diagnosed infants and children weighing 7.5-20kg, and those who have used their EpiPen® Jr and have no other dose available.
It was reported on the TGA website https://www.tga.gov.au/alert/epipen-jr that due to the critical nature of the ongoing EpiPen® Jr shortage, the TGA is allowing one batch of EpiPen® Jr, that has not met all the required quality specifications, to be supplied. This batch has been found to be affected by very low-level contamination with another medicine, pralidoxime. The TGA in conjunction with Mylan Australia has assessed the level of pralidoxime per EpiPen® Jr to be far below 0.1% of the usual dose for both adults and children. This was caused by a manufacturing issue between production batches of different medications. The manufacturer has taken action to prevent the issue for future batches. Pralidoxime is an antidote used to treat people who have been poisoned by organophosphates (a pesticide), and its safety profile has been well established in humans, including children. It is important to note that this batch is not yet available in Australia, but will hopefully arrive in Australia on 17 December or shortly thereafter. The TGA is working with Mylan Australia on details of its supply and will publish updated information as it becomes available. The conditional release applies to batch number 9KC652.
The TGA have reviewed data provided by Mylan Australia on the contaminated EpiPen® Jr batch and determined that the risk of not having adrenaline available to treat anaphylaxis is far greater than the risk of being exposed to a very small amount of pralidoxime.
Please note that supply of EpiPen® 300mcg adrenaline (epinephrine) autoinjectors is NOT affected.
Mylan Australia, the supplier of EpiPen® and EpiPen® Jr in Australia and New Zealand, has set up the following process to ensure that people at risk of a potentially life-threatening allergic reaction (anaphylaxis) have access to the emergency treatment they may need:
- Parents/carers requiring an EpiPen® Jr are to contact their local pharmacy.
- During this supply crisis only ONE EpiPen® Jr will be dispensed to each patient once the batch 9KC652 arrives from the United States.
Patients with an EpiPen® Jr that has recently expired should keep and use this EpiPen® Jr in an emergency according to instructions on the ASCIA Action Plan. Whilst the use of an expired EpiPen® Jr adrenaline autoinjector is not ideal, research suggests that recently expired devices retain potency. Therefore, if no other EpiPen® Jr is available, use of a recently expired EpiPen® Jr to treat anaphylaxis is advised, as stated on the ASCIA website allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-storage-expiry-and-disposal
To ensure that people at risk of anaphylaxis have access to the treatment they may need, ASCIA recommends that supply should be restricted to patients with an EpiPen® Jr prescription for a new diagnosis or where an EpiPen® Jr device has recently been used and there is no other EpiPen® Jr available.
Schools and early childhood education/care (ECEC) centres
ASCIA requests that schools and early childhood education/care (ECEC) centres take into account the current supply issues, by not requesting additional EpiPen® Jr devices to be brought to the school or ECEC centre for each child at risk of anaphylaxis, and to limit the replacement of general use devices at this time.
Where there is no alternative available ASCIA advises schools and ECEC that it may be necessary to accept recently expired EpiPen autoinjectors during nation-wide shortages.
Parents should be able to bring EpiPen® Jr devices to and from school each day with the child.
Parents and carers requiring documentation for schools and ECEC during the out of stock period can use this ASCIA document:
General advice during this EpiPen® Jr supply crisis:
- Identify your closest hospital and ways to access emergency care in your local area.
- Reconsider travel and other activities in remote locations away from medical help and hospitals.
- Always have a mobile phone that is sufficiently charged to call an ambulance.
- Carry an ASCIA Action Plan with you in case of emergency.
ASCIA recommends the following general advice to reduce the risk of allergic reactions:
- If possible prepare food at home and use fresh ingredients for meals.
- Always read ingredient lists and labels on packaged foods carefully and look for variations in ingredients.
- Make treat foods to take to social occasions/Christmas parties.
- Supervise young children around food at all times.
- For adults consider not consuming alcohol as this can diminish the level of supervision provided for children, and increase the risk of a food allergic adult accidentally consuming their food allergen/s.
- If eating away from home, take food that has been prepared at home.
Insect sting allergy:
- Always wear shoes outdoors.
- Avoid grass and gardens.
- Wear long pants and long sleeve shirts that are not brightly coloured.
- Drive with car windows closed.
Emergency treatment if you do not have an EpiPen
- ASCIA recommends calling 000 (Australia) or 111 (New Zealand) if a person has any signs of anaphylaxis (severe allergic reaction) after using an EpiPen (in date or expired) if available.
- If there is no access to adrenaline call an ambulance early if there are signs of an allergic reaction and you are uncertain if there are signs of anaphylaxis.
- Always follow the ASCIA Action Plan. Keep the person with allergy lying flat or sitting on the ground/lap with legs outstretched in front of them (not dangling).
- The person having an allergic reaction should not stand or walk as this can cause a sudden drop in blood pressure. Babies/children should not be held upright.
Prescribing of adrenaline autoinjectors
Clinicians should continue to provide prescriptions for EpiPen® Jr according to current ASCIA recommendations www.allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-prescription
While two EpiPen® Jr autoinjectors are usually prescribed, please advise parents/carers that only ONE EpiPen® Jr will be dispensed to each patient during this time, until Australia has normal stock levels.
ASCIA recommends that in public hospitals priority for dispensing EpiPen® Jr is given to patients who have received adrenaline in the emergency department and who have no other access to an EpiPen® Jr.
ASCIA does not recommend prescribing adrenaline ampoules in place of adrenaline autoinjectors due to the significant risk of overdose.
Optimal storage of EpiPen® and EpiPen® Jr
- EpiPen® should be stored between 15 ͦC and 25 ͦC, and out of direct sunlight. As temperatures in Australia far exceed 25 ͦC people need to be aware of where they keep/place their EpiPen®.
- If an EpiPen® is kept in hot locations for extended periods it is likely to be less effective if it has expired.
- Always try to keep EpiPen® in a cooler location out of direct sunlight during the summer months. Never store the EpiPen® in the car. If going camping or to the beach consider purchasing a temperature control device through Allergy & Anaphylaxis Australia’s online shop.
Can a higher dose of adrenaline be given to a young child if no EpiPen® Jr is available?
In Australia and New Zealand, there are currently two doses of adrenaline autoinjectors available:
- EpiPen® (0.3mg) is usually prescribed for adults and children over 20 kg.
- EpiPen® Jr (0.15mg) is usually prescribed for children 7.5*-20 kg.
*Whilst 10-20kg was the previous weight guide for a 0.15mg adrenaline autoinjector device, a 0.15mg device may now also be prescribed for an infant weighing 7.5-20kg by health professionals who have made a considered assessment. Use of a 0.15mg device for treatment of infants weighing 7.5kg or more poses less risk, particularly when used without medical training, than use of an adrenaline ampoule and syringe.
A general guide to adrenaline autoinjector dose:
- Children under 7.5kg are not usually prescribed an adrenaline autoinjector. If anaphylaxis is suspected only a 0.15mg device should be given. Higher dose adrenaline autoinjectors should NOT be administered to children under 7.5kg.
- In children weighing 7.5-20kg, a 0.15mg adrenaline autoinjector should be used. However, if only a 0.3mg device is available, this should be used in preference to not using one at all.
- ASCIA Guidelines for adrenaline autoinjector prescription are available at www.allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-prescription
We thank you in advance for your consideration of others at this challenging time.