The Therapeutic Goods Administration (TGA) will release a batch of lower quality kids’ EpiPens in an attempt to reduce Australia’s critical EpiPen-Jr shortage. But it won’t arrive until December 17 and stocks just ran out.
EpiPen-Jr is a children’s version of the EpiPen, an adrenaline shot used to treat anaphylaxis and cardiac arrest. EpiPen Jr is distributed in Australia by pharmaceutical company Mylan, and manufactured in the United States by Pfizer company Meridian Medical Technologies.
Due to manufacturing delays from the contract manufacturer, Meridian Medical Technologies, a Pfizer company, EpiPen® Jr 150mcg Adrenaline (epinephrine) Auto-Injector is out of stock in Australia. Supply of EpiPen® 300mcg Adrenaline (epinephrine) Auto-Injector is not affected.
Until stock is available, parents and carers requiring an EpiPen® Jr 150mcg Adrenaline (epinephrine) Auto-Injector should seek guidance from their health care professional (GP or pharmacist).
Just to be clear. Stocks of the EpiPen Jr are all out.
Mylan’s advice for parents
Pharmacies across Australia were limiting supply of EpiPen Jr to just one per child. Doctors normally advise parents to have two EpiPens on hand in case emergency services are delayed. Many parents also choose to have one pen at home and one with the school.
In their statement Mylan provided these tips for parents who no longer have access to life-saving allergy medication:
- Be aware of how far you are from a hospital
- Reconsider travel/activities away from medical help/hospital locations
- Always have a mobile phone that is sufficiently charged
- Still carry an ASCIA Action Plan with you in case of emergency
Understandably, parents are furious.
“For anyone with children who have an EpiPen Jr. Be aware there is a shortage. Rant. This is the 2nd time in about 18mths I cant believe with such a life-saving medication that this can happen,” Michah Bryant wrote on Facebook.
TGA steps in
New stock of the full-quality EpiPen Jr is not expected to arrive until 31 January. That is why the TGA has taken an extraordinary step to increase the supply. It’s something they would very rarely do.
“Due to the critical nature of the ongoing EpiPen Jr shortage, the TGA is allowing one batch to be supplied that has not met all the required quality specifications,” the Administration said on its website.
“The TGA found several batches of Epipen Jr were affected by very low-level contamination with another medicine, pralidoxime. This was caused by a manufacturing issue between production batches of different products. The manufacturer has taken action to prevent the issue for future batches.
“Pralidoxime is used to treat people who have been poisoned by pest-control chemicals and its safety profile has been well established in humans.”
According to the TGA, the risk from reducing quality standards for the life-saving allergy medication is lower than that of not having adrenaline available to treat anaphylaxis.
Unfortunately, even that lower-quality supply of EpiPen Jr will not reach Australia until December 17.
Where to get help
People requiring an EpiPen Jr 150 mcg adrenaline (epinephrine) auto-injector should contact their local pharmacy and GP.
The risk from not having adrenaline available to treat anaphylaxis is high and people with responsibility for potentially affected children should familiarise themselves with the full range of advice provided by ASCIA.
We will continue to provide updates about the supply situation.
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