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9th March 2020
Mylan Australia has advised that despite there being sufficient supply of EpiPen®. unprecedented, disproportionate demand has meant that some pharmacies are experiencing supply delays and are seeing stock outages at some wholesalers,
To ensure equitable distribution of EpiPen® nationally, Mylan has commenced controlled supply to pharmacies. Pharmacies now need to call the Mylan EpiPen Customer Service hotline on 1800 931 625 to place an order for EpiPen®. Only orders placed by pharmacies via Mylan will be processed and stock will still be delivered to pharmacies via wholesalers.
25th February 2020
Mylan Australia has advised that there has been sufficient supply of EpiPen® Jr 150 microgram adrenaline autoinjectors since early February 2020 at wholesalers and at Mylan’s warehouse to meet current patient needs in Australia.
Orders from wholesalers and pharmacies are being filled as they are received. As a result, EpiPen® Jr has been removed from the Therapeutic Goods Administration (TGA) Medicines Shortage Information Initiative website. https://apps.tga.gov.au/prod/MSI/search#search-msis
There are currently no supply shortages of EpiPen® 300 microgram adrenaline autoinjectors in Australia or New Zealand.
Mylan Australia’s dedicated, toll-free EpiPen Customer Service hotline 1800 931 625 remains up and running for any enquiries.
To ensure that supply channels are aware of this news, Mylan has emailed the attached notice to pharmacists. The notice is also being distributed by the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia.
26th March 2020: There have been no changes to the PBS listing for EpiPen® adrenaline (epinephrine) autoinjectors. When accessing the PBS website http://www.pbs.gov.au/medicine/item/8698T it is important that prescribers are aware that they have to click on “Note” on the top left hand side of the webpage, to access the following information:
For more information go to https://www.allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-prescription
27th March 2020
Mylan has issued this letter in response to the recent announcement by the Food and Drug Administration (FDA) about safety issues for some EpiPen®, EpiPen® Jr, and generic products on the the FDA website This announcement relates to device malfunctions and user administration that may cause product safety issues with some EpiPen® and EpiPen® Jr, as well as their generic products.
On 24th March 2020 Pfizer and Mylan published a notification in the US about a very limited number of cases in which the administration of EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg autoinjectors, and their authorised generic versions of these strengths, may potentially be delayed or prevented. This notification resulted from routine studies and evaluation of real-world data that Mylan and its manufacturing partner Meridian Medical Technologies, a Pfizer company, undertake about how healthcare professionals, patients and carers administer EpiPen®, which is a critical life-saving device.
The information in this notification serves as an important opportunity to provide precautionary handling instructions and remind people with severe allergy and their carers about the correct administration of EpiPen®, and recommendation to carry two EpiPen® or EpiPen® Jr autoinjectors or the authorised generic version at all times. Potential issues and user errors are listed below.
- Device failure from activation caused by sideways force to remove blue safety release
In Australia and New Zealand there have been no reports of problems with the removal of the blue safety release. The advice in Australia and New Zealand is to hold the device in one hand (fist around the device) and remove the blue safety release with the other hand. Removing the blue safety release using sideways forces may activate the EpiPen prematurely. To prevent this premature activation, patients and their carers should to follow the clear instructions on how to use EpiPen® on the ASCIA website. https://www.allergy.org.au/hp/anaphylaxis
- Device failure from inadvertent or spontaneous activation due to raised blue safety release
In a very limited number of cases, EpiPen® devices may have a blue safety release that is slightly raised. The function of the blue safety release is to ensure the device does not activate prior to its intended use. It should not be removed until the time of use. If the blue safety release is raised the device may activate prematurely, which could potentially delay or prevent emergency treatment when needed.
If the blue safety release is raised, the autoinjector should NOT be dispensed or used, since premature activation may occur. Internal testing has shown that the probability of a raised blue safety release at 4.6 mm (height of the raised safety pin in the image below) resulting in spontaneous activation rate is 4 units in 1 billion. If the blue safety release is raised, contact Mylan (In Australia: 1800 274 276; In New Zealand: 0800 579 811), to obtain a replacement device at no additional cost. Return the device to the tube and close the lid. Do not attempt to force the blue safety release back down.
- Difficulty removing the device from the carrier tube
EpiPen® marketed in Australia and New Zealand is labelled and packaged in Australia using a different packaging process, so this issue is not relevant in Australia or New Zealand.
- Certain identified use errors
The issues identified in the US are not relevant in Australia or New Zealand because administration guidelines in Australia and New Zealand do not recommend the swing and jab technique, that is used in the US.
You may also report a side effect to a medicine directly to the TGA. For more information on how to report side effects to the TGA go to: https://www.tga.gov.au/reporting-problems
Mylan, the supplier of EpiPen® and EpiPen® Jr in Australia and New Zealand, has set up the following process to ensure people at risk of a potentially life-threatening allergic reaction (anaphylaxis) have access to the emergency treatment they may need when there is a shortage of adrenaline autoinjectors in Australia or New Zealand:
- Patients requiring an EpiPen® are directed to contact their local pharmacy.
To ensure people at risk of anaphylaxis have access to the treatment they may need during shortages:
- Only one autoinjector per patient is usually dispensed and supply may be restricted to patients with an autoinjector prescription for a new diagnosis, or because their autoinjector has expired or has recently been used.
- Schools and early childhood education/care (ECEC) centres should not request additional autoinjectors to be brought to the school or ECEC centre for each child at risk of anaphylaxis, and should limit the replacement of general use autoinjectors.
Whilst the use of an expired adrenaline autoinjector is not ideal, research suggests that recently expired devices retain potency. Therefore, if no other autoinjector is available, use of a recently expired autoinjector to treat anaphylaxis is advised, as stated on the ASCIA website allergy.org.au/hp/anaphylaxis/adrenaline-autoinjector-storage-expiry-and-disposal
- EpiPen® (300 micrograms) is usually prescribed for adults and children over 20 kg.
- EpiPen®Jr (150 micrograms) is usually prescribed for children 7.5-20 kg. Children under 7.5kg are not usually prescribed an adrenaline autoinjector.
Content updated 30th March 2020