EpiPen shortage putting children’s lives at risk
Outraged parents are calling for the government to allow competition to the EpiPen after being forced to use out-of-date and even contaminated stock over the summer months.
EpiPen is an auto-injection device that delivers set doses of adrenaline to help stop severe, sometimes deadly, allergic anaphylactic reactions.
It is the only form of auto-injection device available in Australia but recurrent shortages over the past three years have forced people to rely on out-of-date stock and even contaminated stock of the child's version, called EpiPen junior.
From November to the end of January, the only EpiPen junior stock available was contaminated with another drug but the Therapeutic Goods Administration advised parents to still use the contaminated stock in emergencies.
Melissa Mooney, whose 11-year-old son Jacob suffers from severe food allergies, set up parent group Food Allergy Goal to campaign to get a competitor to come into the Australian market to as a backup to relieve reliance on EpiPen, manufactured by Pfizer and distributed by Mylan.
"From our perspective as parents, this latest shortage was a whole level of extraordinary because of the fact they were giving us contaminated product," she told The Sunday Telegraph.
"It's beyond me how that is conceivably acceptable to inject your child who is in anaphylactic shock with a contaminated product, it was insane. Sure this cannot be the only option we have.
"Mylan has experienced issues time and time again, it's not completely reliable because they have let us down on a number of occasions.
"It is important to have a continuous supply. You need reliable supply of medication. There are alternatives and we really need to explore them."
Food Allergy Consultant Simone Albert, whose 14-year-old son Oliver also requires an EpiPen, organised a petition more than a year ago for a second autoinjector to come into the Australian market. She presented it to the federal government's inquiry in allergies last November.
"Other countries have options, we don't have choice and it's a big problem as food allergy is a chronic illness and life threatening," she said.
"We have had three shortages in the past three years."
Mount Annan mum Sarah Santoso, whose son Hudson, 3, and daughter Abigail, 8, are both anaphylactic, said she had great difficulty finding stock due to the shortage, so she kept expired EpiPens as a backup. EpiPens expire after 12 months.
"It was really hard to find one and that is why we don't throw old EpiPens out, if need be we would use the expired one, but the schools won't accept an expired pen. I don't know why there is a shortage," Ms Santoso said.
In 2018, the US Food and Drug Administration approved a generic version of EpiPen in the hope it would bring the price down. The generic is not available in Australia.
EpiPen in the US retails for $300 to $600 ($445 to $890) for a two-pack. In Australia, due to a cost agreement with the pharmaceutical benefits scheme, EpiPens are bought for $60. Patients with allergies can obtain two EpiPens on prescription subsidised by the government.
A pharmacist who asked not to be named said there was continual problems obtaining stock this week despite the Therapeutic Goods Administration lifting their shortage notice and Mylan confirming there was now plenty of stock available.
"They say they have stock but it's not adequate stock," he said.
"The shortages are every year, on a repeated basis and you can expect it to happen again this year."
Sydney Allergy specialist and Immunologist Dr Brad Frankum said a lack of competition in Australia was contributing to the problem.
"We don't have a manufacturer in Australia that is the first problem, therefore we are at the mercy of supply from overseas and they international markets presumably get serviced before we do.
"What we desperately need is for another company to start manufacturing a similar product."
Consumers have also complained of short-dated stock. Each EpiPen has a 12-month expiry but many are sold with less than that.
Immunologist Professor Connie Katelaris from Campbelltown Hospital said short dating was a common problem.
"That happens as a function of being at the mercy of overseas supplier that send us whatever stock," Prof Katelaris said.
"We know that the expiry date on the EpiPen is very conservative, they are good to use beyond that, but when there is an expiry on a product, it is hard for people to ignore that."
A spokeswoman for Australian distributor Mylan blamed the shortages on manufacturing delays from Pfizer's Meridian Medical Technologies and said there was plenty of stock now in Australia.
Pfizer said in a statement "the reasons for the current supply situation are complex and multi-faceted on a global scale. We have taken a number of steps to help resolve supply constraints, including continuing to make needed capital investments, further increasing hiring and training of a specialised workforce, and recently qualified a second packaging line to run in parallel with existing lines."