By Narda Gilmore
December 04, 2019 13:28:45
Australia faces a critical shortage of child-sized EpiPens, the life-saving devices used to treat people undergoing a severe allergic reaction, prompting the Government to greenlight drugs that have failed quality standards.
- The Government is rationing the vital medical device used to treat severe allergic shock in children
- The EpiPen Junior shortage, caused by overseas manufacturing problems, is unlikely to be resolved until at least the end of January
- Parents of children with allergies are advised to use out-of-date or contaminated EpiPens in an emergency
The Federal Government has also restricted sales of the devices, and advised parents to use EpiPens past their expiry date.
The Therapeutic Goods Administration (TGA), which regulates medicines, has taken the extraordinary step of approving a batch of EpiPens that are known to be contaminated with another drug.
EpiPens inject adrenaline into people undergoing anaphylaxis, a severe reaction that can be fatal within minutes if untreated.
Stocks of EpiPen Junior, which is used for children who weigh 10 to 20 kilograms, began running low last month as a result of overseas manufacturing problems.
The Government has told pharmacists to supply just one junior device per patient until the shortage is over.
It is advising parents to use the EpiPen in an emergency, and then to use an expired one if a second dose is needed.
‘Extremely stressful’ for parents
Three-year-old Stefan Stipic has a long list of severe allergies, and his mother Maria says she is at her wits’ end trying to replace his emergency adrenaline.
“To have a situation where his life-saving medicine’s not … readily available is extremely stressful,” Ms Stipic said.
Stefan’s childcare centre will not accept an expired EpiPen, which adds to the urgency of the Stipic family’s problem.
“It’s resulted in me having to … get a letter from my GP to satisfy my son’s childcare that I’m doing everything I can to fill the script,” Ms Stipic said.
“I would say it’s a crisis. This is a life-saving medication and people need to have easy access to it.”
According to the TGA, supplies are unlikely to return to normal until at least the end of January.
In response, it has approved one batch of EpiPen Junior that failed to meet strict quality controls.
The batch is not yet available in Australia but it is known to be contaminated with traces of another medicine, Pralidoxime.
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The administration says a lack of EpiPens poses a greater risk to patients than minor exposure to the other drug.
Push for alternatives
The head of the Royal Australian College of General Practitioners, Harry Nespolon, said the decision was understandable, though the situation was not ideal.
“If a child’s having an anaphylactic reaction which will potentially result in their death, I think most parents would choose to give them the EpiPen even though it’s slightly contaminated,” he said.
EpiPens are the only products in Australia that allow patients to self-administer adrenaline — and the current shortage is not the first.
Doctors and groups representing patients have demanded an alternative supply, and Ms Stipic said having another option would bring great relief to families like hers.
December 04, 2019 07:23:58
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