Confusion reigns over EpiPen availability

Patient frustration at difficulty accessing EpiPens is understandable – but it’s unfair to call pharmacy “complacent,” says a leading pharmacist

Allergy and Anaphylaxis Australia chief executive Maria Said has told Fairfax Media’s Dana McCauley that the organisation is receiving a significant number of complaints from parents who are attempting to access EpiPen Junior for children with allergies.

“Many pharmacists have become complacent,” Ms Said told the Sydney Morning Herald and The Age

“During a crisis, they need to be calling wholesalers and placing an order every week – but many are not doing it unless pushed to by the consumer.

“We’re frustrated, customers are continuing to contact us.”

Ms Said later told the AJP that the shortages of EpiPen – which recently saw a shortage resolved, then followed by another – was “very frustrating for consumers,” but that she also understood that it was frustrating for pharmacists as well, “because the process has changed for them when ordering during a shortage”.

On February 6 2020, Mylan Australia issued a notice to patients, pharmacists and prescribers that there is sufficient supply of EpiPen Junior 150mcg adrenaline (epinephrine) Auto-Injector at wholesalers, as well as at Mylan’s warehouse, to meet current patient needs in Australia.

Mylan said that orders from wholesalers and pharmacies are being filled as they are received.

“As a result, EpiPen Jr 150 mcg Adrenaline (epinephrine) Auto-Injector has been removed from the Therapeutic Goods Administration’s Medicines Shortage Information Initiative website,” Mylan advised at the time.

However Ms Said told the AJP on Thursday that she still knew of patients who had to visit “four, five or six” pharmacies before they were able to find a store that was able to sell them an EpiPen right away, or order one with confidence that it would arrive within 24 hours.

“We’ve had people say that they’ve ordered – but some have been waiting nine weeks,” she said.

“Schools and child care services purchase them over the counter to put in their first aid kids; during a shortage they can’t access them, because they don’t have a prescription and that restriction is on.”

However now that the shortage is over, schools and child care providers are still being told that they can only purchase the product on a PBS prescription, she said.

“There are numerous issues, and I think we need better communication so that consumers can access lifesaving medicines. That’s critical to this – we’re not talking about a cream where there’s 10 other brands, we’re talking about life-saving devices.

“We need better pathways so people can have a reasonably streamlined process, instead of the challenges that we currently have.”

The Pharmacy Guild’s Victorian branch president, Anthony Tassone, told the AJP that pharmacists were working to address the issue, but that communication was indeed an obstacle.

“Community pharmacies across Australia have been experiencing an unprecedented level of medicine shortages across their dispensaries for quite some time and work tirelessly to do whatever they can to ensure patients receive the medicines and care they need,” he said.

“To accuse pharmacies of being ‘complacent’ is an indication of not having a full appreciation of the breadth of the issue and the many factors beyond pharmacy’s control.

“EpiPen products have been facing repeated and long standing supply interruptions from the manufacturer which pharmacies and patients have had to deal with for a while.

 “Whilst the TGA medicine shortage initiative website may not list a current shortage or indicate that a shortage has been resolved – there can be a lag time between; stock being available from the manufacturer, the stock being received from wholesalers who distribute to pharmacies, the wholesalers fulfilling back order or previous order commitments, and the stock actually reaching the pharmacy.”

Mr Tassone called for a broader conversation with government, manufacturers, health practitioners and consumers together to address the problem of medicine shortages, which he noted is not isolated to Epipen auto-injectors.

“Mandatory notifications by manufacturers to the TGA for critical medicine shortages in a certain time frame was a good first step, but it was only a first step with clearly more work needing to be done,” he said.

“It would be nice if the stock could immediately arrive in our dispensaries once a manufacturer had resolved their own supply problems – but sadly in reality that’s just not the case.”

Mr Tassone also said that the Guild would welcome the opportunity to meet with Allergy and Anaphylaxis Australia to help collaborate on providing best care to patients.

In December 2019, Mylan had also contacted healthcare professionals regarding access to Epipen Jr, letting pharmacies know that two batches of stock with trace levels of pralidoxime had become available to help address the shortage.

While this shortage is now resolved, at the time Mylan instructed pharmacies to place orders with wholesalers even if they wholesaler was showing a zero stock level, due to continual shipping to wholesalers; to phone wholesalers to request back orders if the wholesaler did not automatically place them on back order; and to refresh orders with wholesalers on a weekly basis.

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  1. George Papadopoulos

    Pharmacists are overwhelmed, perhaps burnt out, by the endless amount of out of stocks. They are not complacent. Why are there not any statutory expectations or even penalties for manufacturers who cannot take reasonable measures to ensure critical drugs are always available?

    • Karalyn Huxhagen

      exactly. I work as a lcoum and see pharmacies that use multiple different wholesalers just to try and stay ahead of shortages. at the moment you need a full time stock controller just tasked with searching out who has what.
      Myaln may have Epipen but it has not reached rural Qld at this point-probably due to the wholesalers clearing their back orders.
      we need another supplier of this product to come to market to improve the flow of the product.
      I remember having a discussion with a top dog of the company at APP a few yrs back about the shortage issue. His clear words was that Australia was a minute part of their worldwide business. So when products go short we were in the small end of the supply market. It did not give me or the Guild President standing beside me much comfort for Australia receiving stock as a priority

      • Paul Sapardanis

        To your last paragraph Karalyn, I wonder if the US has the stock outages as smaller markets that pay less? Just a thought.

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