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Critical drugs could be rationed following EpiPen shortage

Critical medicines could be rationed in Australia in the wake of an EpiPen shortage that left some allergy sufferers without emergency treatment.

The EpiPen crisis, which saw pharmacies around the country drained of stock, is just one of a growing number of shortages of essential medicines, often sprung on patients with no notice.

New laws being considered by the federal government could force drug companies to report all shortages to Australia’s drug regulator as soon as they are anticipated, triggering rationing in serious cases.

Pharmaceutical companies that do not comply could be named and shamed, or face significant fines, under the potential legislation to be introduced next year.

More than 200 drug shortages were being reported this week by the Therapeutic Goods Administration, but the real figure is likely to be more than 1500. It includes antibiotics, chemotherapy drugs, diabetes medication and painkillers used in surgery.

Dr Bastian Seidel, president of the Royal Australian College of General Practitioners, said doctors received no advance warning of the EpiPen shortage, and the same thing often happened with other crucial medicine supply issues.

“We just find out on the hop when the pharmacist or local chemist calls and says ‘I can’t get it’,” Dr Seidel said.

The EpiPen shortage dragged on for months, exposing some adults and children at risk of anaphylaxis, a life-threatening allergic reaction.

Although the problem was first reported in November, Australia’s only supplier of adrenaline auto-injectors, Mylan, did not officially notify the Therapeutic Goods Administration until January.

Disability carer Ali Hogg said she didn’t know about the issue until she went to the pharmacy to buy an EpiPen in February.

They were all out, with a massive waiting list.

Having already thrown out her expired EpiPen, Ms Hogg, who is allergic to garlic, was forced to go almost two months without the lifesaving device.

When she eats garlic, “my throat swells up and it restricts my breathing”, Ms Hogg said. “I could definitely die.”

She was eventually able to order an EpiPen through a hospital pharmacy.

Mylan are now shipping thousands of EpiPens into the country every week, however some pharmacies were still reporting this week that they were yet to be restocked.

A Mylan Australia spokeswoman said the shortage was the result of manufacturing delays involving manufacturer Meridian Medical Technologies, a company of pharmaceutical giant Pfizer.

It is not always clear what prompts medicine shortages. The Therapeutic Goods Administration said that due to the increasing global nature of supply chains, drugs were sometimes made by the same manufacturer. So when that manufacturer encountered problems, it affected multiple drug suppliers.

Last year it was a manufacturing problem that saw hospitals forced to ration a powerful painkiller used in millions of operations, while an oestrogen patch shortage hit women with menopausal symptoms.

Earlier this year, there was a shortage of the antidepressant medication duloxetine after some generic manufacturers suddenly discontinued the product.

Anthony Tassone, from the Pharmacy Guild of Australia, said customers were forced to visit multiple pharmacies or go back to their doctor to be prescribed a different drug.

“When you have a medication that is used to treat a mental health condition become in short supply, some patients become anxious, which is the last thing they need,” he said.

In Australia, pharmaceutical companies have been given the opportunity to report their shortages through a voluntary system, but a number have failed to do so, despite the impact on patients being considered extreme.

Mandatory reporting would not prevent the shortages occurring, but experts say it could help doctors and the government prepare advice on alternatives and, in the most serious cases, to ration essential drugs.

It would also give competing suppliers advance warning so they could prepare for flow-on demand.

The TGA is seeking views on how a new mandatory medicine shortage alert system should work, which drugs and devices should be included, and possible penalties, ahead of the proposed new laws to be introduced next year.

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