‘If nothing changes then nothing changes.’

Pharmacists report the worst shortages they can recall, as an AMA head suggests stockpiling of critical drugs and a return to Australian manufacturing

Patients are being slammed by the cost of paying for brand name drugs when generics have run out, a leading pharmacist has told the AJP, calling for a more “agile and streamlined” way of enabling pharmacists to substitute and maintain subsidies for patients.

This week mainstream media outlets have reported on the medicines shortage crisis, with the ABC’s Angela Ross writing that, “Australians with chronic health conditions are having to take drastic stop-gap measures because of a continuing medication shortage, medical specialists say”.

Attributing some of the problem to the COVID-19 pandemic, Ms Ross spoke to Adelaide endocrinologist Wilton Braund, who highlighted shortages of cortisone and carbimazole.

He noted that “desperate” pharmacists had been ringing international suppliers to attempt to source medicines and “then applying to access it through a federal special-access scheme”.

She spoke to Hobart pharmacy owner Rhys Jones, who said he had been using “time-consuming workarounds,” such as that he employed to deal with estradiol patches in shortage: “Instead of having one strength, which might be a 50mcg dose, patients have to use two 25mcg doses to get the same result, which means the box may only last two weeks rather than four weeks, so there’s a cost to the patient”.

Meanwhile Australian Medical Association national vice president Dr Chris Moy told The Australian that the pandemic had “exposed the fact that Australia has essentially relied on the world market because for other countries, it’s easier for them to manufacture drugs and at a cheap price”.

“We should be looking at far more reaching proactive intelligence and procurement ability, and also look at stockpiling critical medications if we need to,” he said.

“The pandemic has exposed that because of weak supply chains,” he told reporter Jess Malcolm.

The AJP spoke to Pharmacy Guild, Victorian branch president Anthony Tassone, who said that, “The issues outlined in the ABC online article have been reported on multiple occasions by members to the Guild, and I can say—have personally experienced repeatedly in my own pharmacy”.

“Members are reporting, and I personally agree, that they cannot recall medication shortages ever being as bad as it is now and probably getting worse,” Mr Tassone said.

“There’s multiple issues and consequences of the ongoing medicines shortage situation that are of concern to the Guild, our members and most importantly patients. 

“It is well known that cost can be a barrier for patients accessing healthcare and treatments including the out-of-pocket costs for medicines. 

“In situations where all generic brands are unavailable of a medicine, as has recently been the case with sertraline and for certain strengths of blood pressure lowering agent candesartan – it is unfair that patients are expected to be slugged the brand price premium for the originator brand for matters beyond the control of them and their local pharmacy.”

Mr Tassone noted that precedents exist for a temporary waiving of the brand price premium in the case of widespread shortages of generic brands – “but this process from the TGA and Department of Health simply must be more responsive and be enacted more quickly so that patients aren’t unfairly left more out of pocket than necessary”.

 “We also need to have a more agile and streamlined way of serious shortage notices to be authorised and issued by the TGA to allow pharmacies to substitute for different strengths or forms of a medicine and maintain PBS subsidies for eligible patients to ensure continuity of care,” he said. 

“As a continuing member on the TGA Medicine shortages working group, the Guild will continue to advocate in the interests of patients to ensure timely and affordable access to medicines and this would include PBS subsidy for eligible patients for imported brands of medications to fill short falls of brands that are not available in Australia.

“COVID is not solely responsible for our medication shortages issue – but has merely shone a spotlight on the frustrations and ongoing challenges that prescribers, pharmacies and patients have been faced with for years. 

“The last thing we need is to make a pandemic and health crisis worse with patients not being able to access their medication for treatment of potentially serious chronic conditions.

“It has gotten to the point where the Guild has assisted some members have their patients contact their local member of parliament to express concerns of the continual medication shortage issue for the Federal government to look at what other levels of intervention they can consider to mitigate gaps in accessibility.  

“If nothing changes then nothing changes.”

As for more on-shore manufacturing capability, Mr Tassone said that this “would certainly go some way to helping reduce the risk of medication shortages, but this is a complex problem without a simple solution”.

“But we must work together and continue to try and resolve it for the benefit of patients.”

Last week the AJP reported on new updates to the list of Section 19A approvals to import and supply medicines to address medicine shortages, including the approval of Sertraline 100mg tablets, USP (Cipla), Sertraline 50mg tablets, and Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg Film-coated Tablets (TEVA UK Ltd) to alleviate shortages.

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