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Newcastle Herald
Newcastle Herald
Gabriel Fowler

Blanket drug ban weighs on patients' life and death battle against obesity

62-year-old Bridget, of Mayfield, says the blanket ban on pharmacy-compounded weight loss drugs will be a devastating blow to her efforts to get her health back on track. Pictures by Jonathan Carroll.

THERE is only one way forward, says Bridget, a 62-year-old Mayfield woman who is waging her own war against obesity, one kilogram at a time.

That is with the help of medication which will soon become unavailable to her, and tens of thousands of others.

From October 1, the federal government and Therapeutic Goods Administration's blanket ban on compounded weight loss medication will create serious supply hurdles.

Bridget underwent bariatric surgery two years ago which helped, she said, but eventually she started to gain weight again. Then she found Ozempic, which she considers a lifesaver.

"For me it's impossible to lose weight without it," Bridget said.

With it, she has lost 20 kilograms at a slow and sustainable rate which makes "a huge difference", she said.

"In terms of non-scale victories, just being able to cross your legs, that's a huge thing for me to just be like other people," she said.

"It's very depressing, when you get fat ... to do things, and to exercise is much more difficult, going out is much more difficult - you can't buy clothes, you're very self conscious, it's horrible ... there are a multitude of things which make life very difficult and depressing."

Stopping 'the food noise'

However, as more prescription drugs became less available, doctors would not prescribe it without a diabetes diagnosis, so Bridget turned to a compounded substitute, which stopped "the food noise".

Now that supply also looks likely to be cut off.

Dr Matt Vickers, a GP and clinical director for Eucalyptus, a digital only telehealth clinic, is calling on the government to come up with "a more nuanced approach".

In the midst of chronic shortages of a broad range of medications, the compounding of medications in regulated licensed pharmacies has been an excellent solution, Dr Vickers said.

"At the end of 2023, we saw a complete shortage of basically all of the available weight loss medications," Dr Vickers said.

"They were available internationally in other markets, but unfortunately the manufacturers were not making them available here in Australia.

"We had tens of thousands of patients then who were suddenly without medication and unable to access it, including a large number of diabetic patients."

Due diligence

A lot of effort went into doing the due diligence around whether it was an appropriate option to provide access through compounding, he said.

"We partnered with only a very select few of the compounding pharmacies who we already had existing relationships with, understood what their safety and quality standards were, and conducted a significant volume of testing ... through a number of different independent university laboratories ... which is above and beyond what the regulations around compounding actually call for.

"And it wasn't until we had that data and were confident around the safety and quality of these medications before we offered it to patients."

Replicas of the weight-loss drug Ozempic, compounded in pharmacies, will be banned in Australia from October 1. PIcture by Associated Press.

There was a "very brief, sudden" consultation period and process with a very select number of stakeholders about some "dodgy" backyard operations which existed before the medications shortage, already existing outside regulations frameworks, he said.

Calls for "nuance"

"The TGA has taken the decision to ban the compounding of GLP one medications more broadly because they're unable to stop what was occurring with the people that were already doing the wrong thing under the existing legislation and regulations that exist," Dr Vickers said.

An option was for a more collaborative approach with licensed pharmacies, with closer scrutiny and systems in place to manage the risks.

"We want to assure patients we're doing everything we can from our end to try and provide continuity of care so that they can continue on what is, for most cases, essentially a lifesaving medication for them," Dr Vickers said.

"Obesity is one of the biggest risk factors or contributors to chronic disease worldwide. We have a real problem here in Australia, so we're hopeful that in the near future we will see these issues resolved, and patients being able to access what they need, in a safe and high quality environment."

Without access to the medication, the result is straight forward, Bridget said.

"The ramifications are I'm going to get fat again, that's it," she said.

Supply update

The TGA says the pharmaceutical company that supplies Ozempic, Novo Nordisk, has recently advised the TGA and the Ozempic Medicine Shortage Action Group (MSAG) that supply will remain limited for the rest of 2024.

Ozempic is a brand of the medicine called semaglutid, delivered to patients via a weekly injection, subsidized on the Pharmaceutical Benefits Scheme for the treatment of type 2 diabetes under certain conditions.

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