Pharmacies making copycat Ozempic could face a ban — what does it mean for custom weight loss drugs?

Australia’s medicines regulator is considering restricting pharmacists from mass-producing copycat versions of drugs like Ozempic. (ABC News/Evan Young)

Pharmacists that mass-produce their own versions of popular weight-loss drugs have been put on notice after Australia’s medicines regulator warned of a crackdown.

Late last year, the ABC revealed several compounding pharmacists had been manufacturing unauthorised versions of Ozempic at scale and shipping them to customers across Australia, using a regulatory loophole.

Now, as revealed in an exclusive interview for a future Four Corners program, the Therapeutic Goods Administration (TGA), which regulates medicines in Australia, has proposed a change which would effectively ban compounded injectable weight loss drugs from being made or sold in Australia.

The change could affect thousands of patients — so here’s a breakdown of what we know, and what it means for you.

What are compounding pharmacists, and what is compounded medicine?

A compounding pharmacy is a specialist pharmacy that is able to create medications on-site and essentially “customise” them for patients.

Doctors might prescribe compounded medication for their patients if what they need isn’t commercially available, for example a liquid formulation for a child who can’t swallow a tablet.

Because pharmacists do this on a one-on-one basis, compounded medications are not tested for safety, quality or efficacy by the TGA.

Compounding is legal, but pharmacists need to follow strict regulatory guidelines that dictate when and why a medicine might be compounded.

It’s due to a grey area in these guidelines — which says existing medicines may be replicated when there isn’t a suitable commercial option — that some compounding pharmacies have been producing off-brand Ozempic and Mounjaro.

What are Ozempic and Mounjaro — and why are they used for weight loss?

The two drugs are approved for use in Australia for treating type 2 diabetes. Overseas they are available under different names and strengths for the treatment of obesity.

Ozempic (with the active ingredient semaglutide) and Mounjaro (tirzepatide) work by helping to control blood sugar levels in the body, in part, by mimicking a digestive hormone called GLP-1. They also slow the transit of food through the digestive tract, helping people feel fuller for longer.

This can help adults manage diabetes — and can also have the side effect of helping people lose weight.

Several large peer-reviewed studies have shown they can help people shed up to 15 per cent of their body weight, so doctors in Australia have started prescribing the medications “off-label”, for use in weight loss.

The drugs have exploded in popularity, leading to today’s global shortage.

Ozempic and Mounjaro are now facing rolling shortages and supply problems in Australia as a result of global demand and widespread off-label use for weight loss.

Why is the TGA proposing to stop compounding pharmacists making weight loss drugs if there’s a shortage?

The regulator is concerned about the safety and efficacy of drugs it has no control over.

The fact these medicines are being produced in large numbers, when compounded medicines are meant to be provided for individuals only, is another area the regulator is worried about.

The concern about manufacturing in bulk quantities is that if something goes wrong, it could affect a lot of people.

“Public health and safety concerns have emerged around the complexity and commercial scale of some compounding of extemporaneously prepared GLP-1 RAs, which are sterile medicines containing high-risk active substances,” the TGA said in a statement.

The TGA said it was also concerned about the unknown nature and safety of the ingredients used in manufacture.

Are compounded medications really that unsafe?

Short answer: we don’t know, because compounded medications aren’t individually tested for safety, quality and efficacy by the TGA.

Because they aren’t listed on the Australian Register of Therapeutic Goods (ARTG) there’s no requirement for side effects to be reported, so there’s no good record of how many people are taking compounded medications for weight loss, or what side effects they are having.

There’s another important thing the TGA is worried about: people on compounded weight loss medications may be less likely to report side effects at all.

This could be because they haven’t told people they are taking them, or because they may have gotten a script from an online telehealth provider instead of their regular GP, and they are worried that without that relationship patients may be less likely to complain if something goes wrong.

Pharmacy Guild president Trent Twomey said while there was “zero evidence to prove there is a safety concern” over compounded weight loss drugs, there was also “zero evidence to say that it is safe”.

He warned against punishing compounding pharmacists who were doing the right thing.

“They [the TGA] need to differentiate between the pharmacist that’s making a single product off a single script because the doctor needs it, the patient needs it, and it’s unavailable — and these few cowboys out there that are bulk manufacturing, because there’s a very big difference.”

Several compounding pharmacists the ABC has spoken to have argued producing off-brand weight loss drugs is helping patients access crucial medication they couldn’t get otherwise.

What’s the reaction been like from patients?

If the emails ABC has been receiving are anything to go by, people are very frustrated.

Those who have been using these medications have battled supply issues for more than a year. For many, compounding was the only option to continue treatment.

Although these medications can be highly effective for weight loss, studies have also shown when patients cease taking the drugs, most of the weight lost will be regained.

Weight cycling (repeatedly gaining and losing weight) can also be bad for your health, so patients who start on these medications are keen to secure an ongoing supply.

Consumers Health Forum CEO Elizabeth Deveny said it was understandable patients were frustrated and is calling on the government to do more to get a better supply of the brandname medications into Australia.

“What we’ve been hearing for some time now … is people who need Ozempic for their health, such as people with diabetes, have had a very difficult time getting access to that medicine,” Dr Deveny said.

What happens now, and what should patients taking compounded weight loss drugs do?

The TGA is consulting with stakeholders about the proposed amendments in the coming weeks.

The agency said it would consider all responses before a final decision is made by June 2024.

In the meantime, the TGA is encouraging patients to talk to their doctors to get more information.

The Royal Australian College for General Practitioners president Dr Nicole Higgins said it had been a challenging time for patients taking these medications.

“I urge them to speak with their local GP about the options that they have for supporting their weight change,” she said.

“The risk, though, of having an unregulated medication that’s being distributed throughout Australia that is not consistent with our national rules is of huge concern.”

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