The Therapeutic Goods Administration (TGA) will move to ban compounding pharmacists from making their own versions of injectable weight loss drugs due to concerns the compounded products may not be safe or effective.
The skyrocketing demand for drugs such as Ozempic and Mounjaro, which are approved for diabetes and widely used off-label for weight loss, has led to global supply problems and chronic shortages in Australia.
Last year, the ABC revealed the shortage was enabling Australian pharmacists to use a regulatory loophole to replicate the brand name drugs and ship them to consumers with a script across the country.
Now the TGA has unveiled a proposal to immediately stop pharmacists from being able to compound GLP-1 type medications including semaglutide, the active ingredient in Ozempic.
In a confidential letter to stakeholders obtained by the ABC, the TGA said the current exemptions were not designed to allow commercial-scale manufacturing driven by patient demand for weight-loss medications.
Compounded medications are normally custom made on a one-on-one basis and are intended to help individual patients access medication that is in shortage or is not available in a suitable form.
The agency said high-volume online prescribing models were “leaving large numbers of patients exposed to unregulated medicines … where the safety and quality of these provided medicines cannot be assured.”
The most high-profile telehealth company to provide compounded products is the Woolworth’s-backed Eucalyptus, which owns the brands Pilot and Juniper.
Last year, the startup announced patients would be supplied with syringes containing a compounded version of semaglutide, which is the active ingredient in Ozempic amid ongoing supply issues.
In a statement today, Eucalyptus clinical director Matt Vickers said the company commissioned expert testing of the compounded medications it sells and that “the substances are safe, stable and efficacious for patients to use”.
A number of other telehealth providers, as well as individual practitioners, have been prescribing and selling compounded weight loss medications since last year.
In an exclusive interview with the ABC’s Four Corners program for an investigation to air later this year, TGA chief medical advisor, adjunct professor Robyn Langham, explained the regulator’s concerns.
“What’s happening, we believe, is that there is a large amount of product being developed in anticipation of medications being prescribed and that’s not consistent with the exemption under the Therapeutic Goods Act,” she said.
“The exemptions clearly state that the pharmacist can produce an individual product for an individual patient once prescription has been received.”
Risks to the public
In the letter to stakeholders, the TGA outlined its key concerns, including that the side effects of compounded weight loss drugs were not being recorded.
“Unlike for manufacturers and sponsors of TGA-approved medicines, there is no legal obligation for prescribers and pharmacists to report clinically significant adverse drug reactions to a regulator.
“Additionally, consumers may be less likely to report adverse drug reactions from medicines that have been sourced from online prescribing sites, outside of the care of their usual doctor.”
The letter also conceded there had been challenges enforcing product quality standards in compounding operations.
“There is a potential for significant quality issues, such as bacterial and fungal contamination due to poor compounding practices,” it said.
What should patients do?
Professor Langham urged patients who have compounded GLP-1 medications in their possession to contact their doctor for advice.
“Patients should discuss with their doctors what they need to be doing,” she said.
“Our advice has always been that these drugs are unknown and that we can’t tell people whether they work. And it’s really the safety aspect that concerns us most.”
She said the TGA would continue to investigate any company producing these products outside of the current exemptions and advocate to change legislation so the public is better protected.