To say that Ozempic is a blockbuster drug is an understatement. Manufacturer Novo Nordisk is scrambling to expand production sites to maintain up with global demand.
While Ozempic is barely approved for the treatment of diabetes in Australia, it is usually marketed overseas for weight reduction under the brand name Wegovy.
Social media is filled with posts and endorsements by celebrities who’re using it for weight reduction. Faced with limited access in Australia, some individuals who need the medication for diabetes can’t access it.
Others are turning to the web to source it from compounding pharmacies – a practice Australia’s regulator, the Therapeutic Goods Administration (TGA), plans to clamp down on.
How doctors are prescribing Ozempic
Use of Ozempic for weight reduction in Australia is taken into account “off label”. This is when a health care provider prescribes a drugs for a purpose outside of what’s approved.
Ozempic is barely approved for use for the treatment of diabetes in Australia, but its off-label prescribing for weight reduction is driving shortages which the TGA thinks will last until 2025.
To manage these shortages, Australian doctors and pharmacies are being asked not to start out recent patients on Ozempic and to prioritise it for patients with type 2 diabetes who’re already stabilised on this medicine.
However, the TGA says it:
doesn’t have the facility to manage the clinical decisions of health professionals and is unable to stop doctors from using their clinical judgement to prescribe Ozempic for other health conditions.
Why can’t we just make more?
The energetic ingredient in Ozempic, semaglutide, is a fragile peptide molecule made up of two small chains of amino acids. It’s only one in a family of medicine which might be classified as GLP-1 inhibitors.
Because it’s a peptide, its manufacture is complex and requires specialised facilities beyond those used to make normal chemical-based drugs.
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It can also be delivered via an injection, meaning that it must be manufactured under strict conditions to make sure it’s each sterile and temperature controlled.
This means increasing production just isn’t so simple as just deciding to fabricate more. Its manufacturer needs time to construct recent facilities to extend production.
Compounding pharmacies are making their very own
Compounding is the practice of mixing, mixing, or altering ingredients of a drug to create a formulation tailored to the needs of a person patient.
Australian law allows pharmacists to compound only when it’s for the treatment of a selected patient to satisfy their individual clinical need and there is no such thing as a suitable commercially manufactured product available. An example is making a liquid type of a drug from a tablet for people unable to swallow.
Compounded products will not be held to the identical safety, quality and efficacy standards required for mass produced medicines. This recognises the one-off nature of such compounded medicines and the skilled training of the pharmacists who prepare them.
Recently, pharmacies have been counting on these compounding rules to supply their very own Ozempic-like products at scale and ship them to consumers around Australia.
However, there are risks when using these products. The US Food and Drug Administration (FDA) has recently warned consumers of the hazards of using compounded formulations that contain particular salt formulations of semaglutide. It has received more reports of uncomfortable side effects in patients using these products.
How the regulator plans to tighten the loophole
The TGA is taking plenty of steps to tighten the compounding loophole and there are ongoing investigations on this area.
In December 2023, the agency issued a public safety warning on the hazards of those compounded medicines.
More recently, it has proposed removing GLP-1 drugswhich incorporates Ozempic, from Australia’s compounding exemptions. This would effectively ban pharmacies from making off-brand Ozempic. This proposal is currently under consultation and a final decision is predicted by June this yr.
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If you would like to access the drug for weight reduction before the shortage is over, remember that compounded products will not be similar to approved Ozempic and haven’t been evaluated for safety, quality and efficacy.
Supply of copycat versions can also be prone to be limited, given the continuing TGA crackdown.