Do not initiate new patients on semaglutide: TGA

The Therapeutic Goods Administration (TGA) has issued firm prescribing advice on semaglutide (sold as Ozempic), the hugely popular glucagon-like peptide-1 receptor agonist (GLP-1 RA) that has been impacted by supply issues since May last year.
 
According to the latest advice, prescribers should not initiate semaglutide prescriptions without a compelling clinical reason, while alternative medications should be considered for patients who are already taking the drug.
 
A continuous supply cannot be guaranteed for the remainder of 2023, and the shortage is expected to continue throughout 2024. For this reason, it is now recommended that current semaglutide supplies be reserved for those who have no other treatment options available to them.
 
Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, told newsGP that GPs can best prepare for the prolonged shortage by familiarising themselves with the Australian Type 2 Diabetes Glycaemic Management Algorithm that outlines the various treatment options available.
 
GPs can also recall patients to review their medications and discuss the situation.
 
‘I would do an audit on diabetes patients to proactively recall people using GLP-1 RA agents and discuss the alternatives with them to ensure they don’t feel unsupported and have ways they can manage their diabetes’ Dr Deed said.
 
‘If there has been off-label use of semaglutide, then also recall these patients and explain about alternative options.’
 
Ozempic is now a household name, known mostly as a weight loss drug after it went ‘viral’ due to celebrity endorsements and social media influencers, which led to a global shortage. In Australia, it is only approved for use in people with inadequately controlled type 2 diabetes and there are tight restrictions on promotional activities for prescription medicines.
 
Only three months ago, the TGA had advised that semaglutide supply and availability ‘continues to improve’ and Novo Nordisk, the pharmaceutical company that manufactures the drug, anticipated a steady production stream. At this time, it was still recommended to be prescribed only to patients with registered indications due anticipated demand; however, initiating therapy was permitted.
 
Novo Nordisk has since advised that the disruption in supply is largely a result of off-label prescribing for weight loss. Despite this, the pharmaceutical company has continued a sponsored social media ‘obesity awareness campaign’ that includes a link to its website with information on semaglutide.
 
The campaign is currently under review by the TGA and a warning specifically targeted at those who promote semaglutide remains on the regulator’s website, where it reminds advertisers and social media influencers that advertising prescription medications to the public remains prohibited by law.  
 
Dr Deed says consistent messaging is key when consulting with patients who feel strongly about accessing semaglutide for off-label use and that GPs can also utilise weight management guidelines to assess what strategies are most appropriate.
 
‘Explain that they will be told the same message at the pharmacies, that the availability is very limited, and we all have been instructed not to commence prescribing with semaglutide at this stage,’ he said.
 
‘The “meat” in the sandwich here is the consumers who can be influenced by messages that may not be aligned to their best interest or their individual health needs.
 
‘The messages come from many sources and the role of a GP is to filter these messages and give a clearer and focused message on what may or may not work for that person.
 
‘We need training as health professionals to overcome embedded beliefs influenced by these sources on social media. The name itself should be clear to people – these are “social” media, not “health” media.’
 
Meanwhile, two additional brands of GLP-1 RAs, Wegovy and Mounjaro, are expected to become available in Australia after both were approved by the TGA.  
 
Wegovy is an alternative dosing of semaglutide also produced by Novo Nordisk, and has been TGA approved for weight management in people with obesity, or those considered overweight with at least one weight-related comorbidity.
 
Mounjaro (tirzepatide) is a dual acting glucose-dependent insulinotropic polypeptide and GLP-1 RA manufactured by Eli Lilly that is only approved for type 2 diabetes management. The pharmaceutical company has so far been unsuccessful in securing PBS funding, but nonetheless plans to launch its product in Australia by the end of the year.
 
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