Semaglutide shortage prompts caution around off-label prescribing

27/05/2022 3:04:02 PM

GPs are being asked to prioritise the drug for people with diabetes, but with supplies critically low, what are the alternatives?

Person preparing semaglutide — GPs are being advised to carefully consider off-label prescribing of semaglutide.

The Therapeutic Goods Administration (TGA) has recently notified the healthcare sector of a shortage of diabetes medication semaglutide (sold as Ozempic).

The shortage is significantly affecting people using the drug for its approved use for type 2 diabetes.

Strong demand for the medication has resulted in supply issues at pharmacies, and the RACGP recently reminded GPs to exercise care and consideration regarding off-label prescribing of the drug while there are shortages, to ensure people with type 2 diabetes are prioritised for the medication.

While the TGA confirmed the increased demand is due to ‘extensive prescribing’ for obesity management, semaglutide is not currently indicated for this.

Off-label prescribing by GPs and other specialists to patients for weight loss has in part been due to social media influencers touting the drug as a ‘miracle’ weight-loss treatment, with one TikTok user ‘sharing her journey’ to ‘help and educate people’ as she ‘educates’ herself.

The medicines regulator advises that healthcare professionals should limit prescribing and dispensing of semaglutide to its approved use to ‘prioritise essential continuity of care’ for people with type 2 diabetes during the current shortage.

Dr Gary Deed, Chair of RACGP Specific Interests Diabetes, agrees.

‘There are [other] TGA-approved medications for management of obesity,’ Dr Deed told newsGP.

‘These always should be used in a framework of lifestyle and diet changes, and liraglutide is a suitable alternative GLP-1RA [glucagon-like peptide-1 receptor agonist] given daily for weight and obesity management.

‘It is important to allow access of people with type 2 diabetes to usual medication – and this should be a medical priority.’

Dr Deed also cautions that when utilising any medication off label it is ‘imperative’ that the prescriber details adequate consent and acknowledgement of risks and potential side effects.

‘Notably with semaglutide – nausea and vomiting, being a category D drug,’ he said.

‘So careful explanation of this risk in women of reproductive age and adequate timeframes for withdrawal of this medication prior to pregnancy needs documentation or alternatively, contraceptive advice.’

In Australia, semaglutide has been approved for the treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise:

as monotherapy when metformin is not tolerated or contraindicated
in addition to other medicinal products for the treatment of type 2 diabetes.

Reports of patients with diabetes experiencing supply shortages of their medication indicate they are frustrated more with prescribers recommending it and pharmacies overselling it, rather than other people purchasing it.

For social media users promoting the drug as a weight-loss treatment, Dr Deed warns that although the ‘TikTok phenomena’ might be engaging for some patients, it should not be relied on as an effective treatment.

‘All the efficacious management does involve supportive dietary change and physical activity,’ he said.

‘So [for] patients seeking through TikTok one solution, management for obesity is probably a little naïve.’

While patients prescribed semaglutide for approved use for treatment of type 2 diabetes have access via the PBS for around $130 per month, when used as an alternative weight-loss treatment, semaglutide injections cost much more.

Should the semaglutide shortage continue, Dr Deed has some recommendations – costs aside – for GP prescribers managing patients with diabetes.

‘Consider changing to the alternative GLP-1RA once weekly, such as dulaglutide, and explain to patients they need to monitor their response to the change and make timely appointments to be reviewed in the transitional time,’ he said.

He also notes GPs could use this time to review their management of patients with type 2 diabetes and overweight or obesity.

‘[GPs can] review current therapies to see if there is a need to re-emphasise lifestyle and dietary approaches to support them,’ he said.

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Dr Niloshan Jeyarajah 28/05/2022 12:07:08 AM

What worries me is this attack on people using ozempic for weight loss, saying this is the reason as to why there is a "shortage". Yet there is no clear reason given by the drug company as to why the shortage is there in the first place (manufacturing or ingredients). A lot of medicine is reactionary, you have high blood pressure, diabetes or cholesterol here is a medication. We dont try and act proactively and stop the cause, which is obesity. Instead we stigmatized people who are overweight refusing pharmaceutical aid. Ozempic is helpful at stopping all of the consequences of obesity by helping people lose weight. Problem for big pharmaceutical companies is that means this means billions of dollars lost. I would want the TGA, RACGP and AMA to ask novo for a clear answer as to what is actually stopping the manufacture of more ozempic, to clarify if there is a barrier to more production, or if they would prefer we just prescribe it for just type 2 dm to protect their revenue stream.

Dr Robert Charles P Hills 31/05/2022 8:22:57 PM

I have worked as a Bariatric "Physician" for over a decade. I have prescribed many medications to try and help my patients in their fight against the neurophysiological regulatory disorder that causes their obesity. Yes, there are some medications that have been "approved" for treating obesity. In my experience, Ozempic has proven to be far more effective in more patients than anything I have previously prescribed. In my practice, it is often effective at quite low doses, making it more affordable for the long-term control these patients require.

One thing Dr Deed seems to have overlooked is that Diabetics have far more TGA-approved pharmaceutical options available to them than the person with obesity, despite both being chronic, debilitating and life-threatening conditions. Diabetics also have access to many PBS-subsidised options. There is NO PBS support for any anti-obesity medication.
Obese patients are just as deserving of treatment with Ozempic as are Diabetics.

Dr M 7/06/2022 2:50:33 PM

I agree with above comments.
It has been really useful and affordable medication for weight loss in the obese and will help with down stream complications of obesity. Other than supply issues I am not sure why there is such controversy with its use off label. It is cheaper and superior to saxenda, contrave and duromine.
We are constantly advising patients to loose weight to help their knee/hip/back OA, HTN etc and this medication gives them good results.
Many medications are prescribed off-label and as long as patient is aware of risks and benefits then we should be able to offer this with those with BMI >30