Following a Four Corners investigation, the Federal Government will close a loophole which allowed replica versions of popular diabetes drugs like Ozempic to be manufactured. Prompted by safety concerns, the Government's announced a ban on compound pharmacists from making these replicas.
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00:00 The government says that these compounded versions of weight loss drugs that are not
00:05 officially made by pharmaceutical companies and are instead made by compounding pharmacists
00:11 and that they're not properly checked for safety, quality or efficacy by Australia's
00:15 regulator the TGA.
00:17 Now that's by design because compounding pharmacists are allowed to make individual one-on-one
00:22 versions of a drug, for example if you need a formulation for a sick child, and it makes
00:26 sense that the government can't be checking every single dose that those kinds of pharmacists
00:30 make.
00:31 But what they say has happened is that pharmacists and also telehealth companies have been providing
00:37 these compounded versions of weight loss drugs to thousands and thousands of patients and
00:41 there's no regulatory oversight and they think that this could be a danger and pose a public
00:46 safety risk.
00:47 Well we've got to hear a bit from Mark Butler, let's go to that now.
00:52 The doctors groups, the pharmacy groups, the pharmacy board, the medical board, consumer
00:57 groups like Diabetes Australia and the Eating Disorders Collaboration, they all say this
01:03 is an unacceptable risk to public safety and it should be shut down.
01:07 So Elise, tell us about what's prompted this decision.
01:11 Well this is something that I've been investigating since last year.
01:14 We had an announcement from one of the largest telehealth providers, Eucalyptus, which has
01:18 the brand you might have heard of called Juniper Weight Loss, that they would start supplying
01:22 compounded medications through a pharmacy to their patients.
01:26 And I think that's one of the things that really got the regulators concerned, that
01:30 that could mean that there is such a large number of people taking these drugs.
01:33 But we found that there were at least five other compounding pharmacies in Australia
01:38 making these medications and dozens and dozens of doctors prescribing them.
01:43 After that we continued looking at this and found that there were also unregulated dodgy
01:47 pharmacists who weren't allowed to be compounding these medications that were making them in
01:52 really filthy conditions and selling them to Australians but also exporting them illegally
01:57 overseas.
01:58 And so the government's saying that this lack of regulation poses an unacceptable risk and
02:03 that because of that all compounding pharmacists should be banned from making these medications
02:07 to ensure that Australians are safe.
02:10 So what sort of reaction are we expecting?
02:12 Well I suspect today we're going to hear from patients who are on these medications who
02:15 are really frustrated.
02:17 We know that there's been global shortages of both the brand name Enzempic and Wunjaro
02:21 diabetes drugs for years on and off because there's such a huge demand and the pharmaceutical
02:27 companies just can't keep up with supply.
02:30 So compounding seemed like a really good option for some patients to allow them to have continued
02:34 supply of these drugs.
02:36 When people are taking these medications for weight loss, the research shows that when
02:39 they cease taking the medications, they will regain the weight unless they're doing other
02:44 things to maintain that weight loss.
02:46 So it's going to be a real issue for Australians.
02:49 And the other concern is that it could place pressure on the existing supplies of brand
02:53 name drugs like Enzempic and that could mean that people with diabetes struggle to access
02:57 these medications as well.
02:59 And tell us about that demand in Australia and obviously this ban is not going to allay
03:04 that demand, it'll only increase it I suspect, but that demand in Australia for those drugs
03:09 and whether it's increasing?
03:10 Well it is increasing rapidly.
03:12 One of the interesting things about compounded medications is that we don't have and the
03:16 government doesn't have any good figures about how many Australians are actually taking them.
03:21 So all we know is from telehealth companies when they say they have tens of thousands
03:26 of people and some of them are taking these medications.
03:29 But from my investigation I think that the use of compounded medications is far more
03:33 widespread than the authorities understand and that it really could pose a public safety
03:39 risk.
03:40 It really takes one thing to go wrong in a batch that could be made in a mass form that
03:45 it could mean that hundreds of people or even more could be affected by this and it could
03:50 have devastating consequences.
03:51 And for those who use these drugs, be it the pharmacy made ones or otherwise, they can
03:57 expect these shortages to continue?
03:59 Yeah, the TGA has put out a supply update that says that we're expecting Enzempic stocks
04:04 to be affected until at least the end of 2024 and Wunjaro stocks until at least September.
04:10 But we've seen these updates rolling for years in stock, out of stock and that's just an
04:15 ongoing issue but I'm sure that the announcement of this ban, which doesn't take effect until
04:20 October so that patients do have time to go and talk to their doctors and come up with
04:24 a plan, but it will increase pressure on those already stretched stocks.
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