Why there’s a shortage of this crucial diabetes drug
What happens when a shortage of an effective medication happens because people who the medicine isn’t intended for are drying its stocks? We explain here
- There is a global shortage of a popular and effective medicine used by people with type 2 diabetes because more and more people (who don’t necessarily have type 2 diabetes) have been showing up at their doctors asking for the medication because of its weight loss effects.
- In 2018, diabetes was the second deadliest disease in South Africa, after tuberculosis.
- The drug, known as Ozempic, delays the emptying of the stomach, which makes people feel full for longer, and so results in weight loss. People with type 2 diabetes need the medicine to control their blood sugar levels.
People with type 2 diabetes in South Africa have been left without one of their most effective — and cheaper — treatments because doctors are now also prescribing it widely as a weight loss drug.
The medicine, Ozempic, given as a weekly injection, can help people with type 2 diabetes — a condition that leads to almost as many people dying in South Africa as tuberculosis, the No 1 killer in the country — stay alive.
There has been a shortage of the medication for about six months now. Novo Nordisk told activists the drug should be fully restocked again in February.
People with type 2 diabetes have too much sugar in their blood because their bodies don’t make enough of the hormone insulin. Insulin lowers blood sugar levels because the hormone tells the body’s cells to take up glucose (a type of sugar) and use it for energy. If type 2 diabetes isn’t treated, it can make people go blind, lead to heart problems or damage someone’s nerves. Because untreated high blood sugar causes damage to nerves in the body and blocks blood flow by narrowing the blood vessels, it can result in limbs, such as feet, having to be amputated.
Ozempic, which is made by the Danish pharmaceutical company, Novo Nordisk, lowers the blood sugar of people with type 2 diabetes by causing someone’s pancreas to release extra insulin when they eat. But it has another effect, too: it helps to make you feel full for longer after meals, which leads to eating less.
The medicine comes in a 1.5ml injection pen, which costs between R1,200 and R1,500. Depending on how much help a patient needs to control their blood sugar, a weekly dose of between 0.25mg and 2mg is prescribed. Each millilitre in the tube contains 1.34mg of the drug, so one pen can last someone between one and eight weeks.
In South Africa, Ozempic is only registered to treat type 2 diabetes. But doctors have the power to prescribe the medicine “off-label” too — meaning for a reason other than what is indicated on the packet insert, which in this case is to help people who are heavily overweight or obese lose weight. Someone is considered heavily overweight when their body mass index is 25 or higher, and obese when this number reaches 30 or more.
Tauhierah Tavares, 48, who was diagnosed with type 2 diabetes in 2020, has been using Ozempic to keep her blood sugar under control. “I understand medicine shortages because I work in a hospital, but when I found out it was out of stock because people were using it for weight loss, I found that unfair,” she says. “I need it for my health.”
Is Ozempic a miracle cure?
The trend to use Ozempic for weight loss took off on social media in 2022 — not only in South Africa but around the world. #Ozempic, for instance, has 300-million views on the social media platform TikTok (South Africa’s fastest growing social media platform for access to news).
The “unexpected demand” drained stock globally in May 2022, Novo Nordisk told Australia’s medicines regulator.
South Africa’s stocks dried up three months later, from about August.
At first, people with diabetes could switch to an alternative called Trulicity, which is also taken as a weekly injection and works like Ozempic. But then Trulicity’s manufacturer, the US pharma company Eli Lilly, announced its stocks are running low too, for reasons “closely related to the shortage of Ozempic''. The medicine will only be fully restocked from March 31, the producers say.
Ozempic is part of a group of medicines called GLP-1 receptor agonists. These drugs look to the body like a hormone released in the gut, called glucagon-like peptide 1 (GLP-1), and which prods the body not only to release insulin when someone eats but also make the stomach empty into the small intestine slower. This way you feel full for longer and so your appetite is kept in check.
One Ozempic pen, which could be enough for eight weeks’ supply, is at least R500 cheaper than an injection filled with either of two other drugs people can use to control their blood sugar. But because these alternatives have to be taken daily, instead of once a week like Ozempic, one pen would be enough to last only about two weeks. Moreover, research shows the type of drug in Ozempic is longer acting and works better for weight loss than the other options on the market.
The trend to use Ozempic for weight loss took off on social media in 2022 — not only in South Africa but around the world
Prescribing medicines for people looking to lose weight is part of a change in the way doctors approach weight loss.
Research shows that many obese or heavily overweight people aren’t able to lose weight (and keep it off) by exercising and restricting what they eat because of their genes or not being able to buy healthy food easily (rather than simply not having enough self-discipline to make good food choices).
In people who have a body mass index of over 35, some of the best solutions that keep the weight off for a few years, studies show, are bariatric surgery (an operation that makes your stomach smaller and so helps you to eat less) or appetite-suppressing medicines such as Ozempic.
When researchers analysed the findings of 20 different studies that investigated how well people could keep the weight off they had lost after following a very low-energy diet for up to 16 weeks, they found that after a year and a half people who used anti-obesity drugs fared better than those who exercised only or used dietary supplements.
The science behind using medicine to help people lose weight is now so acknowledged that the American Academy of Paediatrics published first-of-its-kind guidelines in January to treat obesity in children and teenagers this way. In South Africa, about one in eight children between the ages of five and nine, and one in five children aged 10 to 14 are obese, according to a report on overnutrition from the Children’s Institute at the University of Cape Town (UCT).
But Joel Dave, head of the division of endocrinology at UCT, cautions: Ozempic only works while you take it and “doesn’t address the underlying reasons for weight gain — so people need to take it lifelong, if they want to maintain their weight loss”.
Are doctors allowed to prescribe drugs off-label?
Prescribing a medicine off-label is not illegal in South Africa, but there are rules around it. The Medicines & Related Substances Act says medicines must be registered for a specific use. In the case of Ozempic this is for helping people with type 2 diabetes control their blood sugar level. Using it to treat any other condition would be risky as the South African Health Products Regulatory Authority (Sahpra) would not have reviewed how it works in such cases.
When prescribing a medicine off-label, doctors have to decide whether it’s the best option for their patient. Because the Consumer Protection Act also applies to medicines, prescribers must get a patient’s consent for offering an off-label treatment because a consumer has the right to receive goods that are “reasonably suitable for the purposes for which they are intended”. In the case of medicines, this would be the one indicated in the package insert. Under this law, the health professional must also warn the patient about any dangers of using the medicine in this way, but this is not really possible without enough data on its alternative use.
What is being done to increase stock?
Tobeka Boltina, head of the clinical, medical and regulatory affairs department of Novo Nordisk South Africa, says that they are aware of how serious the situation is and that they “are working closely with authorities” to avoid upsetting patients’ treatment.
She adds that the pharma company is looking into registering Wegovy, a product similar to Ozempic but used specifically for weight loss, in South Africa. Because Wegovy is meant as a weight loss medicine, this could take pressure off the demand for Ozempic.
Sahpra says it has not yet received such an application.
Elsewhere, for example in Australia, authorities have approved products that are similar to Ozempic and have been registered in other countries for use, to prevent people from having to go without their medicine.
This is the equivalent of prescribers in South Africa making use of a section 21 application to import a medicine. However, these products could be more expensive and are only approved if there are no other drugs available in the country, or if the other options haven’t worked.
South Africa has several alternative treatments for lowering diabetes patients’ blood sugar and patients should consult their health-care professionals on which alternative is best for them.
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