Showing posts with label test. Show all posts
Showing posts with label test. Show all posts

Friday, 22 September 2023

Diabetics face critical medicine shortages as their drugs are snapped up for weight loss treatment

Many of Britain’s 4.3 million registered diabetics face a critical medication shortage as their treatments are snapped up by dieters trying the latest trend, weight loss jabs. A leading testing expert says the UK’s diabetes epidemic means key drugs should be saved for patients who critically depend on them.

‘Wonder’ weight loss drugs, such as Wegovy, have hit the headlines in recent weeks. They can help people shed 10%-15% of their bodyweight, largely by supressing their appetite. But some of these weight loss jabs are based on semaglutide, first developed for treating type 2 diabetes. This means the boom in demand for ‘magic bullet’ weight loss jabs is contributing to a major shortage in key diabetes medication, says a leading expert in the field.

Leading blood testing expert, Dr Avinash Hari Narayanan (MBChB), Clinical Lead at London Medical Laboratory, says: "There's now a global shortage of semaglutide-based drugs for treating diabetes. Key among these is Wegovy’s sister drug, Ozempic, used by the NHS as a treatment for managing blood glucose levels in people with type 2 diabetes, which accounts for 90% of all diabetes cases in the UK. This will result in both acute and chronic medical complications if left unmanaged."

He went on to say: "Both Wegovy and Ozempic are produced by the Danish pharmaceutical giant Novo Nordisk. The problem is that Ozempic has increasingly been prescribed off label (outside of its approved licence) for weight loss as an alternative to Wegovy. Now Novo Nordisk is warning of shortages of Ozempic stretching into 2025.

"Ozempic and Wegovy became a social media phenomenon earlier this year as a weight loss cure, with demand for semaglutide spiralling after celebrity endorsements. That’s not what Ozempic was intended for and has resulted in demand far outstripping supply. 

"Now Novo Nordisk’s official weight loss drug, Wegovy, is finally available in the UK on the NHS and as a private prescription. However, though this will relieve the demand on critical Ozempic stocks, supplies of all semaglutide-based treatments remain limited. Patients being treated for type 2 diabetes need to know that there are sufficient stocks of this treatment and, if not, patients need a plan to mitigate against supply disruptions.

"Novo Nordisk now has a market cap of $419.79bn, making it the world's 17th most valuable company.  Astonishingly, the market value of the Danish company has exceeded the size of Denmark’s domestic economy (£395.40bn). 

"We're keen for Novo Nordisk to continue concentrating on the production of vital diabetes treatments, over other semaglutide-based products. The company has stated that it will prioritise treatments for existing patients, rather than focusing on introducing new people to Wegovy weight loss treatments.

"We support Diabetes UK in urging clinicians to follow Department for Health and Social Care guidance, which states clinicians should not prescribe these drugs outside of their licensed use until the supply issues are rectified. 

"It’s not only in the UK restricted supplies are causing problems; there’s also a worldwide shortage. America’s FDA lists Wegovy and certain Ozempic dosages as being in short supply. So too does Australia’s Therapeutic Goods Administration (TGA), which says supplies of Ozempic will remain limited to diabetes treatments only until at least the end of December 2023, and that patients prescribed Ozempic for other conditions should contact their doctor to have their treatment reassessed.

"The shortage doesn’t only impact on semaglutide-based drugs. All “GLP-1 analogues”, as this family of drugs are known, are in short supply. These include the brands Ozempic, Rybelsus, Trulicity, Victoza, Saxenda, Byetta and Bydureon. This appears to be pan-market disruption, complicated by exceeding demands."

He went on to say: "‘All these drugs signal to your body to make more insulin (the hormone that controls the amount of sugar in your blood) reduce the amount of glucose (gluconeogenesis) that your liver makes, slow down the digestion of food, so that it takes longer for your body to absorb the sugar from meals, reduce your appetite by increasing satiety.

"It’s the final effect that's created this unexpected surge in demand. But, there's some welcome news of another GLP-1 analogue drug just about to reach the UK. The National Institute for Health and Care Excellence (NICE) has approved the use of tirzepatide (brand name Mounjaro) for treating type 2 diabetes in England and Wales. Supplies of this new drug should come on stream within three months.

"Again, it’s vital this new medication is prioritised as a further treatment for type 2 diabetes, rather than for any other purposes. It, too, is likely to be in hot demand by people seeking to lose weight the easy way. In the US, clinical weight loss trials show Mounjaro is even more effective than Ozempic, with patients achieving 26.6% weight loss over a period of 84 weeks.

"By 2030, diabetes cases in the UK will have risen by 50% compared against 2007 levels, according to Diabetes UK. Unmanaged or undiagnosed diabetes is one of the leading causes of death. Diabetes is usually linked to factors like weight, lifestyle, age and family history. 

"One in ten people will have diabetes by the end of the next decade, and one in three will be at a much increased risk of developing it. The truly frightening fact is that it's quite common for people to have diabetes and not be aware of it.

"Fortunately, there's a simple blood test that will categorically confirm whether or not you have type 2 diabetes, even in its earliest stages, long before any symptoms have developed. This home test checks your levels of HbA1c. 

"This biomarker is used to confirm whether you have (or are at risk of developing) diabetes. For anyone who already knows they have diabetes, regular HbA1c checks are also essential to monitor progress. 

"The London Medical Laboratory’s “Diabetes - Diagnosis and Monitoring test” can be taken at home via the mail, or at one of the many drop-in clinics that offer these tests across London and nationwide in over 95 selected pharmacies and health stores."

For full details visit https://www.londonmedicallaboratory.com/product/diabetes-check

Sunday, 15 May 2011

Testing... Testing...

When times change, we must change with them. Now we have easy to use, portable blood test machines to help us control our diabetes. But more than the actual mechanics of just doing a test, there is little point unless we know what to do with the information you gain as a result.

It can be hard to remember sometimes, but you are more than just a number! With the arrival of the capacity for people with diabetes to do daily blood testing, it might seem that you spend your life looking at little screens with numbers on that seem to judge you on a small but often stressful way.

Be in no doubt, the ability to do your own tests (to self-monitor your blood glucose levels) is a very important tool in your own self-management. But as machines get cleverer and do more things for you, it's possible to feel a little left behind. More to the point, if all you see are 'bad numbers', then it's very hard to keep up the motivation to keep testing.

Not all diabetics are encouraged to test, but there are some clear guidelines laid down. Put simply, diabetics on insulin should be testing daily, while Type 2 diabetics need not test unless they want to or there is a good reason for them to do so. Some people are encouraged not to test, and I even hear stories about (and have experienced myself) doctors suggesting that someone with diabetes reduce how often they test order to save the NHS some money.

In March 2010 NHS Diabetes published a report on self-monitoring of blood glucose (SMBG) for people with Type 2 diabetes which stated, "The data from clinical trials show that in patients treated by lifestyle modification or oral agents, SMBG with appropriate education and clear objectives leads to an improvement in blood glucose control. The improvements in blood glucose control when SMBG is used without education and clear objectives are so small as to be of doubtful clinical benefit."

In keeping with the recommendations contained within NICE Clinical Guideline, it was suggested that SMBG should only be provided routinely to people with Type 2 diabetes not treated with insulin or sulphonylureas (pill meditation such as Metformin) where there is an agreed purpose or goal to testing and that "Individuals with non-insulin treated diabetes who are motivated by SMBG activity and use the information to maximise the effect of lifestyle and medication should be encouraged to continue to monitor."

NICE also recommended that people with Type 2 diabetes should expect to have their long-term glucose control checked every 2-6 months - this HbA1c result will give an indication of the overall blood glucose level over previous months [see additional info on HbA1c on p.11].

The report also acknowledged that patients should be shown how to interpret their results and how to use these results to make any appropriate lifestyle changes, "This has the potential to improve both the quality and the efficiency of blood glucose self-monitoring." By Sue Marshal.

Dr William Polonksy was the principal investigator of the Structured Testing Program study (STeP) the results of which were published in February 2011 in Diabetes Care.

He comments, "The HbA1c has been perceived as the gold standard for monitoring glycaemic control for a long time, but it does not provide information about the peaks and troughs in blood glucose levels during the day."

The STeP study used 12 months of data based on using SMBG (the self-monitoring of blood glucose), which is an established part of therapy for diabetics on insulin but in this case was applied to people with Type 2 not on insulin (but who may have been on other medications). They were asked to test several times a day for three days only. Then they repeated this activity each month, with a review with their doctor of the results every three months.

ONE STEP AHEAD "Diabetes and its resulting secondary complications are a significant and growing burden on individuals, society and national healthcare system," says Polonsky, "At the same time, healthcare budgets for individual care are being continually eroded. We must therefore redefine our strategies for management diabetes and use the available resources more effectively."

He points out that one of the best ways is more blood testing with well-designed data capture, "Blood glucose data should provide immediate feedback about the effects of food choices, activity, and medication on glycaemic control. It is crucial for people with diabetes to understand the close link between their lifestyles and behaviour and their metabolic responses. Most of the participants in the STeP study agreed that seeing how their behaviour actually affected their blood sugars motivated them to take on more responsibility for their condition and to change their lifestyle."

The other side of the fence is the experience of the healthcare professionals (HCPs, whether doctors or nurses). It's known that 90% of doctors do not download blood test data. Clearly, blood testing needs to be easy to do and to review, for both patients and HCPs. The STeP study showed that most of the physicians welcomed these changes in patient behaviour and found that their patients were more willing to participate in managing their condition. Says Polonsky, "As patients became more acquainted with using the meters they found that the tool actually reduced consultation time. Most of the physicians found that the detailed profiles gave them a better sense of how and what medication to prescribe."

Dr Satish Garg, also involved in the study, notes that, "the global diabetes epidemic requires immediate action. At present, some 50% of those people currently diagnosed with Type 2 diabetes fail to effectively manage their blood glucose levels. Looking at HbA1c is not enough as it shows only long-term glycaemic control over three months and doesn't reflect the important daily (and hourly) fluctuations.

It does not demonstrate to people with diabetes when and they their blood glucose values rise or fall, and it does not tell them how to react in order to correct them." For the healthcare system he says, "Structured SMBG also gives healthcare professionals the accurate data they need to recommend effective therapy changes.

Whereas a high HbA1c value merely indicates that a change in therapy is needed, structured SMBG instructs HCPs exactly what changes to make." Lat est result s Speaking on behalf of Roche, which sponsored the study, Franz Walt says, "For the patient, the focus must be on individual diabetes management; for the doctor, on the effective therapy management based on accurate information and data.

“Taking responsibility for their own therapy is a cornerstone in modern diabetes therapy, and blood glucose values obtained by the patient according to the structured testing concept form the foundation for the essential and information doctor-patient dialogue." Being able to discuss data might also help you address what could be termed 'clinical inertia' - when it's agreed, 'let's not do anything at the moment'. It's not just the testing, but the quality of what you DO with it.

If you can see the impact of behaviour or medication on your blood test results then you're more likely to keep to the programme.

LIVING › seeing how their behaviour actually affected their blood sugars motivated them to take on more responsibility for their condition and to change their lifestyle Dr. W. Polonsky There are two issues regarding blood testing for people with type 2 diabetes.

First is access to strips on prescription.

Because strips are seen as costly, and with the NHS facing cuts (as always), strips for Type 2s have been targeted as a way of cutting back. That means that people who want to test are being held back from doing so.

Second is a bizarre belief that because blood testing can be unpleasant (apparently) and that people might find it hard to do, that they need not bother.

OK, so not many people WANT to stab themselves in the finger, no matter what the reason, so Type 2s can be forgiven for not 'wanting' to, but that does not mean that they shouldn't.

There's several pharmaceutical companies looking to help Type 2s test more, and a few online pharmacies that have spotted the trend who are offering simple, cost-effective meters and strips so that you can buy them if you want them and forego the hassle of dealing with an unyielding GP.

Among the many blood test meters out there, some are aimed at those with Type 2 diabetes with some added features for those who test infrequently or who do not have to use carb-counting to help control their condition.

For example, the OneTouch VITA from Lifescan (http://bit.ly/Lifescan_Vita) can help users link the effects of food to their blood glucose level. It is particularly recommended for Type 2 diabetics on insulin as it can also help to show how food choices affect their blood glucose levels. Increased awareness of this on the part of the patient should lead to greater control of their diabetes.

Among the meters and strips that are more easily available online are those for the Wavesense Jazz (www.arcticmedical.co.uk) and IME-DC meter (http://bit.ly/Desang_IME-DC). Other meters are widely available from chemists - you can chat to your pharmacist about costs per pot of sensors. A very rough guide is about 70p per strip. Yes, that adds up if you're testing five times a day, seven days a week - that's two pots of 25 strips every two weeks. But if you're testing once a day for three days a week, then you might think it a seriously good investment in your longterm health.

● People don't blood test because they (often understandably) don't see the point of doing it. As Polonsky explains the results, "We not only saw improvements in blood glucose control but in well-being too. Those who tested understood the numbers, felt their interaction with their GP was useful and generally felt less stressed about having diabetes. They could perceive the usefulness of treatment as they saw evidence that the changes were making a difference." That's the point.

● CONTRIBUTORS

Dr. William Polonsky, Associate Clinical Professor in Psychiatry, University of California. Author of Diabetes Burnout: What to do when you can't take it anymore. Founder of the Behavioral Diabetes Institute www.behavioraldiabetes.org STeP study was sponsored by Roche and utilised the Accu-Chek 360 view tool.

Dr. Satish Garg, Professor of Medicine and Paediatrics, Young Adult Clinic Barbara Davis Centre for Diabetes, University of Colorado School of Medicine. Editor-in-chief of Diabetes Technology and Therapeutics.