Pharmacists have shared concerns around the impact of GLP-1 and insulin shortages on patients and workload, while the Royal College of GPs highlighted risks to patient safety from unregulated semaglutide use.
Shortages of GLP-1 receptor agonists are expected to continue for the next 18 months, with the Department of Health and Social Care (DHSC) citing supply issues caused by an increase in demand for licensed and off-label indications.
Vice chair of the Royal College of GPs, Dr Victoria Tzortziou-Brown, last week warned that unregulated use of semaglutide for weight loss was posing a ‘genuine threat to patient safety’.
‘Its growing popularity for personal use without prescription through unregulated online outlets is troubling – posing a genuine threat to patient safety, as people may not be buying what they think they are, and potentially contributing to supply shortages,’ she said.
Last month NHS England announced a £40m pilot to explore ways to make specialist drugs accessible to patients living with obesity outside of hospital settings.
Dr Tzortziou-Brown said that government plans to expand the use of semaglutide through a pilot scheme in primary care may well prove to be a highly valuable in tackling obesity, but that it ‘made it all the more vital that adequate supplies of the drug are secured’.
‘Sudden shortages in any drug can disrupt treatment plans which means additional appointments have to be held and patients may need to be closely monitored as they’re put on an alternative medication – intensifying the existing workload crisis, and causing worry for patients.’
Dr Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies told The Pharmacist that it was ‘concerning’ that pharmacists were having to deal with semaglutide shortages and problems accessing medication for patients with diabetes.
‘And yet we're seeing that this has been used off licence by some private clinics. If prescribers are involved in prescribing this, we need to ensure that those patients who are in need of it get it,’ she added.
And she said that she would be meeting with manufacturers Novo Nordisk to understand what the next steps would be around the shortage.
Novo Nordisk told The Pharmacist last week that it had increased production by running its factories 24 hours a day, seven days a week. But the manufacturer said that this will take time to take effect, and that it therefore envisaged intermittent supply shortages over the next 18 months.
Community pharmacist Mark Burdon told The Pharmacist that he welcomed the comments from the RCGP, saying that making patients aware of shortages would be ‘helpful’ in managing patient expectations.
‘I think the more that we can get this into the public domain, the better,’ he said.
‘Because at the minute they think that we're just fobbing them off,’ he added.
‘And of course for the patient it’s very unsettling, it's awful. It is absolutely dreadful.’
And he said that while the shortage of GLP-1s were ‘a big concern’, he was also worried about increasingly short supplies of insulin Tresiba FlexTouch, which is also manufactured by NovoNordisk and is prescribed to treat diabetes mellitus in adults, adolescents and children aged one year and above.
‘It could be a major problem, because we need to organise an alternative on an individual basis. And the workload involved, [for] the GP practice nurses – there’s just no way you could do it.’
And this might mean switching patients from a single-use pen to one with a reusable cartridge, which would require staff to train patients in using a new device and could lead to usability issues for some patients, suggested Mr Burdon.
He said that while practices had been instructed to stop initiating patients on GLP-1s in the last year, there were still lots of patients that would already need switching to a different medication now, which would mean a huge increase in workload for practices.
‘It’s awful, absolutely dreadful. And just on top of everything else. We’re all busy anyway. And the GPs and everybody else are just completely just frazzled as it is, without more work.’
The latest guidance from the DHSC instructs clinicians not to prescribe GLP-1 RAs outside of their approved use, to avoid starting people with type 2 diabetes on any GLP-1 RAs, not to switch between drug brands or substitute with lower dosages, and where alternative treatments need to be considered, discuss and agree a new management plan with those people affected.
Esther Walden, deputy head of care at Diabetes UK, welcomed the guidance but said that it was ‘disappointing that the shortages are ongoing and are predicted to continue until at least mid-2024’.
She said that while Diabetes UK understood that off-label prescribing can be beneficial in some circumstances, the charity ‘cannot support it when it is directly contributing to ongoing shortages for those people living with type 2 diabetes and the impact this has on managing it well’.
She added: ‘We would encourage clinicians to be mindful of this impact and prioritise helping people to manage their diabetes.
And she said that people living with type 2 diabetes should be reassured that there are a number of alternative treatments available to help manage their condition.
‘Healthcare professionals should work with patients to find the best course of treatment for them including non-medication-based remission programmes where available, taking into account people’s individual needs and concerns,’ she added.
The Primary Care Diabetes Society (PCDS) and Association of British Clinical Diabetologists (ABCD) have produced additional guidance which recommend supporting eligible people to access weight management and remission services.
‘Eligible people with T2DM [type 2 diabetes mellitus] who would like support with weight management should be signposted to available weight management programmes,’ the guidance reads, suggesting national programmes and structured self-management resources ‘in addition to local pathways’.
The guidance also said that ‘whilst short delays accessing the usual GLP-1 RA prescription may be considered manageable, longer delays suggest the need to switch to an alternative glucose-lowering therapy’.
It added: ‘Even where other GLP-1 RA preparations are intermittently available, there may be insufficient capacity to accommodate switching everyone to an alternative brand.
‘DHSC advises against switching between GLP-1 RA preparations. Discuss with the person with T2DM that intermittent supply of their GLP-1 RA may be associated with increased side effects and erratic blood glucose control, with potential to increase diabetes-related complications.
‘This may be a particular concern for people co-prescribed insulin therapy, where hypoglycaemia may also be a concern.’
And the guidance document sets out which treatment is most suitable for different patients.
Weight loss medications investigated for mental health risks
Meanwhile, semaglutide and liraglutide-containing medications are being evaluated by the European Medicines Agency (EMA) for possible risks of suicidal thoughts and thoughts of self-harm.
This follows concerns raised by the Icelandic Medicines Agency after three cases of suicidal thoughts or thoughts of self-harm were reported.
This includes one case of suicidal thoughts following the use of Saxenda (liraglutide), one of suicidal thoughts following the use of Ozempic, and one additional case of a patient experiencing thoughts of self-injury following the use of Saxenda.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is also considering whether the review should be extended to include other GLP-1 receptor agonists.