Exclusive GP practices are facing a pre-Christmas rush to get tens of thousands of patients switched to alternative insulin injections, as supplies of some insulin products could soon run out, with the manufacturer warning that interruption of insulin treatment is ‘potentially life-threatening’.
The products – Sanofi’s Insuman Basal, Comb 25 cartridges and prefilled pens – are used by nearly 50,000 people in the UK and are likely to be in short supply for the next eight months, the drugs company said.
Sanofi said some stock will still be in the supply chain.
But GP leaders said the situation was ‘serious’, and practices would have to err on the side of caution and switch patients to an alternative, to avoid potentially life-threatening consequences of running out of the drug.
In a letter sent out to NHS healthcare professionals earlier this month, Sanofi said there would be a ‘possible supply shortage in the United Kingdom of some Insuman presentations (recombinant human insulin) from 1 December 2015’ due to ’limited capacity at the manufacturing site’ and that ‘supply is expected to return to normal in July 2016’.
It apologised for the ‘inconvenience and difficulty that this issue may cause’ and warned: ’Interruption of insulin treatment is potentially life threatening. Therefore replacement with alternative insulin formulations is needed to avoid hyperglycaemia and serious complications.’
The four specific products affected are Insuman Basal 100 IU/mL and Insuman Comb 25 100 IU/mL cartridges, and Insuman Basal Solostar 100 IU/mL and Insuman Comb 25 Solostar pre-filled pens.
For patients on Insuman Basal preparations the alternative human insulins are Humulin I and Insulatard, while those on Comb 25 products can be switched to Humulin M3, Sanofi said.
Sanofi told Pulse that ‘approximately 48,000 patients in the UK are prescribed Insuman Basal or Insuman Comb 25’, and that there are a ’small number of patients’ for whom the Insuman products may be the only suitable insulin preparations. It has ’reserved a supply that we can make available on a case-by-case basis’ for this group.
The company said it was ‘difficult to estimate’ how many other patients would need to switch, as ‘there is already some available stock within the supply chain’, but that it was ‘working closely with the EMA and the relevant national health authorities to minimise the impact of the shortage on patients and healthcare service providers’.
However, Dr Bill Beeby, GPC representative in the north-east, said the risks of running out of insulin were ‘serious’ so practices would need to get on and switch patients to an alternative.
Dr Beeby said: ‘When you’ve got someone on insulin, it is quite serious – people can’t do without insulin they would have to be switched and that’s going to involve considerable workload.’
The Insuman shortage is the latest in a long line of drug shortages that GPs say can take up to an hour of their time every day, and comes just as GPs were also notified this month they should call in patients with diabetes who are on pioglitazone, because of shortages of that drug due to last until February.
Dr Andrew Green, chair of the GPC clinical and prescribing subcommittee, said the shortage ‘could not have come at a worse time of year’.
He said: ‘This one is particularly problematic as a simple switch to an alternative is not possible, and most patients will need input to manage the change safely.’