A shortage of a versatile medicine used to treat immune disorders has forced US hospitals to stop treatment for many patients.
Hospitals have begun rationing the immunoglobulin drugs (IG), prioritising patients that are most at risk of death if they go without.
Patients needing the drugs have weak immune systems, therefore there are fears that without IG, those patients could become gravely ill.
Manufacturers report the demand for the drugs has rocketed in line with increasing diagnoses of a variety of diseases.
The shortage has reached a crisis point, Michelle Vogel, vice president of patient advocacy and provider relations at CSI Pharmacy, a specialty pharmacy, told The Wall Street Journal (WSJ).
WSJ reports that in June, Cincinnati Children’s Hospital sent letters to 150 families of IG patients informing them of the shortage.
The hospital said some patients would see their treatment suspended or reduced in order to conserve supply for patients with life-threatening conditions, but it is not clear which conditions these are.
IG is used to treat immune disorders such as lupus, myositis and Guillain-Barre syndrome.
Derek Wheeler, chief of staff at the Cincinnati Children’s Hospital, said: ‘We’re essentially rationing to the patients with the greatest need.’
Those who aren’t given IG are being put on alternative medications while in limbo, it is reported.
Massachusetts General Hospital has also cancelled many infusion appointments since June, the director of the hospital’s center for disaster medicine, Dr Paul Biddinger, confirmed to WSJ.
Dr Biddinger said the hospital is predicted to see a shortfall of half its normal supply, up from the original 10 per cent.
He added: ‘For the patients affected, it’s been very significant. It puts them at elevated risk of infection. It puts them with increased severity of symptoms.’
The hospital expects the shortage to last into 2020 – but it began a few months ago.
In January, John G Boyle wrote an article for The Immune Deficiency Foundation (IDF), where he is the president, and said: ‘Right now, though, the plasma supply is tight – here in the US and globally.
‘It’s not as simple as churning out more pills.
‘The manufacturing and distribution of IG is complex because it is a plasma-derived treatment.’
Plasma is a component of blood, and inside are antibodies which are harvested and injected into patients to boost their immune system.
A shortage could occur because there is a lack of plasma donation, or there may be a disruption with any member in the supply or delivery chains – including manufacturers.
Manufacturing companies have cited a variety of reasons for the tight supply, particularly an increasing demand for IG.
Both Takeda Pharmaceuticals Co. and CSL Ltd. said there have been higher rates of diagnosis of conditions that IG has long treated, and more conditions the drug can be used for.
Amid unpredictable trends, plasma-derived drugs take seven to 12 months to produce and supply to customers, according to Takeda.
And more than 1,000 plasma donations are needed to make a one-year supply for one patient, Takeda has said.
Takeda also said there have been interruptions in supply or shipment of important IG products, while another company, Pfizer Inc, blame a third-party manufacturer for their drop in supply over July.
Mr Boyle said experts are reluctant to admit there is a shortage of IG, and the US Food and Drug Administration does not recognise the extent of the problem.
The FDA said three IG products are in shortage – two from Takeda and one from Bio Products Laboratory.
However, The American Society of Health-System Pharmacists, which uses different criteria to classify shortages, lists additional IG products from CSL and Grifols SA.
The global market for IG drugs is projected to be worth $17billion by 2023, up from $11billion in 2018, according to WSJ.