Hospital trusts have been advised to conserve supplies of some alteplase and tenecteplase injections amid supply issues that could continue for the rest of 2022, the government has warned.
In a national patient safety alert issued on 3 August 2022, the Department of Social Care (DHSC) and NHS England said that “manufacturing constraints” at Boehringer Ingelheim are affecting the global supply of alteplase (Actilyse) 10mg, 20mg and 50mg injections and tenecteplase (Metalyse) 10,000 unit injections.
Both alteplase and tenecteplase are thrombolytic drugs that are solely manufactured by Boehringer Ingelheim, with alteplase licensed for treatment of acute ischaemic stroke, acute myocardial infarction (MI) and acute massive pulmonary embolism with haemodynamic instability, while tenecteplase is licensed for the management of acute MI.
As a result of the shortages, which the manufacturer said are expected to improve “in early 2023”, the alert asks trusts to conserve stock of alteplase “for patients with acute ischaemic stroke, given the lack of an alternative and the significant risk of harm without receipt of treatment”.
Hospital pharmacy teams have also been asked to order alteplase injections “in line with their allocations”, which amount to “approximately half of normal demand” for alteplase 20mg injections and “approximately two thirds of normal demand” for alteplase 10mg injections.
“Boehringer Ingelheim has also put restrictions in place for tenecteplase to ensure stock is not depleted earlier than anticipated,” the alert continues.
While the alert notes that there are “no other therapeutic options for the treatment of acute ischaemic stroke” other than alteplase, streptokinase and urokinase are listed as possible alternative treatments for MI and dissolution of thrombi and emboli.
In response to the supply issues, on 4 August 2022, all strengths of both alteplase and tenecteplase were added to the government’s list of medicines that wholesalers cannot export from the UK or hoard.
In a statement to The Pharmaceutical Journal on 4 August 2022, Boehringer Ingelheim said the stock issues “are being caused by increased global demand and the challenging manufacturing process”.
Despite efforts to address manufacturing capacity at its facility in Germany, by doubling production over the past decade, the statement said that the manufacturer has “reached a point where the production of these medicines is no longer guaranteed to keep up with demand”.
“Boehringer Ingelheim currently expects a temporary supply shortage or supply interruption affecting these medicines in the UK and Ireland.
“We are in close contact with the DHSC, devolved nations and other relevant organisations in order to inform healthcare professionals and patient organisations of the situation and ensure a coordinated and collaborative approach,” the statement continued, adding that the company is “also looking at longer term solutions to increase supply for life saving indications”.
Charlotte Nicholls, head of policy and influencing at the Stroke Association, said the association is “aware of the current UK supply issues of alteplase, a drug used in thrombolysis treatment for stroke, which is also affecting several countries globally”.
“While this is concerning, we are reassured that the suppliers, NHS and the DHSC have robust policies in place to ensure that hospitals have sufficient drug supplies for patients who need thrombolysis treatment following a stroke,” she said.
“The current supply issue is expected until early 2023 and should not affect any stroke patients from accessing acute treatments in hospital.”
This is the latest medicine shortage to affect the NHS, with the Pharmaceutical Services Negotiating Committee having “escalated” its concerns to the DHSC.
Meanwhile, on 2 August 2022, The Pharmaceutical Journal revealed concerns from pharmacists that shortages of the osteoporosis medicine alendronic acid are affecting patient care and contributing to medication errors.
- This article was amended on 8 August 2022 to clarify that Boehringer Ingelheim expects shortages of alteplase and tenecteplase to improve in 2023, not resolve