Manx Care responds to global drug shortage

Wednesday, 30 November 2022

Manx Care is currently experiencing a supply issue with two drugs that are used in the treatment of strokes and heart conditions.

This global supply issue (which could continue for the rest of 2022) is having an effect across all NHS trusts in the UK, and therefore impacts the Isle of Man’s supply of these drugs.

Manx Care has been advised to conserve supplies of some alteplase and tenecteplase injections. Manx Care absolutely has stock in hand and is doing everything possible to preserve that stock. This may include the use of alternative and equally effective drugs for certain conditions (such as acute myocardial infarction), given that one condition (acute ischaemic stroke) can only be treated with alteplase. These mitigations are in line with recommendations from the Department of Health and Social Care (UK) and the NHS.

Hospital pharmacies across the UK have been directed to order these drugs in line with their allocations rather than over-ordering, and Manx Care is acting in line with this.

Dr. Sreeman Andole, Executive Medical Director and Stroke Consultant, said:

“We don’t want to alarm any members of public – we are notifying you to ensure we are being open given the current global situation which may have an effect on the Island.

“We have looked at our use of these drugs – our current usage is low and we’re preserving stocks and using alternatives where it’s clinically safe to do so. This is in line with guidance provided by NHS and DHSC (UK).”

Technical note:

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.

In a national patient safety alert issued on 03 August 2022, the Department of Health and Social Care (UK) 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.

As a result of the shortages, which the manufacturer said are expected to improve “in early 2023”, the alert asks trusts to conserve their stocks 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 pharmacies are also 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.

The alert also assures that restrictions are put in place by Boehringer Ingelheim for tenecteplase to ensure stock is not depleted earlier than anticipated.

Whilst 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.

We acknowledge that this is concerning, but it should be emphasised that the NHS and suppliers have robust policies in place to ensure that hospitals have sufficient drug supplies for patients who need thrombolysis treatment following a stroke. 

The current supply issue is expected to last until early 2023 and should not affect any stroke patients from accessing acute treatments in hospital.

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