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Tenecteplase (and common sense) in short supply during the COVID ‐19 pandemic
Author(s) -
Parsons Mark,
Churilov Leonid,
Schutte Aletta E,
Levi Christopher
Publication year - 2020
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/mja2.50836
Subject(s) - covid-19 , tenecteplase , pandemic , business , virology , medicine , thrombolysis , outbreak , disease , myocardial infarction , infectious disease (medical specialty)
The coronavirus disease 2019 (COVID19) pandemic has had a huge impact on medical practice, with pharmaceutical supply chains compromised across the world.1 Tough decisions with respect to rationing of resources in acute health care have necessarily been made. However, we are concerned about health policy decisions in stroke thrombolysis being made without the requisite level of evidence and, even more troublingly, with lack of consideration for the flowon effects on thrombolytic drug supply for patients with myocardial infarction (MI). On 17 April 2020, Boehringer Ingelheim Australia (manufacturer of a tenecteplase product) noted the unprecedented demand for tenecteplase in Australia, possibly “due to the desire to increase safety stock holding; possible changes in clinical management of [ST elevation myocardial infarction] patients, with potential closure of [percutaneous coronary intervention] facilities leading to increased demand for thrombolysis; and ... potential for offlabel use of tenecteplase in patients with acute ischaemic stroke” (Marika Tetere, Medical Director Australia and New Zealand, Boehringer Ingelheim, personal communication). The company indicates that there is a limited supply of tenecteplase, and “due to a complex production process and capacity limitations driven by global demand, it is not possible to scaleup production to supply tenecteplase at the high levels the above mentioned changes require” (personal communication, as above). This is because tenecteplase is recombinant technology produced by cell culture with a limited production. If this increased demand for tenecteplase outstrips its fixed supply, it will almost certainly lead to a period of tenecteplase being unavailable in Australia. Concerningly, recent proposals (that have accelerated during the COVID19 crisis) to adopt tenecteplase as the recommended thrombolytic agent for stroke reperfusion will potentially limit access to tenecteplase for patients with acute MI. This is of particular concern in rural Australia where tenecteplase is the current emergency treatment for acute MI (often prehospital) in order to offer timely myocardial revascularisation. This lifesaving treatment is at risk if the stroke community moves to tenecteplase at this stage. Importantly, tenecteplase has level 1 evidence as a thrombolytic for MI, but not yet for acute stroke, where the closely related agent alteplase is the only licensed stroke thrombolytic in Australia, North America, Asia and Europe.