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Use of tenecteplase for thrombolysis of stroke patient (13HDC01676)
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(13HDC01676, 15 February
House officer ~ General physician ~ District health board ~
Regional public hospital ~ Emergency department ~ Alteplase ~
Tenecteplase ~ Thrombolysis ~ Stroke ~ Policies ~Training ~ Open
disclosure ~ Right 4(1)
A 77-year-old man presented to an emergency department (ED) of a
regional hospital after suffering an ischaemic stroke. Upon medical
review, a decision was made by a house officer, in consultation
with the consultant on call, that the man was an appropriate
candidate for thrombolysis.
Thrombolysis is the breakdown of blood clots using types of
drugs called tissue plasminogen activator (tPA) drugs and can be
used in patients who have suffered an ischaemic stroke or a heart
attack. There are a number of risks associated with thrombolysis,
including intracerebral haemorrhage (bleeding in the brain).
The man consented to receiving thrombolysis and the house
officer decided to prescribe tenecteplase rather than alteplase.
Tenecteplase and alteplase are both tPA drugs, but in New Zealand
tenecteplase is used for treatment of a heart attack (myocardial
infarction) rather than ischaemic stroke. The house officer
prescribed tenecteplase because she understood from nursing staff
that there was no alteplase available at the hospital and was aware
of studies which supported the use of tenecteplase in stroke.
Although it was usual practice for stroke thrombolysis to be
administered in the Intensive Care Unit (ICU), the house officer
decided to treat the man in the ED rather than the ICU. The house
officer followed the New Zealand Formulary guidelines for the use
of tenecteplase in heart attack. In doing so, she prescribed at
least twice the dose of tenecteplase recommended for treatment of
ischaemic stroke. In addition, the house officer prescribed
tenecteplase to be administered as a 10% bolus with the remainder
to be administered as an infusion over one hour (the correct mode
of administration for alteplase), whereas tenecteplase should be
given as a single bolus (ie, all at once). The house officer did
not discuss her prescription of tenecteplase or the fact that the
drug was administered in ED rather than the ICU with the consultant
Partway through the administration of tenecteplase, the house
officer was informed that alteplase was available at the hospital
in the ICU. She telephoned the consultant on call for advice about
whether or not to continue the infusion, who advised that the
infusion should continue. Following the infusion of tenecteplase
the man initially showed signs of improvement, but a computed
tomography (CT) scan showed that he had suffered a brain bleed
(intracerebral haemorrahage). The man died a few days later.
The DHB's relevant policy titled "the Stroke Pathway" referred
to alteplase in some places but did not explicitly specify
alteplase as the tPA drug to be used in the case of stroke
thrombolysis. There was also confusion amongst nursing staff about
the correct process for administering thrombolysis, and the house
officer had not been oriented to "the Stroke Pathway"
It was held that the house officer breached Right 4(1) in
failing to transfer the man to the ICU, in deciding to prescribe
tenecteplase at the dose and via the mode of administration that
they did, and in failing to consult the consultant on call about
the use of tenecteplase.
It was also held that the DHB breached Right 4(1) in failing to
ensure its staff had the right tools, including adequate policies
and training, to provide stroke thrombolysis safely.
Adverse comment was made about the consultant on call as she did
not appear to have provided the man or his wife with a timely and
clear explanation of what had occurred. Open disclosure about the
error and its potential consequences needed to occur, either to the
man if he was competent, or to another appropriate person, in this
case his wife.