View as “PDF version”
Patient Safety Tip of the Week
August 8, 2023
Another Spinal
Injection of Tranexamic Acid
We just recently did
another column on inadvertent spinal injection of the highly neurotoxic substance
tranexamic acid (see our February 21, 2023 “Tranexamic Acid Errors Just
Won’t Go Away”). Since then,
yet another incident has been reported but it has some elements worthy of a new
column.
The new report (Harby
2023) involved a 31-year-old man who underwent surgery for a right leg
fracture. Anesthesia was administered
via an injection of 20 mg (4 ml) of hyperbaric bupivacaine 0.5% at
the L3-L4 interspace. About 120 seconds after receiving the injection, the
patient had significant back and gluteal discomfort, followed by myoclonic
movements in the lower limbs and a generalized convulsion. Arterial blood pressure was elevated to
170/100 mmHg, and his heart rate increased to 120 beats per minute.
Immediate intravenous sedation with midazolam and fentanyl, followed by phenytoin
(1000 mg) by intravenous infusion when seizures persisted. General anesthesia
was induced by a thiopental sodium and atracurium infusion, and he was intubated
and mechanically ventilated. Maintenance of anesthesia was attained with isoflurane
and atracurium, and subsequent doses of thiopental sodium were given to control
seizures. The attending anesthesiologist suspected intrathecal administration
of the incorrect medicine after discovering a used tranexamic acid ampule in
the trash. Subsequently, cerebrospinal fluid (CSF) lavage was done by inserting
two spinal 22-gauge Quincke tip needles on level L2–L3 (drainage) and the other
on L4–L5. Intrathecal normal saline infusion (150 ml) was done in
1 hour by passive flow. The patient was stabilized, and he was transferred
to the intensive care unit (ICU).
Seizures continued intermittently and he remained under general
anesthesia and a thiopental drip, with intermittent tachycardia and fluctuating
blood pressure requiring other interventions. On the third day after surgery,
sedation was discontinued. On the fourth day postoperatively, he opened his
eyes in response to voice instructions, followed simple directions, and
breathed on his own. Cranial computed tomography revealed no abnormality. He
was extubated, and was discharged from the ICU on the
sixth day and transferred to the ward 48 hours after weaning from mechanical
ventilation. The patient was ultimately discharged home and monitored at
6-month and 1-year intervals and found to be in excellent condition with no
neurological symptoms.
The use of cerebrospinal fluid lavage was based upon
an article by Tsui (Tsui
2004), in which that intervention was used following inadvertent
intrathecal administration of lidocaine and bupivacaine (that case did not
involve tranexamic acid). It’s, of
course, impossible to know whether the CSF lavage played a beneficial role in
this case, but it was certainly an innovative approach once the possibility of spinal
injection of tranexamic acid was considered. One of the problems in previously
reported cases has been unfamiliarity of the syndrome by clinicians. In the
present case, it seems the early appearance of myoclonus and seizures tipped
off the anesthesiologist to consider the possibility. The occurrence of
seizures implies that the tranexamic acid has already reached the cranial
cavity. But perhaps the CSF lavage might have prevented even more from reaching
the brain.
The authors do note
that, due to the frequency of this error, the manufacturer recently altered the
look of the two ampules (photo appears in their article). They note that previously
referenced case reports were the result of misreading between tranexamic acid and
0.5% hyperbaric bupivacaine ampules, which appeared identical from the outside.
There are two important points we need to make. First, don’t
store dangerous medications in a location where someone might inadvertently
pick it up, prepare it, and administer it. We learned that lesson many years
ago when concentrated potassium chloride was sometimes inadvertently given IV
to patients, resulting in fatalities. We also stressed it in our columns on the
mistaken administration of methylene blue instead of the intended trypan blue
in ophthalmology cases (May 20, 2014 “Ophthalmology:
Blue Dye Mixup” and September
2014“Another
Blue Dye Eye Mixup”). So, don’t keep tranexamic acid in locations
where you don’t need it.
Second, barcoding is an obvious technological solution to help avoid such
misadministration. But, as we pointed out in see our June 2022 What's
New in the Patient Safety World column “Where
Are You Barcoding?”, many OR’s have
yet to implement barcoding. ISMP (ISMP
2022) noted that Crystal Clinic
Orthopaedic Center, which adopted
barcode scanning technology in all perioperative and procedural settings prior
to medication administration, requires some anesthesia-provider medications to
be scanned and documented on the medication administration record (MAR). Tranexamic
acid was specifically mentioned as one of those medications.
Consider the following recommendations that have appeared in
our prior columns, taken from the World Health Organization (WHO
2022), the US Food and Drug Administration alert (FDA
2020), ISMP Canada (ISMP
Canada 2022), NAN (National Alert Network) Alert (NAN
2020), and ISMP (ISMP
2022):
· Don’t store tranexamic acid in locations where
you don’t need it
· If you do sometime need it, store tranexamic
acid injection vials separately from other drugs, in a way that makes the
labels visible to avoid reliance on identifying drugs by the vial cap color
· To prevent reliance on identifying the drug
by viewing only the vial caps, never store injectable drug vials in an upright
position, especially when stored in a bin or drawer below eye level. Store them
in a way that always makes their labels visible.
· Add an auxiliary warning label to note that
the vial contains tranexamic acid and should never be administered intrathecally
· Check the container label to ensure the
correct product is selected and administered
· All syringes used in the OR must be clearly labeled
·
Utilize
barcode scanning when stocking medication cabinets and preparing or
administering the product
· Utilize barcode scanning prior to dispensing
as well as when accessing the drug in surgical and obstetrical areas
· Minimize look-alike vials (caps) by
purchasing these products from different manufacturers if necessary
· Consider purchasing labels that state,
“Contains Tranexamic Acid” to place over the vial caps
· Consider NRFit syringes and connectors for
local anesthetics used for regional anesthesia administered via the neuraxial
route. NRFit connectors are incompatible with Luer connectors, thus preventing
misconnections with drugs intended for IV use, such as tranexamic acid.
·
Consider
the use of pharmacy-prepared or commercially available premixed containers of
tranexamic acid, which would be less likely to be confused with local
anesthetic vials. Pharmacy preparation and labeling of syringes or infusions
would help alleviate these errors.
If your facility uses tranexamic acid, it would be wise to
perform a FMEA (failure mode and effects analysis) to
identify and mitigate any current vulnerabilities you find.
Some of our prior
columns on inadvertent spinal administration of tranexamic acid:
June 4, 2019 “Medication Errors in the OR
– Part 3”
July 9, 2019 “Spinal Injection of
Tranexamic Acid”
June 14, 2022 “Spinal Tranexamic Acid
Again!”
February 21, 2023 “Tranexamic Acid Errors Just
Won’t Go Away”
References:
Harby SA, Kohaf NA. Accidental intrathecal injection of tranexamic
acid: a case report. J Med Case Reports 2023; 17: 55
https://jmedicalcasereports.biomedcentral.com/articles/10.1186/s13256-023-03768-6
Tsui B. Common sense medicine: using cerebrospinal lavage to
treat accidental excessive intrathecal drug injection in obstetric patients.
Anesth Analg 2004; 98: 434-436
World Health Organization. Risk of medication errors with tranexamic
acid injection resulting in inadvertent intrathecal injection. 2022
US Food and Drug Administration. FDA alerts healthcare
professionals about the risk of medication errors with tranexamic acid injection
resulting in inadvertent intrathecal (spinal) injection. 2020
ISMP Canada. ALERT: Substitution Error with Tranexamic Acid
during Spinal Anesthesia. ISMP Canada Safety Bulletins 2022; 22(6):
https://ismpcanada.ca/wp-content/uploads/ISMPCSB2022-i6-Tranexamic-Acid-Spinal-Anesthesia.pdf
ISMP (Institute for Safe Medication Practices). An
Interview: Success with Barcode Scanning to Enhance Perioperative Medication
Safety. ISMP Medication Safety Alert! Acute Care Edition 2022; 27(16): August
11, 2022
NAN (National Alert Network) Alerts. Dangerous Wrong-Route
Errors with Tranexamic Acid. ISMP 2020; September 9, 2020
https://www.ismp.org/alerts/dangerous-wrong-route-errors-tranexamic-acid
Print “PDF version”
http://www.patientsafetysolutions.com/