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Patient Safety Tip of the Week
February 21, 2023
Tranexamic Acid
Errors Just Won’t Go Away
Tranexamic acid has become fairly widely
used as an intervention for post-partum hemorrhage in obstetric patients. As a
result, it is showing up in locations where it can lead to inadvertent spinal
injection of this substance that is toxic to the nervous system. We’ve done columns on the devastating
consequences of inadvertent spinal injection of tranexamic acid (see our
Patient Safety Tips of the Week for June 4, 2019 “Medication Errors in the OR
– Part 3”, July 9,
2019 “Spinal Injection of
Tranexamic Acid”, and June 14, 2022 “Spinal Tranexamic Acid
Again!”). A key contributing factor in all cases is the similarity between
vials of tranexamic acid and vials of anesthetic drugs.
A recent
review (Moran 2023) after they
found 3 additional cases in South Africa notes that. “in anticipation of its use
at cesarean delivery, tranexamic acid
ampoules are now frequently kept in the
anesthetic drug trolley in the operating
room, creating a risk of tranexamic acid being mistaken for a
spinal anesthetic drug and injected intrathecally before
cesarean delivery.” It also notes that the
risk of this drug error is heightened
by the similarity in shape and size of the ampoules containing
tranexamic acid and those containing drugs used for
spinal anesthesia (eg, bupivacaine).
Moran et al. go on to point out that in some cases the drug error
may not be recognized because
anesthetic practitioners may be
unaware of the acute neurotoxic effects of intrathecal tranexamic
acid. They cite an example,
from 1 of the 3 recent cases
they became aware of, that the presentation of convulsions and
cardiovascular instability
after administration
of the spinal anesthetic was ascribed to eclampsia.
They cite a 2022 World
Health Organization alert (WHO
2022) and a 2020 US Food and Drug
Administration alert (FDA
2020) on the issue. While they note the importance of disseminating
information about tranexamic acid accidents, they acknowledge that is not
enough and that more needs to be done.
They recommend the following steps:
· 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
· Add an auxiliary warning label to note that
the vial contains tranexamic acid
· Check the container label to ensure the
correct product is selected and administered
·
Utilize
barcode scanning when stocking medication cabinets and preparing or
administering the product
Our June 14, 2022 Patient Safety Tip of the Week “Spinal Tranexamic Acid
Again!” discussed a case published by ISMP Canada (ISMP
Canada 2022) in which both tranexamic acid and bupivacaine were stored in
the same drawer of the drug cart.
The ISMP Canada case also highlights the potential flaws in
double checks. The hospital’s investigation found that a form of confirmation
bias (“seeing what you expect to see”) likely contributed even though a double
check had been performed.
A key point we always make is “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.
But you may need tranexamic
acid in obstetric cases.
However, it is not needed so urgently that you need to keep it where an
anesthetist might inadvertently pick it up. Tranexamic acid should
always be
stored separately from anesthetic drugs used in the operating room. It should be stored in a secure container away from the
anesthetic drugs cart. And it should never be put on the table set up in preparation for administering
a
spinal anesthetic.
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.
It is worth reiterating recommendations from the 2020 NAN (National
Alert Network) Alert (NAN
2020):
· Separate or sequester tranexamic acid in
storage locations and avoid storing local anesthetics and tranexamic acid near
one another.
· 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.
· Minimize look-alike vials (caps) by
purchasing these products from different manufacturers.
· Consider purchasing labels that state,
“Contains Tranexamic Acid” to place over the vial caps.
· Utilize barcode scanning prior to dispensing
as well as when accessing the drug in surgical and obstetrical areas.
· 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. A premixed container of IV tranexamic acid
in a sodium chloride solution for injection, 1 g/100 mL (10 mg/mL), is
commercially available. While the only approved indication for tranexamic acid
is to reduce or prevent hemorrhage for patients with hemophilia undergoing
tooth extraction, this product could be used off-label to treat other forms of
bleeding. However, vials of tranexamic acid may still be needed since loading
doses may be required prior to infusion (or a smart infusion pump
loading dose feature could be used that automatically switches to a continuous
infusion once the loading dose has been delivered). Also note:
local anesthetics may be available at some locations in premixed containers or
prepared by pharmacy for use in regional anesthesia.
And it’s worth your while to review the recommendations from
ISMP Canada (ISMP
Canada 2022) discussed in our June 14, 2022 Patient Safety Tip of the Week “Spinal Tranexamic Acid
Again!”.
Moran et al. in the current review point out that regulatory
bodies, suppliers, and manufacturers also have an important role in resolving
this problem. They suggest those entities could help ensure that tranexamic
acid drug ampules carry clear warning labels about the correct route of
administration. They stress that a coordinated international effort is required
to prevent inadvertent intrathecal tranexamic acid administration.
But, until industry gets it act together and packages
tranexamic acid in a safer manner, the following recommendations are crucial:
· Don’t store tranexamic acid in areas where it
is not needed
· Always segregate tranexamic acid from
anesthetics in areas where it is sometimes needed
· Use any method you can to flag vials of
tranexamic acid as being potentially dangerous
· All syringes must be clearly labeled
·
Implement
barcoding in the OR or any other area where tranexamic
acid might be used
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!”
References:
Moran NF, Bishop DG, Fawcus S,
Morris E, Shakur-Still H, Devall AJ, Gallos ID,
Widmer M, Oladapo OT, Coomarasamy
A, Hofmeyr GJ. Tranexamic acid at cesarean delivery: drug-error deaths. BJOG.
2023 Jan;130(1):114-117
https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17292
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
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