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Patient Safety Tip
of the Week
June
14, 2022
Spinal
Tranexamic Acid Again!
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” and
July 9, 2019 “Spinal
Injection of Tranexamic Acid”).
ISMP
Canada just issued a safety alert about another such incident (ISMP Canada 2022). (Actually, the error in this incident was identified
only when the same error occurred during a subsequent procedure later in the
day.) The patient was scheduled for an orthopedic surgical procedure. In the
operating room, tranexamic acid was inadvertently injected into the cerebrospinal
fluid, instead of the intended local anesthetic bupivacaine. The patient
reported extreme pain and demonstrated unusual movements during the procedure,
and experienced seizures while in the recovery room. The patient remains bed-bound
and is living with extreme chronic pain.
In our June 4, 2019 Patient Safety Tip of the
Week “Medication
Errors in the OR – Part 3” we
happened to mention the inadvertent spinal administration of tranexamic acid as
one of the medication errors occurring in the OR setting. Tranexamic acid is an
antifibrinolytic agent used in the control of traumatic, surgical, and
obstetric hemorrhage. In 2015, Patel and Loveridge (Patel
2015) did a review of obstetric neuraxial drug
administration errors. That review included four deaths from spinal tranexamic acid administered at caesarean section.
At that time, they had four key recommendations to avoid such errors:
1.
careful reading of the label on any drug ampule
or syringe before the drug is drawn up or injected
2.
labeling all syringes
3.
checking labels with a second person or a device
(such as a barcode reader linked to a computer) before the drug is drawn up or
administered
4.
use of non-Luer lock
connectors on all epidural/spinal/combined spinal-epidural devices.
Then,
in our July 9, 2019 “Spinal
Injection of Tranexamic Acid”, we
discussed a more recent review by Patel et al. (Patel
2019). They identified 21 reports in the literature of accidental spinal
administration of tranexamic acid injected during spinal anesthesia or analgesia.
These included seven elective caesarean sections and six patients having
orthopedic surgery. Death was
reported in 10 patients, and 10 of the remaining 11 patients required intensive
care admission for management of refractory convulsions and/or tachyarrhythmias.
Typical symptoms and signs include severe
pain in the back, buttocks and legs, myoclonus starting in the legs,
generalized convulsions, severe tachycardia and hypertension, and
ventricular arrhythmia. In addition, there was usually no sensory or motor
block as you’d expect if the intended bupivacaine had been administered.
In almost all cases there was an error
related to the ampule containing the tranexamic acid. There was similar size
and appearance to the ampules of the intended medication (usually bupivacaine
or similar agent). Failure to check the label contributed in
many cases. One case involved confusion between the IV line and a spinal
catheter that had been inserted for chronic pain management.
Some organizational factors that were
reported included a lack of formal drug handling or storage policy, and lack of
resources. In three cases, syringes or vials containing tranexamic acid were
prepared by personnel other than the practitioner administering spinal
anesthesia. On one occasion, the tranexamic acid ampule was stored in the same
location as local anesthetics. The ampule was passed unchecked from the
assistant to the anesthetist, who also failed to check the ampule.
Patel et al. note that all errors could have
been prevented if the recommendations in their 2015 paper had been followed.
They also suggest that manufacturers of tranexamic acid should be encouraged to
design ampules with recognizable size, shape, fonts
and color or, alternatively, tranexamic acid might be manufactured in a vial.
The also advise that tranexamic acid, and other non‐anesthetic drugs,
should be stored in a separate location in or outside the operating room, to
limit the possibility of picking up the wrong drug.
Our previous columns on medication errors in
the OR have noted one critical factor contributing to many incidents is that
one person (the anesthetist) often orders the medication, prepares it, and
administers it. That bypasses the usual chain in the medication administration
system in which you have several sets of eyes (physician, pharmacist, and one
or more nurses) checking the medication. Double checks would be an obvious
potential solution, but a double check failed in the current Canadian case. We
don’t see many OR’s in which such double checking
actually occurs. Also, barcoding could go a long way to avoid such
misadministration. But many OR’s have yet to implement barcoding (see
our June 2022 What's New in the Patient Safety World column “Where Are You Barcoding?”).
In an
editorial accompanying the 2019 Patel study, Palanisamy and Kinsella (Palanisamy
2019) focus on two important points: (1) reducing
the similarity of the ampules and (2) segregating the storage of the drugs.
They noted that tranexamic acid and bupivacaine are both patent‐expired
drugs that are supplied by a surprising number of generic manufacturers. They
stress that ampules of similar size increase the likelihood of mistakes and
suggest manufacturers could make ampules distinctive with different colored
neck and head rings in addition to the labelling issues. They also stress that
facilities should physically segregate tranexamic acid from commonly
administered spinal medications. Because tranexamic acid is not frequently
administered, it can be housed in a location that is distinct from anesthetic
drugs. Note that we (in our June 4,
2019 Patient Safety Tip of the Week “Medication
Errors in the OR – Part 3”)
and Patel et al. in the above paper have suggested tranexamic acid might be stored
outside the OR. But Palanisamy and Kinsella make a plea not to banish
tranexamic acid from the labor and delivery ward and operating room. They note
tranexamic acid is a safe, inexpensive and modestly
effective treatment and that the number needed to treat for IV tranexamic acid
to prevent one maternal death from hemorrhage is 267, whereas the number needed
to harm for inadvertent administration of tranexamic acid would be much higher.
A NAN
(National Alert Network) Alert in 2020 described 3 additional cases of
accidental spinal injection of tranexamic acid instead of a local anesthetic
intended for regional (spinal) anesthesia (NAN 2020). Container mix-ups were involved in each
case. In each case, seizures occurred shortly after the inadvertent spinal
injections.
In
that NAN alert, ISMP notes that it had previously described 3 such cases (ISMP 2019) and pointed out that the similarity of
vials of tranexamic acid to those of the local anesthetics was a key
contributing factor. Moreover, these cases are often being performed in areas
where barcoding has not been implemented (see our June 2022 What's New in the
Patient Safety World column “Where Are You Barcoding?”). And, in some cases, syringe labeling
issues may be contributory factors.
Even
the orientation at which you store the vials may be important. The NAN alert
notes “While label colors and vial sizes are different, the caps on
ropivacaine, bupivacaine, and tranexamic acid vials may have the same blue
color and could lead staff to select a vial based on cap color, without reading
the label, especially if the vials are stored upright with only the caps
showing.”
The
NAN alert recommended the following prevention measures:
- 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.
The
hospital in the recent Canadian case immediately issued a safety alert, both
hospital-wide and province-wide. They suggested the following strategies:
- Enhanced
vigilance with dosing, preparation, and administration of medications via
the spinal/ epidural route
- A
2-person visual check of medication vials before spinal/epidural
administration. The check includes verification of the drug name,
concentration, expiry date, and a final check of the vial prior to administration
- Application
of a warning sticker on tranexamic acid vials to provide an additional
visual cue
Note
that the hospital also began providing tranexamic acid for injection in glass ampules
to differentiate it from medications in vials, but
acknowledged that there have been case reports of mix-ups between ampules of
tranexamic acid and local anesthetics.
ISMP
Canada had these further recommendations:
- Store
medications intended for IV administration (e.g., tranexamic acid)
separately from those intended for neuraxial administration (e.g., local anesthetics).
- Store
medication vials in a way that makes the label visible to practitioners
before selection. For example, where vials are stored in a drawer, they should
be laid flat, with the label visible, instead of being placed upright
(with only the vial cap visible).
- Communicate
widely and in multiple ways any time changes in medication supply are
contemplated, both during planning and implementation
- Include
a prominent warning on the tranexamic acid label that states, “FOR INTRAVENOUS
USE ONLY”.- Consider attaching an auxiliary label
to the vial cap stating, “Tranexamic Acid”.
- Use
equipment (e.g., syringes and infusion tubing) with neuraxial
route-specific connectors (e.g., non-Luer lock)
for spinal/epidural procedures.
- Encourage
medication suppliers to provide tranexamic acid for injection in diluted
form, in a ready-to-use minibag for IV infusion,
as is commercially available in other countries
- Conduct
an independent double check of any medication intended for neuraxial administration
(with a second person or a barcode reader) - Reading aloud the label and incorporating
mindful pauses into the verification process may be helpful.
- Promptly
assess unusual or unexpected patient reactions or behavior in the
operating room to identify a potential adverse drug reaction or medication
error, particularly when medications have been administered via the
neuraxial route.
The
ISMP Canada alert also has an important point we made in our columns on response
to serious incidents – seizing and sequestering any evidence when an adverse
incident occurs (see our Patient Safety Tips of the Week for July 24, 2007 “Serious
Incident Response Checklist” and May 31, 2022 “NHS
Serious Incident Response Framework”). The involved hospital only identified the
nature of the error when they found discarded vials of tranexamic acid from the
second case. The alert recommends each facility develop a method of disposal in
the operating room that enables the review of discarded vials following a
critical incident, while ensuring adherence to medical waste disposal policies.
Our June
2022 What's New in the Patient Safety World column “Where Are You Barcoding?”) was basically a plea for all hospitals to
extend their barcoding capabilities to areas such as the OR and radiology
suites. It is unfathomable that our most powerful medication safety tool is not
being used where medications are frequently administered.
And,
while we still recommend use of double checks when administering anything
spinally, the current Canadian case illustrates that double checks often fail.
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 (listed below) on the mistaken administration of
methylene blue instead of the intended trypan blue in ophthalmology cases. But
tranexamic acid is being used more frequently in a variety of procedures, so it
may not be practical to eliminate it from most OR or
labor and delivery settings. That editorial by Palanisamy and Kinsella (Palanisamy
2019) provides a strong argument against
banishing tranexamic acid from the OR or labor and
delivery suite. However, hospitals could still do an inventory of use of
tranexamic acid in each of their OR’s and selectively remove tranexamic acid
from those that almost never use it. For example, an OR that is dedicated to
ophthalmology cases might never use it. You could still store tranexamic acid
in your labor and delivery rooms and those other OR’s where it is frequently
used, while still making sure it is not stored in proximity to your anesthetic
drugs.
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”
Some of our prior columns on medication
errors in the OR:
March 24, 2009 “Medication Errors in the OR”
May 20, 2014 “Ophthalmology: Blue Dye Mixup”
September 2014 “Another Blue Dye Eye Mixup”
November 3, 2015 “Medication
Errors in the OR - Part 2”
June 4, 2019 “Medication
Errors in the OR – Part 3”
References:
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
Patel,
S, Loveridge, R. Obstetric neuraxial drug administration errors: a quantitative
and qualitative analytical review. Anesthesia and Analgesia 2015; 12: 1570-1577
Patel
S, Robertson B, McConachie I. Catastrophic drug errors involving tranexamic
acid administered during spinal anaesthesia.
Anesthesia 2019; 74(7): 904-914 First Published: April 15, 2019
https://onlinelibrary.wiley.com/doi/abs/10.1111/anae.14662
Palanisamy A, Kinsella SM. Spinal tranexamic acid - a new
killer in town. Anaesthesia 2019;74(7): 831-833 Epub April 15, 2019.
https://onlinelibrary.wiley.com/doi/full/10.1111/anae.14632
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
ISMP
(Institute for Safe Medication Practices). Dangerous Wrong-Route Errors with
Tranexamic Acid—A Major Cause for Concern. ISMP Medication Safety Alert! Acute
Care Edition 2019; 24(10): May 23, 2019
https://www.ismp.org/resources/dangerous-wrong-route-errors-tranexamic-acid-major-cause-concern
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