The Operating Theatre Journal April 2022

Risk of medication errors with
tranexamic acid injection resulting
in inadvertent intrathecal injection
WHO is alerting health care professionals about the risk of administration
errors that can potentially occur with Tranexamic Acid injection. There
have been reports of Tranexamic Acid being mistaken for obstetric
spinal anaesthesia used for caesarean deliveries resulting in inadvertent
intrathecal administration.
Intrathecal TXA is a potent neurotoxin and neurological sequelae are
manifested, with refractory seizures and 50% mortality. The profound
toxicity of intrathecal TXA was described in 1980. A 2019 review
identified 21 reported cases of inadvertent intrathecal injection of TXA
since 1988, of which 20 were life-threatening and 10 fatal. Sixteen were
reported between 2009 and 2018.
WHO recommends early use of intravenous TXA within 3 hours of
birth in addition to standard care for women with clinically diagnosed
postpartum haemorrhage (PPH) following vaginal births or caesarean
section. TXA should be administered at a fixed dose of 1g in 10 ml (100
mg/ml) IV at 1 ml per minute, with a second dose of 1g IV if bleeding
continues after 30 minutes.
TXA is frequently stored in close proximity with other medicines,
including injectable local anesthetics indicated for spinal analgesia
(e.g., for caesarean section). The presentation of some of the local
anesthetics is similar to the TXA presentation (transparent ampoule
containing transparent solution), which can erroneously be administer
instead of the intended intrathecal anesthetic resulting in serious
undesirable adverse effects.
Endo Begins Shipment of
Premixed Ephedrine Sulfate
Injection in Ready-to-Use Vials
Endo International plc announced recently that its Par Sterile Products
business has begun shipping premixed Ephedrine Sulfate Injection in a
ready-to-use 50 mg/10 ml single-use vial.
“We are pleased to launch this new ready-to-use product as part of our
agreement with Nevakar,” said Scott Sims, Senior Vice President and
General Manager, Sterile Products at Endo. “This is a demonstration
of our commitment to deliver quality, life-enhancing therapies to
healthcare providers—when and how they need them.”
Ready-to-use, or RTU, products help streamline operations for hospitals
by eliminating the need to prepare or transfer the product before
patient administration. This may reduce waste and costs, optimize
convenience and workflow, and heighten accuracy and compliance by
reducing the chance for preparation error—all of which support quality
patient care.
This is the first product launch under the previously announced exclusive
licensing agreement between Nevakar Injectables, Inc., a privately
held biopharmaceutical company, and Endo’s subsidiary, Endo Ventures
Limited (EVL). Under the agreement, the companies are collaborating
on five differentiated sterile injectable products in the U.S. Nevakar is
responsible for developing the drugs and obtaining approval from the
U.S. Food and Drug Administration, and EVL is responsible for product
launch and distribution through Endo’s Par Sterile Products business.
SOURCE Endo International plc
Recently, obstetricians from several countries have reported
inadvertent intrathecal TXA administration and related serious
neurological injuries.
TXA is a lifesaving medicine, however, this potential clinical risk should
be considered and addressed by all operating theatre staff. Reviewing
of existing operating theatre drug handling practice is required in order
to decrease this risk, such as storage of TXA away from the anaesthetic
drug trolley, preferably outside the theatre.
References:
South African Medical Journal 2019;109(11):841-844. DOI:10.7196/
SAMJ.2019.v109i11.14242
Yamaura A, Nakamura T, Makino H, Hagihara Y. Cerebral complication
of antifibrinolytic therapy in the treatment of ruptured intracranial
aneurysm. Animal experiment and a review of literature. Eur Neurol.
1980;19(2):77-84. doi: 10.1159/000115131. PMID: 6893025.
Patel S, Robertson B, McConachie I. Catastrophic drug errors involving
tranexamic acid administered during spinal anaesthesia. Anaesthesia.
2019 Jul;74(7):904-914. doi: 10.1111/anae.14662. Epub 2019 Apr 15.
PMID: 30985928.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-alertshealthcare-professionals-about-risk-medication-errors-tranexamicacid-injection-resulting
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