Administration Errors or When Good Drugs Go Wrong

Pharmacovigilance often focuses on drugs’ inherent risks – side effects, interactions, and long-term consequences. But what happens when healthcare providers give the drug to the right patient in the wrong place? Administration errors – mistakes that occur during prescribing, dispensing, or giving medications – are one of the most preventable causes of patient harm. Yet, they remain a significant challenge in healthcare.

The inadvertent spinal (intrathecal) administration of a drug intended for another route is one of the most dangerous forms of administration error. When this occurs, even well-known and effective drugs can become toxic and cause significant harm.

What is Inadvertent Spinal Administration?

Healthcare providers commit inadvertent spinal administration when they mistakenly inject a medication intended for intravenous, intramuscular, or other non-spinal routes into the spinal space. This error can happen during procedures like spinal anesthesia or epidural injections when healthcare providers fail to ensure the correct drug is administered via the appropriate route.

Spinal administration is used for specific medications, including anaesthesia agents like bupivacaine. However, drugs not intended for this route, such as digoxin or tranexamic acid, can cause severe adverse reactions when healthcare providers inadvertently inject them into the spinal canal. The spinal space is highly sensitive, and drugs administered intrathecally can directly affect the central nervous system. The consequences of this kind of error can be catastrophic.

A Case Study on Tranexamic Acid Administration Errors

Tranexamic acid (TXA) is an antifibrinolytic agent commonly used to reduce blood loss during major surgeries and trauma, effectively lowering morbidity and mortality rates. However, its growing use, including off-label applications, has led to more frequent reports of adverse events and administration errors. These errors, such as incorrect dosing or unintended intrathecal administration, can result in serious outcomes like seizures, myoclonus, and arrhythmias.

Recently, the DrugCard platform identified a case report in the medical literature involving a 75-year-old woman (ASA III) who underwent lumbar spine surgery. She received topical TXA for hemostatic control despite intraoperative dural tears. Postoperatively, the patient experienced severe back pain, perianal burning, and painful lower limb myoclonus, prompting emergency surgery. While no structural complications were found, her symptoms persisted, requiring ICU admission, sedation, and supportive care. The patient’s condition gradually improved, and she was discharged one week later without neurological sequelae.

When Administration Errors Lead to Neurotoxicity

Tranexamic acid (TXA) can reduce inhibitory neurotransmission of GABA-A and glycine receptors, increasing neuronal excitability and causing potential proconvulsant effects. This mechanism explains the neurotoxic effects seen with intrathecal TXA, including imbalanced motor, sensory, and autonomic neurotransmission.

Administration errors, such as unintentional intrathecal application, significantly increase the risk of these neurotoxic effects. This case report highlights the importance of recognizing the early signs of neurotoxicity resulting from inadvertent intrathecal TXA administration.

The authors note that this is a rare complication, particularly associated with spinal topical use, and emphasize the critical need to ensure dural integrity before applying topical TXA. A dural tear could allow TXA to enter the intrathecal space, leading to severe neurotoxic outcomes.

Important Note:

Tranexamic acid (TXA) is listed on the ISMP’s High Alert Medications list for acute care settings. When mistakenly administered via a neuraxial route, TXA becomes a potent neurotoxin, with a mortality rate of approximately 50%. Even if patients survive, they often face severe complications such as seizures, permanent neurological damage, and paraplegia. This highlights the critical need for vigilance in its administration to prevent devastating outcomes.

The Risks of Intrathecal Digoxin Administration Errors

The DrugCard platform identified a case of administration error involving a 24-year-old female who accidentally received intrathecal digoxin instead of bupivacaine during a routine cesarean section. The patient underwent spinal anaesthesia without immediate complications, but it was later discovered that 375 mcg of intrathecal digoxin had been administered. This led to respiratory distress, encephalopathy, and bilateral hearing loss, requiring intubation. Despite significant initial neurological deficits, the patient made substantial progress during a one-month inpatient rehabilitation program. She regained mobility with assistive devices and improved cognition and functional mobility. This case emphasizes the serious risks of administration errors and the importance of quick intervention to enhance recovery outcomes.

The Role of Pharmacovigilance

Pharmacovigilance is critical in identifying and addressing administration errors, particularly high-risk medications. By analyzing adverse event reports and case studies, pharmacovigilance specialists can monitor trends and highlight drugs that may pose a higher risk of harm when administered via the wrong route. Reviewing inadvertent spinal drug administration cases provides valuable insights into preventive measures. It also guides the development of better safety protocols.

Conclusion

Inadvertent spinal administration errors are a serious concern in pharmacovigilance and patient safety. While the medications themselves may be effective and safe when administered correctly, an error in the route of administration can lead to severe and sometimes fatal consequences. Healthcare providers can reduce the incidence of these errors through careful monitoring, improved procedures, and ongoing education. This ensures that healthcare providers always use good drugs correctly to benefit patients.