To Promote Patient Safety, Don’t Criminalize Medical Errors

Originally published by our sister publication Anesthesiology News

BOSTON—Criminalizing unintended errors during anesthesia administration could drive up malpractice costs and cause clinicians to flee the profession. The better approach could be to build a culture of safety that minimizes the chance for medical and medication error, according to a presentation at the Anesthesia Patient Safety Foundation’s (APSF’s) 2024 Stoelting Conference.

Medical error is the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim, said APSF President Steven Greenberg, MD, and the Jeffrey Vender Anesthesiology Chair of Research and Education at Endeavor Health, and a clinical professor at the University of Chicago Pritzker School of Medicine.

Substitution error, the most common type of medication error, is a longstanding challenge for anesthesia professionals.

An example of this is a 1987 case in which epinephrine was given instead of pitocin, leading to a mother’s death (APSF Newsletter 1987, Winter issue). Studies suggest that perioperative medication errors can be seen in approximately 1 in every 20 anesthetics (Anesthesiology 2016;124[1]:25-34).

“Criminalization of error has tremendous unintended consequences for healthcare,” Greenberg said. They could include physicians leaving the field altogether; exacerbating workforce shortages caused by the COVID-19 pandemic; or practicing defensive medicine meant to ward off lawsuits, which ultimately means unnecessary tests and increase expenses for the entire healthcare system.

Greenberg said the APSF plans to inform prosecutors about the risks from criminalizing unintended harm, and to provide comfort to clinicians who make an honest mistake.

In contrast, he said: “We all know cases, in the literature and the newspapers, of when healthcare professionals—unfortunately—intend to harm. By definition, this is not an error.”

Besides criminal referrals in such cases, it would also be appropriate to criminalize reckless patterns of behavior, or an error committed while under the influence of drugs and alcohol, Greenberg said.

Any other errors should be seen as the result of human frailty, with systems in place to minimize them and a culture of respect that enables everyone in a healthcare organization to speak up about practices that can lead to error. One simple approach is to be aware of look-alike medications, incidents which the APSF collects from its global constituency and publishes on its website.

“Anesthesiology departments should create a culture of no blame. We should operate on the principles of just culture, where every single one of us has a place at the table to recognize threats and do something about it,” said Greenberg, who was a member of a task force that created the APSF statement on criminalization of medical error.

Greenberg also encouraged reforms for the dispensing of high-risk drugs to lower the likelihood of error.

“We only should use override methods for urgent and emergent clinical circumstances; and when we do that, we should institute a double verification system,” he said, noting that he led an initiative at his own hospital system to employ the double verification system before the performance of subarachnoid blocks among anesthesia professionals. Before administration, two clinicians look at a vial to make sure it is unexpired and the right dose, right concentration and for the right patient.

Mistake Leads to Positive Change

At the same conference, Paul Lefebvre, JD, described a contemporary case of substitution error, when an anesthesiologist mistakenly gave tranexamic acid (TXA) instead of mepivacaine during a subarachnoid neuraxial block for a 60-year-old man undergoing total hip arthroplasty. This caused seizures, which resolved after the patient underwent a cerebrospinal fluid lavage and spent four days in a medically induced coma. After this, his rehabilitation proceeded smoothly, without permanent effects from the error.

Lefebvre, an attorney at the anesthesia-specific liability insurance company Preferred Physicians Medical (PPM), noted that the two medications were packaged in look-alike containers and stored in close proximity. Besides that, the facility had recently procured medications from a new vendor, and the latest supply of mepivacaine had the same color cap as the TXA vials. Upon discovering her mistake. the anesthesiologist informed Lefebvre about what had happened, and PPM retained local counsel in anticipation of litigation.

Lefebvre supported the clinician’s decision to promptly disclose the event to the patient’s wife, given that it was a clear error and no investigation was necessary.

The patient’s family sued the anesthesiologist, practice group and hospital, leading to a confidential settlement that Lefebvre reported was within PPM’s coverage limits.

Following this incident, the anesthesiology practice group made changes to boost patient safety. Two people now check to ensure that the correct local anesthetic is used during a neuraxial block, and TXA is no longer stored near local anesthetics. In addition, anesthesiologists now order TXA in prefilled infusion bags from the pharmacy in preparation for orthopedic cases, as another defense against substitution error.

“Encourage the reporting of near misses at your facilities,” Lefebvre advised, in an ethos that treats medication errors as learning opportunities and not cause for punishment.

By Marcus A. Banks

Greenberg reported receiving grants from Fresenius Kabi, Merck and Senzime.