Medical Malpractice: Going Off-Label Can Cost You Big-Time

Every year, physicians perform millions of off-label epidural steroid injections (ESI) to treat neck and back pain — despite the risk of rare but serious and sometimes fatal neurological side effects and despite the fact that the Food and Drug Administration (FDA) has never approved corticosteroids for injection into the epidural space.

Off-label drug use isn't necessarily a breach of the standard of care. The FDA considers doctors who use steroids off-label "part of the practice of medicine and not regulated by FDA." The courts, as this month's case shows, took a sterner view.

In 2013, a 60-year-old Colorado woman underwent ESI at The Surgery Center at Lone Tree (osmag.net/YoHAn4) with Kenalog (triamcinolone acetonide), which the FDA warned cannot be used for epidural injection. The patient received 4 injections of the glucocorticoid on the right side of vertebrae L1 and L2, court records show. Soon after the final Kenalog injection, in the recovery area, the patient lost motor function and complete sensation from the waist down. She and her husband sued the surgery center, and were awarded $14.9 million. She remains a paraplegic.

The side effects of Kenalog are rare and typically minimal when properly administered, but the risks are significantly greater when injected into the spine. Two years before the woman received the injection, Bristol-Myers Squibb, aware that Kenalog could cause spinal cord injury during ESI, petitioned the FDA for permission to modify Kenalog's warning label to read "Not for Epidural Use." In part, the warning now reads: "Spinal cord infarction, paraplegia, quadriplegia, cortical blindness and stroke (including brainstem) have been reported after epidural administration of corticosteroids."

Physicians will always err. It's up to other healthcare professionals to serve as checks and balances to help prevent patient harm. When a physician orders a medication for a procedure, whomever at the facility orders the drug should review the order before delivering the medication to the point of care or to the automated dispensing system.

Again, the FDA's label change for Kenalog had been in place for 2 years before the woman's incident, so someone at the facility had a duty to protect the patient — and all back pain patients at the center — by alerting ordering physicians about the potential risks of Kenalog for ESI, and perhaps even restricting it from the facility's formulary.

The patient's nurse also had a responsibility to the patient in terms of the 5 rights of medication administration: right patient, right drug, right dose, right route and right time. Most surgical facilities specialize in a limited array of procedures, so nurses routinely become familiar with various procedures and associated perioperative medications. Nurses often witness or play a role in informed consent, so they had an additional opportunity to prevent the use of Kenalog by ensuring that the patient understood what was going to happen.

If the nursing team wasn't familiar with Kenalog, then it was their responsibility to educate themselves so they could advocate for the patient and ensure the 5 rights. In the Colorado case, that would have afforded another opportunity to confer with the pharmacist and ordering physician to avoid a catastrophic error.

The surgery center itself also had an administrative duty because it employed the nursing and pharmacy teams, and should have been aware that Kenalog was routinely purchased and administered for epidural injections despite explicit FDA and manufacturer warnings.

The debate regarding off-label use will continue as medicine evolves, and physicians will continue to routinely prescribe and administer medication for off-label purposes. When a medication like Kenalog has a special warning, however, off-label use becomes riskier and may even be contraindicated. Patient safety is the foremost priority at every facility. It is the duty of each provider to ensure that patients have accurate, up-to-date and complete information before undergoing any procedure. Excellent communication by surgeons and staff is the key to mitigating risk to the patient and to the surgical facility. OSM