Drug errors with narcotics raise potential for liability
Both over- and under-prescribing pose legal risks
(Editor's note: This story package is the second part of a two-part series on prescribing errors. In last month's issue, we addressed liability risks. In this month's issue, we discuss liability with narcotics as well as "alert fatigue" with electronic medical records.)
According to an analysis of 2,646 malpractice claims from all medical specialties closed at The Doctors Company in Napa, CA, 5.8% contained medication-related errors. Of these, 18% included narcotic analgesics, with hydrocodone accounting for eight claims (27% of the total).
Hydrocodone is the most widely prescribed pain medication in the United States, and a Food and Drug Administration (FDA) panel voted to tighten restrictions on prescribing it in January 2013. "If the FDA accepts the panel's recommendation, it will go to the Department of Health and Human Services for final approval. Refills without a new prescription would be prohibited, and only written prescriptions from a physician would be permitted," says David Troxel, MD, medical director of The Doctors Company.
If these restrictions are subject to an "FDA Alert," it will become the standard of care, and if an adverse drug event results from violating it, the physician might be held liable, says Troxel.
Many of the professional liability claims involved adverse events that occurred in the post-anesthesia care unit, intensive care unit, or critical care unit and involved pain medicine overdose, failure of communication between prescribers of pain medications, and inadequate monitoring of patients receiving pain medications, says Troxel. "The most common adverse event is respiratory depression, often in patients with unrecognized obstructive sleep apnea," says Troxel. "This can result in the need for ventilator support and sometimes in death."
Compared to medication-related errors in all claims, monitoring, administration, and ordering errors were more common in claims involving narcotic analgesics, according to the analysis. "A common contributor to these adverse drug events is failure of communication, sometimes resulting in poor coordination of care between physicians, often during hand-offs, and between physicians and nurses, often during shift changes," says Troxel. "Hopefully, monitoring protocols, e-prescribing, and [electronic health record] drug alerts will obviate this problem."
Troxel has seen patients' allegations of overprescribing opioids for chronic pain management result in a medical board action against the physician.
"Physicians are put in a difficult position," he says. "They can be sanctioned for overprescribing opioids, resulting in dependency or addiction, and they can be criticized for failing to prescribe sufficient opioids to relieve patient pain and thereby causing pain and suffering."
Troxel advises physicians who prescribe opioids to take the FDA's Risk Evaluation and Mitigation Strategy (REMS), a three-hour online course on long-acting and extended-release opioids. (For more information, go to http://1.usa.gov/qiruyI.)
"REMS covers three basic components: prescriber training to ensure safe use, patient counseling on safe use and risks, and a medication guide for each opioid, which patients receive when prescriptions are filled," says Troxel.