REMS: Opioid-Related Patient Safety and Liability
by David B. Troxel, MD, Medical Director, Board of Governors
Adverse drug events have become a subject attracting considerable attention, both in medical literature and in the lay press. In a recent report,1 the National Center for Injury Prevention and Control found that the number of overdose deaths from prescription painkillers (including hydrocodone, oxycodone, oxymorphone, and methadone) is greater than deaths from heroin and cocaine combined (both misuse and abuse). Drug deaths outnumbered traffic fatalities in 2011. Hydrocodone is now both the most widely prescribed and the most commonly abused prescription drug in America.
An analysis of 2,646 claims closed by The Doctors Company in 2011 revealed that 5.8 percent contained medication-related errors. These claims involved all medical specialties. The medication-related errors identified in these claims include the following:
The medication classes involved in these medication-related errors include the following:
Narcotic analgesics were the most common class of medications identified in these claims. They include the following:
- Dilaudid (hydromorphone) (3 claims)
- Dilaudid and morphine (3 claims)
- Dilaudid and oxycodone (1 claim)
- Percocet† (oxycodone) (2 claims)
- Oxycodone (1 claim)
- Vicodin† (hydrocodone) (7 claims)
- Norco† (hydrocodone) (1 claim)
- Methadone and oxycodone (1 claim)
- Methadone (2 claims)
- Morphine (4 claims)
- Fentanyl (4 claims)
- Darvocet† (propoxyphene) (1 claim)
Total: 30 claims
†Narcotic analgesics that also contain acetaminophen.
The medication-related errors identified in these 30 narcotic analgesic claims include the following:
When compared to medication-related errors in all claims, monitoring errors in narcotic analgesic claims are more common (34.5 percent versus 20.8 percent), as are drug administration errors (17.2 percent versus 9.8 percent) and ordering errors (10.3 percent versus 6.5 percent).
Opioid Analgesics and REMS
What in the world is REMS? Robotic Exploration of Mars Study? Restoration of Egyptian Museums Society? Regulatory Earthquake Management Systems? Restoration of Epicurean Mannerisms Society? NO. It’s Risk Evaluation and Mitigation Strategies.
Over the past decade, adverse events related to the inappropriate prescribing, misuse, and abuse of long-acting opioids have reached epidemic proportions and have become a source of substantial patient morbidity and mortality—and a growing cause of prescriber liability. As a consequence, the U.S. Food and Drug Administration (FDA) has mandated a Risk Evaluation and Mitigation Strategies (REMS) program for prescribing extended-release and long-acting opioid analgesics. In July 2012, the FDA announced plans to implement this voluntary program on March 1, 2013.
As part of its REMS program, the FDA is requiring opioid manufacturers to provide grants that will fund continuing medical education (CME) programs to advance prescriber understanding and safe use of pain medications. The programs will be designed by independent, accredited organizations that provide CME for health professionals, and they will comply with standards set by the Accreditation Council for Continuing Medical Education (ACCME)—not standards set by the drug manufacturers.
The drugs subject to REMS include hydromorphone, morphine, oxycodone, oxymorphone, and tapentadol in oral dosage forms; fentanyl and buprenorphine used in transdermal delivery systems; and methadone tablets and solutions.
The CME programs are three hours long and cover three basic components: prescriber training to assure safe use, patient counseling (including the use of patient-prescriber agreements) on safe use and risks, and a medication guide for each opioid that patients will receive from the pharmacist when it is dispensed.
In our analysis of the 30 medication-related errors involving narcotic analgesics, we identified the following opioids that are subject to the REMS program: hydromorphone (seven claims), morphine (seven claims), oxycodone (five claims), fentanyl (four claims), and methadone (three claims). Hydrocodone (eight claims) is not included in the REMS program. Thus, not only are medication-related errors involving long-acting opioids a patient safety concern; they are also a cause of significant professional liability for physicians and other prescribers.
The Physicians’ Desk Reference (PDR) Network is collaborating with The Doctors Company on a CME program to fulfill the FDA’s REMS mandate and to help make prescribers aware of the patient safety and liability issues related to opioid prescribing. The PDR Network plans to make this online opioid CME program complimentary to prescribers. The Doctors Company encourages all physicians who prescribe long-acting opioids to complete the training. As an incentive, we will provide CME credits without charge to all prescribers who do so.
The incidence of medication-related errors in The Doctors Company’s 2011 medical professional liability claims is 5.8 percent, and long-acting narcotic analgesics account for 17.5 percent of the medications identified in these claims. We encourage all physicians who prescribe long-acting opioids to complete the REMS CME program for extended-release and long-acting opioid analgesics. Watch for future announcements about how you can advance safe use of pain medications while you earn complimentary CME credits.
1. Centers for Disease Control and Prevention. Prescription painkiller overdoses in the U.S. Vital Signs. Published November 2011. www.cdc.gov/vitalsigns/PainkillerOverdoses.
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