Some crucial context may have been left out of last week’s widely reported story that an FDA advisory panel has recommended bans on Vicodin (hydrocodone plus acetaminophen) and Percocet (oxycodone plus acetaminophen), two popular combination drugs used to treat pain. The panel’s concern is the liver toxicity of acetaminophen, an ingredient in a number of other prescription drugs that would also be banned if the FDA adopts the panel’s advice.
A number of clinicians and patients have expressed alarm at the potential loss of Vicodin and Percocet, both of which are mainstays of pain management in the U.S. In fact, says Carol Curtiss, MSN, RN, BC, a nationally recognized speaker on pain and symptom management and a past national president of the Oncology Nursing Society, the proposed ban could have even more drastic implications than most people yet understand.
This is because, says Curtiss, the FDA is also considering implementing something called Risk Evaluation and Mitigation Strategies (REMS), which would require special certification for all clinicians prescribing noncombination Schedule II opioids like morphine, oxycodone (without acetaminophen or ibuprofen), hydromorphone, and fentanyl—that is, the drugs physicians would have available to effectively treat moderate to severe pain after the ban of Schedule III combination drugs like Vicodin and Percocet. (REMS might also require a national registry for all patients prescribed Schedule II substances.)
combination opioid/non-opioid medications are among the most frequently prescribed analgesics in the U.S. . . . Many prescribers are more comfortable prescribing them than Schedule II opioids. If combinations are banned, and REMs are implemented . . . , only certified prescribers could provide opioids of any strength for patients in pain. A more rational approach would be to decrease the multiple-dosage forms of acetaminophen in the combination products . . . , increase the visibility of overdose warnings for acetaminophen on over-the-counter products and prescriptions, and develop a nationwide education program for the public, patients, and health care providers to understand the rationale for the dose limits.
Should we be worried?
Jacob Molyneux, senior editor