By wonker, via Flickr.
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.)
Says Curtiss:
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
Prillsheila@yahoo.com HELLO who can function if they are in pain? Are you going to realize what the death toll will be if people start killing themselves because you don’t want to give them pain killers! Pain killing drugs have been around since history began……..you better worry about heroin and meth….and leave suffering people alone! Ridiculous!
I’m with Sheila Sud: educate before banning these affordable, essential components of pain control. Why should everyone suffer for the carelessness of a few? (I for one CAN feel the difference between 325 and 500 mg of Tylenol.)We need to stop our elevation of government to the role of cotton wool shielding society from consequences of behavior. Judy’s patient and hospital staff all stand immediately responsible and accountable for missing his OTC meds from that discharge process. Actually, it was likely missed from his admission med list as well, which is why med reconciliation laws were passed—proving my point: the best prevention is knowledgeable bedside care. That commodity decreases with every new regulation passed, by focusing nurses on paperwork to prove regs were met, at the expense of patient face time. I would hope cases like Judy’s will be widely publicized for the edification of patients and providers alike.
A week ago, my podiatrist and I were discussing the ban. At the time, I agreed with him that if anything should be changed it shpuld be all the OTC combination drugs with acetaminophen not the prescribed that ahould have more patient/provider/pharmacist contact and education than the OTC. That was the day before I changed my mind. As a Parish Nurse while visiting an elderly parishioner the day after he was discharged from the ER because he fell , I asked what medications he was taking. Among others was 600mg acetaminophen for arthritis. He showed me his ER discharge papers. They had given him Percocet for pain. For the previous 24 hours, he took 6 Percocet and 4 600mg acetaminophen. He did not know Percocet had acetamoinophen but he knew the risks. Labels were not read, discharge papers were not thoroughly reviewed. Did no one review what meds he was on before they sent him home? I now am FOR removing Rx and OTC combination pain and other combination meds with acetaminophen.
I would first like to see more public education and labeling of pain medications containing acetominophen of the risk of liver damage if not taken as directed or if additional tylenol/acetominophen is taken with the drug. Too many patients adjust their own dose or self medicate, one recent example was a patient I had taking 7-8 extra strength tylenol at a time!
The components of the FDA’s opioid REMS have not been determined. Patient registries and special prescriber certification are only 2 of many possibilities, some more and some less restrictive.
Perhaps we should evaluate why adding acetaminophen bumps drugs from Schedule II to schedule III in the first place. Is it less addictive to take Percocet than Roxicodone? If suddenly the combos become unavailable and pain relief is that much harder to come by, every Tom, Dick, and Harry with a sprain is going to flock to the ER for the good stuff… not once, but daily until the pain is gone or they are refused treatment. If you can’t go to just any doc to get narcotic pain relievers, the pain relief specialists will have lines out the door also.
maybe they should just have oxycodone/acetaminophen in doses that are no more than 325mg acetaminophen. i read that there’s no evidence that extra-strength works any better than regular.