August 22, 2012
ASA Responds to PROP Petition to Change Opioid Labels
Physicians for Responsible Opioid Prescribing (PROP), an organization dedicated to reducing morbidity and mortality due to opioids and promoting safe prescribing practices, recently submitted a petition to the Food and Drug Administration (FDA) requesting changes to opioid analgesic labels. Specifically, PROP requests that the FDA:
- Strike the term “moderate” from the indication for non-cancer pain.
- Add a maximum daily dose, equivalent to 100 milligrams of morphine for non-cancer pain.
- Add a maximum duration of 90 days for continuous (daily) use for non-cancer pain.
Members of the Congressional Caucus on Prescription Drug Abuse wrote the FDA supporting PROP’s petition and requesting expedited review.
ASA submitted a letter to the FDA opposing each of these proposed changes. In the letter, ASA notes that access to opioids must be balanced with efforts to reduce the misuse, abuse, and diversion of prescription drugs. However, the changes advocated by PROP are not scientifically founded or practical. "With regard to the first proposed change, it is very common for pain intensity to fluctuate during long-term treatment of chronic non-cancer pain," and "[i]t would not be practical to instruct patients never to take an opioid during intervals when their pain is moderate, but only to do so when their pain is severe." Second, "[t]he population-based conversion factors used to calculate 'equivalent' morphine doses in patients treated with non-morphine opioids differ from patient to patient, and even in the same patient followed across time (e.g., with declining kidney or liver function, or dehydration)." Finally, "[o]ne cannot use population-based, aggregate epidemiological findings to set specific limits that are valid for every patient, given the interindividual differences in pathophysiology and opioid responsiveness of seemingly identical chronic non-cancer pain conditions."
ASA encourages our members to submit their comments to the FDA docket on the PROP petition.