PROP vs PROMPT: Who Speaks for the Pain Doctor?
On July 25, 2012, a group of clinicians from the fields of pain medicine, addiction medicine, primary care, and public health submitted a citizen's petition to the Food and Drug Administration (FDA) requesting changes to the approved label on opioid analgesics. News that Physicians for Responsible Opioid Prescribing (PROP) and Public Citizen, a consumer advocacy organization, has submitted a petition seeking the agency to regulate labeling of opioid analgesics has reignited a debate among pain physicians.1
The crux of the controversy is whether opioids are safe and effective for long-term use in the treatment of chronic non-cancer pain (CNCP). According to a copy of the letter submitted to the FDA, the group states that "an increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients especially when prescribed in high doses." The group would like to see the FDA "enforce laws that prohibit drug companies from marketing products for conditions where use has not been proven safe and effective," noted Andrew Kolodny, MD, president of PROP.
Presently, the FDA-approved label on nearly all opioid analgesics states that they are approved from "moderate to severe pain" and does not include a suggested duration of use or a suggested upper dose limit. According to PROP, the petitioners suggested specific action should be taken by the agency:
- Strike the term "moderate" from the indication for non-cancer pain
- Add a maximum daily dose, equivalent to 100 mg of morphine for non-cancer pain
- Add a maximum duration of 90 days for continuous (daily) use for non-cancer pain
PROP also cited a number of scientific data in its petition, including recent studies of CNCP patients who received chronic opioid therapy, which found that many of the patients continue to experience significant chronic pain and dysfunction. 2,3
The group also noted that over the past decade, there has been a four-fold increase in prescribing of opioid analgesics, which has been associated with a four-fold increase in opioid-related overdose deaths and a six-fold increase in individuals seeking treatment for addiction to opioid analgesics.4
In response to the PROP petition, a multidisciplinary group of clinicians involved in pain management formed Professionals for Rational Opioid Monitoring and Pharmacotherapy (PROMPT).5 According to the group’s Web site, the motivation for forming PROMPT was to address some of the concerns raised by PROP—the safe use of chronic opioids—“by mitigating these risks with appropriate proactive and ongoing validated interventions intended for the benefit of the patient care and public safety,” notes Jeffrey Fudin, BS, PharmD, and one of the founders of PROMPT.
To further explore these two views of opioid safety, Practical Pain Management invited representatives from both camps—Dr. Fudin and Dr. Kolodny—to write commentaries. Read "PROMPT Challenges PROP's Petition" and "PROP Answers Questions Raised About Opioid Label Changes" by clicking on the links. In addition, PPM recently surveyed our Editorial Board members and asked for their opinions on the subject.