In the meantime, they face an admittedly uphill battle with powerful special interest groups included in the opposition. But they believe the facts, once fully understood by the medical community and other stakeholders will drive the change they say will help curb overprescribing of opioids for chronic pain.
With the issue of opioid prescribing taking center stage in workers' comp circles, practitioners are seeking a variety of methods to address the problem. A prominent group of physicians started the Physicians for Responsible Opioid Prescribing with the mission of "reducing morbidity and mortality resulting from prescribing of opioids and to promote cautious, safe and responsible opioid prescribing practices." Those involved in PROP, which now number around 700, say the goal is not to ban the use of opioids for non-cancer patients in chronic pain. Instead, they seek to better inform the medical community that risks of long-term opioid use may outweigh potential benefits for many patients with chronic pain.
PROP. PROP's main advocacy effort on a national scale is to persuade the Food and Drug Administration to change labeling on opioid analgesics. Currently, the FDA indication for most instant-release opioid analgesics is for "moderate to severe pain" while the indication for extended release opioids is for "moderate to severe pain when a continuous, around the clock analgesic is needed for an extended period of time."
In a citizen's petition sent to the FDA last July, PROP explained that the current wording on opioid labels implies "a determination by FDA that they are safe and effective for long term use." PROP argues that evidence suggests the "long term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses."
The petition asked the agency to make the following changes:
- 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.
If FDA were to implement these changes, long-term and high-dose opioid prescribing would still be permitted, but drug companies would be prohibited from promoting these practices because use in this manner would become off-label. The FDA did, in fact, respond to the request within the mandated 180 days. However, it was not quite the answer PROP was seeking.
Since the FDA's response, PROP has picked up support from another federal agency. In March, the Drug Enforcement Administration sent a letter to the FDA urging the agency to approve PROP's petition. Supporters believe their arguments are strong.
"More people are dying of painkiller overdose deaths than heroin and cocaine combined. And the number of people dying from accidental drug overdoses now exceed deaths from car accidents," said Dr. Andrew Kolodny, chair of the Department of Psychiatry atMaimonides Medical Center in Brooklyn, N.Y., and president of PROP. "I think that ultimately change will be inevitable because we have an epidemic that is continuing to get worse and a medical community that is beginning to recognize that when you treat common chronic conditions such as low back pain with long-term opioids, you harm far more patients than you help."
Despite the evidence and strong support from a variety of practitioners, public health officials, and researchers, there are well-organized groups opposed to labeling changes.
The opposition. Representatives of pain clinics, pain patient advocacy organizations, and lobbyists for chain pharmacies are among those opposing the label change, as are drug manufacturers, especially those who make extended release opioids. "The primary market for their medications is people with chronic non-cancer pain," Kolodny said.
But there are other, less obvious opponents. The American Medical Association and the Cancer Action Network, a lobby group for the American Cancer Society are among them.
Another big contingent is pain patients themselves. There are people "on long term opioids who believe they are being helped by the opioids and if the FDA were to make the change that they would be forced off their medications," Kolodny said. "They are being misled to believe we are pushing for a ban on long-term opioids, which is totally not true."
Much of PROP's activities center around education for medical providers and patients. The group's website has a variety of tools and resources available to assist physicians who prescribe opioids to understand some of the nuances.
Other advocacy efforts.
Advocacy on the state level is a prime area for those seeking responsible opioid prescribing, Kolodny says. He is hopeful a rewritten version of a model policy on opioid prescribing by the Federation of State Medical Boards will be more in line with medical evidence on opioid risks and benefits.
"Many people want to do something and recognize how serious it is," Kolodny said. "In the future we will move to provide them with state advocacy tool kits. Workers' comp and medical practice are regulated on a state level, so there needs to be advocacy there. And when state laws are passed, to make sure they are done well so we all have access to opioids when necessary."
By Nancy Grover
Read more at the WorkersComp Forum homepage.
July 15, 2013
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