The California Workers’ Compensation Institute has unveiled a second research paper on opioid prescribing in the California workers’ comp system.
The paper is titled ” Prescribing Patterns of Schedule II Opioids Part 2:
Fentanyl Prescriptions in California Workers’ Compensation”.
There has been increasing concern over the cost and increasing use of opioids in the system. The CWCI paper is likely to increase that scrutiny.
It will not surprise me if the incoming administration at the DIR/DWC choose this as an issue for additional regulation. Where in the pecking order this might come is not clear.
After all, the next DWC administrator will have to deal with issues surrounding a physicians fee schedule as well as possible regulations on nutriceuticals and medical foods.
Essentially, the second CWCI study claims (as did the first study), that a small percentage of physicians are accounting for a large percentage of the opioids prescribed in California workers’ comp.
A piece written by Greg Jones for Workcompcentral.com several months ago noted that Steve Cattolica of CSIMS had objected to a press release of the first study in that it implied that physicians were dispensing much of these out of their offices, a claim that was not documented in the study.
I’ve included a link below to a pdf version of the second study. But here is the summary of the study:
“Parts 1 and 2 of the CWCI Schedule II Opioid Prescribing Patterns research series have shown that the 10 percent of physicians who write the most Schedule II opioid prescriptions for injured workers in California are associated with 79 percent of all workers’ compensation prescriptions for these types of narcotics, and for 84 percent of the fentanyl prescriptions. Most of the fentanyl prescriptions were transdermal patches, which have limited FDA approved uses and have been the subject of multiple FDA warnings. California workers’ compensation pain management guidelines also say the patches should only be used for chronic pain patients requiring round-the-clock therapy, who have developed a tolerance for other opioids, and whose pain cannot be managed by other therapy. Furthermore, there was no evidence of cancer-related illness or injury among any of the injured workers in the study sample, indicating that off-label use of fentanyl lozenges or tablets, which are only FDA approved for breakthrough, chronic cancer pain, has become an issue in the California system. The study found that off-label use of fentanyl was concentrated in the 10 percent of the claims (1,690 cases) with the highest volume of Schedule II opioid prescriptions, where nearly 12 percent (199 cases) had prescriptions for lozenges or tablets. The rate of off-label use was even higher for the top 10 percent of medical back cases with the most Schedule II opioid prescriptions – where 77 of the 525 patients, or nearly 15 percent, were prescribed fentanyl lozenges or tablets.”
Focusing on Fentanyl prescribing, the report points out FDA concerns about Fentanyl:
“Of the Schedule II opioids included in the Institute’s study, the most potent is fentanyl, which is 75 to 100 times more powerful than oral morphine. Although fentanyl can be administered intravenously, all of the fentanyl prescriptions in the Institute study sample were either administered via a skin patch (transdermal) or as a lozenge or effervescent tablet (transmucosal). Due to increases in dosing errors and abuse of fentanyl drug products, the FDA has issued several warnings regarding the drug. For example, in July 2005, the FDA issued a health advisory regarding the safe use of fentanyl skin patches in response to reported fatalities among patients using the narcotic,2 and in December 2007, the FDA issued another safety warning in response to continued reports of life-threatening side effects.3 The FDA also has issued several recall notices of fentanyl patches for reasons of accelerated drug release or leaking gel – both conditions potentially leading to adverse reactions. In addition, in September 2007, the FDA issued a more specific warning regarding Buccal Fentanyl (Fentora and Actiq),4 stating “Buccal Fentanyl should be used only to treat breakthrough cancer pain (sudden episodes of pain that occur despite round-the-clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opioid) pain medication and who are tolerant (used to the effects of the medication) to narcotic pain medications. This medication should not be used to treat pain other than chronic cancer pain.” Despite these admonitions, use of fentanyl in workers’ compensation systems continues to ncrease, as evidenced by CWCI’s March 2011 study, as well as a 2010 NCCI study and a recent federal court suit by the US Postal Service against Cephalon, the manufacturer of fentanyl lozenges and effervescent tablets.”
For those not following this controversy, workers’ comp analyst and blogger Joe Paduda has been a prominent voice chiding doctors groups on the issues. Here is an extended quote from one of Paduda’s blog posts:
“This morning’s WorkCompCentral had a piece by Greg Jones noting complaints by medical specialty groups about the study on physician prescribing of opioids recently released by CWCI. I received a copy of the letter as well, and frankly was surprised – for several reasons. What was most troubling was the statement that “Alone, the report’s findings do not indicate that there is anything inappropriate.”
Paduda stated “I would argue that the findings absolutely indicate there is something very, very wrong going on here. In fact, a relatively few physicians are “handling the bulk of the prescriptions”; that was amply demonstrated in the analysis and results provided in the report, the details of which were discussed in detail therein.”
Challenging the doctor groups, Paduda claimed” Why was this not surprising to the medical society? Was it not surprising that a relatively few physicians were treating patients with low back sprains and strains for extended periods with relatively high doses of narcotics, when all evidence-based clinical guidelines do not support such treatment?”
According to Paduda, “The letter suggested CWCI conduct a deeper analysis to determine whether the treatment was appropriate based on treatment guidelines. Huh? Every treatment guideline I’ve heard of, including ODG, ACOEM, Washington State – none of them supports extended use of opiods for treatment of musculoskeletal issues. None. I would also note that the letter called into the question the methodology itself. The author of the letter’s statement “it is clearly misleading to use the initial diagnosis” is inaccurate. Even a cursory review of the study methodology reveals the researchers used a rather sophisticated clinical grouper to identify the PRIMARY diagnosis, which may well not be the initial diagnosis.”
In concluding Paduda notes that “Finally, the letter asserted that others had mis-cited or misinterpreted the CWCI work, and requested CWCI somehow correct, clarify, or take steps to correct those misinterpretations. Studies are cited and discussed and reviewed and analyzed in the media and by individuals all day every day; I just don’t think CWCI has the time, resources, or obligation to monitor what everyone says about their research.I guess is the net is I’m really taken aback by the letter. There’s clearly abuse going on here, along with bad medicine and out of control prescribing of very addictive, dangerous medications that are ripe for diversion and abuse. I’m just very surprised that instead of taking this seriously, a medical society would attack the messenger. There’s something very rotten going on, and denying it is the wrong approach.”
We haven’t seen the last word in this controversy, and there may be questions about the methodology or sampling of the CWCI study.
And we haven’t actually heard from some of the doctors involved, for example. Nor have we heard from some of the worker patients, many of whom I suspect would be highly trusting of their physician’s judgment in such matters.
But one thing is for sure. The issue will get further scrutiny.
Category: Medical treatment under WC