Amid growing concern over the overuse and abuse of powerful narcotic painkillers, the Food and Drug Administration (FDA) has announced plans to adopt a massive new program to better control the prescribing, dispensing and distribution of extended-release opioids such as oxycontin, fentanyl (including Duragesic patches), methadone tablets, and some morphine tablets – many of which have become popular as pain management drugs in workers’ compensation. The announcement comes just as the California Division of Workers’ Compensation is considering the addition of controversial pain management guidelines to the Medical Treatment Utilization Schedule, which would create a much more liberal standard for the use of these medications in treating injured workers who suffer from chronic pain.

The opioid painkillers, already classified as Schedule II narcotics, are subject to restrictions imposed by the FDA and the U.S. Drug Enforcement Agency, but their use has grown dramatically in recent years. While these medications are effective painkillers, they also can be highly addictive and dangerous. Despite increased warnings from the FDA about their risks, the agency continues to receive reports that opioids are being prescribed for relatively minor injuries such as ankle sprains, suggesting that some physicians are not exercising adequate caution in prescribing these medications. Similarly, an Institute study last June documented widespread use of opioids in California workers’ compensation, with doctors prescribing these drugs in one quarter of all back injury cases without spinal cord involvement – typically sprains and strains. Furthermore, after controlling for claimant occupation, wages, demographic characteristics, nature and cause of injury, and drug interactions, the Institute found that claims involving greater numbers of opioid prescriptions and morphine equivalent milligrams were associated with longer periods of disability, higher costs and greater likelihood of attorney involvement. Preliminary results from new CWCI research (due for release in March) show a dramatic rise in the number of prescriptions and associated costs of Schedule II drugs in California workers’ compensation between 2002 and 2008.

The problems that arise from widespread use of opioids to treat relatively minor injuries are compounded by patients who ignore the instructions provided when the drugs are dispensed; by individuals who gain inappropriate access to the medications, which have become popular street drugs; and by companies that market them illegally. In an article published earlier this month, The New York Times reported that the 24 drugs that the FDA is considering for the new program together accounted for 21 million prescriptions written for 3.7 million patients in 2007. The article further noted that hundreds of patients in the U.S. die each year and thousands more are injured because these medications are inappropriately prescribed.

In the past, the federal government’s response to concerns over drug safety has been to either issue a warning or to pull the drug off the market, but the decision to implement the new program for opioids was based on a statute enacted two years ago that allows the FDA to apply Risk Evaluation and Mitigation Strategies (REMS) to respond to certain issues. In announcing the plan last week, Dr. John K. Jenkins, Director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, said the intent is to assure that physicians who prescribe these medications are trained in their safe and proper use and that only those physicians are allowed to prescribe these drugs. Thus, physicians could be required to obtain additional training before being allowed to prescribe these medications. Lists of the brand name and generic opioid products that may be subjected to the REMS program are on the second page of this Bulletin. As a first step in developing the program, the FDA will begin meeting next week with manufacturers, patient and consumer advocates, and the public to gather information and suggestions on how to best implement the program.

Brand Name Products

Generic Products

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For further background on the issue, CWCI also submitted comments to the DWC last Friday (2/20/09) outlining concerns with the proposed adoption of the ODG-based Chronic Pain & Postsurgical Treatment Guidelines into the Medical Treatment Utilization Schedule (MTUS). Those comments on the proposed MTUS changes, as well as Institute comments filed at public hearings over the past several months, are available at no charge to the public in the Regulatory section of our website at www.cwci.org.