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California’s Off-Label Drug Problem

The California Workers’ Compensation Institute reports that more than 14% of claims with minor back injury had at least one prescription for Actiq or Fentora, with no evidence of cancer-related illness among any of the injured workers in a recent study. This is interesting since these are opioid medications primarily meant for the treatment of cancer patients. Kelli Miller, writing for WebMD, notes,

[This] practice, called “off-label” prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.

“Off-label” means the medication is being used in a manner not specified in the FDA’s approved packaging label, or insert. Every prescription drug marketed in the U.S. carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA.

Stephanie Goldberg of Business Insurance writes,

Medications such as … Actiq are being used off-label to treat injured workers, prompting the workers comp sector to focus on curbing inappropriate prescribing that may be pricey and dangerous. …

For example, a recent update proposed for the California Medical Treatment Utilization Schedule could limit off-label use by requiring physicians to prove with a study or alternate guideline that that treatment contrary to the state’s schedule is appropriate.

If a claimant has been prescribed these types of off-label medications, it is a good idea to ensure the drugs are being taken properly. Drugs like Actiq can be sold on the street for as much as $25 a pill and can cause severe, even fatal, side effects in the wrong hands. It is important for adjusters and case managers alike to take these types of opioid prescriptions seriously and closely monitor the prescriptions and usage by claimants.