Study Finds Most Fentanyl 'Lollipop' Prescriptions Are Off-Label

A recent Prime Therapeutics study found significant patterns of "off-label" prescribing for transmucosal fentanyl lozenges on a stick (Actiq) among patients taking the powerful painkilling "lollipop." Prescribing the drug according to US Food and Drug Administration (FDA) guidelines is important for patient safety reasons because of the drug's serious side effects, including its addictive nature.

"The FDA has only approved Actiq for use by cancer patients who are already taking a long-acting, chronic painkiller but suffer from severe spikes in pain," stated Pat Gleason, PHARMD, director of medical and pharmacy integration services for Prime. "The Prime study, however, found that only slightly more than 10% percent of the patients receiving the drug over a 3-month period in 2005 met those guidelines. Nearly 90% of Actiq prescriptions in our study were off-label, or not prescribed according to the guidelines set forth by the FDA."

The study analyzed patient claims from a Midwestern commercial health plan from April through June 2005. Of the 95 patients who received prescriptions for the lollipop during that time, only 21 had a diagnosis of cancer or AIDS. In addition, only 10 of those 21 patients were taking a long-acting opioid painkiller. Overall, 84 of the 95 fentanyl lollipop prescriptions—nearly 90%—were for off-label purposes. The study also found that more than 15% of those prescriptions were for more than the FDA's recommended 120 lollipops per month, suggesting that some patients may be overusing the drug.