Study: Most pain lollipops given off-label

Jan. 16, 2007 at 12:10 PM
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ST. PAUL, Minn., Jan. 16 (UPI) -- About 90 percent of prescriptions written for the Actiq painkiller "lollipop" -- OK'd for cancer/AIDS patients -- are off-label.

So concludes a study by pharmacy benefits manager Prime Therapeutics, which found significant off-label prescribing of the product, in spite of a risk of serious side effects.

Actiq, a berry-flavored lozenge on a stick made by Cephalon, contains fentanyl, a synthetic opioid with a high potential for abuse and overdose, and which carries a high risk of fatal respiratory complications, the study authors said.

Doctors are free to prescribe the lollipop off-label -- or beyond its approved use -- but the Food and Drug Administration advises strict adherence to Actiq's prescribing guidelines, they said.

"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," said Pat Gleason, 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 three-month period in 2005 met those guidelines. Nearly 90 percent of Actiq prescriptions in our study were off-label, or not prescribed according to the guidelines set forth by the FDA."

Prime said it recently started programs to promote Actiq's safe use, including a monthly limit of 120 doses of Actiq or a newer, similar pain drug called Fentora. Under the program, patients are also required to have prior authorization from their doctor, and prescriptions are limited to a 12-month period.

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