A new study by Prime Therapeutics, a pharmacy benefit management company, released data on the use of Actiq lollipops for pain relief that suggested the drug may be misused. The study found that 90 percent of prescriptions written for Actiq are for off-label uses not approved by the FDA. Clients of Prime Therapeutics include Blue Cross/Blue Shield and other major health plans.

The Actiq lollipop, a berry flavored lozenge on a stick, is an orally dissolvable form of fentanyl citrate manufactured by Cephalon. The opiate fentanyl is also available dispensed in patch form or in vials for injection. When taken in excess, or in conjunction with medicines that enhance their effects, opiates may depress respiratory function or even cause breathing to stop. Patients who use alcohol or other sedatives, tranquilizers or pain medications while taking fentanyl in any form are at high risk for respiratory failure. The most threatening danger of the misuse of Actiq is death by respiratory failure.

Prime Therapeutics’ research group consisted of Actiq patients accessed through health plan claims from April 2005 through June 2005. Only 21 of the 95 patients receiving prescriptions for Actiq actually had cancer, the therapeutic use for which Actiq is approved. Ninety percent of the Actiq prescriptions were for other uses. More than 15 percent of the prescriptions exceeded the FDA’s recommended dosage of 120 lollipops per month. These data imply an overuse of the medication by these off-label usage patients.

Many chronic pain patients will need increases in medication dosage over time in order to cover their pain. The off-label use of the Actiq lollipop and its overuse suggests that some patients using this medication may be at risk for drug abuse.

In 2006 Prime Therapeutics offered their clients a program for promoting the safe use of Actiq. The program recommendations included:

• prior authorization from doctors for use of Actiq,
• a limit of 120 doses of Actiq per patient per month,
• and a limit of one year for using Actiq.

Chronic pain can be caused by many different disorders. Anyone suffering from chronic pain should consult their doctor about the dangers of using Actiq. For all patients using Actiq, it is imperative to keep Actiq lollipops, which a child could mistake for candy, stored in a safe, childproof area of the home.

Sources: “Study: Most pain lollipops given off-label,” United Press International, January 16, 2007; “Study finds 90 Percent of Actiq “˜Lollipop’ Prescriptions are Off-label,” Prime Therapeutics Release, January 16, 2007.