Transdermal System Helps Patients Control Pain

The Ionsys device, made by the Alza division of Johnson & Johnson (New Brunswick, NJ, USA), is a compact, noninvasive, self-contained, and pre-programmed analgesic system, designed to adhere to a patient's upper arm or chest. The system uses a low-level electrical current to deliver preprogrammed amounts of an opiod painkiller called fentanyl from an adhesive strip containing two hydrogel reservoirs on the skin directly into the bloodstream with the push of a button. The system has built-in safeguards to ensure that patients do not overmedicate themselves, and is intended for use in a hospital setting only, since fentanyl can cause life-threatening respiratory depression. The system has been cleared by both the European Commission (EC) and the U.S. Food and Drug Administration (FDA).

Each Ionsys system contains 10.8 mg of fentanyl hydrochloride, equivalent to 0.7 mg of fentanyl, and delivers 40 micrograms of fentanyl per dose, to a maximum of 80 doses. The system then becomes inoperative. If the maximum dose is not reached, the system will then become inactive after 24 hours of use. The most common side effects associated with the Ionsys system in clinical trials were nausea, vomiting, headache, and pruritus. These were mostly of mild-to-moderate severity.

Fentanyl is an opioid agonist substance with high potential for abuse similar to hydromorphone, methadone, morphine, and oxycodone. Fentanyl can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered in situations where a healthcare professional is concerned about an increased risk of misuse, abuse, or diversion.



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