New analgesia device is needle-free

July 24, 2006

The Food & Drug Administration recently approved the fentanyl iontophoretic transdermal system (IONSYS, Alza Corp.), the first needle-free, patient-activated transdermal analgesic (PATS) system. IONSYS is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. Alza said that it expects to start distributing IONSYS in 2007.

Eugene Viscusi, M.D., director of the Acute Pain Management Service at Thomas Jefferson University Hospital in Philadelphia, described IONSYS as a drug-delivery system as opposed to a patch. He said IONSYS provides on-demand systemic delivery of fentanyl HCl for up to a maximum of 24 hours or 80 doses (40 mcg each, delivered over a 10-minute period), whichever comes first. He explained that the drug must be in an ionized form so that it can be driven across the skin in the presence of an electric field.

The manufacturer cautioned that IONSYS should be used only for the treatment of hospitalized patients and that to reduce the risk of an overdose, only the patient should activate IONSYS dosing.

The manufacturer also warned that the fact that IONSYS contains fentanyl should be considered in situations when healthcare professionals are concerned that patients may misuse, abuse, or divert the product. Patients who are opioid-tolerant may not be good candidates for analgesia with IONSYS, said Leslie Schechter, Pharm.D., an advanced practice pharmacist at Thomas Jefferson University Hospital, because these patients may require higher doses of opioids than can be delivered by IONSYS. Individual patient requirements must be assessed prior to initiating therapy.

In addition, a significant amount of fentanyl remains in the system following maximum dosage administration, so a dialogue should occur between the pharmacy and nursing departments regarding the proper disposal of IONSYS, said Suzanne Nesbit, Pharm.D., BCPS, a clinical pharmacy specialist in pain management at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore.

Patients should be titrated to an acceptable level of analgesia before treatment with IONSYS is initiated, Schechter said, because the device cannot deliver a bolus dose of fentanyl. She recommended that intravenous (IV) opioids be used postoperatively to achieve adequate pain control and then IONSYS treatment initiated to maintain analgesia.

The drug, dose, and dosing schedule of the IONSYS system cannot be changed, said Nesbit, so its use reduces the risk of drug product mix-ups and prescription errors. IONSYS can also reduce hospital pharmacists' and technicians' workload, Schechter said, because they won't have to prepare hydromorphone and fentanyl syringes for IV PCA use. In addition, Schechter said that decreased use of IV PCA should mean fewer PCA programming errors and drug selection errors to investigate.

TIPS TO REMEMBER IONSYS

THE AUTHOR is a writer based in New Jersey.