Transdermal PCA in Acute Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System
REPORT
Transdermal PCA in Acute Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System
Acute postoperative pain con-
tinues to be undertreated, with
up to 75% of patients in the
United States failing to receive
adequate postoperative pain
relief.1,2 Postoperative pain man-
agement was revolutionized with
the introduction of patient-con-
trolled analgesia (PCA) using IV
or epidural delivery routes more
than 20 years ago.3 Opioids are
the primary treatment for acute
pain management,4 either alone
or increasingly as part of a multi-
modal analgesic strategy—char-
acterized by administration of 2
Chair
Eugene R. Viscusi, MD Professor of Anesthesiology Director, Acute Pain Management Thomas Jefferson University Philadelphia, Pennsylvania Faculty John Fanikos, RPh, MBA Director of Pharmacy Business Brigham and Women’s Hospital Boston, Massachusetts Michael H. Huo, MD
Despite advances in pain man-
agement technology, the advent
of acute pain services, and pro-
fessional practice guidelines
aimed at improving postoperative
pain management, inadequacies
and treatment gaps still exist, and
improvement remains a priority.7
An analgesic intervention that might help to mitigate clini- cian concern is the fentanyl ion- tophoretic transdermal system (IONSYS), a credit card–sized, self-contained, and prepro- grammed investigational product candidate intended to provide |
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or more drugs (eg, opioid and
nonopioid analgesics, used in combination) that act by different mechanisms, and along differ- ent pain pathways—an approach that is recommended by the American Society of Anesthesi- ologists (ASA) and the American existing PCA modalities have limitations that include inva- sive access, challenges in titration of analgesic effect, cumbersome pump technologies, impaired patient mobil- ity, and limited drug preparations that have been associ- ated with programming, medication, and dosing errors.
pain relief for adult inpatients
requiring opioids following sur-
gery.8 It is a needle-free system
that is applied to the skin on the
upper arm or chest.8 A generally
imperceptible electrical current
then delivers a small dose of fen-
tanyl directly through the skin and into the systemic cir- culation. The FDA approved IONSYS in 2006; however, it was never launched in the United States due to required changes in manufacturing. The enhanced design will be reviewed by the FDA in the near future for use in patients with moderate to severe postoperative pain.
Professor
Department of Orthopedic Surgery UT Southwestern Medical Center Dallas, Texas
Pain Society.5,6 However,
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