FDA Issues Safety Communication Regarding Medications Utilized in Intrathecal Pumps
On November 14, 2018, the Food and Drug Administration (FDA) issued a safety communicationto all patients with implanted intrathecal pumps, their caregivers and health care providers, and medication compounding companies warning of the dangers of utilizing medications in intrathecal pumps that have not specifically been approved for intrathecal pump use.
Intrathecal pumps are programmable devices that are implanted in the abdomen and utilize a thin flexible tube to carry small amounts of medication directly to the fluid surrounding the spinal cord. Only Infumorph (preservative-free morphine sulfate injectable solution) and Prialt (preservative-free ziconotide sterile solution) are approved for use in intrathecal pumps, and not all types of implantable intrathecal pumps are approved for use with Prialt. The FDA specifically indicated that fentanyl, hydromorphone, bupivacaine and clonidine were not approved for use in intrathecal pumps. Additionally, any compounded mixture of two or more different medications is also not approved for use in intrathecal pumps.
Potential adverse events resulting from the use of non-approved medications in intrathecal pumps, identified by the FDA, included pump damage and failure, unintended dosing errors, accidental overdose or withdrawal symptoms, infections, damage to brain and spinal cord due to toxicity and granuloma formation.
The FDA recommends reviewing the specific pump label information to identify which medications and medication concentrations are approved for use with the specific pump type and to avoid utilizing any unapproved medications for intrathecal delivery.
The impact of this safety communication on Medicare Set-Aside Arrangements is unknown at this time; however, the FDA is clearly indicating that fentanyl, hydromorphone, bupivacaine, clonidine and compounded medications should not be utilized in intrathecal pumps.
ABOUT THE AUTHOR
As an attorney and former physician assistant, Erin O'Neill (PA-C, JD) brings more than 20 years of a unique combination of medical and legal experience to the medicare set-aside arena on behalf of MEDVAL's clients. Prior to becoming an attorney, O'Neill was a Physician Assistant-Clinical Coordinator at the University of Pittsburgh Department of Orthopedic Surgery. To read more of Medval's blog, click here.
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