FDA Warns on Use of Non-approved Pain Meds with Intrathecal Pumps

November 19, 2018

The FDA has issued an alert warning that use of nonapproved drugs with spinal pumps can lead to mechanical failurs and patient complications.

The FDA has issued a public alert regarding the use of pain relief medications that are not approved for administration with implanted devices that deliver medication into intrathecal spaces. The alert went out on Nov. 14 to healthcare providers and patients.

Although various drugs and drug combinations have been used with implanted devices to treat and alleviate pain, the particular compounded drugs identified in this report include: hydromorphone, bupivacaine, fentanyl, and cloridine. They have not received specific approval for use with automated pumps.

The FDA has become aware that intrathecal administration of these and other drug combinations using automated pumps is becoming more common. As a result, there have been reports of either adverse side effects or inadequate pain relief.

The FDA is alerting healthcare providers and patients that the continued use of medications not approved with particular implanted pumps could result in dosing errors, pump failures, and other safety concerns for patients.

According to Debra Pasko, PharmD, MHA, senior director of medication safety and quality the ASHP, the FDA has been investigating the safety of implantable pumps for some time.

“I think why this is coming out now is because there has been more scrutiny about any type of infusion into the intrathecal space,” she tells Drug Topics. She noted the New England Compounding Center (NECC) case as a driving force behind the additional scrutiny. In 2017, 753 patients in 20 states developed spinal fungal infections after they were injected with  preservative-free steroids manufactured by NECC; 64 patients died. Now, the FDA is increasing its oversight of these devices and the medications used with them.

For pharmacists who work in the operating room and other procedural areas, Pasko says that taking an active role in treatment where implantable devices are being used could help prevent both mechanical and molecular complications.

“If [physicians] really wanted to use an implantable device and a drug not approved with the device,” Pasko says, “then [they] really need to inform the patient and there needs to be some form of consent, because you’re basically using the drug as an unapproved indication.”

Pasko suggests that pharmacists in these environments can also take the initiative to suggest other means of infusion that don’t require the implanted pump, thereby avoiding the conflicts with dosage or pumping failure.

When using nonapproved medications with these pumps, pump failure is more likely, because they may contain fluids, preservatives, or other ingredients that might damage the pump tubing or lead to corrosions of the pump.

In addition, automated dispensing pumps are calibrated using the approved drugs, taking into account their unique characteristics and concentration for the individual patient. When approved medications are combined with those not approved for use with the device, the predetermined calibrations are disrupted, which could result in reactions between medications or even incorrect dosages delivered to the patient.