FDA Warns Against Using Unapproved Meds in Implanted Pain Pumps
https://www.medscape.com/viewarticle/904885
The US Food and Drug Administration (FDA) is alerting healthcare providers about the risk for complications with intrathecal administration of pain medications that are not approved for use with implanted intrathecal pumps.
These complications may include dosing errors, pump failure, opioid withdrawal, and infection, as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress.
“The treatment of pain has become increasingly complex,” FDA Commissioner Scott Gottlieb, MD, said in a news release.
Implanted pumps that deliver medication directly into the spinal fluid can play an important role in treating pain, but their use must be “judicious and their instructions for use must be carefully followed. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” said Gottlieb.
In a safety communication, the FDA reminds providers that the only approved medicines identified in FDA-approved implanted pump labeling for intrathecal infusion to treat or manage pain are morphine sulfate preservative-free injectable solution (Infumorph, West-Ward Pharmaceuticals) and preservative-free ziconotide sterile solution (Prialt, TerSera Therapeutics).
The FDA advises providers to review current labeling (ie, instructions for use) of the implanted pump, because not all pumps are currently approved for use with Prialt.
In reviewing medical device reports and other information, the FDA discovered that patients are sometimes treated with medications that are not approved for use with an intrathecal implanted pump. Such drugs include compounded medicines, hydromorphone, bupivacaine, fentanyl, and clonidine.
Any mixture of two or more different kinds of medicines and any compounded medicine (eg, to achieve higher concentration or different formulation of an FDA-approved medicine) are not approved for use, the FDA said.
Using drugs not approved for use with these pumps “may lead to serious risks to patients due to pump failure or dosage errors,” the FDA said.
The FDA has determined that implantable intrathecal pump failure is more common with the use of medicines not approved for use with the pump. Some medicines or fluids may contain preservatives or other characteristics that can damage the pump tubing or lead to corrosion of the pumping mechanism, it points out.
Dosing errors are also a risk with unapproved medicines. Programmable implanted pumps employ dose calculation software, and the accuracy of calculations depends on use of the approved medicine, approved medicine concentration, and approved medicine characteristics. A problem may arise, for example, if there is more than one medicine in the pump reservoir. In such cases, the pump software can calculate the dose only on the basis of the infusion rate of a single medicine, the FDA said.
Healthcare providers are encouraged to report problems with implanted pumps to the FDA’s MedWatch Adverse Event Reporting Program.
Filed under: General Problems
What do you think could happen if a patient with a pain pump is in fact being treated with a Med other than what the pump Mfg states must be used? Should this be discussed with the doc? Can he make disparaging marks in the pts chart, hold a grude, mistreat that pt? Can the doc discharge the pt from his care? What do you advise any pt in this situation to do?
So if the FDA has put out an OFFICIAL WARNING against using “unapproved” compounded meds.. should that be considered providing an “experimental drug” in the pump and many/most/all insurance companies will not pay for experimental drugs. What would happen if the pt made an inquiry to their insurance company about their opinion of paying for what the FDA has determined to be a experimental drug in pain pumps.. IMO – the same argument could be use for doc giving pts ESI using Depo-Medrol or other cortisteriods when both the FDA and Pfizer has put out strong warnings against using this – perfectly good medication – via ESI’s… does that make this particular class of meds in their particular application “experimental”. Many countries has banned the use of this class of drugs in ESI applications. Of course, if the pt wanted to do the inquiry confidentially, could hire an attorney to send the letter to the insurance company and the pt can hide behind the attorney/client privilege. I am sure that if the doc is putting this “crap” in one pt’s pump… they are putting it in all of his/her pts’ pumps. I walked my wife out of the first pain clinic that was going to put in a pump and was told that they only used compounded meds – knowing that I was a pharmacist – I told him that I was not comfortable with that and I was told that it was a “big boy issue” .. a “liability issue” and that I did not understand. My wife had a PCP that was providing her oral meds… and it took me two years to find another pain clinic that would implant the pump and only use the approved product (Infumorph) and that was about 12 yrs ago… she is on her second pump.. battery has 5-7 yr lifespan and will be getting a third pump in the next 6 months – battery again is at end of its lifespan. If it was not doing a good job.. .she would not have the first one replaced nor would she be headed to having the second one replaced soon …
Thank you Steve, this is helpful!