What’s New in the Patient Safety World

December 2013

FDA Alert on Spinal Procedures and Anticoagulants

 

 

One of the cases in the recent round of actions by the California Department of Public Health (CDPH #CA00332399) was that of a patient who developed a spinal epidural hematoma and paraplegia on removal of an epidural catheter while she was on low molecular weight heparin (LMWH). The epidural catheter was removed by a physician’s assistant on the order of a physician, neither of whom was privileged to insert or remove such catheters and neither of whom was aware the patient was on LMWH.

 

Think this case is an extremely rare event? Think again. The FDA has just issued a safety alert with updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (FDA 2013).

 

The full version of the FDA announcement has details of over 100 cases of spinal or epidural hematoma related to neuroaxial analgesia or spinal puncture in patients on enoxaparin over a 20 year period.

 

The FDA recommends that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations will be added to the labels of anticoagulants such as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products.

 

The FDA alert recommends use of a preprocedure checklist that asks whether a patient is receiving anticoagulants and identifies the appropriate timing of anticoagulant dosing in relation to catheter placement or removal. Both the dose and the elimination half-life of the anticoagulant should be considered. For example, for enoxaparin placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses such as those used for DVT prevention. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin.

 

The FDA alert recommends a postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal.

 

There are several practical issues raised in the CDPH case that are also valuable lessons. There are certain procedures that require specific hospital privileges that we strongly recommend you mandate the provider take a refresher course and satisfactorily complete a post-test at least every 2 years. Examples we recommend this for are moderate sedation and ordering PCA pumps. The same should apply to insertion and removal of epidural catheters.

 

Prior to insertion of an epidural catheter you can attach a checklist that must be completed before the epidural kit can be opened. That checklist should include a checkbox to indicate that the provider is privileged to insert the catheter. It should include another checkbox asking whether the patient is on anticoagulants and not allow the kit to be opened if the anticoagulants have not been discontinued for the specified period (we recommend that a table of the “safe” timeframes after discontinuation be part of the checklist, too).

 

The hospital in the CDPH case also began adding orange stickers with “Anticoagulant Therapy” to be placed on all epidural dressings after insertion.

 

The hospital also added a hard stop to physician ordering of Lovenox or various heparin preparations that requires a response to the following question “If patient has had any spinal procedures or epidural indwelling catheters in the last 48 hours please select from the list, otherwise select none”.

 

They also noted a couple features in their IT systems that might make ordering of anticoagulants in patients with epidural catheters more likely. One is use of a “renew all orders” button. Such could be clicked without the provider recognizing that an epidural catheter had been placed in the interim. Another was that physicians apparently could enter some orders via a nurse communication screen rather than the CPOE screen. Orders entered in this manner apparently might escape review by pharmacists or might not trigger any alerts. You should look at your systems to see whether such features are present.

 

It would also be important to include something about anticoagulation status in your “Ticket to Ride” communication tool to alert providers in areas such as Radiology that manipulation of the epidural catheter may be risky (or to alert them that procedures that might be done in Radiology, such as lumbar puncture, might be risky)

 

The consequences of spinal epidural hematomas are devastating. Development of systems to avoid this preventable complication are key.

 

 

References:

 

 

CDPH (California Department of Public Health). Complaint #CA00332399.

http://www.cdph.ca.gov/certlic/facilities/Documents/2567CommunityRegionalMedicalCenter-OMZ011-FresnoCounty.pdf

 

 

FDA. Safety Announcement. FDA Drug Safety Communication: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins. November 6, 2013

http://www.fda.gov/Drugs/DrugSafety/ucm373595.htm

 

 

FDA. Safety Announcement. FDA Drug Safety Communication: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins. November 6, 2013 (full version).

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM373735.pdf

 

 

 

 

 

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