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.
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
Print “PDF
version”
http://www.patientsafetysolutions.com/