SAFETY OF EPIDURAL STEROID INJECTIONS

To encourage healthcare providers to 1) inform patients about the significant risks and potential lack of efficacy of epidural steroid injections, 2) request their informed consent, and 3) inform patients of alternative therapies and their risks and benefits; further, 

To recommend pharmacist involvement in the medication-use process associated with epidural steroid injections when such injections are medically necessary.

Rationale

Use of epidural steroid injections to treat low back pain is increasing, despite not being a labeled indication and sparse literature confirming the safety and efficacy of the treatment. These drugs, in this route of administration, have narrow therapeutic indices, and there are quality assurance issues related to the compounding of the preparations used in epidural injections. The safety of epidural steroid injections has been referred to in the FDA Safe Use Initiative (SUI), in which 13 stakeholders were involved in assessing evidence of neurological complications of injections. Several recommended practices resulted, including a controversial preference for nonparticulate steroid injections for use in cervical transforaminal injections. In addition to the concerns about particulates in the injections, there are very significant safety concerns due to the proximity of intrathecal, epidural, and subdural spaces and how the injections are administered. Skillful technique is required to appropriately administer these drugs. Radiographic contrast is often used to guide the needle to injection sites. Improper technique can cause vasospasm and stroke, which is not related to particulates in the injection.

In April 2014 the FDA released a drug safety communication stating that rare and serious neurological effects can result from epidural steroid injections. The safety communication noted that “the effectiveness and safety of epidural administration of corticosteroids have not been established, and FDA has not approved corticosteroids for this use” and recommended that healthcare providers “discuss with patients the benefits and risks of epidural corticosteroid injections and other possible treatments.” ASHP concurs with those recommendations and encourages use of an informed consent process in addition to other institutional protocols, including pharmacist involvement in the medication-use process when such injections are medically necessary, to promote the safe use of epidural steroid injections.