California Society of Health-System Pharmacists s2

CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS PROPOSAL IN STP FORMAT

PROPOSAL: Safety of Epidural Steroid Injections

SUBMITTED BY: Board of Directors

DATE: July 16, 2017

SITUATION:

1. CSHP Professional Policy #2015-04 directs CSHP to adopt ASHP policies and other guidance documents as CSHP Professional Policy

2. To adopt as CSHP policy all ASHP Policy Positions, Guidelines, Bulletins, and all official Statements in the current edition of the Best Practices for Health-System Pharmacy of the ASHP, except when such policies differ substantially from CSHP policy.

3. To endorse the use of ASHP Position Statements, Guidelines, and Technical Assistance Bulletins by its members in their practice settings.

4. CSHP will review all ASHP Policy Positions by 2020 for possible adoption as CSHP Professional Policy.

5. ASHP has policy 1605 Safety of Epidural Steroid Injections.

1605 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.

6. CSHP does not have a professional policy on safety of epidural steroid injections.

TARGET:

1. CSHP provides resources to its members, their patients, and the public per the 2017-2021 Strategic Priorities and Goals.

2. CSHP develops professional policy in congruence with other professional organizations, but adopts policy as an independent professional society.

3. CSHP has a professional policy that addresses safety of epidural steroid injections.

CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS PROPOSAL IN STP FORMAT

In 2012, New England Compounding Center (NECC) dispensed non-sterile methylprednisolone epidural injections that killed 64 people and sickened 800 more. NECC failed to follow regulations specific to the compounding of injectable medication. Since then,

Federal regulations enforced by the FDA and state regulations enforced by boards of pharmacy have been implemented nationwide regarding sterile compounding by pharmacies. Regulations have also been implemented that require some pharmacies to be registered with the FDA as outsourcing facilities that must adhere to FDA GMPs. The California State Board of Pharmacy enacted new sterile compounding regulations in 2016 that are enforceable and closely mirror the version of USP 797 in force at that time. All of these sterile compounding regulations have their basis in USP 797 and other USP standards.

ASHP 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.

PROPOSAL:

1. Adopt the following as CSHP Professional Policy:

Epidural Steroid Injections

CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS PROPOSAL IN STP FORMAT The California Society of Health-System Pharmacists:

1. Supports the efforts of the California State Board of Pharmacy, the United States Food and Drug Administration, and the United States Pharmacopeia to ensure the safety, potency, and efficacy of sterile compounded medications.

2. Encourages healthcare providers to inform patients about the significant risks and potential lack of efficacy of epidural steroid injections, request their informed consent, and inform patients of alternative therapies and their risks and benefits.

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

RESOURCES REQUIRED FOR PROPOSED ACTION(S)

Financial: Minimal EVP time: Minimal Staff time: Minimal

CSHP BOARD ACTION: The CSHP Board of Directors approved this proposal on July 14, 2017 for consideration by the 2017 House of Delegates

ACTION:

☐ Bylaws update ☐ Rules and Procedures of the House of Delegates ☐ Update Administrative Policy catalog ☒ Update Professional Policy catalog ☐ Staff Procedural manual ☐ CCTF’s volunteer hand book ☐ Minutes only ☐ Any other (please state)

HOD ACTION: