VICTORY FOR PRACTICING INTERVENTIONAL PAIN PHYSICIANS
On October 5, 2015, the Center for Drug Evaluation and Research, the U.S. Food and Drug Administration (FDA), the Department of Health and Human Services, notified the American Society of Interventional Pain Physicians (ASIPP) of the status of citizen's petition o f the non-adaptation of the 17 recommendations developed by Multisociety Pain Workgroup (MPW).
SEE LETTER
In response to the
FDA citizens petition on behalf of ASIPP and letter written to the FDA by 1,040 practicing pain physicians to amend the April 23, 2014, Drug Safety Communication regarding epidural corticosteroid injections for pain and not adapt 17 recommendations developed by MPW. The FDA has determined that that will not amend the drug safety communication; however, they will not adapt 17 recommendations by the MPW.
A letter signed by 1,040 interventional pain physicians was sent on June 26, 2014, and ASIPP filed a citizen petition on September 3, 2014. The FDA held hearings on November 24-25, 2014 2014, on drug safety of epidural steroid injections. On March 4, 2015, the FDA informed ASIPP that they were unable to reach a decision on our petition because it raised complex issues requiring extensive review and analysis by agency officials.
Finally, FDA has reached an agreement providing a major victory for practicing interventional pain physicians avoiding micromanagement and additional bureaucracy created by MPW.
If you recall, on April 23, 2014, the FDA issued Drug Safety Communication warning of "rare but serious neurologic problems after epidural corticosteroid injections for pain" and "injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death." The FDA has not accepted our request to amend this.
There were also 17 recommendations provided by MPW which were not based on scientific evidence or even consensus among interventional pain physicians. They were developed in closed door meetings by societies that, as a majority, were not practicing interventional pain management. These standards were published in Anesthesiology (2015; 122:974-984) and JAMA (2015; 313:1713-1714), essentially they read that even for cervical and lumbar interlaminar epidural injections the following:
1. All cervical and lumbar interlaminar epidural steroid injections should be performed using image guidance, with appropriate anteroposterior, lateral, or contralateral oblique views and a test dose of contrast medium.
2. Cervical and lumbar transforaminal epidural steroid injections should be performed by injecting contrast medium under real-time fluoroscopy or digital subtraction imaging, before injecting any substance that may be hazardous to the patient.
3. Cervical interlaminar epidural steroid injections are recommended to be performed at C7-T1, but prefer- ably not higher than the C6-7 level. (The cervical epidural space is widest at the C6-T1 levels. Gaps in the ligamentum flavum are more frequent with ascending cervical levels.)
4. No cervical interlaminar epidural steroid injection should be undertaken, at any segmental level, without preprocedural review of prior imaging studies demonstrating sufficient epidural spatial dimensions for needle placement at the target level.
5. Particulate steroids should not be used in therapeutic cervical transforaminal injections.
6. A nonparticulate steroid (eg, dexamethasone) should be used for the initial injection in lumbar transforaminal epidural injections and others such as stopcock.
In contrast to this, MPW with their influential Current Procedural Terminology (CPT) Committee and Relative Value Update Committee (RUC) essentially lambasted ASIPP for asking for specific codes for interventional pain management to be performed only under fluoroscopy and they have gained approval for 2 blind codes for cervical/thoracic and lumbar interlaminar and caudal epidural injections.
In addition, the typical patient presented in a vignette is a pregnant patient receiving cervical and lumbar interlaminar epidural injections blindly with 120 mg
of methylprednisolone in each region.
Multiple manuscripts and correspondence on this issue:
2. U.S. Food and Drug Administration. Drug Safety Communications. FDA Drug Safety Communication: FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain, April 23, 2014.
www.fda.gov/downloads/Drugs/DrugSafety/UCM394286.pdf
3. Letter to Margaret Hamburg, MD, Commissioner, and Salma Lemtouni, MD, MPH, Office of the Center Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), RE: FDA Safe Use Initiative of Epidural Steroids Evaluation with Assignment of Responsibility to Multisociety Pain Workgroup (MPW) from American Society of Interventional Pain Physicians (ASIPP) and 1,040 interventional pain physicians, June 26, 2014.
Click here
5. Rathmell JP, Benzon HT, Dreyfuss P, Huntoon M, Wallace M, Baker R, Riew KD, Rosenquist RW, Aprill C, Rost NS, Buvanendran A, Kreiner DS, Bogduk N, Fourney DR, Fraifeld E, Horn S, Stone J, Vorenkamp K, Lawler G, Summers J, Kloth D, O'Brien D Jr, Tutton S. Safeguards to Prevent Neurologic Complications after Epidural Steroid Injections: Consensus Opinions from a Multidisciplinary Working Group and National Organizations. Anesthesiology 2015; 122:974-984.
7. Manchikanti L, Candido KD, Singh V, Gharibo CG, Boswell MV, Benyamin RM, Falco FJE, Grider JS, Diwan S, Staats PS, Hirsch JA. Epidural steroid warning controversy still dogging FDA. Pain Physician 2014; 17:E451-E474.
8. Manchikanti L, Falco FJE, Benyamin RM, Gharibo CG, Candido KD, Hirsch JA. Epidural steroid injections safety recommendations by the Multi-Society Pain Workgroup (MPW): More regulations without evidence or clarification. Pain Physician 2014; 17:E575-E588.
http://www.ncbi.nlm.nih.gov/pubmed/25247907
9. Candido KD, Knezevic NN, Chang-Chien GC, Deer TR. The Food and Drug Administration's recent action on April 23, 2014 failed to appropriately address safety concerns about epidural steroid use. Pain Physician 2014; 17:E549-E552.
10. Manchikanti L, Hirsch JA. Neurological complications associated with epidural steroid injections. Curr Pain Headache Rep 2015; 19:482.
11. Manchikanti L, Falco FJE. Safeguards to prevent neurologic complications after epidural steroid injections: Analysis of evidence and lack of applicability of controversial policies. Pain Physician 2015; 18: E129-E138.
12. Manchikanti L, Benyamin RM. Key safety considerations when administering epidural steroid injections. Pain Manag 2015; 5:261-272.
13. Manchikanti L, Malla Y, Cash KA, Pampati V. Do the gaps in the ligamentum flavum in the cervical spine translate into dural punctures? An analysis of 4,396 fluoroscopic interlaminar epidural injections. Pain Physician 2015; 18:259-266.
14. Manchikanti L, Nampiaparampil DE, Candido KD, Bakshi S, Grider JS, Falco FJE, Sehgal N, Hirsch JA. Do cervical epidural injections provide long-term relief in neck and upper extremity pain? A systematic review. Pain Physician 2015; 18:39-60.
http://www.ncbi.nlm.nih.gov/pubmed/25675059
