Hydrocodone Restrictions: What Will Happen and What You Can Do

Unquestionably, the FDA’s plan to reclassify hydrocodone-acetaminophen combinations from Schedule III to Schedule II status,¹ intended to address the increased abuse and overdose deaths related to these drugs, will make life more difficult for those rheumatology patients who rely on Vicodin or similar drugs for chronic pain. These are the preferred opioids among risk-averse users such as women, the elderly, and non-injecting users -- just the types of patients most likely to see a rheumatologist.²  

Almost concurrent with the plan to up-rank the hydrocodone combinations, the FDA announced the long-awaited approval of Zohydro ER, a long-acting form of hydrodone which has the added advantage for rheumatology patients of not being combined with acetaminophen, and thus less likely to have gastrointestinal effects. But Zohydro ER was approved initially as a Schedule II drug, so the same conditions will apply, and the Agency may be reconsidering the approval in response to a letter sent earlier this month by 29 Attorneys General who are concerned about its increased narcotic strength and lack of abuse-deterrent properties.

The restrictions on hydrocodone, expected to gain approval from the Department of Health and Human Serviced and the Drug Enforcement Administration next year, will complicate your life as well as your patient’s. The expected impact on your practice:
 
•    You will need to sign a written prescription rather than phoning or faxing the order, except in emergencies (when a written prescription must follow within 7 days) or for patients in certified hospice programs.  
•    Patients will need to visit you in person to renew the prescription.
•    Prescriptions will be limited to a 90-day supply. (Multiple prescriptions, but not refills, may be filled sequentially.)
•    You will face stricter reporting and record-keeping requirements.

Judging from the 2010 report of the American College of Rheumatology’s Pain Management Task Force, these formulations are likely to be last-resort options for many rheumatologists, who appear generally reluctant to prescribe opioids.³

In any case, “evidence of long-term efficacy of these agents for prolonged nonmalignant pain in all age groups is not available,” wrote David Borenstein MD, a rheumatologist with Arthritis and Rheumatism Associates of Washington DC, a member of the Task Force, and president of the ACR that year. He also observed that proinflammatory cytokines oppose the actions of opioids.⁴

The Task Force recognized the Catch-22 about pain in rheumatology:  Many patients come to you primarily seeking pain relief, but rheumatologists’ education on opioid therapies in pain management “appears at best limited,” while your training focused on treating inflammation. With pain management as with everything else, Borenstein concluded three years ago, rheumatologists “must be time-efficient with their advice so that they can remain in a financially successful clinical setting.”

Given the impending restrictions on hydrocodone-containing drugs, what are your alternatives?

1.    Supplement your patient’s focus on pain by monitoring and addressing concurrent symptoms such as fatigue, sleep difficulty, and depression.⁴ A recent review offers specifics. ⁵
2.    Consider buprenorphine, which is less likely to induce tolerance and attract abuse. (However, it is expensive and requires special training to prescribe.)⁶ SNRIs such as duloxetine also have non-opioid pain-relieving properties, Dr. Borenstein observes. Another option he suggests is tramadol, a non-opioid that works on opioid receptors.
3.    Reconsider whether joint injections are an option.³
4.    If repeat visits for refills become a problem, turn to your network of ancillary providers: Physical therapists (because exercise can provide substantial pain relief), behavior therapists to address coping mechanisms, perhaps nutritionists for weight control.⁴  
5.    To assure that you are following accepted procedure for prescribing these drugs, consult “Phases of Opioid Prescribing” (Table 3 in “Rational Use of Opioids for Chronic Nonterminal Pain”).⁶  This resource also includes checklists on documenting prescriptions and guidance on tapering or discontinuing opioids.
6.    The American Medical Association updated its CME curriculum on pain management last June.⁷

References:

1.    Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research. Oct. 24, 2013.  Accessed Dec. 2, 2013 at http://www.fda.gov/drugs/drugsafety/ucm372089.htm
2.    Cicero TJ, Ellis MS, Surratt HL, Kurtz SP.  Factors influencing the selection of hydrocodone and oxycodone as primary opioids in substance abusers seeking treatment in the United States. Pain (2013) 154:2639-2648.
3.    American College of Rheumatology Pain Management Task Force.  Report of the American College 599of Rheumatology Pain Management Task Force. Arthritis Care Res (Hoboken). (2010) 62:590-9. doi: 10.1002/acr.20005.  
4.    Borenstein D. The role of the rheumatologist in managing pain therapy.  Nat Rev Rheumatol (2010) 6:227-231. Doi:10.1038/nrrheum.2010.27  
5.    Tauben, D. Chronic Pain Management: Measurement-Based Step Care Solutions. Pain Clinical Updates (International Association for the Study of Pain). December 2012. XX:1-8 Accessed Dec. 16, 2013 at thtp://www.iasp-pain.org/AM/AMTemplate.cfm?Section=Clinical_Updates&CONTENTID=18056&TEMPLATE=/CM/ContentDisplay.cfm&SECTION=Clinical_Updates
6.    Berland D and Rodgers P. Rational Use of Opioids for Management of Chronic Nonterminal Pain. American Family Physician (2012) 86:252-258. 
7.    AMA Releases Updated Pain Management Education Program. American Medical Association press release. June 26, 2013.  Accessed Dec. 16, 2013 at http://www.ama-assn.org/ama/pub/news/news/2013/2013-06-26-pain-management-education-program.page  Accessed December 16, 2013