States' Rights, Zohydro, and Pain Management

April 21, 2014
B. Eliot Cole, MD, MPA

Following the approval of Zohydro last year, attorneys general across the country requested the FDA reconsider its decision until the medication could be reformulated to include abuse-deterrent properties. Now, two states have moved to reduce access to Zohydro. Will the courts uphold these decisions, or will other states follow in their wake?

The governors of Massachusetts and Vermont decided recently to reduce or restrict the prescribing of Zohydro (hydrocodone) in those states until the manufacturer reformulates the drug to have abuse-deterrent properties. Massachusetts Governor Deval Patrick ordered an outright ban on prescribing and dispensing Zohydro, while Vermont Governor Peter Shumlin announced an emergency order requiring physicians to conduct a thorough medical evaluation and risk assessment before prescribing Zohydro. Last year, 28 state attorneys general sent a letter asking the Food and Drug Administration (FDA) to reconsider its approval of Zohydro or require it to be reformulated to make it resistant to crushing.

While some prescribers may feel that banning an FDA-approved medication is a drastic step, others may conclude that such action is necessary. America is experiencing an unprecedented number of opioid-related fatalities, and when states feel the federal government is not taking adequate measures to solve the problem, they are allowed to “raise the bar” when it comes to the public safety. For example, New York state now discourages emergency room physicians from prescribing opioids for chronic pain conditions; requires prescribers to check the I-STOP prescription tracking system before prescribing or dispensing Schedule II, III, or IV medications; and designates carisoprodol and tramadol Schedule IV (they are currently not controlled substances by the DEA) and hydrocodone Schedule II (currently designated Schedule III by the DEA).

This is certainly not the first time states have moved on their own to address issues of public safety. When it comes to medical states’ rights issues, I can name several examples off the top of my head, including “triplicates” (triplicate prescription forms) in California being replaced by single-copy, serialized, tamper-resistant prescriptions; restrictions on therapeutic abortions, the need for separate medical boards for every state, and limitations on what is covered by Medicaid programs.

Historically, appeals to states’ rights have also been used to justify all manner of social evils such as slavery, literacy tests for people of color, and controlled substance laws with racist overtones. In practice, the application of states’ rights has potentially allowed the quality of health care practitioners to vary from one jurisdiction to another.

I find it curious that I still need a state-specific driver’s license, and an individual medical license for contiguous states if I want to be certain my orders/prescriptions are honored across state lines, yet I have only one national commercial pilot’s license that is honored throughout the US. If the federal government pays for the majority of medical care in the US (eg, Medicare, Medicaid, Tricare) why not have one universal professional license? Do we really need to address states’ rights for access to Zohydro? What about other opioids? Should health care really differ in each state?

I believe that most well-meaning efforts to limit access to particular opioids, to require special prescription forms to be used, or to increase scheduling beyond that mandated by the DEA, will sadly increase the likelihood that pain is undertreated. Rates of overdose from lawful prescription medications will decline (but rates may increase from illicit heroin overdoses), while the burden of pain will increase. This is a zero-sum game in which someone wins at the expense of someone else’s loss.

I know the FDA must regulate the pharmaceutical industry and has no direct relationship with health care practitioners, yet it impacts how and what I prescribe. Keeping current with approved labels, following FDA edicts/mandates, and knowing relevant drug-drug interactions often takes more time daily than the actual time I spend making basic treatment decisions. Let’s hope that states rights’ do not restrict or overburden us, nor harm our legitimate patients in pain by making it more difficult for them to obtain relief.

B. Eliot Cole, MD, MPA, is a member of the Pain Management editorial advisory board. He has served in executive positions for several prominent pain management organizations and societies, including the American Society of Pain Educators and the American Academy of Pain Management. He has been a pain management fellow, clinician, educator, and advocate for nearly 30 years and has practiced in a variety of settings serving a wide range of patients.