A Change in Opioid Prescribing
In the latest change to controlled substance prescribing, hydrocodone has moved to Schedule II among controlled substances. In recognition of well-publicized reports that 99% of the worldwide supply of hydrocodone in 2007 was consumed in the United States, the US Drug Enforcement Administration (DEA) enacted the Final Rule on October 6, 2014.
This change, roughly a decade after it was first recommended, moved the hydrocodone combination products to Schedule II, joining pure hydrocodone products, among others. Given that hydrocodone’s proclivities for abuse, diversion, and overdose are not dependent upon combination with other products, this change made administrative sense.
The labeling change is likely to generate a slow decline in the prevalence of hydrocodone-containing prescriptions. The change reinforces the message from physicians that this is not a trivial medication. It also brightens the red light in the minds of those patients who, even when the medication is appropriate, are leery of receiving a prescription. The added attention that this labeling change has generated is an opportunity to enhance the necessary education and understanding among both prescribers and the general public as to the dangers, and hopefully the limitations and untoward long-term effects, of these medications.
Some disruptions have been minimized, even though, according to the DEA, hydrocodone combination prescriptions issued prior to October 6, 2014, with refills may be dispensed as long as such dispensing occurs before April 8, 2015. Many pharmacies do not have software that allows them to dually track prescription rules. As a result, those pharmacies have already begun requiring new prescriptions. Regardless, hydrocodone combination prescriptions written after October 5, 2014, cannot be refilled.
On the heels of changes to state law and medical board regulations in the past 2-plus years, some of the changes reinforce and simplify rules for prescribing. Schedule II controlled prescriptions cannot be faxed or called in under most circumstances. Patients on call cannot request courtesy refills. As has been the case for Kentucky practices at least since 2012—if not before, based on office protocols—patients who make such requests on call cannot have them fulfilled.
Clinical Challenges Increase
Although this change may, in some respects, make the prescriber’s job easier, in many respects it may (appropriately) increase clinical challenges. Much of the hydrocodone prescribing in the United States today, we are told, is still for fibromyalgia and chronic headaches. The medical literature has long underscored that these are conditions which are much more likely to be worsened, not benefited, by chronic opiate prescribing. Chronic low back pain is another difficult-to-treat condition in which much of today’s hydrocodone prescribing is found.
Educating patients on the primary and proper roles that daily aerobic exercise, focused muscle strengthening and flexibility improvement, and thorough hydration can have on all three of these conditions must be moved to the primary, central roles that they play, despite the time consumption as well as subtle and sometimes overt resistance patients have to these messages. Additional multidisciplinary disease-specific messages, of course, complement these messages. It is immensely important that this change does lead to more attention, not less. Rubber-stamping prescriptions, not analyzing the clinical situation or taking steps to potentially lead to a different outcome, must be avoided as a responsibility of the profession.
Therein lies a key point, however. The failure to apply or (as a patient or prescriber) to follow through on appropriate treatment recommendations alone does not constitute an indication for opiate therapy. Failing to deliver on these messages is no more acceptable than leaving patients to remain with unaddressed pain. Insurers and government payers also bear some culpability in these matters because of limitations that they place on physical therapy, either in required copayments or absolute limitations in the number of covered visits, as examples.
In the long run, the change in hydrocodone labeling will hopefully lead to greater clarity in muddy waters and would not affect access by those who would still derive genuine benefit from these agents. Nevertheless, this is probably an area that will require more than one generation to entirely recalibrate.
There are patients who are so far and so deep into chronic opiate/controlled substance therapy that they may not ever be able to be weaned. The general reluctance of most specialty pain clinics to engage in the long-term management of these patients places a de facto expectation and an almost no-win scenario on primary care today. Failure to recognize and overcome this very tenacious issue with other, recent regulatory changes has resulted in an increase in the use of street narcotics, diversion, home invasions, and other crimes, as was predicted by some.
We can work with the new generation of graduating prescribers, as well as treatment-naive patients and existing patients, to build an understanding of realistic expectations for all management options as they apply to each diagnosis/problem set. As long as opiates are prescribed, there will be issues with addiction, diversion, death, and other negative consequences. No policy change, no computer algorithm can change this. This month’s change has the potential to be one step in a positive direction.