On March 5, 2014, the DEA issued an NPRM (Notice of Proposed Rule Making) to move hydrocodone combination products (HCPs) from their current classification as Schedule III narcotics to Schedule II, a classification reserved for the most harmful and potentially addictive medications. http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0227.htm.
As one of the most frequently prescribed drugs in workers compensation, this is a most interesting development and its impact will be felt across our industry. Also, in light of the announcement last week that Zohydro, a new formulation of 100% pure hydrocodone being manufactured by Zogenix, is scheduled for release later this month, I find it to be more than coincidence that this more benign version of hydrocodone is now being recommended for movement to the Schedule II classification.
All substances placed under the control of the CSA since it was passed by Congress in 1970 are scheduled or rescheduled by the DEA, as required by the CSA and its implementing regulations, found in Title 21 of the Code of Federal Regulations. Scheduling or rescheduling of a substance can be initiated by the DEA, by the HHS Assistant Secretary of Health, or on the petition of any interested party. (Detailed information on the scheduling and rescheduling process can be found in the first chapter of Drugs of Abuse on the DEA’s website.)
For those who manage claims in workers’ compensation, the rescheduling of HCPs to Schedule II will create more changes than just a reclassification. Procedural requirements include the following:
- Every Class II Rx requires a written prescription from a practicing physician.
- While most states limit Class II Rx’s to 30 days, there are no federal limits to days supply.
- A physician may write multiple paper Rx’s for up to a 90-day supply, but the Rx’s must be written separately.
- Refills for a Class II narcotic are prohibited
While the logistics may present a challenge in our day to day management of claims, I believe this to be a very positive move in our fight against opioid addiction in the US, particularly in workers’ compensation. I strongly believe that the DEA, in its proposed movement of HCPs to the same classification as drugs like Oxycontin, Opana, ACTIQ, etc., is making a clear statement of its concern over the overuse, over prescribing and abuse potential of HCPs.
I trust that all those in the medical community who respond to the NPRM will affirm support of the reclassification and that the result will be less frequent use of HCPs as long term therapy in workers’ compensation.
