Hydrocodone Reclassification: What Pharmacists Need to Know

Under a new Drug Enforcement Administration (DEA) rule implemented today, all drugs containing the opioid hydrocodone have been reclassified as Schedule II controlled substances, prohibiting pharmacies from recognizing refills and phoned-in prescriptions for those medications.

The DEA published the stricter regulatory sanctions on August 22, 2014, in an effort to curb rampant opioid abuse by limiting how hydrocodone products can be prescribed and dispensed. In compliance with the rule, pharmacies can no longer fill prescriptions for hydrocodone-containing medications, such as Vicodin, that have been phoned in or faxed by prescribers. Additionally, pharmacies cannot honor refills of prescriptions for hydrocodone combination products issued on or after October 6, 2014, thus requiring prescribers to submit a new, handwritten prescription for each 30-day supply of the narcotic from now on.

For valid hydrocodone prescriptions submitted prior to today’s date, pharmacies can legally allow authorized refills until April 8, 2015. However, pharmacy groups have pointed out that state laws, payer policies, and issues with pharmacy quality and safety processes may prevent pharmacies from filling those remaining refills.

“Most states have not provided clarity with respect to whether such refills will be valid under state law. Moreover, most pharmacies will not be able to process such refills due to existing quality and safety operations and processes,” the National Association of Chain Drug Stores noted in a statement submitted to a US House of Representatives panel.

Likewise, Michael H. Ghobrial, PharmD, JD, associate director of health policy for the American Pharmacists Association, said his organization has been informed that “some pharmacies may not be refilling pending fills because of software issues with prescription processing tools, confusion around conflicting state laws, and payer policies.”

“Some pharmacies may not be able to reprogram their computer systems in time to recognize, as of October 6, a C-II as refillable until April 8, 2015, and only several states have officially stated that they will allow a similar accommodation in state law authorizing refills on a federal Schedule II drug for up to 6 months,” Dr. Ghobrial told Pharmacy Today.

Relative to the confusion, a recent Pharmacy Times poll revealed that 72% of responders believe the hydrocodone rescheduling will slow down their work flow. Those results reflect the sentiments of Jay Sochoka, RPh, BSPharm, CIP, who argued in a Piller of the Community blog that the move will “add a few more minutes of processing per (hydrocodone) script, which is extra time that a high-volume pharmacist doesn’t exactly have.”