WASHINGTON — In what could turn into a significant change of how retail pharmacy supplies hydrocodone combination products, the Drug Enforcement Administration last week published in the Federal Register a Notice of Proposed Rulemaking to move HCPs from Schedule III to Schedule II, as recommended by the assistant secretary for Health of the department of Health and Human Services and as supported by the DEA’s evaluation of relevant data.
However, the move may severely restrict access to necessary pain medication for legitimate patients. For patients, reclassifying hydrocodone compounds as a schedule II substance would require them to make a doctor’s visit every time they need a prescription. Refills of schedule II drugs are not permissible; and the prescriptions have to be original copies. That represents a cost barrier for many pain sufferers.
The rescheduling of hydrocodone compounds also will have repercussions up and down the supply chain, in large part because of the sheer volume of prescriptions that would be reclassified. In 2012, pain was the No. 2 most-prescribed therapeutic class of medicines, with 472 million prescriptions written, according to IMS Health. The most-prescribed medicine for the year was hydrocodone/acetaminophen, with 135.3 million prescriptions written for the pain-relieving compound.
At the wholesale level, schedule II substances have to be stored in a locked vault vs. being restricted to a caged area, meaning drug distributors would need to make wholesale capital investments in expanding their vault space. And retailers would likewise need to invest in larger security storage units in an effort to be compliant with the new schedule.
The speculation among retail pharmacy experts is that the increase in investment could force many pharmacies, especially smaller community pharmacies serving rural patients, to reconsider carrying HCPs.
Members of the public are invited to submit comments or request a hearing through www.regulations.gov. Electronic comments must be submitted, or written comments postmarked, by 11:59 p.m. EST on April 27. Requests for hearings must be submitted by March 31, the DEA noted.
Once the public comment period has closed and the DEA has considered all comments, the DEA will publish a Final Rule in the Federal Register.
The rescheduling of HCPs was initiated by a petition from a physician in 1999. The DEA submitted a request to HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation.
In 2013, the Food and Drug Administration held a public Advisory Committee meeting on the matter, and the committee voted to recommend rescheduling HCPs from Schedule III to Schedule II by a vote of 19 to 10. With the receipt of that recommendation, the DEA initiated the formal rulemaking process by publishing a notice and soliciting public comments.