Hydrocodone shift to Schedule II considered

Congress, FDA, DEA reacting to problems of misuse; New York State's experience

Sens. Joe Manchin (D-WV) and Mark Kirk (R-IL) and Reps. Vern Buchanan (R-FL) and Ed Markey (D-MA) introduced hydrocodone rescheduling legislation on March 20. The Safe Prescribing Act of 2013 (S. 621) would reclassify hydrocodone products such as Vicodin and Lortab from a Schedule III to a Schedule II controlled substance.

“Under the new restrictions, a written prescription would be required in order to receive hydrocodone painkillers except in cases of emergency,” according to Manchin’s news release. “Pharmacists would require patients to present an original prescription for refills, and traffickers would be subject to harsher fines and penalties.”

As the proposed hydrocodone legislation moves through Congress—by April 24, the Senate bill had drawn 7 cosponsors and the House bill (H.R. 1285) had attracted 50 cosponsors—the same idea is under consideration by federal regulatory authorities. Among the states, New York was the first to move hydrocodone to Schedule II. “We will not be the only one,” Craig M. Burridge, MS, CAE, former Executive Director of the Pharmacists Society of the State of New York, told Pharmacy Today.

Recent federal activity

FDA’s Drug Safety and Risk Management Advisory Committee voted 19–10 on January 25 to recommend rescheduling of hydrocodone from Schedule III to Schedule II. FDA will now consider its advisory committee’s recommendation in a final recommendation to DEA. Then DEA would have to go through a rulemaking process to propose rescheduling.

Steve Simenson, BSPharm, FAPhA, DPNAP, now APhA President, and Marcie Bough, PharmD, former APhA Senior Director of Government Affairs, testified on January 24 of the 2-day advisory committee hearing. APhA did not take a position, but rather provided information, including on the change’s impact on patient access. Bough told Today that “going through the regulatory process is the appropriate venue to consider rescheduling and allows more time for stakeholder input.”

Following the vote, 18 groups—including the American Society of Consultant Pharmacists, National Association of Chain Drug Stores, and National Community Pharmacists Association—signed a February 1 letter urging FDA to reject hydrocodone rescheduling. “No evidence currently exists to show that reclassifying hydrocodone will curb misuse and abuse of pain medications,” these groups wrote. “In contrast, there is evidence that rescheduling medications to higher classifications can reduce patient access to medications and cause harm.”

But Manchin stated in his news release that “the heart-wrenching stories I hear from so many West Virginians underscore the serious need to immediately reschedule hydrocodone.”

Last year, as Congress was considering Prescription Drug User Fee Act reauthorization legislation, Manchin introduced an amendment with language on hydrocodone rescheduling that passed the Senate on May 24, 2012. The House version did not include the language. APhA opposed that language in the context of the congressional amendment process, signing onto May 30, 2012, letters from pharmacy groups to House and Senate offices.

New York State experience

In New York State, hydrocodone was rescheduled as part of the Internet System for Tracking Over Prescribing (iSTOP) law that was signed by the governor on August 27, 2012. The hydrocodone part of the law includes several patient access waivers and became effective February 23, 2013. 

The shift to Schedule II has been “mostly smooth for those pharmacists who were given a heads up of the changes so that they could inform their patients and prescribers,” Burridge said. At community pharmacies, there was “initial yelling at the counter,” he added. “I think people are more aware now, and if they truly do have chronic pain, this will be resolved with their physician.”

The state pharmacists society neither supported nor opposed hydrocodone rescheduling. “There seemed to be a 50–50 split even among our own members and our own board,” Burridge said. But the state society was concerned about the entire iSTOP bill when it emerged from the attorney general’s office because it was “all about punishment … and it had nothing to do with protecting patient access.”

So the state society developed a task force bringing stakeholders—including state legislators, the attorney general’s counsels, the medical society, dentists, and hospice—around a table in its boardroom. One of the first things the task force did was to get the state to put $46 million in the budget to open up more rehab slots for people with addictions. “The task force totally changed the bill from where it was,” Burridge said. “With the waivers and exceptions, we think we took care of most of the issues that would arise from patient access.”