Move from schedule III to schedule II means tighter prescribing rules

The U.S. Drug Enforcement Administration (DEA) recently released its final rule to reschedule hydrocodone combination products (HCPs) from schedule III to schedule II of the Controlled Substances Act (CSA). The change goes into effect on Oct. 6, 2014.

The move by the DEA follows an October 2013 recommendation by the Food and Drug Administration (FDA) and comes more than a decade after the DEA first recommended reclassifying hydrocodone. The move is partially based on findings that abuse of HCPs has risen dramatically in recent years.

Once the new rule is in effect, physicians will not be able to write refillable prescriptions for HCPs, and patients will be limited to a single 90-day supply of any hydrocodone combination medication. The rule also tightens the government’s regulatory control over the drugs and boosts criminal penalties for anyone caught illegally dealing or possessing them.

The shift to schedule II puts HCPs on par with both powerful illegal narcotics such as heroin and methamphetamine and commonly abused medications such as the amphetamines used to treat attention deficit hyperactivity disorder.

Background
Pure hydrocodone drugs have been listed as schedule II drugs for more than 40 years. HCPs, however, are made with specified amounts of other therapeutically active non-narcotic ingredients and were originally in the less-restrictive schedule III.

Enactment of the FDA Safety and Innovation Act required FDA to hold a public meeting to “solicit advice and recommendations” on rescheduling HCPs. In January 2013, the FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 in favor of rescheduling HCPs from schedule III to schedule II.

This recommendation was then forwarded to then-Secretary of Health and Human Services (HHS) Kathleen Sebelius. On Dec. 16, HHS submitted to the DEA its recommendation supporting the rescheduling. HHS had concluded that individuals are taking HCPs in amounts sufficient to create a hazard to their health or to the safety of other individuals or the community, that significant diversion of HCPs exists, and that individuals are taking HCPs on their own initiative rather than on the basis of medical advice.

According to the DEA, large numbers of deaths and emergency department visits have been associated with abuse of HCPs. “Based on these considerations, the DEA believes that the high abuse and dependence potential and harm associated with HCPs support rescheduling into schedule II of the CSA,” reads the final rule.

Opposition from medical groups
Staff from the American Association of Orthopaedic Surgeons (AAOS) office of government relations attended and reported on all FDA public meetings discussing the rescheduling of HCPs, and the issue has been a focus of study and communication by the Patient Safety Committee. In July 2013, the AAOS was among the medical groups that urged the FDA to maintain the current schedule III classification of HCPs.

AAOS also submitted comments to the DEA in April 2014, noting that opioid consumption in the United States is increasing, but that educating physicians and patients is the best way to reduce opioid/narcotic consumption and change patterns of misuse.

“It is important for the DEA to be aware of the significant responsibilities that orthopaedic surgeons and other caregivers face in the management of pain associated with many common acute and chronic musculoskeletal conditions,” the letter states. The letter also points out that although current pain management efforts are focused almost entirely on the use of opioids or narcotics, emerging evidence indicates that “coping strategies and limiting psychological distress are as or more effective for pain relief/management.”

Noting that “isolated reclassification of HCPs to Schedule II will have little or no impact on opioid use/misuse and in fact may lead to an unintended increase of use, misuse, and diversion,” the letter concludes with a recommendation “that the DEA work with the AAOS and other important stakeholder organizations to implement a comprehensive opioid/narcotic medication use/misuse program to address and modify these cultural norms and behaviors.”

The American Medical Association (AMA) also submitted a letter strongly urging the DEA not to finalize its proposal to reschedule HCPs. According to the AMA, evidence indicates that rescheduling HCP medications is “unlikely to decrease diversion, unintentional overdoses, and deaths from opioid analgesics.” Instead, the AMA asserted, “rescheduling will divert scarce healthcare resources and physician time away from delivering health care, including reducing the time healthcare providers have to screen for substance use disorders (including addiction to prescription drugs) and treat those suffering from addiction.”

DEA response
Despite these and other objections to the reclassification, the DEA has moved forward. Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, has pledged that “the agency will continue working with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.”

The AAOS has initiated a comprehensive education program on this topic, including a symposium at the Board of Councilors/Board of Specialty Societies Fall Meeting. However, changing the pattern of U.S. opioid/narcotic consumption will require significant time, resources, and commitment by regulatory, legislative, health policy, and medical professional organizations.

Key Points for Physicians

• Prescriptions for HCPs issued on or after Oct. 6, 2014, must comply with requirements for schedule II prescriptions; refills are prohibited and a maximum 90-day supply may be dispensed at one time. Schedule II narcotic prescriptions cannot be called into pharmacies; a written prescription is required.
• Prescriptions for HCPs issued before Oct. 6, 2014, with authorized refills may be dispensed in accordance with DEA rules for refilling, partial filling, transferring, and central filling schedule III substances until April 8, 2015 (subject to state laws).
• State laws, if more stringent, will govern how HCPs are handled with respect to refills. Providers should also ascertain whether state-based restrictions applicable to allied health professionals with prescriptive authority exist and whether modifications to existing collaborative practice agreements are needed.
• Patients with HCP prescriptions should be notified of the new steps required to obtain prescriptions after Oct. 6, 2014.