DEA Changes to Hydrocodone Combination Products (HCPs)

Angie Szumlinski Uncategorized

 On August 21st the U. S. Drug Enforcement Administration (DEA) published in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II.  As recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS). Effective October 6, 2014, the Final Rule imposes the regulatory controls and sanctions applicable to Schedule II substances on those who handle HCPs.  Upon the effective date of this rule, HCPs prescriptions:

  • may be filled up to six months after the date prescribed
  • may be refilled up to five times within six months after the date on which such prescription was issued.

In addition, there are no dosage unit limitations for prescriptions for schedule III, IV, or V controlled substances unless the controlled substance is prescribed for administration to a resident institutionalized in the long term care setting.

HCPs are drugs containing hydrocodone, itself is a Schedule II drug, and a specified amount of other substances such as acetaminophen or aspirin. The DEA’s efforts to combat prescription drug diversion is commended however the possible benefit of reducing drug diversion may have an adverse effect in LTC settings and possible negative resident outcome. Many residents of LTC facilities live with chronic pain and should receive relief in a timely manner.  There is a risk that stricter controls could delay access to needed medications. Failure to maintain pain management interventions, pharmacological and non-pharmacological, may reduce the quality of life for residents and increase the risk for regulatory citations related to uncontrolled pain.  The DEA recognizes the unique challenges pertaining to handling and using controlled substances in LTC settings and has previously addressed related concerns.

A DEA registered practitioner may not delegate to a nurse, a pharmacist, or anyone else his or her authority to make a medical determination whether to prescribe a particular controlled substance. However, oral prescriptions for controlled substances in schedules III-V (not schedule II) may be communicated to a pharmacy by an employee or agent of the prescribing practitioner. The prescribing practitioner still remains responsible for ensuring that the prescription, “complies with the law and regulations”.

LTC advocacy groups continue to seek relief for long-term care residents who encounter delays in pain management due to burdensome regulatory restrictions. As providers you may want to consider encouraging the DEA and other policymakers to identify solutions to the barriers created by this regulatory change. 

Cathy Angi, RN, NHA
HealthCap Risk Management