Reclassification of Hydrocodone Combination Products Impacts Prescribers and Patients > Michigan State Medical Society


Reclassification of Hydrocodone Combination Products Impacts Prescribers and Patients

Recently, the U.S. Drug Enforcement Agency (DEA) published a final rule to reclassify hydrocodone combination products (HCPs) from Schedule III to the more restrictive Schedule II category of controlled substances. This rescheduling is effective October 6, 2014 and applies to "all pharmaceuticals containing hydrocodone currently on the market in the United States."

As a result, physicians currently prescribing HCPs to their patients will need to recognize the new restrictions this change requires when they write future prescriptions. All prescribers in Michigan will be expected to follow the federal rule and must treat an HCP prescription the same as any other Schedule II prescription.

The following tips are offered to help prescribers prepare for this change:

  1. Beginning October 6, 2014, refills will not be allowed for HCPs.
    It should be noted, however, that prescribers may issue multiple prescriptions enabling a patient to receive up to a 90-day supply of HCPs. Prescribers must consider whether multiple prescriptions and seeing the patient only once every 90 days is appropriate for that patient. Decisions must be based on sound medical judgment and established medical standards. Each prescription (other than the first prescription, if the prescriber intends for that prescription to be fill immediately) must include written instructions that specify the earliest date it may be filled.
  2. Be prepared to issue a new prescription to your patients who may need refills.
    Although the final rule permits a prescription with authorized refills issued before October 6 to be dispensed until April 8, 2015, it is not likely that this option will be available to your patients due to other factors. First of all, Michigan’s law prohibits refills of Schedule II controlled substances. Secondly, most pharmacy quality and safety systems and processes aren’t able to differentiate between the classification of a pre- and post-October 6 HCP prescription. Finally, there are rumblings that some health insurers will not pay for such refills.
  3. Be aware of restrictions related to the prescribing of Schedule II controlled substances.
    HCP prescriptions will either need to be written or electronically prescribed. Prescribers can no longer call in or fax HCP prescriptions unless there is an emergency and the prescriber complies with the requirements of this exception. While electronic prescribing of controlled substances is permitted under both federal and Michigan law, electronic prescriptions for controlled substances (EPCS) are only allowed if the prescriber and pharmacy are equipped with and utilizing software applications that are certified to transmit and receive EPCS, respectively.
    Prescribers need to be aware that in Michigan, a delegating physician may only delegate the prescription of Schedule 2 controlled substances to a nurse practitioner or nurse midwife "if the physician and the nurse practitioner or nurse midwife is practicing within a health facility, specifically a freestanding surgical outpatient facility, hospital and hospice with the patient being located within the facility. The delegating physician may not delegate the prescription of a Schedule 2 controlled substance issued for the discharge of a patient for a quantity for more than a 7-day period."
    Prescribers that delegate the prescribing of HCPs to a physician’s assistant pursuant to a written authorization may need to update that authorization accordingly.
  4. Help your patients understand these new requirements and processes.
    Make sure your patients understand that their new prescriptions will not be refilled and are aware of the procedures they will need to follow going forward.

If you have additional questions, please contact Stacey Hettiger at (517) 336-5766 or You may also download a printable fact sheet (log in) from the American Medical Association which contains details about how the new rule will impact patients and pharmacists for a convenient office reference or handout.


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