The Alliance for Patient Access / IfPA’s Patient Access Policy Blog / Hydrocodone Reclassification Alters Pain Treatment Rules

Hydrocodone Reclassification Alters Pain Treatment Rules

By Amanda Conschafter, blog editor

In the newest move to reduce prescription opioid abuse, the U.S. Drug Enforcement Administration has reassigned hydrocodone combination products (HCPs) to Controlled Substance Schedule II. HCPs, typically a combination of hydrocodone and acetaminophen or aspirin, are FDA approved for the treatment of pain and for cough suppression. But the new, more restrictive classification will reshape physicians’ experience with prescribing HCPs – and could complicate access for patients with legitimate medical need for these therapies.

DEA’s final rule, issued August 22, moves HCPs from Schedule III to Schedule II – where pure hydrocodone is classified, along with morphine.   The five-tier classification schedule (in which Schedule I is the most restricted, Schedule V the least) organizes drugs based upon a number of factors. Among these are how prone the medication is to abuse, how legitimately the drug treats medical conditions, and how likely the drug’s abuse is to lead to addiction.

A more restrictive classification will likely reduce the amount of HCPs in the drug distribution circuit, which officials hope will limit opportunities for diversion or misuse. But the shift also affects patients with legitimate prescriptions and legitimate medical need for HCPs. For instance, Schedule II drugs typically require a physical, written prescription as opposed to a prescription requested by a physician via telephone. Regulators expect this requirement to limit fraud, specifically telephone fraud.

But Schedule II drugs also require more frequent visits to a physician’s office.   In some instances, physicians can prescribe up to a 90-day supply of an HCP for their patients, but extended use will necessitate a visit to the physician. This change affects prescribing physicians as well as patients. More frequent physician visits increase doctor’s workload. And many states restrict physician assistants or nurse practitioners from assuming a portion of that prescribing load. Schedule II status also introduces more stringent record-keeping requirements. Meanwhile, more frequent appointments may disproportionately burden elderly patients, for whom transportation can be a challenge, and patients in rural areas.

The debate over HCPs’ classification has been long-running. The U.S. Department of Health and Human Services considered the issue in 2008, but opted to keep HCPs in Schedule III. Yet growing public concern about abuse, addiction and opioid-related deaths prompted DEA and the Food and Drug Administration to re-examine the issue in 2013. DEA’s final rule is expected to take affect October 6.

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