Drug Enforcement Agency Proposes Change to Hydrocodone Combination Products Category

Citing the propensity of being abused, the US Drug Enforcement Agency (DEA) recommended reclassifying hydrocodone combination products (HCPs) from a schedule III to a schedule II drug. This potential reclassification would increase criminal penalties for misuse and will change protocol in prescribing the drug to patients. The final vote will occur in late April.

After hearing 768 arguments from patients, medical professionals, and representatives from the National Institute on Drug Abuse (NIDA) and Centers for Disease Control and Prevention (CDC), the Advisory Committee voted 19 — 10 in favor of changing the category of HCPs.

Independently, hydrocodone has been defined as a schedule II substance since 1971. However, HCPs in specified doses (classified as containing no greater than 15 mg hydrocodone per dosage unit or not more than 300 mg hydrocodone per 100 mL) were listed in schedule III of the Controlled Substances Act (CSA) when formulated with specified amounts of an isoquinoline alkaloid of opium or one or more therapeutically active non-narcotic ingredients.

The DEA provided a summation of the reasons they voted for the reclassification of HCPs:

• Potential for abuse: Though the CSA does not define abuse, other drugs similar to HCPs set precedence for reclassification. The DEA said members of the public are using sufficient amounts of HCPs to create a hazard to their health, citing “3,376 admissions for drug treatment as the primary drug of abuse and in 6,601 admissions listing HCPs in addition to other drugs in the Treatment Episode Data Set.”
• Widely available/sought illegally: Similar to oxycodone, HCPs are among the top 10 most frequently encountered drugs diverted through legitimate drug channels. DEA investigations conducted from 2005 through 2007 concluded HCPs were diverted from rogue internet pharmacies.
• Effects of HCPs: The Department of Health and Human Services (HHS) states that HCPs are similar to micro-opioid receptors agonists in that they are effective both as an anti-tussive agent and analgesic drug.
• Public health risk: The DEA determines the effects of HCPs constitute it as a public health risk. The CDC found that “from 1999 to 2010, the number of drug poisoning deaths involving any opioid analgesic markedly increased (over four-fold), from 4,030 to 16,651.”