Re-scheduling prescription hydrocodone combination drug products: An important step toward controlling misuse and abuse

By: Douglas C. Throckmorton, M.D.

Hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013. While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States. With the aim of curbing this misuse and abuse, new prescribing requirements go into effect today for hydrocodone combination products, which include products such as Anexsia, Lorcet, Vicodin, and some cough suppressants that contain both hydrocodone and another active ingredient, such as acetaminophen.

Douglas C. Throckmorton, M.D.Under a final rule issued by the U.S. Drug Enforcement Administration (DEA), hydrocodone combination products are now in a more restrictive category of controlled substances, along with other opioid drugs for pain like morphine and oxycodone.  After a scientific review, FDA made the recommendation that DEA take this step in December 2013. We concluded that hydrocodone combination products meet the criteria for control under Schedule II of the Controlled Substances Act, and we believe DEA’s new rule will help limit the risks of these potentially addictive but important pain-relieving products.

Here are some of the key changes that will occur with the reclassification of hydrocodone from a Schedule III drug to a Schedule II drug:

  • If a patient needs additional medication, the prescriber must issue a new prescription. Phone–in refills for these products are no longer allowed.
  • In emergencies, small supplies can be authorized until a new prescription can be provided for the patient.
  • Patients will still have access to reasonable quantities of medication, generally up to a 30-day supply.

After DEA requested a scientific and medical recommendation from FDA regarding a change of schedule for hydrocodone combination products in 2009, FDA considered the eight statutorily required factors related to the abuse potential of hydrocodone. These included such questions as the products’ actual or relative potential for abuse, their liability to cause psychic or physiological dependence, and dangers they might pose to public health. After a thorough analysis of the available information, including a public Advisory Committee meeting to solicit input from outside experts and patients (the committee recommended upscheduling by a vote of 19 to 10), HHS recommended to DEA that hydrocodone combination products be reclassified into Schedule II.

We also recommended two other actions we believe are critical to maximizing the benefits to the public health of rescheduling hydrocodone:

  • Include rescheduling in a broad-based set of actions targeting abuse prevention. In particular, HHS identified a need to work with prescribers and patients to make certain that patients are prescribed the right number of doses of hydrocodone for a patient’s need to avoid unused hydrocodone being available for abuse.
  • Continue to monitor the use and abuse of hydrocodone combination products carefully to assess the impact of rescheduling on public health. Based on the results of this monitoring, we may need to take additional actions to support the appropriate use of hydrocodone combination products while reducing their tragic abuse.

FDA understands that it is crucial to achieve a goal of balancing the risk of abuse and misuse with the need to maintain access to these important medications that provide needed relief to people in pain. Rescheduling hydrocodone combination products is one important action in support of this goal.

Douglas C. Throckmorton, M.D., is Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research

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