Pharmacist Group Applauds FDA Plan to Reschedule Hydrocodone Combination Products


The American Society of Health-System Pharmacists (ASHP) supports the Food and Drug Administration’s (FDA) recent decision to recommend the rescheduling of hydrocodone-containing combination products to Schedule II drugs under the Controlled Substances Act.

The ASHP House of Delegates approved a policy during its session in June 2013, which calls on the organization to:

Advocate that the Drug Enforcement Administration (DEA) reschedule hydrocodone-containing products to Schedule II based on their potential for abuse and patient harm and to achieve consistency with scheduling of other drugs with similar abuse potential.

In a letter sent to this week to Secretary of Health and Human Services Kathleen Sebelius, ASHP noted that the policy was developed after “carefully weighing the potential public health benefit of rescheduling these therapies against concerns about restricting patients’ access to treatment and increasing administrative burdens on pharmacists, physicians, and other clinicians.”

“ASHP has found no evidence that the lower dose of hydrocodone contained in these combination products, or the addition of acetaminophen, lowered the abuse potential of hydrocodone,” said Kasey K. Thompson, Pharm.D., M.S., ASHP Vice President for Policy, Planning and Communications. “Based on an assessment using the criteria the Drug Enforcement Agency (DEA) considers when determining whether to control or reschedule a drug, ASHP believes that hydrocodone combination products are similar to other controlled substances found in Schedule II and should therefore be assigned to Schedule II.”

ASHP called concerns regarding heightened recordkeeping and security processes resulting from rescheduling, “valid,” but believes that they are outweighed by the public health benefit arising from increased control of drugs with high abuse potential. The Society also countered concerns that the inability to prescribe refills would have a broad impact on patient access noting that, “by their very nature prescriptions for acute pain treatment would have limited or no refills.”

The Society also recommended that FDA, the DEA, and other stakeholders monitor the effect of rescheduling hydrocodone combination therapies and other abuse-prevention efforts to assess the impact on patients and providers.

The full text of the Society’s letter is available here.

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