The American Society of Health-System Pharmacists is backing FDA’s recommendation that hydrocodone combination products be reclassified as Schedule II drugs under the Controlled Substances Act.
The American Society of Health-System Pharmacists (ASHP) is backing FDA’s recommendation that hydrocodone combination products be reclassified as Schedule II drugs under the Controlled Substances Act.
Last month, FDA said it would recommend to the U.S. Department of Health and Human Services (HHS) that hydrocodone combination products, such as Vicodin, be reclassified as a Schedule II product, placing tighter controls on the pain medications. FDA said it would formally make the recommendation in December. Such products are currently classified as Schedule III.
In a letter sent to Secretary of Health and Human Services Kathleen Sebelius, ASHP officials said hydrocodone-containing products should be reclassified to Schedule II based on their potential for abuse and patient harm.
“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, PharmD, MS, ASHP’s vice president for policy, planning and communications. “Based on an assessment using the criteria the Drug Enforcement Agency 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.”
Some pharmacy groups, including the National Association of Chain Drug Stores and the National Community Pharmacists Association, have opposed the reclassification.
While acknowledging as “valid” concerns regarding heightened recordkeeping and security processes likely to be caused by rescheduling, ASHP said it believes such concerns are outweighed by the public health benefit arising from increased control of drugs with high abuse potential.