ALEXANDRIA, Va. — Policymakers should consider alternative strategies as they examine a proposal that would put thousands of common, hydrocodone-containing products under the same restrictions as morphine and opium and make it more difficult for consumers using those drugs legitimately to relieve chronic pain, according to the National Community Pharmacists Association (NCPA).
In testimony Friday at the Food and Drug Administration’s advisory meeting on drug safety and risk management, NCPA pointed to such measures as electronic prescription drug monitoring programs and tracking systems as ways to combat prescription drug abuse without impacting patients who rely on combination medications that contain controlled substances.
NCPA said the FDA advisory committee is mulling a proposal that would move hydrocodone-containing medicines such as Vicodin from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.
"While we share concerns regarding the abuse, misuse and diversion of these prescription drugs, these concerns must be balanced with the impact on patients who legitimately need access to them," Ronna Hauser, vice president of policy and regulatory affairs for NCPA, said in written testimony provided to the FDA. "There are numerous hydrocodone-containing combination products that patients need to treat moderate to severe pain from various conditions. Rescheduling the products to Schedule II would create significant hardships for all — leading to delayed access for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care settings."
Hauser noted at the hearing that with hydrocodone in combination being one of the last non-Schedule II drugs available to treat moderate to severe pain, the proposed change would create an inordinate amount of hurdles, such as preventing prescribers from phoning in prescriptions to pharmacies, stopping prescription refills, limiting who can prescribe and, in some instances, prohibiting electronic prescribing.
What’s more, she testified, pharmacies would incur significant administrative and financial burdens under Schedule II procedures. For example, such a move could potentially require more pharmacy staff hours or the purchase and installation of larger safes to accommodate many of the almost 3,000 different combinations of strength, formulation and manufacturer of hydrocodone-containing products.
She added that states already have the authority to place tougher restrictions on the prescribing and dispensing of controlled substances to fit the needs of their citizens as well as the challenges they face.
NPCA noted that the FDA has expressed reservations about the hydrocodone rescheduling proposal in a briefing document. Still, the agency will wait for the advisory committee to offer its post-hearing recommendations before weighing in formally.
"Moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products," Hauser stated, "and it will result in adding to the nation’s health care costs with no assurance of a reduction in diversion and abuse. There are better strategies to address this issue, including electronic prescription drug monitoring programs and tracking systems, and we pledge to work with [the FDA] and other policymakers to develop these viable alternative proposals."
