NCPA Offers FDA Solutions to Drug Abuse Epidemic; Outlines Concerns for Patients with Moving Hydrocodone Products to Schedule Two



Alexandria, Va. - Jan. 25, 2013 To crack down on prescription drug abuse, Federal officials and other policymakers should focus on strategies such as electronic prescription drug monitoring programs and tracking systems instead of risking unintended harm to innocent patients that could result from putting thousands of common, hydrocodone-containing products under the same restrictions as morphine and opium, the National Community Pharmacists Association (NCPA) testified today at the U.S. Food and Drug Administration's (FDA) advisory meeting on drug safety and risk management.

The FDA advisory committee is considering a proposal that could make it harder for patients with legitimate health needs to obtain essential medications by moving hydrocodone-containing products 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," said NCPA Vice President of Policy and Regulatory Affairs Ronna Hauser, PharmD, in written testimony provided to the agency. "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."

The FDA has expressed reservations similar to those voiced by NCPA about the hydrocodone rescheduling proposal in a briefing document. However, the FDA will wait for the advisory committee charged with examining the policy to offer its post-hearing recommendations before weighing in formally.

At the hearing Hauser also noted that:

  • States currently have authority to "act on their own to place tougher restrictions on the prescribing and dispensing of controlled substances," to fit the needs of their citizens and the challenges they face;
  • 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; and
  • 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 nearly 3,000 different combinations of strength, formulation and manufacturer of hydrocodone-containing products.

In conclusion, Hauser said, "Moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, 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 you and other policymakers to develop these viable alternative proposals."

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