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HOPA Weighs in on FDA Proposal to Reschedule Hydrocodone Combination Products

Jordan Wildermuth, MSW, Health Policy and Advocacy Manager

In October, Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, issued a press release on behalf of the U.S. Food and Drug Administration (FDA) stating its intent to submit a formal recommendation to the U.S. Department of Health and Human Services (HHS) to reclassify hydrocodone combination products from Schedule III to Schedule II. The decision comes after years of concern by the FDA regarding the abuse and misuse of opioid products. After the recommendation is reviewed by HHS, a final decision on the appropriate scheduling of hydrocodone combination products will be made by the Drug Enforcement Agency.

HOPA’s pain management workgroup convened in September 2013 to evaluate requests for HOPA’s support of issues related to access to pain medication for cancer patients and respond to legislative, regulatory, and industry changes and practices to ensure the responsible use of pain medications while maintaining access to pain medications for cancer patients. The workgroup, with the support of the Health Policy Committee, concluded that reclassifying hydrocodone combination products would negatively affect the appropriate management of pain and the patient’s quality of life.

HOPA determined that two responses were appropriate for this issue. The first was an opportunity to sign on to a letter addressed to HHS submitted by the Pain Care Forum, a coalition of which HOPA is a member. The Pain Care Forum’s mission is to “balance the fundamental rights of patients and clinicians with the challenge of risk containment for opioid misuse, abuse, and addiction associated with medical prescribing and use of controlled substances.” The letter outlined a three-part proposal that included maintaining hydrocodone combination products in Schedule III, changing the limits on prescriptions for Schedule III medications so that a telephone prescription for hydrocodone-containing products would not exceed a 10-day supply, and limiting the total amount of medication available through the original prescription plus refills to no more than a 90-day supply.

The second response was to send a letter from HOPA to HHS to bring focus to the patient and, more specifically, how pain affects the cancer patient. Among other points discussed in HOPA’s letter, it was noted that until Schedule II narcotics are available through e-prescriptions, oncology patients, while battling cancer and the side effects of treatments, would have to travel to their physician’s office to obtain a hard-copy prescription. For patients living in rural areas, the nearest oncologist office may be several hours away from the patient’s home. HOPA stated that the rescheduling of hydrocodone combination products to Schedule II is likely to cause more access to care problems rather than solving the drug diversion/abuse problem.

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