Patient and health care groups, including the pharmacy community, are calling on the Food and Drug Administration to reject the rescheduling of combination hydrocodone products from Schedule III to Schedule II.


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FDA urged to nix plan to reschedule hydrocodone medications

February 5th, 2013

ALEXANDRIA, Va. – Patient and health care groups, including the pharmacy community, are calling on the Food and Drug Administration to reject the rescheduling of combination hydrocodone products from Schedule III to Schedule II.

The National Community Pharmacists Association said Monday that the groups, including the National Association of Chain Drug Stores, have sent a letter to the FDA noting that the rescheduling, if enacted, would present challenges for patients in accessing the medications they need to manage chronic pain and related conditions.

Last month, the FDA's Drug Safety and Risk Management Advisory Committee voted in favor of rescheduling combination hydrocodone products into Schedule II.

"No evidence currently exists to show that reclassifying hydrocodone will curb misuse and abuse of pain medications. In contrast, there is evidence that rescheduling medications to higher classifications can reduce patient access to medications and cause harm," the letter stated.

"The Institute of Medicine (IOM) has documented that there are 100 million Americans living with chronic pain. That number does not count Americans with acute pain annually estimated by the CDC to be 46 million from surgery alone," the groups explained in the letter. "Rescheduling these medications is a drastic measure that would have far-reaching consequences. Chief among them would be loss of pain control for millions of Americans."

Besides NCPA and NACDS, groups signing the letter included the American Academy of Pain Management, American Association of Nurse Assessment Coordination, American Cancer Society Cancer Action Network, American Society of Consultant Pharmacists, Amputee Coalition, CarsonCompany, Citizen Advocacy Center, Interstitial Cystitis Association, Long-Term Care Pharmacy Alliance, Massachusetts Pain Initiative, NADONA, National Fibromyalgia & Chronic Pain Association, National Hospice and Palliative Care Organization, Pain Treatment Topics, US Pain Foundation and Wisconsin Pain Initiative.

The letter also pointed to patient access difficulties and increased costs for patients and the overall health care delivery system if the scheduling change is approved.

"Prescriptions for Schedule II medications cannot be transmitted by telephone or fax, nor can they be refilled," the letter noted. "The proposed policy change would require patients to see their doctor for office visits with greater frequency simply to refill a prescription. [In addition] rescheduling these medications would unnecessarily introduce inefficiencies and increase health care costs at a time when policymakers are seeking ways of increasing efficiencies and reducing costs."

The groups offered solutions to help curb drug abuse and diversion, including targeting illegitimate drug sellers, better education for prescribers and youth, better utilization of prescription drug monitoring programs, and the creation of permanent medication disposal programs.

"The prescription drug abuse problem can be successfully curbed. However, we urge FDA not to recommend unworkable provisions, such as moving all combination hydrocodone products into Schedule II," the letter stated. "Combatting prescription drug abuse must take a holistic approach. All affected stakeholders must work proactively to tackle and resolve this complex problem."

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