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FDA moves to reschedule hydrocodone
October 25th, 2013
WASHINGTON – Citing escalating levels of drug abuse, the Food and Drug Administration aims to reclassify hydrocodone to put tighter restrictions on the opioid pain reliever.
The FDA announced Thursday that by early December it plans to submit a formal recommendation to the Department of Health and Human Services (HSS) to move hydrocodone combination products from a Schedule III classification to Schedule II.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the rescheduling would place strong controls on the drug, which is indicated for the relief of chronic pain but has become a medication that is too often abused and misused.
"Over the past several years, the Food and Drug Administration has been carefully evaluating and weighing the appropriate use of opioid analgesic drug products. For the millions of American patients experiencing an acute medical need or living with chronic pain, opioids, when prescribed appropriately, can allow patients to manage their pain as well as significantly improve their quality of life," Woodcock explained in a statement. "However, in recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States. While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse."
She said that in 2009, the Drug Enforcement Administration (DEA) asked HHS for a recommendation on whether to change the schedule for hydrocodone combination products, such as Vicodin, to Schedule II.
"Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency's intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule," Woodcock said. "This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which we received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities."
The FDA said it expects that the National Institute on Drug Abuse to agree with its recommendation, which will begin an assessment that will result in a final decision by the DEA on the scheduling of these hydrocodone products.
The National Association of Chain Drug Stores and the National Community Pharmacists Association are among a host of patient and health care groups that oppose the rescheduling of combination hydrocodone products. They say the change would present challenges for patients as well as doctors, pharmacists and other health care providers.
"Pharmacies have a zero tolerance for prescription drug abuse and a 100% commitment to patient care. This proposal is not the best avenue to address abuse and would negatively impact access to needed medications for those who suffer from chronic pain," NACDS said Friday in a statement on the FDA's recommendation to reschedule hydrocodone. "In the interest of patient care, we have worked with patient advocacy groups in opposition to this recommendation as we support and advance workable solutions."
B. Douglas Hoey, chief executive officer of NCPA, said in a statement Friday that the reclassification would create hardships for many patients with legitimate chronic pain, notably those in nursing home and long-term care settings.
"Community pharmacists support aggressive efforts to combat the abuse and diversion of prescription drugs. Such abuse has ruined lives, devastated families and fostered dangerous crimes against pharmacies. At the same time, there are more practical means available to reduce prescription drug abuse," Hoey explained. "For starters, more effective education of prescribers, electronic prescription drug monitoring programs and tracking systems, and shutting down rogue pain clinics are all steps that can combat abuse without harming patients and the pharmacists caring for them."
The FDA's Drug Safety and Risk Management Advisory Committee voted in favor of reclassifying combination hydrocodone to Schedule II — the same restriction as morphine and opium — in a meeting on Jan. 25. Days later, NACDS and NCPA were among a list of organizations who sent a letter to FDA Commissioner Margaret Hamburg that called on the agency to forgo the move.
"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."
Other 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.
In testimony for the Jan. 25 FDA committee hearing, NCPA vice president of policy and regulatory affairs Ronna Hauser explained that the proposed change for hydrocodone — one of the last non-Schedule II drugs for moderate to severe pain — would create an array of obstacles, such as preventing prescribers from phoning in prescriptions to pharmacies, stopping prescription refills, limiting who can prescribe and, in some instances, prohibiting electronic prescribing.
She added Schedule II procedures for hydrocodone would lead to administrative and financial burdens for pharmacies, potentially requiring more pharmacy staff hours or the purchase and installation of larger safes to accommodate many of the almost 3,000 combinations of strength, formulation and manufacturer of hydrocodone-containing products.
"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 in her testimony, "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."