The Food and Drug Administration’s (FDA's) proposal to move a drug containing acetaminophen and hydrocodone (Vicodin) and other hydrocodone-containing products from Schedule III to Schedule II of the Controlled Substances Act would hit those in nursing home and other long-term care settings the hardest, “delaying relief for vulnerable patients with legitimate chronic pain,” according to the National Community Pharmacists Association (NCPA).
The change would mean that nurses and physician assistants no longer would be able to prescribe the medications, and prescriptions could not be written for more than 90 days without a doctor’s visit. Schedule II drugs, which currently include oxycodone (OxyContin), morphine, opium, codeine and others, are considered to have a high potential for abuse that can lead to severe physical or psychological dependence, according to the Drug Enforcement Administration (DEA).
The FDA expects to submit a formal recommendation to the Department of Health and Human Services by early December, Janet Woodcock, MD, director of the agency’s Center for Drug Evaluation and Research, said in a statement posted yesterday on the agency’s website.
“We anticipate that the National Institute on Drug Abuse…will concur with our recommendation,” Woodcock said. “This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.”
The director said the agency is “challenged” in its efforts to balance the need for access to opioid analgesic medications with concerns about their misuse and abuse. In a statement to the media today, NCPA CEO B. Douglas Hoey, RPh, MBA, said that his organization supports efforts to curb abuse and diversion of the prescription painkillers. “At the same time, there are more practical means available to reduce prescription drug abuse,” he added. Better training of prescribers, the use of electronic prescription drug monitoring programs and tracking systems, and the shutting down of “rogue pain clinics” all are solutions, according to the organization.
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