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The Food and Drug Administration is proposing tighter regulations for a commonly prescribed painkiller, a move that would make getting prescriptions for Vicodin, Lortab and other hydrocodone products much more difficult.
FDA officials said Thursday they will ask the Health and Human Services Department to classify hydrocodone combination products as Schedule II drugs, a restrictive category that limits how doctors prescribe the medications and authorize refills.
The proposed change is a response to increasing abuse of highly addictive opioid narcotics, according to Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.
“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,” Woodcock said in a statement.
Vicodin and other hydrocodone/acetaminophen medications such Lorcet, Lortab and Norco are the most commonly prescribed pain medications in the Defense Department.
In 2011, military doctors wrote 409,237 prescriptions for these products, twice as many as the second most-prescribed painkiller, tramadol.
The number of prescriptions written for hydrocodone/acetaminophen also has increased significantly since 2007, up 38 percent.
A 2012 study of Iraq and Afghanistan veterans found that VA doctors prescribed more opiates to patients with PTSD, depression and substance abuse disorders than to veterans with no mental health conditions.
According to the Substance Abuse and Mental Health Services Administration, nearly 35 million Americans in 2008 reported that they had taken prescription painkillers, including Vicodin, for reasons other than medical use at least once.
In 2011, 1.8 million Americans met the clinical definition for dependence or abuse of prescription pain relievers.
A number of industry groups and advocates have opposed the reclassifying of Vicodin and similar hydrocodone/acetaminophen medications as Schedule II drugs.
In March, the National Community Pharmacy Association came out against legislation proposed by Sens. Joe Manchin, D-West Va., and Mark Kirk, R-Ill., to change the medication’s classification.
“[The legislation] would would create significant hardships for many and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care settings,” association CEO Douglas Hoey said.
Other groups that oppose the change include the American Cancer Society Cancer Action Network, the American Academy of Pain Management, the Amputee Coalition and the National Association of Chain Drug Stores.
A 2011 survey of health behaviors among active-duty service members found 1.3 percent of troops said they had abused prescription drugs, while 4.5 percent said they knew of colleagues who had misused them.
Steriods and amphetamines are the most commonly abused prescriptions in the military, according to the survey, with painkillers placing third.
The FDA will make its formal recommendation to HHS in December. If approved, hydrocodone products will join other medications such as oxycodone, methadone, fentanyl, Ritalin and Adderall as Schedule II drugs.
Currently, patients filling prescriptions for Schedule III medications — the current classification of hydrocodone compounds — can refill them over a six-month period without needing a new prescription.
Schedule II medications usually require a new prescription every 30 days, with a maximum of 90 days allowed under some conditions.
Woodcock said the decision was difficult but came after “a thorough and careful analysis of extensive scientific literature.”
“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 said. “The FDA has been challenged with determining how to balance the need ... while addressing the ongoing concerns about abuse and misuse.”
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