On Friday, a key federal panel recommended placing new restrictions on hydrocodone, the highly addictive painkiller found in Vicodin and other pain medications, making it the most widely prescribed drug in the U.S.
At the conclusion of an emotional two-day hearing yesterday, the Food and Drug Administration panel voted 19-10 in favor of changing how drugs containing hydrocodone are classified as controlled substances, a move supported by the Drug Enforcement Agency.
If the agency goes along with the panel's recommendation, which is typical but not required, the drugs would be more stringently regulated, moving to so-called Schedule II from Schedule III.
Panelists who voted for the move said it would send a signal to doctors about the potential dangers of hydrocodone abuse.
"I don't think reclassification is a panacea for the opioid abuse problem in this country, but I think it's an important step to get doctors to rethink their prescribing practices," said Mary Ellen Olbrisch, a professor at Virginia Commonwealth University.
Panelists who voted against the move said it would have unintended consequences, such as driving addicted patients to obtain drugs illegally.
"If prescribing decreases, illicit opioid use will increase, with dire consequences," said Dr. John Mendelson, of St. Luke's Hospital in San Francisco. "I think this is a mistake and we will be back here with other problems."
Physicians and pharmacy groups argued that reclassifying the drugs would burden medical professionals and disrupt patient care.
"Rescheduling the products to Schedule II would create significant hardships for all, leading to delayed access for vulnerable patients with legitimate chronic pain," the National Community Pharmacists Association said in a statement.
In 1970, the Controlled Substances Act was passed, which classified drugs containing hydrocodone as Schedule III substances. Schedule III substances are subject to fewer controls than Schedule II.
For example, if the hydrocodone-containing painkiller Vicodin were reclassified to Schedule II, it would mean you could no longer get it refilled five times before seeing your doctor again. Instead, you could only get a single 90-day prescription, just like it is with oxycodone. Moreover, nurses and physician assistants would no longer be able to write you a prescription.
Hydrocodone belongs to a family of drugs called opioids. Included in the opioid family are painkilling drugs like morphine, heroin, oxycodone, codeine and methadone. Hydrocodone is sold in combination pills and formulas with other non-addictive ingredients, such as acetaminophen and aspirin. It is frequently prescribed to treat conditions involving chronic pain and cough. Doctors in the U.S. wrote more than 131 million prescriptions for hydrocodone in 2011, making it the most prescribed drug in the nation.
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