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FDA’s Painkiller Reclassification: New Limits On Hydrocodone Could Restrict Access For Addicts And Patients

hydrocodone
A mother pleaded not guilty this week to negligent homicide after she snorted hydrocodone and then breastfed her 5-day-old baby. Instant Vantage, CC BY SA 2.0

The U.S. Food and Drug Administration (FDA) is recommending that hydrocodone combination medications, such as Vicodin, be reclassified to increase controls on the painkillers over concern about prescription drug abuse and overdose deaths nationwide.

“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 [Dept. of Health and Human Services] that hydrocodone combination products should be reclassified to a different and more restrictive schedule,” wrote Janet Woodcock, director of the Center for Drug Evaluation and Research, in a statement.

According to the New York Times, the reclassification would reduce the number of refills that patients are prescribed before checking back in with their doctor and require patients to physically take prescriptions to the pharmacy rather than have a doctor call them in — thus, making hydrocodone combination drugs harder to obtain by patients and addicts alike. This policy shift, though new to combination drugs like hydrocodone, is already in place for more powerful painkillers like morphine and stimulants like Adderall.

Hydrocodone is an opioid painkiller usually prescribed for the treatment of chronic pain. Close to three-quarters of all drug overdose deaths in the United States are caused by opioid painkillers. To put that in perspective, a person dies every 19 minutes from a drug overdose in the U.S. Three-fourths of those are opioid users.

In addition to reducing the number of hydrocodone-related deaths, the new limits could also save taxpayers money on prescription drug costs. Data published by ProPublica shows that nearly 1.7 million providers wrote more than 1.1 billion prescriptions for hydrocodone-acetaminophen, including refills, in 2010. That means the U.S. spent about $380 million on Part D Medicare claims for hydrocodone-acetaminophen medications in 2010. Restricting access to these opioids will inevitably lead to less prescriptions being filled, which could save taxpayers huge amounts of money on Medicare expenses in the long run.

Last month, the FDA ensured a commitment to improving safety regulations on pain relievers to address the growing drug abuse problem when it announced class-wide label changes for the drugs. Those changes included measures that will help doctors to tailor their prescribing decisions based on each individual patient’s unique needs.

Woodcock said that the FDA’s planned changes will be submitted to the Dept. of Health and Human Services by December in hopes of receiving approval from the Drug Enforcement Administration (DEA) by 2014. She also said that, although she’s aware that changing the prescribing rules will also affect the patients who need the drugs, the public health risk is far too grave to continue with the regulations as they currently are.

“These are very difficult trade-offs that our society has to make,” she said. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”

“Going forward, the [FDA] will continue working with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.” 

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