In a major policy shift that affects tens of millions of patients, the federal government is tightening rules for prescribing the nation’s most common painkillers. In moving highly addictive hydrocodone-combination products such as Vicodin from a Schedule III class to Schedule II, the U.S. Food and Drug Administration aims to lessen abuse, lower addiction rates, and alleviate the nation’s opioid and heroin epidemic.
The change subjects Vicodin, Lortab, and their generic equivalents to the same prescribing rules as oxycodone and morphine. It has enormous potential benefits, including making fraud more difficult.
But it could burden health-care providers while creating hardships and higher costs for the 50 million Americans a year who get hydrocodone (the most widely prescribed drug in the United States), most of them to ease chronic pain.
The FDA rules, which take effect in about a month, restrict patients to one 90-day supply of medication and require them to see a medical professional to get refills. They limit who can prescribe the drugs and eliminate prescription call-ins.
Under Schedule III classification, a Vicodin prescription could be refilled five times before the patient had to see a physician again. Looser controls inevitably have led to more diversion of Vicodin and other controlled substances onto the street, where they are bought illegally.
Over the next year, the FDA and Congress must monitor the new rules to assess whether they are effective or cause undue burden to patients in chronic pain. After a review, the FDA ought to make whatever changes are needed to ensure that the benefits of the new classification don’t outweigh the drawbacks.
Prescription drug abuse kills more than 20,000 Americans a year — three times as many as in the late 1990s. It has led to the nation’s opioid and heroin epidemic, as some opioid addicts eventually turn to heroin as a cheaper, more potent way to satisfy their addiction.
The issue has pitted advocates who fight addiction against pain management specialists, long-term care providers, and some chronic pain patients, who fear tighter regulations will make it too difficult for them to get the medications they need to live productive lives.
Both sides have legitimate concerns. Other steps may be even more effective in fighting addiction, including better education of doctors and patients and improved state prescription monitoring systems to detect so-called doctor shopping for multiple prescriptions.
Even so, it’s clear that drugs with hydrocodone have been widely abused and over-prescribed. In 2010, the United States accounted for more than 99 percent of the world’s consumption of hydrocodone, the International Narcotics Control Board reports.
In this balancing act, moving hydrcodone-combination drugs to a more restrictive classification is prudent. Serious, systemic efforts to curb the nation’s addiction crisis are overdue. But the FDA must also ensure that the promises of tighter access outweigh the perils.