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Rebecca Farley

Director, Policy & Advocacy, National Council for Behavioral Health

FDA Recommends Tighter Regulations on Opioid Painkillers

October 30, 2013 | Opioid and Heroin Epidemic | Comments
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In a major policy shift, the Food and Drug Administration (FDA) last week recommended tighter controls on certain types of opioid medications prescribed for the treatment of pain. The changes are expected to take effect next year, pending approval from the Department of Health and Human Services and the Drug Enforcement Agency.

The drugs at issue contain a combination of the narcotic hydrocodone and an over-the-counter painkiller such as acetaminophen (examples include the brand-name drugs Vicodin and Lortab, as well as their generic equivalents). Under the FDA’s recommendations, these drugs would be reclassified from Schedule III to Schedule II drugs, making them subject to the same prescription and refill restrictions as more powerful painkillers like OxyContin.

This means that patients would have only 90 days to obtain refills for their medications before they had to see a doctor again, as compared to the current 180 days. Prescribers would no longer be able to phone in prescriptions for these drugs; instead, patients would have to bring doctors’ prescriptions to the pharmacy in person. Additionally, pharmacies would be subject to stricter storage and record-keeping requirements. In some states, nurse practitioners and other non-physician professionals who currently prescribe these drugs would no longer be able to do so.

The use and misuse of prescription drugs has come under increasing scrutiny by public health officials in recent years. According to the Centers for Disease Control and Prevention (CDC), opioid painkillers were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. The misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years. More than 12 million people reported using prescription painkillers nonmedically in 2010 — that is, using them without a prescription or for the feeling they cause.

Supporters of the FDA’s proposed change noted that tighter restrictions on medications containing hydrocodone will help curb the misuse and abuse of these drugs. Yet, patient and provider advocates expressed dismay that the recommendations could reduce access to medically necessary painkillers, particularly in rural areas. Legislation that would have mandated the FDA’s newly announced recommendation failed last year in Congress.