Tag Archives: Schedule III narcotics

DEA clamps down on hydrocodone

HydrocodoneHydrocodone, the nation’s most widely prescribed painkiller, will now be in the same category as other frequently abused medications such as OxyContin and fentanyl. The agency said Friday it had published a rule to reschedule hydrocodone combination products — which include Vicodin and Norco — from Schedule III to the more restrictive Schedule II of the Controlled Substances Act.

Americans consume 99% of the hydrocodone produced worldwide; because of the perception that such products are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists, according to this article.

Combination hydrocodone products are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

Since 2007, more U.S. prescriptions were written for the combination of hydrocodone and acetaminophen than any other drug. In 2012, that was over 135 million prescriptions, or one prescription for every 2.3 men, women, and children in the U.S. that year, according to this article.

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FDA moves for stricter hydrocodone controls

bunchofpillsThe U.S. Food and Drug Administration has recommended reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II, a move that would bring such medications in line with opioid painkillers such as oxycodone and morphine.

In January, an expert panel advising the FDA voted 19 to 10 in favor of the more stringent prescribing requirements. Proponents of the reclassification have noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics have argued that the move would hinder legitimate pain patients from obtaining treatment.

The reclassification must be approved by the Department of Health and Human Services and the Drug Enforcement Administration, which will make a final scheduling decision.

Separately in September, the FDA announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin. The updated labels must state that such medications are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

In addition, because of the risk of addiction and abuse “even at recommended doses,” as well as the greater risks of overdose and death, the drugs must be labeled as “reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said.

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N.Y. imposes stricter controls on hydrocodone

purplepillsIn New York, Attorney General Eric Schneiderman has issued a letter to doctors, pharmacists and other medical professionals alerting them that the widely abused prescription painkiller hydrocodone is now a Schedule II controlled substance under new regulations recently passed by the state. In the letter, Schneiderman calls the drug “highly addictive,” noting that statewide prescriptions for hydrocodone filled increased from 3.8 million to 4.5 million from 2007 to 2009, an increase of 18.4%, while those for oxycodone have increased 82%. In many regions of the state, hydrocodone is the most commonly prescribed controlled substance, according to the letter.

The changes apply only to New York state, although the FDA is currently considering whether to reclassify hydrocodone-containing painkillers from Schedule III drugs to the more restrictive Schedule II on a federal level. In January, an expert panel voted 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

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FDA mulls stronger controls on opioid prescribing

PillsLast week, the U.S. Food and Drug Administration held a two-day hearing to determine if more controls need to be placed on opioid prescribing. The hearing was the result of a citizen’s petition filed by the Physicians for Responsible Opioid Prescribing (PROP) and other advocates.

The petition asks the FDA to change the indication on opioid analgesics like OxyContin from “moderate to severe pain” to “severe pain” and to include a suggested duration of 90 days of continuous use. Current labels on opioid analgesics simply indicate that opioids are to be used for “moderate to severe pain,” without further qualification.

The FDA is still taking comments before it makes its decision regarding this issue, and you can let it know what your views are here.

To hear impact statements from those who testified at the meeting, go here.

Separately, the FDA is considering reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II. In January, an expert panel advising the FDA voted 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

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FDA panel backs stricter controls on Vicodin

The U.S. Food and Drug Administration may be set to reclassify hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II, with an expert panel voting 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

The FDA usually, but not always, follows the advice of its advisory panels.

The misuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the Centers for Disease Control and Prevention.

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FDA mulls hydrocodone reclassification

This week, the U.S. Food and Drug Administration is set to conduct a two-day hearing on whether hydrocodone products such as Vicodin should be more highly regulated like other narcotics like OxyContin and morphine, this article reports. FDA researchers said in recent briefing documents that while chronic pain patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction, the article says. But critics say hydrocodone is potent and highly addictive, and that updating the drug’s classification could help bring the prescription drug addiction epidemic under control, according to the article.

Last year, pharmacy interest groups defeated an amendment to the FDA Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II.

Combination hydrocodone products such as Vicodin and Norco are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

The amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization bill would have rescheduled hydrocodone from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone.

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