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11
MAR
2014
Last Updated March 14, 2014

Long Term Care Providers Protest FDA’s Decision to Reclassify Hydrocodone Medications

Long term care providers are speaking out against a recent decision by the FDA to reclassify certain pain medications across the nation.

Reclassifying HCPs

Vicodin and similar painkillers are being reclassified from Schedule III drugs to Schedule II drugs, according to a proposal in the February 27 Federal Registrar, also known as the Daily Journal of the United States Government. Officials say these drugs have reached abuse levels that equate to an epidemic, which requires addressing.

Despite the widespread abuse, though, the hydrocodone medications also provide necessary pain relief to many kinds of people, including those in nursing homes suffering from long term health ailments.

Hydrocodone itself has been classified as a Schedule II drug for years, but it is the hydrocodone combination products (HCPs), which have remained at Schedule III because up until now, they have been viewed as less dangerous. It wasn’t until July 9, 2012 that a new law titled the “Food and Drug Administration Safety and Innovation Act” recommended a public meeting to “solicit advice and recommendations” in regards to the classification of HCPs. In December of 2013, an FDA advisory committee voted to change HCPs to Schedule II, followed shortly thereafter by the DEA’s agreement.

Who Does it Harm?

According to the proposal in the Federal Registrar, “individuals are taking long term careHCPs in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community” and “individuals are taking HCPs on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs.” These conclusions led to the decision to reclassify the drugs.

As reported in McKnight’s Long Term Care News in October, long term care providers disagree with the decision to reclassify HCPs. They claim it will harm nursing home patients and others in need of pain relief by making the drugs harder to attain and get refills. While the decision may help certain people, it will harm those who need pain relief the most.

“The FDA’s reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care,” Kevin Schweers, a spokesman for the National Community Pharmacists Association, said in October.

You can access the full Federal Registrar proposal here.

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