class of rx painkillers to be subject to more stringent regulations

Back in 2004, the Drug Enforcement Administration asked both the Department of Health and Human Services and the Food and Drug Administration to grant their respective — and required — approvals for reclassifying hydrocodone combination painkillers such as Vicodin and Lortab from Schedule III to Schedule II drugs under the Controlled Substances Act.

According to the DEA, the administrative move, which would introduce much tighter regulations for patients, physicians and pharmacists, was necessary given that the drugs were not only highly addictive, but also overprescribed and sold on the black market.

The FDA ultimately disagreed with this take and refused to reclassify hydrocodone combination painkillers in 2004. However, this all changed in 2013 amid alarming reports of growing abuse of the drug and overdose deaths.

The DHS followed suit in December, echoing these same concerns.

In recent developments, the federal government announced in the Federal Register last week that the official reclassification of hydrocodone combination painkillers as Schedule II drugs will take place as soon as mid-October.

Under the Controlled Substances Act, Schedule I drugs are classified as those which have been determined by the FDA to have no accepted medical purpose (heroin, peyote, ecstasy, etc.) and are therefore illegal. However, Schedule II drugs are those which have been determined by the FDA to have an acceptable medical purpose, but which also have the potential for abuse/addiction (Adderall, Ritalin, oxycodone, Demerol, etc.).

Interestingly, while hydrocodone combination painkillers, which contain other ingredients like acetaminophen and ibuprofen, will be new to the Schedule II list, hydrocodone as a lone drug has been classified as a Schedule II for over 40 years.

How then will these new regulations affect patients, physicians and pharmacies?

  • Physicians will no longer be able to write six-month supplies as a 30-day prescription with up to five refills. Instead, they will only be able to write three-month supplies as a 30-day prescription with up to two refills and will have to see patients needing new prescriptions every three months.
  • Pharmacies and drug companies will have to introduce greater security measures to safeguard the drug and maintain more comprehensive records.

It will be interesting to see how these new regulations play out, meaning how they are received by both the medical community and those patients who suffer from severe pain on a regular basis.

Those who have been injured by a prescription error or a pain medication error should strongly consider consulting with an experienced legal professional to learn more about their rights and their options.

Source: USA Today, “New restrictions on hydrocodone to take effect,” Matthew Perrone, Aug. 21, 2014

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