Prescription Painkillers Containing Hydrocodone May Become More Tightly Regulated

Advisers to the Food and Drug Administration (FDA) will meet this fall to discuss whether prescription painkillers containing hydrocodone should be more tightly regulated, Bloomberg reports. They will evaluate the risks and benefits of hydrocodone preparations that are used to treat pain and coughs.

Emergency room visits related to hydrocodone, the key ingredient in Vicodin and other painkillers, have soared since 2000. Vicodin, which also contains acetaminophen, is subject to fewer regulations than pure hydrocodone, the article notes.

The Drug Enforcement Administration (DEA) wants to change the way drugs that combine hydrocodone with other products are classified, to require patients to have more interaction with doctors in order to obtain prescriptions for them. “It has to do with penalties for trafficking,” Barbara Carreno, a spokeswoman for the DEA, told Bloomberg. “You have to go back to the doctor when you run out of medicine. It’s more oversight by the doctor.” She said that if the FDA decides that the drugs should have more oversight, the DEA will change its drug classification schedule accordingly.

The FDA and DEA have repeatedly passed information back and forth about hydrocodone, without making any final decisions about the drug.

The DEA classifies drugs on a five-stage scale, which takes into account the potential for addiction. Currently, hydrocodone is considered by the DEA to be a Schedule II controlled substance, the second-highest level. Hydrocodone combinations, such as Vicodin, are Schedule III, and therefore have fewer restrictions on sales.

Schedule II drugs must be locked up at pharmacies. Physicians can only prescribe one bottle at a time and patients must have an original prescription in order to obtain the medication. Schedule III drugs can be refilled up to six times without visiting a doctor, who can phone or fax in a prescription to the pharmacy.