FDA Panel Recommends More Restrictions on Hydrocodone
The all-out effort to make all opioid pain-relieving medications more difficult to get continues. Last week an FDA panel voted 19 to 10 to reclassify medications that contain hydrocodone - like Vicodin and Lortab - from Schedule III drugs to Schedule II drugs.
Currently, under the federal Controlled Substances Act, medications containing hydrocodone are classified as Schedule III drugs. This means doctors can call in or fax prescriptions to the pharmacy and can allow up to five refills in a six-month period.
If hydrocodone-containing products are reclassified to Schedule II, only written prescriptions with an original signature by the physician are acceptable and no refills are allowed. If you take a hydrocodone medication on a regular basis, that means in most cases you’ll have to go to your doctor’s office every month to get a new prescription.
The DEA (Drug Enforcement Administration) does allow, but does not encourage, doctors to issue multiple prescriptions for Schedule II drugs at one time under certain conditions. Based on a revised regulation, which became effective December 19, 2007, "an individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance provided the following conditions are met:
Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.
The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription.
The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.
The issuance of multiple prescriptions is permissible under applicable state laws.
The individual practitioner complies fully with all other applicable requirements under the Controlled Substances Act and Code of Federal Regulations, as well as any additional requirements under state law."
The panel held a two-day hearing prior to voting, during which time they listened to impassioned testimony both for and against the reclassification. It was pointed out that two groups of chronic pain patients in particular will likely suffer as a result of changing hydrocodone to a Schedule II drug. One is frail nursing home patients, who would have to make frequent trips to the doctors office in order to get the medication they need.
The second group is people who live in rural areas where there are few doctors available. Reclassifying hydrocodone would ban physician assistants and nurse practitioners from prescribing it, leaving rural residents suffering in pain without anyone to help them.
Finally, it should be noted that the reason the FDA is even considering reclassifying hydrocodone is because the DEA is pressuring them to do so. The FDA denied a similar request in 2008 but the DEA has asked them to reconsider based on new research and data.
In My Opinion…
I am disappointed, but not surprised, at this latest action by the FDA and DEA. In my personal opinion, it’s ridiculous to put such severe restrictions on hydrocodone products. The highest dose of hydrocodone available in a single tablet is 10 mg. Plus, all approved medications containing hydrocodone also have another ingredient - usually acetaminophen, sometimes ibuprofen - which can damage the liver if multiple tablets are taken. While it’s possible to abuse or overdose on hydrocodone, it’s much less likely than with other Schedule II drugs that can be prescribed by themselves and are available in much larger dosages.
Sadly, several people on the panel who voted in favor of reclassifying hydrocodone said they did so in order to send a message to doctors to think twice before prescribing hydrocodone. I’m sorry but I don’t think sending a symbolic message is a good reason to make it so much more difficult for chronic pain patients to get the medication they need in order to function.
While the FDA is not required to accept the recommendations of the panel, it usually does so. Frankly, with the current push to put greater restrictions on all opioids, I will be extremely surprised if this is not approved.
What do you think about reclassifying hydrocodone to a Schedule II drug? If you take a hydrocodone medication, how do you think this will affect your ability to get your medication?
Lowry, F. "FDA Panel Calls for Greater Restrictions on Hydrocodone." Medscape Today. January 28, 2013.
Tavernise, S. "FDA Likely to Add Limits on Painkillers." The New York Times. January 25, 2013.
Drug Enforcement Administration. Practitioner’s Manual. "Section V - Valid Prescription Requirements." Retrieved January 30, 2013.
Karen is the co-founder of the National Fibromyalgia Association. She wrote for HealthCentral as a patient expert for Pain Management.