In their ongoing effort to curb prescription drug abuse, the U.S. Drug Enforcement Administration (DEA) has recently changed the classifications of two painkillers that are sometimes prescribed for fibromyalgia: tramadol and hydrocodone. While the tramadol change will have only minimal impact on patients, the new hydrocodone restrictions are much more severe and could be problematic for many patients.
Effective August 18, 2014, tramadol – previously an unscheduled prescription medication on the federal level – became a Schedule IV drug. A number of states had already proactively reclassified it as a controlled substance due to its potential for abuse.
Tramadol is also known by the brand name Ultram. It is a centrally acting synthetic opioid analgesic approved to treat moderate to moderately severe pain. It works primarily by binding to the mu-opioid receptors to block pain and in a weaker way, by inhibiting the reuptake of serotonin and norepinephrine – similar to the way antidepressants work to help reduce pain.
Schedule IV drugs have only limited restrictions:
- Prescription orders are valid for 6 months.
- Five refills are allowed in a 6-month period.
- Oral prescriptions are allowed.
If you’ve been taking tramadol, you probably won’t notice a great deal of difference unless your doctor has been giving you more than 6-months worth of refills. Also, depending upon the laws in your state, you may now have to show identification when you pick up your tramadol prescription.
Under a new federal regulation, beginning October 6, 2014, hydrocodone combination products (HCPs) will be reclassified from Schedule III to the more restrictive Schedule II. Vicodin and Lortab are two of the best-known HCPs.
According to the DEA, “The Controlled Substances Act (CSA) places substances with accepted medical uses into one of four schedules, with the substances with the highest potential for harm and abuse being placed in Schedule II, and substances with progressively less potential for harm and abuse being placed in Schedules III through V. (Schedule I is reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use.) HCPs are drugs that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin.”
DEA Administrator Michele Leonhart explained the reason for the new ruling. “Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents. [This] action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
There are significant restrictions on Schedule II drugs:
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- Prescriptions must be written. Doctors may not call or fax prescriptions to the pharmacy.
- No refills are allowed. A new prescription is required each time.
If your doctor is willing to do so, the DEA does allow physicians to write up to 90 days worth of an HCP at one time by giving you three separate prescriptions, dated 30 days apart. That way you would only have to make a trip to your doctor’s office every three months.
Whether or not an office visit is required each time you need a new prescription is left up to each individual doctor. Your doctor may allow you to just pick up the prescription.
If you take an HCP on a regular basis, you will need to contact your doctor to find out how your prescriptions will be handled under the new regulations. It would be best not to wait until you need a refill in case there are any problems or delays. You don’t want to find yourself facing withdrawal symptoms because you’re unable to get the medication you need.
What happens if you still have refills left on your current HCP prescription?
When the new ruling was first issued, it was thought that HCP prescriptions with remaining refills would not be honored. However, since then the DEA has issued a clarification determining that existing prescriptions for HCPs with remaining refills my be refilled until April 8, 2015.
The problem is, no one really knows how individual pharmacies will handle these prescriptions. It’s possible they may not be aware of the clarification or may simply decide not to honor the remaining refills. So if you have an HCP with refills left, it would probably be a good idea to check with your pharmacy ahead of time to see how they are going to handle them.
You can see the full ruling in the Federal Register: “Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II”
“Schedules of Controlled Substances: Placement of Tramadol Into Schedule IV.” Federal Register 79 (02 July 2014) 37623-37630.
“Drug Scheduling.” U.S. Drug Enforcement Administration. Retrieved 18 August 2014.
DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products. (2014, August 21). Retrieved September 28, 2014.
Twillman, R. (2014, September 26). Clinical considerations related to hydrocodone rescheduling – American Academy of Pain Management. Retrieved September 28, 2014.