On October 6, 2014 new federal regulations on drugs that contain hydrocodone will take effect. Under the new ruling, hydrocodone combination products (HCPs) will be reclassified from Schedule III to the more restrictive Schedule II. More than 60 different products will be affected by this ruling. Two of the most familiar brand names are Vicodin and Lortab.
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."
What the New Restrictions Mean for You
If you regularly take a medication that contains hydrocodone, the main differences you will see are:
You will no longer be able to get monthly refills. Instead, you will have to get a new written prescription each month.
Your doctor cannot call or fax a prescription to the pharmacy. They will only accept written prescriptions.
Whether or not you will be required see your doctor for a regular office visit each month is up to each individual doctor. If your doctor agrees, you may just be able to pick up the prescription.
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 see your doctor every three months.
What if You Currently Have an HCP That Still Has Refills Left?
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 may be refilled until April 8, 2015.
It is currently unclear how pharmacies will handle these prescriptions. It's possible they may not be aware of the clarification or may 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.
What Should You Do?
If you take an HCP regularly, my best suggestion would be to contact your doctor as soon as possible to find out how your prescriptions will be handled under the new regulations. Don't wait until you need a refill because if there are any delays, you may find yourself having to go several days without the medication you need.
Rescheduling these HCPs has been discussed for several years so I can't say I'm surprised it has finally happened. While I understand the reasoning - hydrocodone by itself has always been a Schedule II drug and adding another drug like acetaminophen doesn't lessen its addictive properties - I hate to see any changes that will make it more difficult for chronic pain patients to get the medication they need.
I'm concerned that moving HCPs to a more restrictive classification will make doctors even more reluctant than they already are to prescribe them. And of course, I'm also concerned about the added burden placed on people in pain by having to get a new prescription every month. I know some of you have to travel several hours to see a pain specialist. Having to make that trip every month - or even every three months if the doctor is willing to write three months worth of prescriptions - will be extremely difficult.
Do you take a hydrocodone combination medication? If so, how will these new restrictions affect you?
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"
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.