DEA: Hydrocodone Combinations Will Be a Schedule II

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whack a moleJust over one year ago, Dr. Kyle Donovan and I published How Changing Hydrocodone Scheduling Will Affect Pain Management in Practical Pain Management.  That article serves as a nice synopsis and review of the DEA regulation and how the regulations applied to hydrocodone combinations as of June 2013, last year, up until the new regulation is signed. The new rule will be enforced 45 days after the official DEA publication of this pre published document, Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II

The following is pasted directly from the DEA website

August 21, 2014
Contact: DEA Public Affairs
(202) 307-7977

DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

AUG 21 (WASHINGTON)–On Friday the U. S. Drug Enforcement Administration (DEA) will publish in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data.  The Federal Register has made the Final Rule available for preview on its website today at http://go.usa.gov/mc8d.

This Final Rule imposes the regulatory controls and sanctions applicable to Schedule II substances on those who handle or propose to handle HCPs.  It goes into effect in 45 days.

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.

“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA Administrator Michele Leonhart, “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”

When Congress passed the CSA in 1970, it placed HCPs in Schedule III even though it had placed hydrocodone itself in Schedule II.  The current analysis of HCPs by HHS and the DEA shows they have a high potential for abuse, and abuse may lead to severe psychological or physical dependence.  Adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish its abuse potential.  The many findings by the DEA and HHS and the data that support these findings are presented in detail in the Final Rule on the website.  Data and surveys from multiple federal and non-federal agencies show the extent of abuse of HCPs.  For example, Monitoring the Future surveys of 8th, 10th, and 12th graders from 2002 to 2011 found that twice as many high school seniors used Vicodin®, an HCP, nonmedically as used OxyContin®, a Schedule II substance, which is more tightly controlled.

In general, substances placed under the control of the CSA since it was passed by Congress in 1970 are scheduled or rescheduled by the DEA, as required by the CSA and its implementing regulations, found in Title 21 of the Code of Federal Regulations.  Scheduling or rescheduling of a substance can be initiated by the DEA, by the HHS Assistant Secretary of Health, or on the petition of any interested party.  (Detailed information on the scheduling and rescheduling process can be found beginning on page 8 of Drugs of Abuse on the DEA’s website at http://www.justice.gov/dea/pr/multimedia-library/publications/drug_of_abuse.pdf.)

The rescheduling of HCPs was initiated by a petition from a physician in 1999.  The DEA submitted a request to HHS for a scientific and medical evaluation of HCPs and a scheduling recommendation.  In 2013, the U. S. Food and Drug Administration held a public Advisory Committee meeting on the matter, and the committee voted to recommend rescheduling HCPs from Schedule III to Schedule II by a vote of 19 to 10.  Consistent with the outcome of that vote, in December of 2013 HHS sent such a recommendation to the DEA.  Two months later, on February 27, the DEA informed Americans of its intent to move HCPs from Schedule III to Schedule II by publishing a Notice of Proposed Rulemaking in the Federal Register, outlining its rationale and the proposed changes in detail and soliciting public comments on the proposal, of which almost 600 were received. A small majority of the commenters supported the proposed change.

As always, we encourage comments!

26 thoughts on “DEA: Hydrocodone Combinations Will Be a Schedule II

  1. discussed above, scheduling or rescheduling a drug does not hinder legitimate access to needed medication. For the reasons discussed earlier in this document, the DEA does not believe that there will be significant impacts, if any, on ultimate users associated with this rulemaking.

  2. A very troubling issue is the use of methadone for pain relief as a part of state Medicaid ” schedules” .The cost of methadone compared to hydrocodone, oxycodone and others is minimal. When this is coupled with dosage/ half life ,etc. Then deaths go up. I was on methadone 100 mg/ day and one day began to wean . No benzos, no Suboxone, nothing. 100mg reduced in one week to 60 mg, two weeks to 30 mg then……..well , it was’nt fun. Cold from 30mg was interesting, after a total of 60 days my receptors were prob reset and life while painful at times is better than wearing ” opiate goggles” which soften all of our realities. I do not recommend this to anyone else. Just did it. Federal bureaucrats including lawmen do not need to be practicing medicine. If a physician chooses a drug based on “medicine by committee” then we are all undone. Thank you

  3. Ok, we have gone through the whole conversation with the doctor about the change in rules for the hydrocodone prescriptions. I’m okay with that. My problem is the urine testing. Now, she has informed us that before she will write a prescription for Hydrocodone, there has to be a urine test. Is this a law, or is it just the doctor’s new rule?

    1. It is not a law. It is the doctor’s policy. In many cases this is considered standard of care, depending on the frequency. Consider for example that diabetic medications would not be ordered without a glucose level and warfarin would not be ordered without an INR.

        1. Sorry not wearing my glasses. Tying to say not a good comparison. Because you don’t treat pain by the level of something through a urine test. You just have to believe a person hurts. No such lab test to evaluate pain..

          1. They’Re testing for two things. Make sure you have the prescribed drug in your system (not selling them) and checking for any illegal drugs (pot, heroin).

  4. I just happened upon this blog. I’m in Alabama. I’m 43 and have severe spinal issues and no insurance. I am in the gap, too much income for state help with medical yet not enough to even see the health plans offered on the healthcare website (I’m exempt. Our income dropped due to my becoming unable to work in 2011). I am in a pickle so to speak. I’ve been on norco’s for the past 6 years and awaiting a decision in my favor for ssdi and the medical care it will allow me for the past 3. My doctor was sanctioned almost 2 years ago because he had a couple of patients on stronger medications not take theirs as prescribed and they Od’d. It didn’t kill them but they Od’d nonetheless. He cannot write schedule 2’s. I’ve fought hard to stay on the lowest pain medication possible so his sanction hasn’t affected me until now.

    Without my medication I can’t walk. I am prescribed a wheelchair but I don’t want to lose my ability to walk or care for myself. I have a spinal birth defect of the tailbone that is excruciating. Without my medication I can’t walk at all. I have an appt. tomorrow to hear the final verdict. I’ve already heard from a friend who is in a chronic pain group that our only option given was either Tylenol 4 or Suboxen (sp?). I can’t find another doctor to take me because I am on this medication and must cash pay. Even if I could the required monthly visits would sink us financially. You would not believe how much my medical costs us monthly now with my prescriptions and the only saving grace was that I only had to see my doctor every three months excluding random drug tests or pill counts.

    I need this medication. I need to somewhat function for my family. I never sold my medications. I always took them as prescribed, good day or bad. I NEVER once took more than prescribed because as a person in chronic pain I know that the help they give, good day or bad is better than not having the help they do give. A bad day may the next day look like a good day depending on the pain levels.

    I found this blog looking to see how Tylenol 4 compares to Norco 10’s and to see if they can even try to prescribe the Tylenol 4 in amounts that would equal my 20mg 4X a day doses of the Norco. Does anyone know if I even have any hope of this helping? Without the meds I am in bed and unable to walk at all. I went off them to gauge my true levels of pain 4 years ago and almost put a bullet in my brain. I”m not trying to be dramatic. It wasn’t the withdrawals, I got past those. It was the excruciating pain. When you have pain of the level I have with no relief you stop thinking rationally. I do not want to go there again.

    I apologize profusely if I am asking this in the wrong forum. I just need answers and I need some hope. This is my life I’m dealing with.

    1. I was just released from my pain management clinic after ONE wonky urine test. Tests, I might add that have a 50% failure rate! After YEARs of being on Fentanyl one bad test (all others were fine) they booted me out of the practice. Right, like I would really decide to start selling them after years of use! I am getting through the withdrawal but the pain is indescribable. I also suffer from severe depression. I fear this will be the end of me.

  5. So, let me get this right.

    On one hand, there’s a tidal wave of support for making an addictive SCHEDULE ONE drug, marijuana, legal for even recreational use.

    While on the other hand, we are expected to wave a banner, because our most commonly prescribed SCHEDULE THREE pain drug will now be significantly more restricted for even legitimate therapeutic use?

    I’m afraid that the only people who will suffer will be suffering people. And don’t think that doesn’t include everyone of us, at any moment, for any length of time.

    If we as a people would devote to medication education even one-tenth of the resources we spend on the war on drugs, our society would not be stuck in this oxymoronic predicament.

    Laws are often an answer but often not THE answer.

    …By the way, heroin futures just went through the roof.

    ~ James Patrick Murphy, MD

    http://jamespmurphymd.com/2014/08/06/basic-pain-care-certification

    1. Oh. Dr Murphy how right you are. I read a comment on another blog today where a pain patient said, “What’s the big deal, just go to the pain doctor.”

      I said this will be a very rude awakening for some patients who’ve never dealt with the stringent rules of schedule ll medications. No refills on the paper, no mistakes on the paper, no call-ins. It will be cuture shock when these patients no longer get these from their PCP.

      And then when the UDS inevitably comes up. I agree with, you, this has only caused a BIG PAIN for patients. Patients who can’t likely afford monthly visits, drug screenings.

      Where do we buy the heroin futures?

      Kim Miller
      Opposition to HB 1-Reform HB 217 aka “Pill Mill Bill”

    2. By the way Dr. Murphy,
      Marijuana is NOT addictive! However, the feeling of RELIEF is, whether its from pain, stress, not sleeping, etc… Unfortunately feeling RELIEF from life’s bull–t is illegal. Need to get it right!

      1. Michele, you are incorrect. Any drug that activates cannabinoid-1 (CB-1) receptors enhances dopamine. Dopamine at the very least is scientifically known to influence reward behavior leading to addiction.

  6. Dr Fudin,

    Thanks so much for your response to my comment. Having had many experiences where pharmacists chose to leave the patient with no medication due to a clerical error on a Schedule ll written prescription, even the amount of acetaminophen (RX said 500, not 325, as per new law) being the only error, I can’t help but wonder why an error such as this, would not not be fixed to allow the patient to receive the scheduled medication when the change is so minor and actually has very little to do with the controlled substance itself.

    This is one of many examples I could provide, but I cannot imagine a scenario where a pharmacist
    would write an “emergency prescription” for a patient these days knowing the DEA is waiting to pounce on their every move.

    See link to;
    Opposition to Kentucky HB 1-Reform HB 217 aka “Pill Mill Bill”
    http://www.facebook.com/pages/Opposition-to-Kentucky-HB-1-Reform-HB-217-aka-Pill-Mill-Bill/595049517218134

    1. True enough Kimberley. That is difficult to dispute. Pharmacists must of course follow the law but they do have significant discretion in certain circumstances. In other cases there is no wiggle room.

  7. I find the things that John Coleman said interesting, but I have had prescriptions that a pharmacist will not partially fill, will not alter, under any circumstances, even if the little box isn’t checked, but everything else is handwritten in duplicate, the number with the amount written next to it and still, nobody will check that box for fear of death from the DEA or whoever.

    This makes it hard to believe that pharmacists are aware of their rights they apply to schedule ll to medications, they do not want to fool with it, or , most likely, they are afraid of any repercussions should they do their best to help a patient with an error on a prescription even if there’s no error and it’s Friday and they know the patient is out of their medications, there is nothing worth the risk, these days to make a pharmacist put there license on the line if they are facing the slightest bit of trepidation

    See link to
    Opposition to Kentucky HB 1-Reform HB 217 aka “Pill Mill Bill”
    http://www.facebook.com/pages/Opposition-to-Kentucky-HB-1-Reform-HB-217-aka-Pill-Mill-Bill/595049517218134

    1. Kimberly, John Coleman was exactly right on his comments. I can tell you in no uncertain terms that all pharmacists are cutely aware of the law with regard to controlled substances as they must deal with these issues daily. A pharmacist may choose not to fill a controlled substance in an “emergency” situation, but that is very different than knowing what is allowable by law.

  8. I think rescheduling hydrocodone is a bad idea. Now dentists and doctors have nothing to call in for emergencies. This change will do nothing to deter addicts, as they aren’t deterred by anything. It is legitimate patients who will suffer, as always. Same old song and dance!

    1. In the case of an emergency situation, federal law permits a pharmacist to dispense a C-II controlled substance upon receiving oral authorization of a prescribing individual practitioner provided that the quantity prescribed is limited to the amount adequate to treat the patient during the emergency. The prescription must be immediately reduced to writing by the pharmacist and must contain all the required information for a prescription except, of course, for the prescriber’s signature. If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable effort to verify the identity and registration of the prescriber. Within seven days after authorizing an emergency oral prescription, the prescriber “shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist.” The prescription must have written on its face, “Authorization for Emergency Dispensing” and the date of the oral order. The pharmacist must attach this signed prescription to the one completed by the pharmacist. Failure on the part of the prescribing authority to deliver to the dispensing pharmacist the follow-up written and signed prescription must be reported to the nearest DEA office by the dispensing pharmacist. Failure to make such a report when required “shall void the authority” for the pharmacist to dispense C-II drugs without a written prescription (i.e., for emergencies). Ref: 21 CFR 1306.11(d).

  9. The FDA did all it could to protect the industry on this one but in the end it had to adopt the Kenny Rogers philosophy. In 1999, Ronald J. Dougherty, M.D., FAAP, ASAM, an addiction medicine specialist in Syracuse, NY and director of a drug treatment center, petitioned DEA to reschedule all hydrocodone products to C-II. DEA sat on the petition for five years before sending it to FDA (DHHS) for a recommendation and medical/scientific assessment, as the law requires. Four years later, FDA denied the DEA request. In 2009, DEA renewed its request and submitted additional data to support it. The second time around, FDA (DHHS) did nothing.

    In 2012, Senator Joe Manchin of WV attached an amendment to a bill that would legislatively reschedule all hydrocodone products to C-II. When the bill arrived at the House, the Manchin amendment was struck and replaced with a requirement for FDA to convene an advisory committee meeting to review the matter. Congressional records show that the Generic Pharmaceutical Association (GPhA), a lobbying organization, spent more than a half million dollars in lobbying expenses for the second half of 2012 and that part of this sum was to defeat the Manchin amendment to reschedule hydrocodone products.

    In January 2013, FDA held the now-required advisory committee meeting and gave each member a 362-page briefing book whose detailed contents strongly recommending that hydrocodone be left alone and not rescheduled (or “upscheduled,” as the FDA referred to it). In the meeting’s agenda, the GPhA was given a generous amount of prime time on the first day of the two-day hearing to present its case for keeping hydrocodone combination products in C-III. Remarkably, DEA, whose request on behalf of Dr. Dougherty’s petition, had occasioned all this, was not invited to brief the panel!

    FDA Commissioner Margaret A. Hamburg, M.D. was informed of this and, much to her credit, the decision to exclude DEA was reversed. At the last moment, the agenda was revised and re-issued to show that DEA was also invited to brief the advisory committee. When the vote was taken, the members rejected the FDA’s position by a vote of 19 to 10 and recommended, instead, to reschedule all hydrocodone products from C-III to C-II. Incidentally, Jeff, three of four pharmacists on the panel voted with the majority.

    While the FDA is not obliged to follow the recommendations of its own advisory committees, in this instance it probably was wise to do so. The tide had clearly turned since 1999 and if the decision to “upschedule” was not made administratively, the threat of renewed legislation was looming large. I talked with Dr. Dougherty about this over the years and he was always eager to keep his idea alive. He retired years ago and the last I heard of him he was in a nursing home somewhere in Florida. That was a couple of years ago when I called to tell him about the FDA committee’s vote. Despite taking some 15 years and a lot of bungling by a lot of bungling bureaucrats, it’s still nice to know – whether one agrees or disagrees with the outcome here – that a single concerned person – in this case, Dr. Dougherty – can still manage to get the wheels of government to turn now and then – slowly, yes indeed, very slowly and subject to all sorts of politics and lobbying – but turn they do and, surprisingly, sometimes in the right direction!

  10. Let us not forget to re-schedule Tylenol #3 and #4. And benzos have a certain number of addicts so make all benzos schedule 2. And women have been known to get “addicted” to lasix to keep weight down – a practice endorsed by many “healers.” Have we no professionalism left, that we need the government to rake in the pill pushers? We need a new level of professionalism if we are to rid medicine of these “candy men” and their prescribing patterns. Or, make all prescriptions schedule 2 with DEA oversight of each rx.

    1. My comment is “awaiting moderation.” Not sure what that means: the point is, codeine sulfate is schedule 2. T #3 and T #4 should also be rescheduled if we follow DEA logic. The problem is not the DEA but poorly trained over-prescribers who will simply write or e-fax schedule 2 drugs with little change in prescribing behavior.

      1. David, Thank you for both of your comments. I actually do agree with you in theory – in fact, I stuck my neck out in a March 2013 blog post entitled “Will Codeine be the New Hydrocodone in New York State?” and basically said just that. And, two months earlier I posted “Effect of Rescheduling Hydrocodone is Unknown“. As you know, New York State did reschedule hydrocodone to a C-II beginning February 23, 2013. Attached are three slides I presented at the 2013 ASHP Midyear Clinical Meeting based on preliminary data. You and I were both wrong, at least as far as NYS is concerned. What actually happened as you can see from the slides is that oxycodone RX’s went up proportionally to hydrocodone RX’s coming down. As one of our pharmacy colleagues (Andy Romand, practicing in a community setting in Las Vegas) pointed out in a comment here, a potential problem is if a prescriber simply writes for Percocet 5/325 instead of Lortab 5/325 thinking they are equipotent when we know that oxycodone is 33% more potent than hydrocodone. The slides also show, inconsistent with our predictions, that codeine RX’s did not increase. There is a small blip in C-VI codeine RX’s, but that was during flu season and is consistent with previous years for codeine cough syrups. So, I do believe there are inherent dangers, and I do believe that all opioids should be tracked equally, but you and I, and many others were wrong in our prediction that codeine RX’s would increase. Nevertheless, it is all very interesting!

  11. Gold jacket, green jacket, who gives a shit?

    As long as prescribers are using the proper equivalence- Norco and Percocet are the same thing. I think the only concern would be docs that incorrectly start opioid naive patients at Norco/Lortab 10 and start at Percocet 10 now (Yeah- that happens) The better measure in years to come will be plain oxycodone rx’s 15 and higher. Just be glad your docs don’t write chronic soma…

    1. Andy:

      Been around this business all of my life (mom/dad/brother/me – 155+ years total practice experience), and I don’t think any of us ever expected to see the avalanche of opioids that came down the pike. I work to reduce opioid usage to a minimum as the stated goal of a task force, and so far we are succeeding. The goal is to stop acute pain from becoming chronic pain.

      No matter how hard we try, we always have that one prescriber who seems to love the potent opioids and believes there is no diversion problem. Try telling that to me as a former Director talking to a DEA investigator examining 500 missing Dilaudid, or to my mom’s “patient” who tried to get 200 Demerol 50 mg tablets while bandaged up like Boris Karloff playing the mummy and having a miraculous cure and running out of the store at breakneck speed when the police officer showed up to have coffee at the soda fountain (again–dating myself).

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