Closing the Vicodin Schedule III Gateway

Today I heard that the FDA approved moving hydrocodone products (e.g. Vicodin, Norco, Lortab) to ‘schedule II’ status.  The final decision has to go through the DEA, and they are expected to support the change.

The change has been argued back and forth for years, with a push more recently from PROP, Physicians for Responsible Opioid Prescribing.  The FDA has been taking comments from the public through an internet portal for a number of months, and appears to have given the decision considerable thought.   I’ll weigh in, not because I think the FDA will hold an emergency meeting over my comments, but rather because I  think that people on both sides of the issue should at least understand each others’ arguments.  Too often, discussions over this type of issue– i.e. issues that don’t have a clear answer–degenerate into sound-bite comments accusing the opposite side of cruelty or stupidity.  One reason I find opioids so ‘blog-worthy’ is because there are so many issues that deserve thoughtful discussion, that have no correct or incorrect position.

Proponents of the schedule change point out that hydrocodone is a gateway drug if there ever was one.  Most of the people I treat for opioid dependence first discovered their love for opioids after taking Vicodin or Norco prescribed for surgery or minor injury, or shared by a coworker.  Hydrocodone is only available in combination medications, i.e. packaged with acetaminophen, aspirin, or antihistamines, although I seem to remember a new product announcement a while back that consisted of hydrocodone alone (correct me if I’m wrong).  The theory, I suppose, is that the additional agent provides some counter-incentive to abuse hydrocodone.  I doubt though that someone needing 30 Vicodin tablets to avoid withdrawal is deterred by the risk of liver toxicity from acetaminophen!

Schedule II medications are regulated more closely than schedule III, where hydrocodone is currently classified.  Schedule II meds include oxycodone and other potent opioids like oxymorphone (Opana), hydromorphone (Dilaudid), and fentanyl.  Most CNS stimulants are also classified as schedule II.  Prescriptions for medications in that schedule cannot be phoned or faxed to pharmacies (although emergency 5-day supplies can be called in, providing a written script is provided within a few days). Doctors can prescribe only 90 days of medication at one time, and have to do so by writing three, 30-day prescriptions, each with identical amounts of medication.  The prescriptions expire after 60 days, making it difficult for patients to fill the third script in the series, since the third script expires on the date that it can be filled.   The policy creates a conflict that makes calls about expired schedule II scripts some of the most common exchanges between patients and doctors’ offices.

Schedule II medications have other restrictions;  they are counted more often in pharmacies and hospitals for example, and criminal penalties for their abuse are steeper than for lower-scheduled medications.

From a neurochemical standpoint, the separation of hydrocodone from other opioids makes little sense.  The effects of opioids are dose-related, and so a large dose of hydrocodone has the exact same effects as a somewhat lower dose of oxycodone.   The dangers of addiction, overdose, and impairment are as significant with hydrocodone as with other opioids.

One of the main arguments for maintaining hydrocodone as schedule III also serves as the basis for arguments to change hydrocodone to schedule II, and relates to access to pain medications.  Right now, hydrocodone products can be ordered by on-call doctors who are unable to physically meet with the patient.  If a dentist extracts wisdom teeth and the patient, two days later, develops ‘dry sockets’, the dentist can call in a few Vicodin to hold the patient over until the next day.  On the other hand, schedule III status allows a physician to call in hydrocodone for patients with abdominal pain or headaches who perhaps should be evaluated more thoroughly before being told to ‘call me in the morning.’    The ability to call in orders for hydrocodone is the reason that Vicodin-based products are among the most-prescribed medications each year.

The argument over the change in schedule comes down, in my opinion, to one discussion:  Should doctors and patients have available an opioid pain medication that can be ordered by telephone.  The need for written prescriptions can be a significant hurdle for rural patients who drive hours to see their doctor.  And while schedule II opioids have a provision for emergency prescribing, many doctors are either not aware of the provision or choose not to exercise the emergency option when contacted after hours– causing significant delay before patients in pain have access to opioids.  The counter argument is that anyone who develops pain after hours that is severe enough to warrant treatment with opioid medications should be seen and evaluated before medications are given to mask the symptoms of a potentially-serious condition.

The attention to diversion of potent opioids over the past few years has had a dramatic effect on physician attitudes about the routine prescribing of opioids.  Many doctors now refuse to prescribe opioids altogether, or provide amounts intended to last for 24-48 hours, rather than the 30-day supplies that used to be given out fairly routinely for patients with painful conditions.  I expect the change in schedule of hydrocodone to have a similar impact on the use of opioids.

But as readers know, my favorite topics relate to unforeseen consequences;  the things that ALWAYS occur that nobody saw coming.  The change in formulation of Oxycontin had the desired effect of reducing nasal insufflation of oxycodone, but likely fueled the increase in heroin use over the past few years— which increased the use of needles.  Was reducing the snorting of oxycodone worth the increase in IV drug abuse?

I’ll try to remember to do a ‘look-back’ in a year or so, to see whether they got it right this time.

5 thoughts on “Closing the Vicodin Schedule III Gateway”

  1. Has anyone actually been successful getting a pharmacy to fill a five day emergency prescription, especially for a patient to run out or forgot to take their script with them when they went out of town and are tying to use a new pharmacy? I sure haven’t.

  2. This is certainly a topic I’m very interested in and concerned about for all sorts of reasons that go far beyond my own convenience or well being despite the fact that I’m no altruist… I’m really interested in hearing your opinions on my point of view on this Dr. Junig as I tend to think so much like you, not to mention the way in which I write. I have great respect for your openness and honesty as a medical professional who had an addiction. There’s no telling how many others there are because of the weight of the social stigma attached to the disorder these days…

    Anyways, on to the topic: Overall, to save others the pain of finding my opinion by having to read all of this post, I think it will be a mistake to reschedule hydrocodone from III to II.

    I certainly understand your idea that it really is no different than any of the other opioids given that if you take enough, you can achieve the same effect. Of course, the same could be said about codeine (aside from the ceiling created by it’s necessity for demethylation to morphine by CYP2D6), or even diphenoxylate for that matter which doesn’t carry the same histamine risks or ceiling effect as codeine, in which the atropine in the Lomotil preparation can easily be separated from it by the simplest of methods for any basic addict with some slight education. Anyways, despite the fact that the aforementioned two opioids share the same “take more and receive more” property you mentioned to characterize hydrocodone as being like the other opioids, they are Schedule V currently (aside from standalone preparations which I believe the DEA classify as Schedule 2 compounds) so would you recommend they be rescheduled also?

    Yes, taking more hydrocodone than usually prescribed can eventually achieve effects similar to those created by the other more potent opioids in Schedule II, however, the Schedules are about regulation due to relative safety of the compounds, and when it comes to opioids, I know that even you recognize them to be very safe drugs overall, save ONE key property: respiratory depression. And even that is a danger that is dramatized and rarely taken into thorough consideration, such as the consideration of how much it really does require to overdose as an opioid naive user, as well as the counteracting effect tolerance has against respiratory depression. As most of us know, most overdoses of opioids are caused by the acclimation of a higher dose of opioids due to tolerance, then the rapid loss of tolerance after and during later withdrawal, and finally the return or relapse to opioids without consideration for the diminished amount of tolerance, therefore returning to the dose they last used before losing their tolerance to that dose (this, and the combination with GABAergic agents such as benzodiazepines, barbiturates and alcohol).

    All of that being said, I do recognize and certainly agree that “good ole’ hydro” is the introductory gateway to the realm of opioids, and my guess would be that this is so because the drug is JUST weak enough to prevent nausea and vomiting when taking intial doses (which would deter most people from wanting to take the drug ever again), but JUST strong enough to give you that trademark opioid buzz and warmth, but when it comes to safety, which is what the Schedules would likely claim to be all about, I believe the key property to focus on would be the potency of respiratory depressant effects of a compound. With that in mind, hydrocodone is undoubtedly a much weaker opioid in and of itself at prescribed doses than are its relatives in CII and equally so, respiratory depression is less of a concern with hydrocodone than others. So, therefore, by taking the ONE effective/reliable opioid indicated for pain that is in a class of less regulation (therefore more commonly prescribed) and less potency (less respiratory depression) out of that class and into the final and most regulated class with ALL of the others, including oxymorphone and fentanyl, then there is NOTHING (classification nor consequence) to distinguish physicians from prescribing more respiratory depressant opioids for pain where a lesser one might be better indicated (for example, a new pain patient with zero opioid tolerance). Diversion unfortunately will always be an uncontrollable issue so as a result of the previous possibility, that also likely puts more respiratory depressing agents on the street instead of the less depressant hydrocodone that so many people take interest in, and I strongly believe (though I realize my points of view are by no means Gospel, not that I’m religious) the action of rescheduling the one and only weaker opioid drug we have in modern useful medicine for pain (for those of you who would argue tramadol, come on… Weaker than codeine and causes serotonin syndrome over 400mg a day??) into the final, most regulated class will only result in MORE overdose-related deaths per year, which is the EXACT opposite effect the FDA claims to want to obtain.

    This doesn’t even cover the issue of patient and physician inconvenience, which will undoubtedly cause an uproar amongst those treated and treating with hydrocodone. Truthfully, if you look at all of the drugs thrown together in the same class of Schedule II, you can’t help but wonder if there should be another class (or perhaps multiple classes) in between everything in Schedule 2 and Schedule I which is illegal and has no accepted medical use. What’s in Schedule 2? You have morphine, then oxycodone (2.5 times the potency of morphine) okay, that’s fine…. But then you have fentanyl (EIGHTY times the potency of morphine!) and sufentanil (Damn near 8,000 times the potency of morphine!!) and all in the same class, nothing to distinguish them from hydrocodone to a newly prescribing physician! And we want to throw hydrocodone into that very same classification?? Hmm… Well I can certainly see both sides of the story but I get stuck at this point and have to stand my ground here. If the FDA and DEA are really concerned about abuse liability, then alcohol and nicotine would be near the top of the list with everything else. I’ve heard MANY heroin users gone clean say they could quit heroin 5 times over before quitting their cigarettes. Yet these two, clearly harmful substances as well with little therapeutic value, are available at regulations requiring only an age reaching to the youngest of our population to buy as much as you want whenever you want…

    This stance isn’t even out of spite as an angry, illicit user of hydrocodone or a legally prescribed, inconvenienced patient of it. I was actually prescribed it for a few years but I requested to be treated with low dose buprenorphine instead because I favored the unique pharmacological profile of the drug and was needing more and more hydrocodone to do the trick (relieve the pain; not scratch the opioid itch). Fortunately this hasn’t been so with my 2mg, divided into two doses daily Subutex.

    I just wanted to share my opinion on the matter as another reader of your blog and enthusiast of the organic chemistry/pharmacology realm (that isn’t a euphemism for drug addict, either, though I’m sure you’ve heard it as such before haha).

    Anyways, thanks for everything you do for this blog and this society. I’d love to hear more of your remarks sometime…

    Oh, and by the way, the standalone hydrocodone preparation you were referring to I believe was Zogenix Pharmaceutical’s ZoHydro. I was absolutely on board with it when they first announced it’s development but then the FDA shut it down because they feared it becoming a “HydroContin” so to speak, though I think one is desperately needed; I was on hydrocodone at the time and would have done anything to lower the completely unnecessary acetaminophen intake then (which I did in fact with some cold water and cheesecloth! I won’t give a tutorial here though…)

    That’s all!

    -Taylor Harris

  3. Thanks Taylor! I’ve gone back and forth on the issue so many times that I can’t even remember how I felt when I wrote the post! It will be difficult getting pain relief to people without seeing them in person. R
    That is good… And bad. Well-known patients with a flare-up of a known condition will no longer get meds with just a phone call. Maybe docs will give them MORE HC now than before, since they can’t call it in…. No easy answers. But thanks for your comments!

  4. Realize that your doc is the person who does it– not you. I couldn’t tell if you knew that— But yes, I am usually able to have 5-day amounts of schedule II meds provided by pharmacists for my patients. The situation rarely comes up, but when it has come up, they have done it. By law, the pharmacist must receive a written script for the meds within a few days; not sure what they do if that doesn’t happen.

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