Commentary: FDA Made Right Decision to Reschedule Hydrocodone

Last June, I testified before a Reference Committee at the annual meeting of the American Medical Association, explaining a resolution that American Society of Addiction Medicine had brought forward to encourage the Food and Drug Administration (FDA) to reschedule hydrocodone combination products from Schedule III to Schedule II. I expected there to be few others testifying. I wasn’t at all ready for the long line of individuals standing at the “con” microphone, ready to speak against the resolution.

There are some significant differences between Schedule II and Schedule III, but those of greatest import are the ones which impact prescribing practices. A physician can prescribe a Schedule III medication by making a phone call to the pharmacy or by calling in an order to, say, a nursing home. A physician can include refills on prescriptions or orders for Schedule III medications. These attributes are not present for Schedule II medications, so patients must be seen monthly and phone orders are not acceptable.

All full-agonist narcotics are similar to one another in terms of their potential risks and benefits. Hydrocodone is a narcotic which, when prescribed by itself, is in Schedule II. It is also manufactured as a combination product with a pain reliever, such as in brand Vicodin, in which hydrocodone is combined with acetaminophen. When in such a combination mixture, the drug has been in Schedule III. This has given the impression that hydrocodone combination products must be safer than other narcotic formulations since such products, along with low doses of certain infrequently prescribed drugs, are the only narcotic formulations on Schedule III.

Of course, the combination drugs have greater risk than the monoproduct. As patients become tolerant to the effects of the narcotic, their dose is often increased to such an extent that the toxicity of the secondary content becomes critically important. This is of particular concern in the nursing homes where use of such medication was widely implemented, as elderly patients often receive a medley of pharmaceuticals with potentially additive toxicities to consider, and where metabolic activity may be poor to start with.

The FDA ultimately agreed that there was little sense to having a drug with greater potential risk in Schedule III than the many drugs with lesser potential risks in Schedule II, announcing late last month their recommendation to reschedule the class. But what of all those physicians who were in line at the “con” microphone, who spoke against the change in classification?

I agree that there are some patients in whom long-term therapy with a hydrocodone combination product has value. Seeing such a patient monthly may represent a hardship in these cases, particularly for the individual with limited mobility. By and large, however, I believe there are many more patients who have been prescribed long-term hydrocodone combination products in error, particularly given the contribution these medications have had to the opioid prescribing epidemic over this past decade. The reclassification, by forcing physicians to consider the need for continued prescribing of the medication each month, will hopefully lead to a taper and discontinuation in such cases. This should lessen what seems to be an ever-increasing population of patients for those in the addiction treatment field.

Stuart Gitlow MD MPH MBA is a member of the American Medical Association’s Council on Science & Public Health, and President of the American Society of Addiction Medicine. This Op-Ed represents his personal opinion and does not imply any position or policy taken by either the AMA or ASAM.

9 Responses to Commentary: FDA Made Right Decision to Reschedule Hydrocodone

  1. Linda | December 3, 2013 at 11:32 am

    I disagree with the decision. The hardship this creates for the immobile, frail, and their families is beyond prudent. Once again, this drug crazy society has taken things too far. I’d like to hear the opinions of those who are pro this decision when they are in a situation with loved ones
    where this makes no common sense at all. If unethical doctors are contributing to the drug epidemic, keep the consequence there, and not with those who are not the problem in the first place.

  2. Robin Beckwith | December 3, 2013 at 9:20 pm

    I, too, believe this decision to reclassify hydrocodone was a mistake and a disservice to those who depend on medications of this type. Incidentally, I am not one of those people, but I know enough nursing home residents, for instance, who require a single, nightly dose(and/or prn/daily)of a hydro-based medication – the one thing that alleviates their chronic pain symptoms while facilitating sleep.

    In several more – or less – years be prepared to see a reversal of this illogical (IMO) scheduling modification wherein hydrocodone assumes its former classification – Schedule III.

  3. Karen Hanneman | December 5, 2013 at 10:34 am

    My son died at age 21; battling heroin addiction that began with prescription pills. Grandma would NEVER harm her grandchildren, yet that is EXACTLY what happens, when these highly addictive and deadly drugs are not SAFEGUARDED properly. In fact Grandma could be an addict too. Isabelle says, “My grandma had back surgery…anything you could think of, she had”. She and her little brother helped themselves; and later moved on to heroin.
    The public needs to know that fatal drug is killing some 40,000 people each year…and that does not include those who are addicted and struggling. LEARN MORE before you feel “inconvenienced” by a monthly doctor appointment. A montly visit to the doctor; beats a monthly visit to the cemetary.

    • Karen Hanneman | December 5, 2013 at 10:36 am

      “Fatal drug OVERDOSE is killing some 40,000 people in our county, each year…”

    • MichaelB | January 7, 2014 at 5:01 am

      Karen. While I am truly, sincerely sorry for what happened to your son, some people are prone to such activities while most are not. Some murderers start out playing with knives from the kitchen and move on to guns; this doesn’t mean we need to outlaw cutlery. And for a lot of people, it’s not a case of something you can trivialize with quotations like “inconvenience,” it’s a financial impossibility. I for one would never be able to afford the $80 per office visit to my Dr. every month to authorize a $4 refill.

  4. Billy Heckle RPh, CACII | December 6, 2013 at 1:25 pm

    The decision to place hydrocodone in schedule II will end up causing more problems than helping anything. There is no evidence that re-scheduling a drug will do anything to reduce drug abuse. Doctors now have little reason to prescribe a hydrocodone combo product when they can prescribe oxycodone alone. The most harmful part of this is the added suffering of the chronic pain patient and those who are recovering from surgery/trauma. Having to arrange a ride to go pick up a prescription is painful and no easy thing for those suffering from pain. This is what happens when people do not look at the whole picture. Those who suffer daily horrible pain and the elderly are being dismissed as collateral damage. The folks who pushed this through should be ashamed. When the suffering of pain happens to you or a loved one, you may see more clearly how cruel this decision is.

  5. Brad Martin | December 7, 2013 at 5:44 am

    At the end of the day, doctors/PAs/NPs often do what is convenient not was is right. That is why we need to change this system to make the right decision easier. Perhaps, making Oxycodone a schedule III drug and Vicodin a schedule II drug would have been a better decision. The fact that Vicodin was schedule II, just bespeaks to how broken our laws are regarding drugs – clearly some bribing was done to make that happen.
    Why should people feel ashamed for doing something they feel is necessary to protect children. Drugs like vicodin are killing our kids more than cars crashes.

  6. Andrew Lomac | March 2, 2014 at 2:38 pm

    What is pathetically typical in this decision is the reluctance of the panel to make recommendations for changing how these medications are dispensed for chronic pain sufferers. Simply making hydrocodone a schedule II drug will not prevent abuses of any other psychotropics. Working on the bigger problem of how to accommodate severe long-term pain sufferers, not just someone with a sprained ankle, is what they sidestepped.

  7. matt | April 7, 2014 at 10:58 am

    Hi my name is matt,and yes this is getting messed up for people like us the ones that don’t abuse need to live on this stuff just to get out of the bed,I am disabled and have been for years now and my doc says 90% of back surgery are failed,,see I live 100 miles away from doc and do all the procedures and comply 100% and do everting recommended and have meen for years,,and now to have to deal with this,,like we don’t have enough to deal with,its just so upsetting it seeks to me they. Are more worryed about the one who abuse this medication rather then the one who most have it to maintain what very little life we can salvage,its just a shame..PS the drug addicts will not have a hard time at all getting what they want one way or another :( sad now……matt

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