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.