Expert: Schedule V Classification for Gabapentin Would Not End Patient Access for Legitimate Medical Reasons, Just Add More Controls

Pharmacy Times interviewed Michael Abrams, MPH, PhD, senior health researcher at Public Citizen’s Health Research Group, to discuss his petition to the DEA and FDA regarding the classification of gabapentin and the closely related drug, gabapentin enacarbil, as schedule V controlled substances.

Alana Hippensteele: Hi, I'm Alana Hippensteele with Pharmacy Times. Joining me is Michael Abrams, senior health researcher at Public Citizen Health Research Group, to discuss his petition to the DEA and FDA regarding the classification of gabapentin and the closely related drug gabapentin enacarbil as schedule V controlled substances.

Would classification as schedule V completely end patients’ access to gabapentin, or would those who need it for legitimate medical reasons still have access to it?

Michael Abrams: Yeah, so the answer is no—thank you for asking. We're not seeking a ban of gabapentin. Gabapentin, as I said, has some clear indications. They're useful for postherpetic neuralgia after shingles, even restless leg syndrome is 1 indication, certain types of other neuropathy, and, of course, its original intent was to control seizures.

So not only are we not seeking a ban on that, but we also aren’t seeking a ban on off label prescribing. That's the doctor’s call. We are, however, by virtue of this action, trying to discourage and ratchet back what we think part of the problem here is that there's too much off label without evidence—that's often a concern for many medications.

But we aren’t even seeking a ban on those things. People can certainly still get their medicines. Our aim, and the aim of this kind of action, and of good regulation from the DEA and the FDA, is to make sure that people can get the medicines they need and use them safely.

And again, just using the simple example of controlling the number of pills that you get when you get dispensed the gabapentin prescription, you may previously have been able to get 120 days’ supply. The DEA might, if they fulfill this as we hope, say now you can only get a 30-day supply before you need to get back to your doctor and connect with them again to see if you still need the medicine or if there any contraindications. You're getting dizzy when you're driving, you're having headaches, you're having seizures, whatever other sorts of things might be contraindicated for that medicine, you get more attention, vis a vis the kind of action that we're calling for.

Alana Hippensteele: Right. Upon schedule V classification, how would the legitimacy of medical reasons that would still be allowed for gabapentin under the schedule V classification be assessed, and would it change the process for prescribing in the pharmacy?

Michael Abrams: As I said, I think what we're likely to see with schedule V, and with this sort of medication and the risks that it poses is quantity limits, more documentation, of course—doctors often blanche at that, but they can do it—and you even see doctors getting more comfortable with prescription drug monitoring programs as the technology gets better, and they get more facile with that. So, we don't think that that's a big barrier, and it really shouldn't change prescribing too much, except that it should ratchet back the types of prescribing we think was cavalier, excessive, or maybe even was diversion from the point of the prescriber to where there was excessive use that sort of the doctor knew maybe was excessive but wasn't acting upon as they should have. So, shouldn't be a huge threat on schedule V to standard practice, and certainly not a threat to on-label indicated use.

Alana Hippensteele: Right. What are some other commonly known drugs that are classified as schedule V, and have there been improvements in the use of those drugs by the public following their classification?

Michael Abrams: Yeah, so this is another good question. So, just a couple examples, Robitussin, the codeine-containing cough medicine is on schedule V, as I said, pregabalin is on schedule V, Lomotil, the anti-diarrhea medicine, is on schedule V as well.

We don't go into in the petition on scheduling these what the results were that sort of interrupted time series analysis. Medical researchers do this and public health researchers do this stuff all the time. It certainly could be done.

I can tell you this much, that is quite germane to this. One of the papers we discovered late when we were drafting a petition which we included, actually did that kind of interrupted time series assessment with gabapentin specifically, and remember I told you that 7 states in the US have gabapentin scheduled already, so, very cleverly, this paper that just came out looked at 3 of those states before and after, and comparative to 10 states and they matched them in a clever way.

They looked at states that had similar rates of opioid misuse or opioid use overall. So comparable states otherwise, but 1 had this interruption where you had the scheduling of gabapentin, the other one didn't, and they see gabapentin rates going down markedly.

So that's a good thing. Okay, what's missing from that? You want to see deaths from gabapentin going down. That's a rare event, so that's hard to discern, more experimentation, more data needed, but it's a good indication. And because of what we know about gabapentin risks, the idea that you can introduce this sort of thing, this sort of control, and see it bend the curve a little bit is encouraging.

Moreover, I'll add 1 more thing that's kind of interesting about this particular study. They looked at several states, I think it was 9 that didn't schedule gabapentin, but put it on their prescription drug monitoring program database. They didn't see the declines that we're seeing when you schedule it. So that would suggest that monitoring may be not enough—you need to do more with more controls—the DEA would be expert at deploying for this kind of medication.

So, there is evidence with gabapentin specifically that these kinds of actions, from the state level at least, may have an impact.