Taming the Beast—Gabapentin. Ban It or Regulate It?

In my last post, I began with a question from Christy.  Her facility was considering banning gabapentin from their facility due to rampant abuse and diversion problems.  My last post dealt with gabapentin’s interesting history and the evidence base for off-label gabapentin prescribing.  This JailMedicine post will deal with the pros and cons of banning gabapentin versus creating rules to regulate gabapentin use and hopefully minimize diversion and abuse.gabapentin

The main points from the last post were:

  1. Gabapentin is FDA approved for seizures and post herpetic neuralgia.
  2. However, most of the demand for gabapentin and prescriptions for gabapentin are for “off-label” uses, namely for chronic neuropathic pain.  Evidence for gabapentin use for other types of chronic pain is not so good.
  3. Despite the poor evidence base, gabapentin is very widely prescribed for all types of chronic pain.  It is also used as a sleeping aid, restless leg syndrome, anxiety and all sorts of other stuff.
  4. Gabapentin has a euphoric and dissociative effect and so is very sought after as a drug of abuse in jails and prisons.
  5. Gabapentin is not DEA regulated and most non-correctional physicians have no clue that it can be—and is—abused.

We correctional physicians need to put this all together in order to make a rational and effective policy regarding gabapentin use in our facilities.  Basically, we must balance the potential benefits of gabapentin against the potential harm to the patient and the potential harm to the institution when it is diverted and misused.

Our basic options are:

  1. Ban gabapentin outright.
  2. Restrict its use by defining exactly what use is acceptable and what we will not allow.
  3. Allow unrestricted use as a formulary medication—although I doubt that any correctional facility that has had experienced a gabapentin “feeding frenzy” is going to opt for this last one!

Which of these options you pick depends (in my mind at least) on whether you are a jail or a prison.  Let’s look at these two situations in detail.

Gabapentin rules for jails.

One basic goal of jail medicine that makes it different from prison medicine is this:  Continuity of Outside Care.  The average jail patient had a medical provider before coming to jail and will return to that same medical provider when he leaves jail—in an average of, say, two weeks.  Assuming that our patient had competent medical care before coming to jail, to a large degree, our job is to continue that care, hopefully without significant interruption.  If the patient takes medications for hypertension, seizures, hyperthyroidism or a host of other problems, I usually will want to continue those medications for the short time that the patient is in jail, even if I myself would not treat the patient in exactly the same way.

If gabapentin has been prescribed for seizures (even though it is a crappy seizure drug), I will not want to discontinue the gabapentin while in jail.  However, most of the gabapentin prescriptions that I am going to see in newly booked jail patients are going to be for (yes, you guessed it) chronic pain.  If I ban gabapentin for this, I have the following considerations:

  1. Gabapentin should not be abruptly stopped.  It needs to be tapered at a rate of no more than 300mg a day.  If a patient comes in taking 3600mg a day, it will take a minimum of two weeks to safely taper her off of the gabapentin.
  2. When she is released from jail (in an average of two weeks.), the gabapentin will just be immediately restarted.

My thinking is that I have not accomplished much in this scenario.  I didn’t accomplish my goal of not allowing gabapentin in the facility—it was there during the taper.  I didn’t win friends.  The jail patient will be angry and so probably will his outside physician.  I did not improve his overall medical care. So if the patient is only going to be in jail for a short time, and if he supplied the gabapentin in appropriately labeled prescription bottles, I will likely continue the gabapentin for his short jail stay.

However, there are limits to this.  First, the gabapentin prescribing by the outside physician must conform to commonly acceptable standards.  I once had a patient who arrived at the jail taking a monster dose of 5,400 mg of gabapentin a day.  I verified that this jaw-dropping prescription was correct by calling the prescribing doctor’s office.  5,400 mg of gabapentin a day far, far exceeds the maximum dose for gabapentin for any indication, which is 3600mg a day.  More investigation led me to believe that this patient had been selling his gabapentin on the street, which is why he had pushed the outside prescriber for more and more gabapentin.  Interesting incidental point:  gabapentin has street value outside of jails and prisons!

Also, gabapentin prescribed for neuropathic pain has an evidence base in the literature.  Gabapentin as a sleeping aid does not.  I will view the situation differently if someone arrives at the jail taking, say, 100mg of gabapentin every night as a sleeper.

Finally, I myself do not prescribe gabapentin (well, rarely, anyway).  If a patient cannot supply their own prescribed gabapentin, I’m not going to fill in the gap.  Once a patient’s outside medication supply runs out, I’m not going to refill it for them.  I usually will call their outside practitioner and discuss my plan to taper and discontinue the gabapentin in this patient, who is going to be incarcerated for a while.  Almost always, the outside practitioner will have no problem with this.  But I should make the call anyway in order to accomplish two goals:  first, the outside provider and I are united in this treatment decision.   Now, the inmate cannot exploit a perceived difference of opinion:  “My outside doctor wants me to be on gabapentin.  Who are you to deny it?”  Second, I have educated the outside practitioner about the abuse potential of gabapentin.  Most of them have no idea.

Gabapentin prescribing in prisons

The situation in prison is different than a short stay in jail.  The medical care of the prison patient is being transferred to the prison medical providers lock, stock and barrel.  These patients will not be returning to their outside medical provider anytime soon.  It is akin to a person moving to another city and finding a new primary care physician to take over their medical care.  The physician in the new city is under no obligation to continue therapies (like gabapentin) that she considers to be inappropriate or less than optimal.  Same thing in a prison:  the prison practitioner can certainly modify a treatment plan to fit the patient’s new prison environment.

Because they feel no pressure to continue outside treatment plans, some prison systems have decided to ban gabapentin entirely. The main driving force for this, of course, is the level of diversion and abuse in that particular prison system.  Gabapentin abuse is a bigger problem for some prisons than for others.

But a total ban on gabapentin is not as easy as it seems.  Some prison systems have banned gabapentin only to return to allowing controlled use of gabapentin later due to the problems of implementing a total ban. Whether you ban gabapentin entirely or just try to beat it into submission with guidelines of appropriate use, here are the issues you are going to have to address:

 What are you going to substitute for gabapentin?

Now, if the gabapentin was prescribed for seizures, it is easy to come up with a list of alternative seizure medications.  Ditto restless leg syndrome–there are better and cheaper alternatives. There are also lots of substitutes for gabapentin prescribed for psychiatric conditions like Bipolar disorder.

But all of those will likely represent only a small minority of incoming gabapentin prescriptions.  Most of the gabapentin prescriptions will be for The Big Two:  diabetic neuropathy and chronic pain.  There certainly are other medications that can be used to treat diabetic neuropathy and chronic pain—just not very many.  Here is the list:

  1. Duloxetine (Cymbalta).  Duloxetine is, in my mind at least, the single best alternative.  Its efficacy is just as good as gabapentin in randomized trials.  I have not heard any reports of significant abuse or diversion of duloxetine.  Perfect!
  2. Venlafaxine. Like duloxetine, venlafaxine has consistently outperformed gabapentin as a treatment of neuropathic pain in blinded trials.  However, venlafaxine can itself has been diverted and abused in correctional settings.
  3. Tri-cyclic antidepressants, especially amitriptyline.  TCAs have also been successfully used to treat chronic pain.  The problem with TCAs is twofold:  first, they themselves, especially amitriptyline, can be diverted and abused.  Also, TCAs can be deadly in overdose.  I myself have personally witnessed two deaths caused by TCA overdose (in my ER days).  TCAs also have lots of interactions with other medications.  If you do use TCAs, use a low dose.  Big doses do not improve efficacy, but do increase the possibility of overdose.  Also, I would recommend using a TCA with less diversion potential like nortriptyline.
  4. Other antidepressants. I have seen SSRIs prescribed for chronic pain.  I have also not heard of significant abuse or diversion of SSRIs. The problem with them is that they have not been well studied as treatments for neuropathic pain.
  5. Other seizure medications like Keppra, Tegretol and Depakote.  These also have been used for chronic pain but, like SSRIs, do not have a great literature base.
  6. Capsaicin cream.  Interestingly, capsaicin cream performed just as well as did gabapentin in the trials!  A definite possibility.
  7. Pregabulin (Lyrica).  The problem with Lyrica in corrections is that it is just as abusable/divertable as is gabapentin.  In fact, they both act on the same receptors.  In my mind, it basically is the same thing as gabapentin–only worse.  Where gabapentin is not a DEA controlled substance, Lyrica is.  Lyrica is also expensive.  You have accomplished little if you replace gabapentin with Lyrica.

“Nothing Works Except Gabapentin”

The next thing you need to decide is what you are going to do when these substitutions fail.  Many patients who are switched to the new agents will do fine. But there will be some who are going to say that nothing else works except gabapentin.  Some of these are sincere–gabapentin can be a great drug for some patients.  But others who say that only gabapentin works want it to abuse or divert.  It often is impossible to tell the difference between these two categories.

If gabapentin is totally banned, some inmates will inevitably file grievances, tort actions and complaints to the state medical board that they are being denied “the only medical therapy that works for me.”  They will enlist family members and outside doctors and advocacy groups to lobby for them.  I know of a couple of prison systems where complaints like these became such a problem that they reversed their decision to ban gabapentin outright.  Be prepared!

If your facility is going to ban gabapentin nevertheless, I would strongly recommend that this be an official decision with the agreement of everyone involved:  the Medical Director, the Director of Nursing, a representative of your pharmacy, the security administrator of your facility and your legal representative.  Having agreement from this diverse group beforehand will go a long way to deal with the inevitable backlash.

The argument against banning gabapentin in prisons.

One of my mentors in prison medicine argues against a total ban on gabapentin in prisons.  His reasoning goes like this:

1.  95% of the inmates prescribed gabapentin do not divert or abuse.  Gabapentin can be a useful and effective drug for them.  Why ban use in the 95% because of the 5% who abuse it?

2.  Also, he says, the 5% who are abusing gabapentin are going to divert and abuse some type of medication no matter what. Since gabapentin is relatively safer in an overdose than, say, tricyclic antidepressants or bupropion, it is better that the inevitable prison black market be for the safer drug–gabapentin.

3.  Instead, says my mentor, it is possible to make and enforce rules for rational and sane gabapentin prescribing.

Rules for gabapentin prescribing.

Here are some rules for gabapentin prescribing for neuropathy and chronic pain that I think are reasonable and in line with the literature.

Decide who you will be eligible for a gabapentin prescription. As I discussed last week, gabapentin has been basis in the literature as a treatment for neuropathic pain.  It is not a viable treatment for “nociceptive” musculoskeletal pain.  So diabetics who complain of painful feet might be proper candidates for a gabapentin prescription, whereas a patient with, say, chronic knee pain due to DJD is not a proper candidate according to the literature.

Decide what medications for neuropathic pain should be tried before gabapentin.  Since several other medications work just as well–or better–for neuropathic pain than does gabapentin and do not have the abuse potential that gabapentin does, I would recommend that gabapentin be a drug of last resort.  Better agents include duloxetine, venlafaxine, tricyclics and capsaicin cream.

Set the maximum dosages.  If you look up maximum gabapentin dosage for neuropathy in one of the many drug compendiums (Tarascon, say), it will give the maximum dosage as 3,600 mg a day.  And it is true that doses this high have been used in gabapentin studies.  But what Tarascon does not tell you is that the studies showed that high doses of gabapentin were no more effective than low doses–but high doses do increase the incidence of gabapentin side effects and, in our world, availability for diversion, abuse and overdose.

So what should the maximum dosage of gabapentin be for neuropathic pain?  Well, interestingly, Pfizer, the original maker of Neurontin, answered this question for us.  Remember that Neurontin was FDA approved for one type of neuropathy– post herpetic neuropathic pain.  And the Neurontin package insert lists the maximum dose for this neuropathic pain as 1,800 mg a day.  So there is your answer.  Maximum dose of gabapentin for neuropathy is 1,800 mg a day.

Once again, though, almost all of the benefit from gabapentin is gained at doses much lower than this theoretical maximum dose.  The Prescriber’s Letter (which is my favorite pharmacy information source) says this (Here): “gabapentin doses above 900 mg/day don’t provide much more pain relief–but do increase side effects. Keep in mind there’s a diminishing return with higher doses . . . doubling the dose does not double drug concentration.”

So although the theoretical maximal dose is 1,800mg a day, the effective maximum dose is just 900mg a day.

Monitor compliance.  It is easy to check compliance with prescribed gabapentin.  You just need to draw a gabapentin drug level.  Decide how often these will be.  Will they be scheduled or random?  Will you check levels in all patients or just those who you suspect of diversion?

Decide what you will do with those caught diverting.  Since gabapentin is not a “must-have” medication, I would recommend that anyone caught diverting gabapentin have their gabapentin prescription stopped.  You will need to decide how long until the inmate will be eligible for another trial.  Six months?  One year?  Whatever it is, it must be consistent.

Uniform prescribing.  Whatever rules or guidelines you develop for gabapentin use, it is essential that they be followed by all the prescribers in your system and, if you have multiple facilities in your system, at all facilities.  Having even one practitioner who ignores your guidelines will result in grievances, complaints and gaming.

As always, the views I have expressed here are my own opinions and the result of my own training and experience.  I could be wrong!  You should carefully review the evidence for gabapentin prescribing yourself!

How do you handle gabapentin in your facility?  I’d like to hear from those of you who work at facilities where gabapentin is banned.  Was the ban successful?  I’d also like to hear from those who have tried to regulate gabapentin.  What are your rules?  What works?  What does not work?  Please Comment!400x492x20150729.jpg.pagespeed.ic.ddFtaqvEHW

 

13 thoughts on “Taming the Beast—Gabapentin. Ban It or Regulate It?

  1. Mary V. Hastings

    We are in the midst of this very discussion now so I am interested to hear what other facilities are doing. The drug costs at our jail are absorbed by our county so the high cost of Gabapentin is a real issue. We are working on a plan to allow it short term when someone first comes in while trying to access their medical records to see the indication for use. In my experience it is way over prescribed for patients who exhibit drug-seeking behavior. I have weaned patients off while they are detoxing from their opioids and they don’t complain of chronic pain anymore. Would love to see some protocols from outside if available.

    Reply
    1. Marsha Odell

      Currently Gabapentin is non formulary and requires the approval of a pharmacist to prescribe.
      Recently a requirement for drug level testing prior to renewal was instituted: no renewal for levels <4.0
      A neuropathic pathway of Tylenol, NSAID, Nortiriptylline and three AEDs on formulary are to be tried before Gabapentin.
      This is a prison system, and apparently the abuse was widespread.

      Reply
  2. Al

    Gabapentin is a great model for this discussion but it limits the discussion to consider only one medication – it would be (perhaps) more helpful to think about the use of all medications. At the outset; one great concern is the outright ‘banning’ of any specific medication. With limited exception, medication is developed and manufactured to treat health problems and no medication should be ‘banned’ without exclusion. That said, there are certain medications that are less appropriate in the correction situation and should be used rarely.

    There are a few off- label uses for Gabapentin beyond neuropathic pain – mood stabilization being one of them. That is not an unrestricted or fully endorsed use – yet it works and is acceptable by some patients (‘at least I’m not crazy’).

    Moving beyond Gabapentin; a central consideration is the misuse / abuse / diversion of [all] medication. There are a great number of medications that have been used by offenders for their own version of ‘off-label therapy’.

    A ‘rational and effective policy regarding medication use in our facilities’ should be the goal of all providers in correctional health – without the coercion of correction administration. The provider in a correction facility becomes the ‘de facto’ PCP for the offender during their stay – much like an ED provider is responsible for the patient once the person is in the ED. A big difference is that you can’t call the PCP and let them come in and ’take over’ – but maintaining good relations with the community providers is important.

    A consideration that, hopefully is used more often than discussed, is verification of reported community medication. A consistent process of contacting the pharmacy (ies) to determine what medication; strength / dose/ / schedule; last dispensing date / amount; and first dispensing date. That information informs the determination of in-facility prescribing. The subsequent use of medication should be based upon good clinical practice standards.

    One pragmatic option is use of the Pharmacy and Therapeutics committee – not always an easy task in smaller facilities – which may consist of the provider, pharmacist and a nurse (nurses will provide a very practical view from the administration aspect). The P&T can develop a rational approach to which medications should have restricted use and what those restrictions should be. Then the provider can stand firmly on those guidelines.

    The P&T committee should also be used to develop guidelines for prevention of and response to diversion issues. As example: when it is necessary to administer methadone / subutex [almost always a pregnancy issue] a separate medication administration pass is used; use of OCP – why, when, when to D/C. Other considerations: when to crush, crush and float, mix in foods, discontinue, etc.

    Reply
  3. Nancy Wolf

    Thx so much it’s always confusing
    I’m going back into a jail from private group FNP/PMHNP
    and I really appreciate the unbiased info
    I’m usually the only one making those decisions and it’s refreshing to hear from a larger jail doc with good rep!

    Reply
  4. DM

    I have been trying to get the Gabapentin situation under control in my facilities ( I am the medical director at a midsize county jail). I don’t think it’s worth the trouble to try to totally ban Gabapentin. It does have its legitimate uses, and it does seem that at least a majority of the inmates have some benefit from it and don’t abuse it.
    I have taken over sole control of the prescribing of Gabapentin and other problematic medications. It needs to be kept consistent, because I have noticed that it tends to slip in during medication reconciliation, and it much easier to taper them off on arrival than after they have been in custody and on it for a while.
    I review the indication and usually request records from the outside providers. If someone is on an reasonable dose with at least some evidence of neuropathic pain, I will generally continue it. I do not allow it for off – label uses. Restless leg syndrome and sleep are not indications. My colleagues on the mental health side also do not use it for any psychiatric indications.
    There are a few inmates who are trickier. They may have some plausible explanation for why they need Gabapentin, like severe back pain, mostly from bulging disks. Most of them will have have had an MRI which shows bulging disks and the like. I do not automatically allow these inmates to get their Gabapentin.
    Determining who gets Gabapentin and who doesn’t in this group is probably the most problematic part of the whole process. I generally try to take into account certain variables when deciding. Age is a big one. I am more skeptical of a 25 year old on a high dose of Gabapentin than I am of a 50 year old on an appropriate dose. Other factors I look at include a history of polysubstance abuse and whether they have been on a stable dose prior to incarceration.
    I have found that a lot of inmates claim to be taking Gabapentin for seizures lately. Since Gabapentin is not a usual choice for monotherapy in patients with generalized seizures, I have been requesting records from their neurologists. I haven’t found a single confirmed legit prescription for seizures yet (I have been seeing the same thing with Lyrica too). Usually these are inmates in their 20’s with a history of substance abuse. They are generally on exceedingly high doses as well. Once I have confirmed that they are not taking the Gabapentin for seizures, I treat the Gabapentin like I would Norco or benzos and taper them off.
    As for talking to the outside providers, I think in many cases that is not a bad idea. There are a few providers out in the community who inadvertently or not seem to be supplying a lot of the local substance abusers. One of them once suggested that I change a inmate over to Gabapentin from Lyrica when I called her about an inmate! Usually an inmate showing up with scripts from these providers get extra scrutiny.
    Once they are in custody, I will not write for more than a month at a time at a time. I will also require inmates to try a lower dose if able. Diversion or noncompliance means an automatic taper.
    I have also set a maximal dose, which is useful for the inmates who keep dropping sick calls wanting a Gabapentin increase. If they are still in pain at the maximal dose, I will consider the Gabapentin ineffective, taper them off and change them to something else, usually Cymbalta.

    So far I have made a large dent in the amount of Neurontin we have been using.

    Reply
  5. Scott Olt

    Gabapentin is now non-formulary in the FBOP. The replacement of choice is duloxetine, and we’ve pretty much got all our former gabapentin users changed over. There was some griping at first, but it went more smoothly than I expected.

    Being mainly a pretrial/holdover facility, we frequently get new inmates coming in on gabapentin, but we put them on a taper and get them on duloxetine. So far, so good.

    Reply
  6. RB

    Remember the fact that neurontin is not FDA approved for anything except seizures and post herpetic neuropathy . This is very useful in the patients who make the claim that “nothing else works but gabapentin”/ My response to that is that nothing else working is not justification to use a medicine that the FDA has not declared to be both effective AND safe for their condition. I work at in a state prison system and also in private practice in the community , and IMO, neurontin has little or no place in a prison and is probably THE single most over- and mis- presricbed drug on the market today. It’s easy to see how this happened. Doctors everywhere are always looking for a safe alternative to narcotics for patients with compliants of chronic pain. Along comes gabapentin. It’s potential for abuse is not recognized at first. Add to this the unethical marketing practices that were employed and pretty soon you have neurontin being prescribed for anything that tingles or hurts, with the providers being unaware of the addictive and abuse potential of the med. (remind you of Ultram yet?) One main way my patients try to argue for it is that their doc on the outside precibed it. They are often particularly vehement if it was a specialist that prescribed. They will ask “So you think you know better than a specialist?” My response is that there is a generation of doctors that is largely unaware of the ethics issues with how this drug is marketed and who believe neurontin is FDA approved for a whole host of conditions for which it is not in fact approved. Most of those patients who claim “nothing else works” – what they really mean is nothing else mood alters them the way the gabapentin does. Hopefully some of the problem will go away when the govt finally realizes this drug needs to be controlled (think Ultram)

    Reply
  7. Ashley

    I’m just an RN but I find this article incredibly relevant and interesting. I work at a high medium/maximum security prison. A lot of our offenders are lifers. Mostly we prescribe gabapentin for seizures and diabetic neuropathy. Many of our diabetics take 3200mg/day. Just in the last year we have started doing random gabapentin drug levels, although there has been so far no set determination in what an appropriate drug level is. Gabapentin is non formulary for us and it is up to the medical director reviewing the formulary exception request to decide if he feels the level is appropriate and the Dx warrants continuation of gabapentin. The providers have tried switching to Cymbalta for many offenders, but they of course say it doesn’t work as well for their nerve pin and we’ve had several older offenders (45+) complain of urinary issues (retention) with the Cumbalta. We usually do Pamelor first because it is formulary but our offenders report no relief of pain with it. I did not know capsaicin creek was an option. Although it is still nonformulary, maybe it would provide another option

    Reply
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