The New Role of the DEA in Epilepsy

Wednesday, March 18, 2015

The Relevance of the DEA for Epilepsy

Epilepsy physicians, people with epilepsy and families had little reason to think about the DEA (Drug Enforcement Agency) until recently. Our only DEA concern was with phenobarbital because it is a controlled substance. However, the DEA now has a prominent role in epilepsy.  The DEA has influenced how we practice epilepsy by prolonging some drug approvals, limiting prescribing for new epilepsy drugs, and preventing the use of cannabis derivatives.

Prolonged Evaluation of Anti-Seizure Medications at the DEA

Drugs approved by the FDA to treat epilepsy in recent years have often been controlled substances including Lyrica, Vimpat, and Fycompa. When the FDA determines that a drug has a potential for abuse, then it is sent to the DEA for "scheduling" before it is available for use. The FDA makes this determination on the basis of eight specific factors including whether the drug is derived from a class of drugs that is already controlled. The DEA reviews the FDA materials and assigns the drug to a schedule (see Table). The length of time that the DEA takes to schedule a drug becomes a problem for people with epilepsy. For example, after the FDA approved Fycompa as safe and effective, it took the DEA more than a year to schedule the drug. During this time, patients did not have access to this new effective drug. This is even more frustrating because the DEA has always followed the recommendation of the FDA so the source of the delay is not clear.

The Epilepsy Foundation has been instrumental in advocating for legislation that will require the DEA to schedule drugs within a specific time frame. The FDA currently must review a drug within six months. It seems equally reasonable that the DEA should have a time limit on how long it can take to schedule a drug. The current bill is moving through Congress and there is some optimism that it may eventually become law. The current bill would require the DEA to schedule drugs within 180 days. While this still seems like quite a long time, it is much better than the open-ended process that let 400 days lapse before Fycompa was scheduled!

Some Anti-Seizure Medications Are Controlled Substances

The idea that new antiepileptic drugs (AEDs) need to be scheduled because of abuse potential is almost comical to most epileptologists. AEDs have never been the subject of abuse and there are no case reports on the abuse of common AEDs. However, some AEDs affect receptor systems in the brain that could give them the potential for abuse. Even if this is the case, it seems reasonable that the DEA would revisit scheduling periodically and either decrease the level of scheduling or remove the drug entirely from the schedule. For example, Vimpat has been available since 2008 but there been no reports or evidence of its abuse in the ensuing seven years. There are few ways to influence the DEA other than legislation. It is possible to lobby the DEA for a change in "rulemaking” but this is a complex process.

The practical application of using a scheduled substance is that only six months of prescriptions can be given and therefore patients are more likely to run out. In addition, electronic medical records cannot typically prescribe controlled substances unless they use a biometric screening method such as a fingerprint reader on the computer. The level of security demanded is particularly ironic since controlled substances can easily be called in on the phone by anyone who is a designee of a prescriber in many states. Using a combination of written prescriptions for controlled substances while other medications are being prescribed electronically, often leads to confusion for both the prescriber and the patient.

Cannabis Derivatives Are Schedule I Substances

Cannabis is currently a schedule I substance and therefore it is illegal under Federal law since schedule I substances are specifically defined as having no therapeutic use. Although many states are decriminalizing the possession of cannabis derivatives, they remain illegal under federal law. Therefore physicians are at risk for prosecution if they prescribe cannabis since physicians who possess a DEA certificate are regulated by the DEA. It seems unlikely that the DEA will unilaterally decide to change cannabis from schedule I. Currently, there is a bill advancing through Congress that would remove cannabis derivatives from schedule I.

Many states are decriminalizing marijuana derivatives, but there is no source of pharmaceutical grade CBD or even reliable sources of CBD that have known amounts of CBD and contaminants. A more realistic solution will be if cannabis derivatives such as cannabidiol (CBD) are found to be safe and effective in clinic trials. They can then be moved out of schedule I. For example, Marinol is a cannabis derivative that is FDA approved for the treatment of cancer nausea, but it is a schedule III drug due to its therapeutic benefit. The best case scenario is that CBD would be approved by the FDA in the next two years and would be available for general prescribing.

Schedule Characteristics Example

I

No currently accepted medical use and a high potential for abuse

Heroin, LSD, ecstasy, methaqualone, peyote, cannabis

II

High potential for abuse; potentially leading to severe psychological or physical dependence

Stimulants (cocaine, methamphetamine, Ritalin), narcotics (meperidine, oxycodone)

III  

Moderate to low potential for physical and psychological dependence

Combination products with < 15 mg hydrocodone (Vicodin), products containing < 90 mg codeine (Tylenol with codeine), ketamine, anabolic steroids, testosterone, Marinol, Fycompa

IV

Low potential for abuse and low risk of dependence.

Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, phenobarbital

Preparations containing limited quantities of certain narcotics

Cough preparations with less than 200 mg codeine/100 ml (Robitussin AC), Lomotil, Lyrica, Vimpat

Summary Points

  • Current practices of the U.S. Drug Enforcement Agency (DEA) are affecting access to some of the newer seizure medications and research into promising new therapies. 
  • The Epilepsy Foundation is actively advocating for changes to improve access to new therapies and speed up research.  Learn more about EF Advocacy work.
  • Become part of the advocacy movement – join the Speak Up, Speak Out now!
  • Learn more about medical marijuana and the Epilepsy Foundation’s position.
Authored by: Nathan B. Fountain MD | Chair, Epilepsy Foundation Professional Advisory Board on 3/2015

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The mission of the Epilepsy Foundation is to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives.

 
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