State-Imposed Restrictions on Gabapentin
In recent years, we have seen a growing number of instances where federal law and state law are not in perfect alignment with regard to certain medications. As one example, we’ve seen a number of states pass laws allowing for the medical and/or recreational use of marijuana compounds even though marijuana is classified as a schedule I controlled substance by the federal Drug Enforcement Agency (DEA). Federal law prohibits the writing of prescriptions for schedule I controlled substances but yet many states allow for the use of medical marijuana for a list of approved conditions. As another example, the majority of states have created a mechanism that allows for the availability of naloxone without a prescription, even through the federal Food and Drug Administration has not approved naloxone on an over-the-counter basis. We wrote about this topic on our blog a few months ago but if you missed that article, you can read it here. As a third example, many state-based restrictions on gabapentin have surfaced in the past two and a half years, representing a deviation from federal law.
The reason for these state-imposed changes to the guidelines for certain medications is that states have reevaluated the risks and benefits of these medications. The risks and benefits of any particular medication are not static but rather, they change and evolve with time. When the risks and benefits of a medication change, new prescribing guidelines may be appropriate for that medication. Over the past few years, a new risk has emerged with gabapentin in the form of potential abuse. In April, we featured an article on our blog that detailed the growing problem of gabapentin abuse. If you missed that article, you can read it here. When a drug has the potential for physical and/or psychological abuse, controlled substance designation is justified. The particular schedule that is assigned depends on the potential for abuse and the relative benefits of the drug.
The DEA maintains a federal list of controlled substances, and gabapentin has not been classified as a controlled substance for purposes of the federal list. In July 2017, Kentucky became the first state in the nation to classify gabapentin as a schedule V controlled substance. Since then, four other states have followed suit – West Virginia in June of 2018, Tennessee in July of 2018, Michigan in January of 2019 and Virginia in July of 2019. We will almost certainly see more of this trend in 2020 and beyond. These changes are impactful to patients, since the designation of a medication as a controlled substance carries certain restrictions for prescribing, dispensing and refilling. For example, prescriptions for controlled substances can only be written by a practitioner who is registered with the DEA. Prescriptions for controlled substances may be refilled up to five times within six months of the original prescription date. This is shorter than the authorized refill period for non-controlled substances, which is typically one year. For controlled substances, after five refills have been dispensed or six months have passed from the original prescription date, a new prescription is required.
There are other states that have not gone so far as to classify gabapentin as a controlled substance but have taken steps to monitor the use of gabapentin through state-level prescription drug monitoring programs or PDMPs. A few examples of states that monitor gabapentin prescribing by way of the state-level PDMP are Ohio, Minnesota, Illinois, Wyoming and Massachusetts.
In addition to the risk for abuse, the FDA recently issued a warning that serious breathing problems may result from the use of gabapentin or pregabalin (Lyrica) in certain patients. Patients who are taking other drugs that may suppress breathing (such as opioids), patients with chronic obstructive pulmonary disease (COPD) and elderly patients are at a greater risk of experiencing breathing problems when also taking gabapentin or pregabalin. The FDA issued this warning in response to case reports which identified patient deaths when gabapentin or pregabalin was used in individuals with at least one risk factor for respiratory problems. As a result of this new risk being identified, the FDA will require manufacturers of gabapentin and pregabalin to include information about the increased risk of breathing problems in the prescribing information for these drugs. In addition, the FDA will require manufacturers of these drugs to conduct clinical trials that more closely evaluate the risk of breathing problems in patients using the drugs. You can read the full press release here.
past few years, the use of gabapentin or pregabalin with opioids has been
established as a potentially dangerous combination for patients. Due to the
heightened risks that have emerged with gabapentin, a trend has been observed
that involves the use of urine drug screens to monitor for the use of opioid
drugs. While urine drug screening represents a prudent clinical practice on the
part of the prescriber to guard against the use of a potentially dangerous drug
combination, it also creates the potential to increase Medicare Set-Aside (MSA)
amounts. Currently, CMS includes at a
minimum bi-annual urine drug screening when prescription opioids are
involved. To date, CMS has not taken
an official position regarding urine drug screen monitoring in the absence of
opioid prescriptions. We will continue to monitor these
clinical scenarios and post updates here.