Gabapentin is among the most dispensed medications in the United States and is frequently prescribed for off-label indications, including pain. In recent years, some states have adopted policies to regulate gabapentin through controlled substance scheduling, prescription drug monitoring program (PDMP) reporting requirements, or both.
In a recent study in the International Journal of Drug Policy, researchers conducted a comprehensive analysis of state-level laws related to gabapentin scheduling and PDMP reporting from 2016 to 2024, documenting variation in policy adoption and implementation across jurisdictions.
CPHLR spoke with Katherine Gora Combs, MPH, a doctoral candidate in epidemiology at the University of North Carolina’s Gillings School of Global Public Health, about what motivated this research, trends observed in state policy activity, and how these data may inform future public health research.
CPHLR: What first drew your attention to gabapentin as a policy issue, and what made it feel worth examining at the state level?
KGC: Gabapentin is one of the top five dispensed medications in the United States. With most of the use being for off-label conditions, particularly for pain, concerns of non-medical use are high. This, combined with studies showing increasing gabapentin fatal overdose involvement, highlights gabapentin regulation as a potentially important lever for public health policy intervention. Supply-sided regulations to alter medication prescribing often involve either scheduling the medication as a controlled substance, requiring the reporting of these medications in a prescription drug monitoring program (PDMP), or a combination of both. Most scheduling of medications is done at the federal level through the Controlled Substance Act, but states do have the authority to schedule medications at the state-level under their police powers. I was interested in exploring the existing variation in state-level approaches to regulating gabapentin prescriptions.
CPHLR: You found that most scheduling and PDMP reporting policies occurred between 2016 and 2019, with far fewer changes after that. What do you think drove this wave of action — and the slowdown that followed?
KGC: I think the concentration of policies between 2016 and 2019 occurred for a few reasons. Studies documenting misuse of gabapentin, most of which were led by researchers from the University of Kentucky, started really emerging in the literature in 2015 and 2016. Gabapentin involvement in overdose was also measured initially across multiple states using 2015 fatal overdose data. Given the research's attention to this topic in 2015-2016, I was not surprised to see that most policies were implemented in the years following this rise in documented evidence. Though I cannot say this definitively, I believe that the COVID-19 pandemic, which began in 2020, likely played a part in the slowdown of policy implementation as attention needed to understandably shift to addressing that public health challenge.
CPHLR: Michigan rescinded its gabapentin scheduling policy — do you think this could inspire future shifts in policy implementation in other states?
KGC: Though I am not aware of any other states that have considered removing gabapentin from their list of Schedule V controlled substances, Michigan’s action could serve as a model for other states to take a second look at their policy. However, in contrast to Michigan’s decision, which they noted was primarily driven by a desire to align their regulations with that of other states in the region, shifts should be informed by the evidence of the public health effects of the policy and by the public health needs of the state.
CPHLR: How did MonQcle support the policy surveillance process as you tracked gabapentin regulations over time?
KGC: MonQcle was an integral part of our policy surveillance process. The tool helped ensure that we were capturing all the necessary data while gathering legal text, and also provided an easy point-and-click interface to minimize error and improve quality control. Not to mention, the smooth integration with LawAtlas, which helps our work be disseminated is a huge plus!
CPHLR: What questions do you hope future research will be able to answer with the data you’ve created?
KGC: There remains a significant gap in the literature of the effect of state-level scheduling or mandated reporting of gabapentin prescriptions on many health outcomes, including population-level utilization, prescriber behavior, non-medical use, and overdose involvement. Additionally, more research is needed to understand potential unintended effects of the policy on vulnerable populations, including users with chronic pain and historically marginalized groups, to ensure that the policies are not resulting in undertreatment or increased barriers to care.
Read the analysis in the International Journal of Drug Policy