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Concerns over pain-management alternatives prompt state audit


The workers compensation industry is raising concerns over gabapentinoids, a drug class that has risen in popularity as a pain-relieving alternative to opioids.

Experts worry that such drugs, increasingly being used off-label for pain management, are being prescribed in combination with opioids, which could increase the potential for a deadly overdose.

Gabapentin is an anti-seizure neuropathic drug that is considered a depressant that can slow breathing — increasingly so when combined with opioids. Pregabalin, known by the brand name Lyrica, is another generic neuropathic drug that experts say raises the same concerns. Together the drugs fall under the class known as gabapentinoids.

The Texas Division of Workers’ Compensation announced Nov. 15 that it will audit providers to ensure compliance with the state’s formulary that recommends against combining gabapentinoids with opioids. That audit will examine co-prescribing patterns from June 1, 2022, through May 31, 2023.

Workers compensation experts say the Texas audit will help draw attention to what many have flagged as a growing concern for injured workers.

“There has been well-documented literature for over a decade that talks about the abuse potential for gabapentin and the risk of respiratory depression,” said Reema Hammoud, Southfield, Michigan-based assistant vice president of clinical pharmacy for Sedgwick Claims Management Services Inc.

The frequency with which the drugs are prescribed in Texas is “not necessarily the concern,” a spokeswoman with the Texas Department of Insurance wrote in an email, adding that the focus is on “whether it is medically necessary or appropriate to combine the drugs with opioids.”

“Evidence-based medicine used in the Texas workers compensation system indicates that combining gabapentin or pregabalin and opioids is not recommended and may have dangerous side effects,” the spokeswoman wrote.

Gabapentin, approved by the U.S. Food and Drug Administration in 1993, remains unscheduled by the federal government, meaning it is less scrutinized. However, seven states have so far scheduled it as a controlled substance, and 12 states have added it to prescription drug monitoring programs — all over concerns it has a similar profile to addictive drugs that have severe side effects.

The newer pregabalin, first approved in 2004, is scheduled as a controlled substance by the federal government — a differentiation that has some experts baffled, as the drugs have similar profiles for addiction and side effects.

Federal regulators and advocates have called on the FDA to reschedule gabapentin as a controlled substance — a recommendation that hasn’t gained traction. The FDA in 2019 put a black box label — considered the most stringent for drugs — on gabapentin and pregabalin, warning of “serious breathing problems” for certain patient populations already taking central nervous system depressants – such as opioids — or those with lung problems. 

For the workers compensation industry, which is typically liable for side effects, including death, for injured workers who are harmed by treatment, the drugs have gained additional scrutiny regardless of whether the federal government catches up.  

“We’ve watched (the drugs) for a while because it’s long been reported that they are highly pursued by the communities that are abusing drugs, like opioids,” Nikki Wilson, Omaha, Nebraska-based senior director of clinical pharmacy services at Enlyte LLC, which provides benefits management services for injured workers. In Enlyte’s latest drug report for 2022, gabapentin and pregabalin were listed as the fastest-growing class of drugs prescribed to injured workers.

“Respiratory depression, of course, is how we get to overdose with opioids,” she said.

Combining gabapentin with opioids was associated with a nearly 60% increase in the odds of opioid-related death, according to data published by the medical journal PLOS Medicine in 2017.

The issue is problematic for those who take the nerve drugs prescribed to them by a doctor treating a work injury and who take opioids obtained illegally or outside of the workers comp network — which the industry is not always able to track, experts say. 

To help manage the concern, many benefit managers are providing letters to physicians who prescribe gabapentin or pregabalin to injured workers, and many are focusing on patient education about the dangers.

“This co-prescribing is still a pattern,” said Johnny Taylor, Tampa, Florida-based assistant vice president, ancillary networks, pharmacy, at GBCare, part of Gallagher Bassett Services Inc.

“Because of this, we’ve developed a program where we use gabapentin, opioids in combination as part of our risk scoring for interventions. And those types of interventions could be in the form of a drug review, like a drug utilization assessment, or perhaps a peer-to-peer discussion with the prescriber.”