I came across a very good illustration of a lost pharmacy business due to the DEA’s heightened scrutiny of buprenorphine scripts. A community pharmacy in West Virginia was raided by the DEA, which decided that the pharmacy was excessively dispensing buprenorphine (Subutex and Suboxone). Ultimately, the DEA revoked the pharmacy’s registration based on this “excessive” dispensing.
It has been clinically proven that medications containing buprenorphine effectively treat opioid use disorder by reducing chances of opioid relapse and the risk of overdose. Many medical providers specializing in opioid use disorders prescribe buprenorphine as the only feasible alternative. In fact, the federal government itself encourages clinicians to prescribe it. But – as the West Virginia case illustrates – the DEA takes a very tough approach on dispensing them. As a result, many patients cannot fill these prescriptions because pharmacies are afraid to stack on them.
During the hearing in this case, the DEA also argued (in addition to its main claim of excessive furnishing) that some of the scripts were suspicions and that the pharmacy did not clear the red flags, such as: prescriptions were filled for Subutex instead of Suboxone, some patients travelled long distances and paid cash.
In response, the pharmacy presented evidence that the patients travelled long distances because no other pharmacy was able to fill their scripts in their localities and that some insurances did not cover these medications (or patients were uninsured). It also explained that Subutex was cheaper to fill than Suboxone. To reduce the cost to the patients and/or the plan, pharmacy often substituted Suboxone with Subutex, which it was allowed to do under state law.
Two judges heard this case (one was a superior court judge and another DEA’s Administrative Law Judge). And both ruled in favor of the pharmacy.
While, this West Virginia pharmacy and its owner ultimately prevailed, the damage was irreparable. Unable to fill controlled substance scripts, the pharmacy lost most of its payor contracts and had to shut down.
The article explains this so-called “Prescribing Cliff” when there are more prescriptions for buprenorphine than could be filled because pharmacies set their own thresholds of how much of this product they can purchase not to trigger DEA’s or wholesalers’ attention to its dispensing practices.
Some industry experts argue that these DEA tactics actually exacerbate the opioid epidemic by scaring pharmacies away from dispensing buprenorphine when it is desperately needed to address the epidemic.
Because this case put the problem in the spotlight, hopefully the DEA reevaluates its tactics and coordinates its enforcement actions with other agencies which actually encourage prescribing and dispensing of buprenorphine. We surely need some sort of consensus.