Editorial written by the Pittsburgh Post-Gazette Editorial Board

Buprenorphine, the only drug currently available at pharmacies to treat opioid use disorder (OUD), is becoming increasingly difficult to obtain. It’s an unfortunate side effect of a pharmacy system under pressure and, ironically, regulations that were meant to curb the opioid epidemic in the first place.

New guidelines must make a clear distinction between opioids that cause addiction, and opioids that treat it – specifically buprenorphine, a medicine that, when used properly, safely staves off withdrawal by replacing some of the effects of illicit opioids. Its effectiveness is tied to its molecular similarity to other, more addictive opioids.

Unlike methadone, buprenorphine doesn’t require daily attendance at an opioid treatment program (OTP), and the strict supervision that comes with it. In rural areas, OTP sites are rare and far apart. Many people with OUD, especially those who are poor, can’t get to a site every day. While legislation to free methadone from these requirements advances at the federal level, buprenorphine remains the only OUD treatment option that is available at most pharmacies.

But, unfortunately, as an opioid itself, federal regulations implemented in the last decade aiming to curb suspicious opioid prescriptions now also affect treatment options. While these regulations were necessary to reel in pharmacies that acted as pill mills, supercharging the epidemic, addiction-management drugs should not be treated the same way.

These restrictions are a strain for pharmacies already struggling under middlemen all too content to reimburse pharmacies at unsustainably low rates for the medicines they supply. While filling buprenorphine scripts was never lucrative, the trend is bleak: Updated reimbursement rates for patients on Medicaid have made these patients a financial drain on pharmacies.

Meanwhile, the legal framework for buprenorphine offers no guidelines, only punishments.

According to a 2022 Journal of the American Medical Association study, pharmacies may be “flagged by wholesalers and distributors as suspicious when aggregated pharmacy orders of opioid products, including buprenorphine, are above a prespecified, but largely unknown, threshold or opioid quota.” A pharmacy’s available supply of buprenorphine may then be restricted or cut off altogether. In the worst case, they can be reported to the Drug Enforcement Administration (DEA), opening them up to a slew of legal repercussions.

These issues are also symptomatic of the broader collapse of the pharmacy business due to middlemen, known as pharmacy benefits managers (PBM), paying reimbursement rates that force pharmacies to take a loss on supplying life-saving drugs. And buprenorphine is among the medications with the worst reimbursement rates.

In McKeesport, for instance, the abrupt closure of a pharmacy left roughly 150 people with OUD scrambling to find other providers. As the Editorial Board described in urging PBM reform, this creates a financial contagion: These patients are a net drain on pharmacy businesses, because their medications cost more to fill than the reimbursements PBMs pay for them.

But it gets worse. Wholesalers and the DEA, often unaware of recent pharmacy closures, will look at a patient traveling for long distances or crossing state lines for their medications, and identify him or her as an addict trying to game the system — rather than someone desperately trying to do the opposite by managing their addiction treatment. This can result in pharmacies’ opioid quotas being cut, not to mention law-enforcement investigations, meaning those businesses can serve even fewer patients.

Then there’s the stigma of treating people with OUD. They are often more desperate, with fewer resources and more complex treatment needs than other patients. The only other way for these patients to stave off withdrawal is through the illegal drug market, now increasingly tainted with fentanyl or horrifying animal tranquilizers. There is no leeway for people with OUD to miss a dose without serious consequences.

Pharmacists describe frantic phone calls from patients hours away, patients they can’t help because they don’t have the necessary buprenorphine stock or the capacity to shoulder extra costs. With the support for helping these patients so low, and the cost of accepting them so high, some pharmacies are no longer accepting OUD patients at all.

Treating OUD is a dynamic and changing field, shifting with the makeup of the opioid drug supply and new discoveries in addiction treatment. For example, prescription doses of buprenorphine have risen in tandem with the potency of new, super-strong additives like fentanyl. While the use of buprenorphine has been shown to help patients with OUD live longer, an ideal treatment time frame has not yet been established. No one knows how long buprenorphine patients should use their medication. This makes capping its supply a guessing game.

But what we can say right now is that the supply, artificially controlled by regulation, is not meeting the demand.

Pennsylvania stands at a critical juncture for treating the opioid epidemic: Funds from the lawsuit against massive drug manufacturers are currently bolstering local nonprofits and community organizations doing frontline work. This is the time to ensure that treatment standards keep up with known best practices.

Wholesalers and regulators must stop treating buprenorphine, the medication helping people emerge from opioid addiction, as primarily a cause of addiction. And PBM reform must ensure pharmacies are reimbursed fairly for the life-sustaining medicines they dispense.

Because right now, the already fragile system of care for people with OUD is on the verge of collapsing entirely. Public and private authorities must not let reforms designed to combat the opioid epidemic become policies that extend it.