You're dealing with a life-threatening illness that has an effective treatment. The only problem is the medication is only available at about 60% of pharmacies. What now?
This isn't a hypothetical for patients with opioid use disorder (OUD) in the U.S. And it's not limited to those living in care deserts -- areas where people lack nearby, convenient healthcare access. In fact, even in densely populated areas there may be multiple pharmacies that do not carry buprenorphine, one of three medications approved by the FDA to treat OUD and the only one that doesn't require frequent visits to a clinic (methadone) or an injection.
In recent research I co-authored and published in JAMA Network Open, we uncovered that one of the reasons why medications for opioid use disorder (MOUD) are underutilized may be due to lack of access at pharmacies. Facing heavy scrutiny and reporting requirements from federal organizations like the Drug Enforcement Administration (DEA), pharmacies are hesitant or sometimes unable to stock MOUD. Less than two-thirds of pharmacies surveyed reported having the medication on their shelves, something which would be unthinkable for medications used to treat other chronic illnesses.
The DEA is compounding the issue with its proposed telehealth policy changes. The official decision on these changes is postponed until November, but if accepted, access to MOUD would be limited to 30 days when prescribed via telehealth; after that, MOUD treatment would be abruptly stopped until the patient has an in-person exam. With so much uncertainty around prescribing guidelines, pharmacists are perhaps even more hesitant to make medication accessible.
The barriers to care for OUD are already high: there are societal pressures and stigma on top of system failures, making treatment -- and recovery -- difficult. The persistence of these barriers threatens to worsen the opioid epidemic.
Medication for OUD Works and Must Be Accessible
Buprenorphine is an undeniably effective treatment for OUD. Research proves its ability to reduce opioid-related overdoses and deaths -- substantially more than treatment without medication.
In a 2020 study examining the impact of MOUD, buprenorphine and methadone were associated with reductions in overdoses and opioid-related acute care. Another study found that both treatment options reduced opioid-related mortality by over 38% and 59% respectively, compared to supportive care without medication.
Unlike methadone for OUD treatment, buprenorphine can be prescribed in-person or over telehealth and it can be filled at a patient's pharmacy. Despite this, people with OUD are not accessing buprenorphine. A recent study in the New England Journal of Medicine found that only 21% of patients with OUD received prescriptions for buprenorphine after an overdose, a figure that worsens among Black and Latino patients (12.7% and 18.7%, respectively). This research indicates that buprenorphine is greatly underutilized. And our research supports that some of that underutilization may be due to lack of access.
When Prescription Doesn't Equal Treatment
Assuming a patient is able to overcome obstacles like stigma and often onerous in-person treatment requirements, a written MOUD prescription is necessary, but not sufficient -- there's no guarantee the prescription can be filled.
Our research is based on an internal log, in which 5,283 pharmacies across 32 states were called on the behalf of 3,779 patients to confirm buprenorphine stock at their local pharmacy. Only 3,058 (57.9%) reported supply of the medication. This leaves far too many pharmacies (more than 42%) without the ability to offer patients this life-saving medication.
We also found that buprenorphine availability varied significantly by state. Depending on the location, availability dipped as low as 37.1% in Florida, a state with more restrictive policies than states like Washington, where 83.9% of pharmacies reported stock. Even still, California had only 46.8% of pharmacies report stock. This signals a larger problem with federal regulations (like buprenorphine's schedule III regulation), given that buprenorphine is difficult to access in a state known for progressive legislation.
Limitations on Pharmacies
As unfortunate as these numbers are, they're just one piece of an ongoing pharmacy-level challenge, and pharmacies themselves are not necessarily to blame. A study similar to ours reported that 20% of pharmacies contacted chose not to dispense buprenorphine.
Why might they make this choice?
Federal guidelines and policies play a role in limiting access to buprenorphine. The medication is classified as a Schedule III controlled substance, meaning that it is subject to stricter state and federal regulations. By stocking and filling buprenorphine prescriptions, pharmacies are subject to additional scrutiny from the DEA -- a burden many don't want to bear, especially amidst murky policy changes.
During the COVID-19 pandemic, Congress suspended parts of the Ryan Haight Act, a mandate that required physicians to have conducted an in-person evaluation in the last 2 years to prescribe controlled substances via telemedicine. This change -- which should have resulted in more freedom for providers and pharmacies and, in turn, increased MOUD accessibility -- in some cases spurred more restrictions, with chain pharmacies like Walmart reverting back to Ryan Haight era policies while the public health emergency was ongoing. My colleagues have had multiple experiences with various other pharmacies also rejecting buprenorphine prescriptions issued via telehealth, even though they were generated with fully licensed providers.
Pandemic policy changes aside, pharmacies are still forced to navigate regulations without straightforward guidance. Corresponding responsibility policies don't include specific guidelines for buprenorphine dispensing, leading pharmacists to follow standard red flag protocols -- the same protocols used against opioids -- and restrict access unnecessarily.
These policy limitations are just one set of barriers among many. Some drug distributors have indicated reluctance to carry buprenorphine after paying significant settlements for their role distributing opioids like oxycodone and hydrocodone leading up to the opioid overdose epidemic. Even if a pharmacist can stock buprenorphine, some may choose not to stock the medication consistently due to their own stigma against people with OUD (i.e., they are discouraging patients with histories of addiction from coming to their pharmacy). Or they may not report having stock over the phone for fear of robbery. Pharmacies could even incur additional financial risk; "Pharmacy Benefit Managers," the insurance middlemen who deal with reimbursements, may reimburse pharmacies less than the actual cost of the medicine. These social and financial costs are discouraging considerations for pharmacies.
Any solution to this issue will require a multi-pronged approach. But it is unequivocal that the current system isn't working. Limiting access to the point where patients, pharmacists, and providers are forced to constantly make adjustments just to organize treatment is irresponsible -- especially in light of an ongoing opioid overdose epidemic that is still considered a national public health emergency.
There is not enough access to life-saving medication like buprenorphine. Our research indicates that one contributing factor is the lack of medication stocked at pharmacies. Regulators should work on ensuring buprenorphine's availability at all pharmacies.
Scott G. Weiner, MD, MPH, is an emergency physician, and director of research at Bicycle Health.