News & Updates — Grantee Spotlight

Today, the National Association of Boards of Pharmacy and the National Community Pharmacists Association will begin distributing a first-of-its-kind practice guideline to the nation’s 60,000 community pharmacists. It’s part of an ambitious effort to increase access to buprenorphine, a lifesaving treatment for opioid use disorder (OUD). Studies have found fewer than 60 percent of pharmacies have the medication in stock, putting patients with OUD at risk of treatment interruptions and overdose. The Pharmacy Access to Resources and Medication for Opioid Use Disorder (PhARM-OUD) Guideline is designed to educate pharmacists about the importance of providing access to buprenorphine and help them navigate a complex set of regulatory and clinical barriers to access. FORE spoke to Tyler J. Varisco, PharmD, PhD, assistant professor at the University of Houston College of Pharmacy, who led the FORE-funded project, about how the guideline was developed and what he hopes it will accomplish. It’s been endorsed by a wide array of professional societies and advocacy organizations, including the American Society of Addiction Medicine, the American Pharmacists Association, the American Association of Psychiatric Pharmacists, the American Society of Health-System Pharmacists, and Vital Strategies.

Much of your research focuses on how the decisions pharmacists make at the pharmacy counter influence access and treatment outcomes for substance use disorders. How did you become interested in this topic?

Varisco: It started with my first job as a pharmacy technician. We had a patient on buprenorphine. She was very, very adherent to her medication but only bought three to five films at a time and paid with cash. I suspect it was because she didn’t want to her employer to know about her diagnosis. Coming to the pharmacy a couple of times a week was a major red flag for the pharmacist in charge and he eventually dismissed her as a patient. I was just told, “We’re not going to serve junkies.” As I progressed in my career, I continued to see how that stigma laden perspective interferes with access. Beginning my career at the tail end of the opioid prescribing crisis was also formative. We were ordering and dispensing large quantities of hydrocodone but triaging patients seeking buprenorphine. The contradiction spurred me to study how pharmacy-specific factors influence controlled substance supply, which revealed significant gaps in access to buprenorphine.

What stood out in your research?

Varisco: Looking at data from prescription drug monitoring programs, I was struck by how much variation there was in pharmacies dispensing buprenorphine and how much risk that posed for patients. Using data from Texas, we found the majority of physicians who prescribed buprenorphine were sending their patients to a single pharmacy. This meant patients had to travel farther to fill prescriptions. It also put patients at higher risk if there was a supply disruption because they had fewer pharmacies to turn to. My research also showed that when physicians had more pharmacies to refer to, their patients were more likely to be adherent to treatment.

Because that makes it easier to fill prescriptions?

Varisco: Yes. When it comes to a life-saving medication, having widespread and redundant sources is critical. In a subsequent study, we found that more than a quarter of patients prescribed buprenorphine will change their pharmacy within six months and that patients who changed pharmacies were about 1.67 times more likely to have a gap in therapy of seven days or longer. I don’t think many pharmacists realize how serious these short interruptions in therapy are. Within the first two weeks of a sudden interruption, the patient’s risk of mortality increases by about a factor of nine. A pharmacist may think, “Well, they’re going to be a couple of days delayed in filling their prescription.” But this is not missing a single dose of diabetes medication. This is potentially plunging that patient into withdrawal and the constellation of bad things that can occur if a patient cannot fill their prescription on time.

“For years, NABP has advocated strongly for pharmacists’ role in expanding patient access to approved medications like buprenorphine to treat OUD. NABP’s collaboration with NCPA and UH to develop a buprenorphine dispensing guideline for pharmacists was a natural convergence of our shared goal to ensure patients can access the treatment they need. NABP furthered this effort by hosting a public comment period for the draft guideline and convening an expert panel to review the comments, consider revisions, and finalize the document. NABP appreciates the opportunity to support the project and hopes this guideline will help pharmacists to fulfill their role in preventing opioid overdose deaths.”

Lemrey “Al” Carter, PharmD, MS, RPh‚ Executive Director/Secretary, National Association of Boards of Pharmacy

Why are pharmacists reluctant to stock or dispense the drug?

Varisco: There are a number of factors at play. Even at top pharmacy schools, it’s rare for pharmacists to receive extensive training about OUD or addiction, so many may be unaware of how effective buprenorphine is and the danger that delays or interruptions in treatment present. Many pharmacists are also concerned that ordering buprenorphine from pharmaceutical distributors will raise alarms about diversion and could trigger an investigation or a suspension in shipments of controlled substances. They know that distributors are obligated under the terms of opioid settlements to flag orders above a certain threshold. But under the current system for monitoring controlled substance distribution, pharmacists aren’t permitted to know the numerical value of the threshold, so some limit dispensing or they avoid ordering buprenorphine altogether.

How did you develop the guideline for such a multidimensional issue?

Varisco: It’s the result of a collaboration between the two national associations and three schools of pharmacy: mine, the University of Texas at Austin, and the University of Southern California. We started by interviewing community pharmacists to get a sense of how stigma might play into their dispensing decisions and how administrative, financial, and regulatory barriers to buprenorphine dispensing might vary by region. We convened focus groups in three states — California, Texas, West Virginia.

How much variation did you find?

Varisco: Quite a bit. In Texas, where I live, we found pharmacists have very little experience with dispensing buprenorphine because there are so few treatment providers outside of urban areas. In West Virginia, the pharmacists had more experience with buprenorphine but said they would refuse prescriptions for patients who were not in the same county, which is problematic. In California, where the state has expanded access to buprenorphine through the Medicaid program, we found many independent pharmacists were still reluctant to carry it because of the financial burden of maintaining an inventory and concerns related to distributor thresholds. We shared these and other findings with a panel of experts who helped develop and refine the final recommendations. The panel included past and present members of state pharmacy boards and community pharmacists, as well as people who worked in drug enforcement and with pharmaceutical distributors. It also included addiction medicine physicians and psychiatric pharmacists who have expertise in substance use disorder treatment.

It’s quite an extensive document, with nine main and 39 supporting recommendations. How would you summarize the main takeaways?

Varisco: First and foremost, it is critical that pharmacists treat OUD as they would any other chronic disease and recognize that lack of compassion and support for patients with the disease has deadly consequences. Many of the recommendations encourage pharmacists not to assume ill intent on the part of customers. If they have concerns about why a patient may be traveling to obtain a prescription or seeking one early, they should inquire about it rather than refusing to fill their prescription. If there is a delay in reaching a prescriber, the recommendation is to provide a one, two, or three-day supply to ensure a patient doesn’t go into withdrawal.

How do you address pharmacists’ concerns about being investigated or reaching a threshold that limits their supply?

Varisco: If they’re not rapidly expanding the quantity of buprenorphine they’re dispensing, they’re highly unlikely to hit a distributor threshold. Our guidance is that they should dispense up until they are notified that they crossed the threshold rather than attempt to guess or interpret what their threshold may be. If they do reach it, they can work with their distributor to modify that threshold to ensure that they’re able to fulfill the medical needs of their patients. All three distributors do have a process to file and modify a pharmacy threshold.

Do you have plans to engage patients themselves in ensuring access as well?

Varisco: Yes. We’re going to be working with the Behavioral Health Foundation in Tennessee and Faces and Voices of Recovery, and the O’Neill Institute to gather input from people with OUD on their experiences at pharmacies. We’ll work with a patient workgroup to develop tools that help patients advocate for themselves. We’re envisioning a patient bill of rights that focuses on explaining protections under the Americans with Disabilities Act, which we think applies to inappropriate refusals at the pharmacy counter. We also want them to create educational materials to help patients understand the dispensing process, pharmacy barriers to access, and information on what to do if a pharmacy cannot dispense their medication.

What additional supports might help patients obtain prescriptions with more ease?

Varisco: I think having knowledgeable, trained peer navigators available to go into pharmacies with patients could make a tremendous difference. Having them report on their encounters is also absolutely crucial. The American Society of Addiction Medicine has a portal on their website that allows patients to report pharmacies who refuse buprenorphine prescriptions. Having more access to tools like that and getting that information back to pharmacy organizations and boards of pharmacy can be incredibly useful here.