URI Pharmacy professor part of first-of-its-kind pilot study published in New England Journal of Medicine, showing patients can safely start care in community pharmacies without physician visit

Researchers at the University of Rhode Island College of Pharmacy, Rhode Island Hospital and Brown University found that pharmacists — not just physicians and clinicians at doctors’ offices — can safely and effectively start patients with opioid use disorder on lifesaving treatments without a prior visit to a physician. With more than 100,000 people dying in 2022 from overdose deaths and an ongoing opioid crisis stretching across the country, improving access to medications for opioid use disorder such as buprenorphine through pharmacists is a critical step.

The first-of-its-kind study, described in a letter to the editor in the Jan. 12 edition of the New England Journal of Medicine, documents the experience of 100 patients who started on the evidence-based medication buprenorphine by coming to a specially trained pharmacist for their care. Once stabilized on the medication, 58 patients were randomized to receive either continued care in the pharmacy or usual care in a clinic or physician’s office. After one month, the patients in the pharmacy group showed dramatically higher rates of retention in care: 25 (89 percent) continued in the pharmacy compared to just 5 (17 percent) in the usual care (physician or clinic) group.

“We have a serious treatment gap. We are missing 90 percent of the people with opioid use disorder whom need and want treatment,” said Jeffrey Bratberg, a clinical professor of pharmacy practice at the URI College of Pharmacy and an investigator on the study. “Pharmacists are an underutilized partner in the healthcare workforce, especially the behavioral healthcare workforce. There is a pharmacy within 5 miles of where 95 percent of Americans live.”

For the study, researchers visited addiction medicine specialists around the state to recruit patients, many of which were not being adequately served by the health care community, and were not being treated for their opioid use disorder. Many participants were unemployed, unstably housed, or otherwise lacking access to care. The study gave them the opportunity to receive safe, convenient same-day treatment at times that were convenient for them, helping maintain their adherence to the program.

“This is a population that’s not being served that should be served, and this is one way we can help do that,” Bratberg said. “A great majority had already been on medication, and for whatever reason, couldn’t stay on treatment, largely because of the social determinants of health. Worldwide, this is the first time someone can walk into a pharmacy and get buprenorphine without a physician visit, expanding their access to care. We found patients who get started in the pharmacy really like that care, and they tend to stick with it. Compared to no care, it’s a dramatic difference in quality of life for them.”

Genoa Healthcare, whose six pharmacies in Rhode Island were involved in the study, supported a team of 21 pharmacists to be trained in how to provide the induction and buprenorphine care. Linda Rowe-Varone, a clinical pharmacist who participated in the study and earned her doctorate of pharmacy at URI, said one of her patients is a mother who lives near the Genoa Healthcare pharmacy in Providence. This woman finds the pharmacy hours much more convenient than the clinic she previously visited and, in contrast with the clinic, the pharmacy feels so safe that she brings her children to appointments. Rowe-Varone said she loved participating in the study.

“I met people who could be my family members, my neighbors, people I work with, people I pass walking on the street, and they would come into our pharmacy for help,” she said. “They wanted to become healthy again. I feel as if we’re right there for them.”

The unique collaboration between Genoa Healthcare, the researchers, and state leadership at the Rhode Island Department of Health and the Department of Behavioral Health, Developmental Disabilities and Hospitals created the legal and policy infrastructure to support the study and test out the pharmacy care model. 

“Treatment with medications can only work if it is available and accessible in the community,” explains Dr. Josiah D. Rich, a study physician and professor of medicine at Brown School of Medicine. “This disease kills by stigma and isolation. Our study showed that a diverse patient population could benefit from treatments offered in a community pharmacy.”

The opportunity to open up the pharmacy for addiction treatment is set for 2023: Changes President Joe Biden signed into law eliminate the X waiver, which was previously required to prescribe buprenorphine. Currently, 10 states allow pharmacists to obtain Drug Enforcement Agency authorization to prescribe controlled substances, which means use of the study’s findings could be swift.

“Dramatically increasing capacity to provide good, lifesaving treatment for people with opioid use disorder through pharmacies is an approach that could be ramped up today,” said Dr. Traci Green, the study’s principal investigator and co-director of Rhode Island Hospital’s Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose. “It’s a gamechanger.”

Green, who led the study, is an epidemiologist and an adjunct associate professor of emergency medicine and epidemiology at Brown University’s Warren Alpert Medical School. She, along with Rich and Bratberg also serve as expert advisors to the Rhode Island Governor’s Overdose Prevention and Intervention Task Force.