Rhode Island Hospital has been awarded $1.6 million from the National Institutes of Health (NIH) to study the effectiveness of providing medication and care at pharmacies to people with opioid use disorder, compared to usual care pathways at specialty clinics and doctors’ offices. The unusual approach could mean a major expansion of treatment at a time when the crisis is claiming the lives of 120 Americans every day and six Rhode Islanders every week, according to Traci Green, co-director of Rhode Island Hospital’s new NIH-funded Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose and a senior research scientist.

“Treatment with medications is a critical tool in the opioid crisis, but can only work if it is available and accessible in the community,” said Green, the study’s principal investigator.  “Other countries have long provided addiction care in the pharmacy, and now is the time to learn if it can work here in the United States.”

Currently, patients with an opioid use disorder who are prescribed buprenorphine or naltrexone– two types of Medication Assisted Treatment (MAT) – must see an approved physician or go to a DEA-approved opioid treatment facility for their care. Patients typically then have the medications dispensed at the clinic or go to the pharmacy to pick them up. The trial will allow pharmacists trained in the foundations of addiction treatment to instead be the one, convenient and community-located place patients go for their care and to get their medication.  At the “one-stop” community pharmacy visit patients will fill their prescriptions, obtain medication management and receive follow-up care. The goal is to increase patient engagement and make maintenance therapy more convenient and accessible.

The three-year study is being undertaken in collaboration with the University of Rhode Island College of Pharmacy, the Rhode Island Department of Health, CODAC Behavioral Healthcare and the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities and Hospitals. The state had previously received State Targeted Response funding from the federal Substance Abuse and Mental Health Services Administration to pair novel academic research studies about medication treatment improvements alongside “real-world” investments.

Last August, Nicole Alexander-Scott, director of the Rhode Island Department of Health, signed the first Rhode Island collaborative pharmacy practice agreement for medications for opioid use disorder. It authorizes Genoa Healthcare pharmacies to provide medication treatment in collaboration with medical providers at CODAC, Inc, the largest not-for-profit provider of medications for opioid use disorder in the state and the operator of a similar program at the Rhode Island Department of Corrections. Under this agreement, pharmacists must complete a thorough, 13-hour training in provision of addiction care including the same one buprenorphine prescribers complete; follow the protocols and guidance of the prescriber; and provide timely updates to CODAC on patient experiences.

“Easily accessible treatment for addiction is vital,” said Dr. Alexander-Scott. “This novel approach reflects our philosophy of removing barriers to treatment and recovery for people with opioid use disorder so that we can prevent overdoses and save lives.  We know early treatment is effective and starts people on the road to recovery sooner; this helps the patient, their family and their community.”

Green and her team of researchers had previously secured NIH funds to assess what other countries and other U.S. settings were doing with regards to pharmacy addiction care and to conduct a pilot of pharmacy-provided medication. That took place during fall 2018, with 11 patients testing out the care model for over a month, paying over 70 visits to Genoa pharmacies. Genoa has six sites in Rhode Island.

“With this model, our pharmacists are able to provide specialized care within the neighborhoods our patients live and work, at times that are convenient to them. Our expectation is that this model will improve patient access to care and lessen the stigma that clients experience in treating substance use disorder, which in turn will help them stay in therapy longer and relapse less often,” said Genoa Healthcare chief executive officer Mark Peterson.

“What is so promising about this new project is that it will make options for treating opioid use disorder more accessible in a number of settings,” said Linda Hurley, president and CEO of CODAC. “For example, people who live in rural areas, far from the nearest opioid treatment provider, will be able to receive medication at their community pharmacy.  Access to care at pharmacies also offers a viable alternative for those who may not need the comprehensive and evidence based services provided by opioid treatment programs.  In the midst of the current opioid overdose crisis, pharmacy-based care has the potential to provide critical—and potentially lifesaving—services to individuals who might not otherwise have received treatment.”

“Pharmacists are the most accessible, yet underutilized healthcare providers that specialize in medication safety and disease state optimization. With fewer than 1 in 5 patients receiving any treatment for opioid use disorder, pharmacists are essential to compassionately manage medication-based therapy in partnership with addiction specialists,” said Jeffrey Bratberg, clinical professor of pharmacy practice at the University of Rhode Island, academic collaborations officer for the state Department of Health, and a member of the Governor’s Overdose Prevention and Intervention Task Force.

Green, who is leading the study, is an epidemiologist in the Department of Medicine and co-director of the COBRE on Opioids and Overdose, which was established in 2018 to research innovations to address the opioid epidemic. She also serves as an expert advisor to the Governor’s Overdose Prevention and Intervention Task Force and is an associate professor of emergency medicine and epidemiology at Brown University’s Warren Alpert Medical School.

In addition to establishing the COBRE, Lifespan last year opened the Lifespan Recovery Center, a multidisciplinary, evidence-based, recovery-oriented program that meets the full spectrum of medical and social needs of individuals who have opioid use disorders.