Medications for opioid use disorder can be lifesaving for those who need them, but deadly for young children—even in small amounts. To better understand the risk of PUE to these medications, the Foundation collaborated with FDA to identify knowledge gaps in current storage and emergency response information provided to parents/caregivers/household members who take MOUD and live in households with young children. Through a thorough scan of existing literature on the topic, discussions with experts, interviews/conversations, and online polling of individuals with and without lived experience, we developed message frameworks and strategies to reduce risk of PUE and poisoning, without adversely affecting patient access or contributing to stigma.
Buprenorphine is a safe and effective prescription medication used for the treatment of Opioid Use Disorder (OUD). Initiation of buprenorphine takes careful planning: patients must already be experiencing mild to moderate withdrawal symptoms or risk precipitated withdrawal. An increase in fentanyl in the illicit drug supply further complicates buprenorphine initiation and maintenance adding to the access challenge.
The Foundation, in collaboration with FDA and the Substance Abuse and Mental Health Services Administration, held a two-part virtual public meeting on “Considerations for Buprenorphine Initiation and Maintenance Care” to support efforts to develop products and approaches to treat OUD.
This report summarizes the discussions and presentations which explored solutions, innovative public health interventions and needed investments in research and product development to spur progress.
The FDA Foundation partnered with FDA’s Center for Drug Evaluation and Research to gain a deeper understanding of individuals’ experiences with substance use disorders (SUDs) – and specifically with SUD treatment. Our approach was to track individual treatment journeys to identify the specific challenges they faced and the supports they found helpful. Our goal is to use this ethnographic research to identify potential system improvements and engagement opportunities that can help inform FDA’s work in the prevention and treatment of SUDs. For this project, we looked at two specific issues: experiences exploring or using medication for opioid use disorder (MOUD), and trajectories of treatment for individuals who have pursued SUD treatment more than once.
Individuals exploring the use of medication to treat SUDs do not travel their paths alone. They are connected to networks of providers, peers, and family members who may have their own experiences, opinions, training, and expertise. Mapping individuals’ experiences led us to also map the experiences – and potential influences – of prescribing clinicians, non-prescribing clinicians such as counselors and therapists, and pharmacists. Individuals and these provider groups demonstrated generally positive views of MOUD and SUD treatment in general.
The FDA Foundation convened, in conjunction with FDA’s Center for Drug Evaluation and Research, a roundtable on “Payor Perspectives on Substance Use Disorder Treatment.” The purpose of the roundtable was to hear key stakeholders’ perspectives on health insurance coverage of pharmacological treatments for SUDs, including how FDA approvals and labeling affect payors and insurance coverage.
Patient advocates, clinicians, payors, health economists, and federal leaders all participated. Attendees discussed the data framework insurance companies utilize in making coverage decisions for patients receiving substance use disorder treatments. The convening additionally generated real-world insight into how regulatory decisions are applied in ways that impact people’s daily lives.
The FDA Foundation, in collaboration with FDA and the National Institute on Drug Abuse (NIDA), hosted a virtual public workshop to discuss a practical research agenda toward treatment development for stimulant use disorder.
Meeting participants responded to a proposed practical research agenda that focuses on innovation in clinical trial design and candidate endpoints for the evaluation of potential treatments for stimulant use disorder.
The Foundation collaborated with the FDA to explore reasons for use, attitudes toward cessation, and unmet treatment option needs for individuals who excessively use nicotine, cannabis, and alcohol or have been diagnosed with a related substance use disorder. Learnings included noted similarities in behaviors and are noted in the summaries on nicotine and cannabis use.