Providers, You Are the Missing Piece: Your Patients With OUD Need You

As of 2023, more than 5 million people ages 12 or older in the U.S. have opioid use disorder (OUD). Although evidence shows that patients receiving medication for their OUD die of all causes at half the rate of those who do not receive such treatment, only an estimated 1 million people (18%) are receiving FDA-approved treatment.

Primary care providers (PCPs) are uniquely positioned to make a positive impact in addiction care, just as they have for other chronic conditions. Many may already provide medical care to people who have OUD, putting them in a key position to prescribe medications for OUD in addition to other aspects of routine care. To aid in the effort to remove barriers to prescribing medication to treat OUD, Congress amended the Controlled Substances Act in 2022 to remove the requirement that prescribers obtain a waiver to prescribe medications such as buprenorphine to treat OUD.

Right now, PCPs are an underused resource who could be even greater allies in treating OUD, supporting both patients and their families. They know their patients, have developed a strong rapport, and can incorporate screenings and interventions into their medical practice. PCPs could be the primary reason a patient with OUD gets life-saving care. However, PCPs and other prescribers have expressed the need for more treatment options, resources, and support to address substantial treatment gaps.

To inform and encourage prescribers, FDA launched the Prescribe with Confidence campaign in May 2024 in collaboration with federal and other partners. Our hope is that this campaign will play a critical role in supporting PCPs who have less experience treating OUD. The campaign provides information and resources such as handouts, testimonials, and free training for clinicians so that they feel more confident when treating this chronic health condition.

This campaign is just one part of the agency’s long-running efforts to address the overdose crisis under our Overdose Prevention Framework. Since its launch in 2022, our vision has been to undertake impactful, creative actions to prevent drug overdoses and reduce deaths under its guiding principles.

In alignment with our priority of advancing the development of evidence-based treatments for substance use disorder, FDA has taken a number of actions. These include helping to facilitate the development of new formulations, including approving a long-acting injectable buprenorphine and a generic naltrexone extended-release injectable suspension; issuing guidance to support the development of new devices to treat OUD; hosting a public meeting to explore and consider buprenorphine initiation and maintenance dosing strategies when treating OUD; and collaborating with federal partners to host a listening session on the use of high-dose buprenorphine for the treatment of OUD in the context of fentanyl. Taken together, these efforts demonstrate how FDA is using every regulatory tool we have at our disposal to address OUD.

Looking forward, promoting awareness for how clinicians can treat OUD is another important tool within our Overdose Prevention Framework. Research shows that OUD is effectively treated with medication, and there is an opportunity to support healthcare providers — including PCPs — in providing OUD treatment across their careers.

We invite and encourage PCPs and other clinicians to collaborate with us to address the overdose crisis. We invite your feedback, your ideas, and your reflections on treating patients with OUD. We invite you to share your own knowledge and to discuss the real-world evidence regarding the treatment of OUD. We encourage you to use the resources provided through our campaign to feel empowered, supported, and confident when prescribing medication to treat OUD. But most importantly, we invite and encourage you to Prescribe with Confidence.

Robert Califf, MD, is the Commissioner of Food and Drugs and a primary care physician. Marta Sokolowska, PhD, is the Deputy Center Director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research (CDER).

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