FDA In Brief: FDA takes new steps to help mitigate overprescribing of opioid medications as effort to reduce rates of new addiction

For Immediate Release: Jan. 30, 2018

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"We’re taking an all of the above approach in our efforts to combat the immense public health emergency of opioid addiction. With millions of Americans misusing prescription opioids and more than 40 people dying every day from overdoses involving opioid medications, it has become abundantly clear that we need to do everything we can, along with our partners, to get ahead of this crisis,” said FDA Commissioner Scott Gottlieb, M.D. “Appropriate prescribing practices and education are important steps within our statutory authority to help address the human and financial toll of this crisis. We can and must do more to arm physicians – who are the gatekeepers of prescription opioids – with the most current and comprehensive guidance on the appropriate management of pain. Many people who become addicted will first be exposed to opioids through a lawfully prescribed medication. Often it’s for an immediate-release formulation of an opioid drug. We need to do more to ensure that prescriptions are written for only appropriate purposes and durations of use. Opioids should rarely be our first resort when treating patients in pain. We must continuously reexamine how opioids are being prescribed when deemed an appropriate course of treatment. The Blueprint is one tool for achieving these goals. We’ll continue to seek feedback from a broad group of stakeholders and explore a range of approaches that, when combined with other steps we’re taking to tackle this epidemic, help ensure proper treatment for pain and better addresses the crisis of opioid addiction.."

Today, the U.S. Food and Drug Administration took several important steps as part of its efforts to address the opioid epidemic by releasing a revised Blueprint for opioid prescriber education and holding a public hearing to explore additional frontline measures to curb overprescribing and the rate of new addiction.

The revised Blueprint contains core content for training that drug manufacturers are required to make available to prescribers. The revised Blueprint broadens content to include information on acute and chronic pain management, safe use of opioids or other non-opioid or non-drug treatments, as well as material on addiction medicine and opioid use disorders. Once finalized later this year, together with the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS), the blueprint will apply to manufacturers of both immediate-release opioid analgesics intended for use in the outpatient setting and extended release/long-acting formulations and be required to be offered, for the first time, to other health care professionals who are involved in the management of patients with pain, including nurses and pharmacists, in addition to prescribers. The revised blueprint is being released in advance to ensure these continuing educational materials and activities are made available in a timely manner.

As noted in a statement released today by FDA Commissioner Scott Gottlieb, M.D., the meeting is serving as an opportunity to receive input from a broad group stakeholders as the FDA explores new approaches to encourage appropriate prescribing of opioid analgesics through the FDA’s REMS authorities. Among other things, the agency’s Opioid Policy Steering Committee (OPSC) is considering ways to use these authorities to augment existing prescribing and dispensing practices, such as utilizing electronic prescribing systems and interfacing with state prescription drug monitoring programs, while maintaining appropriate prescribing for patients in medical need. Discussions at the meeting, including possible packaging, storage and disposal solutions, as well as the revised blueprint being released today are in addition to broader ongoing considerations by the FDA about whether mandatory prescriber education is appropriate and how the agency would operationalize such a requirement. These, and other steps, are a part of the FDA’s commitment to take all reasonable steps to address the crisis of opioid use disorder.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.