FDA Takes New Steps to Mitigate Opioid Overprescribing

FDA Takes New Steps to Mitigate Opioid Overprescribing

As part of its ongoing efforts to address the opioid crisis, the US Food and Drug Administration (FDA) has released a revised blueprint containing core content for training that drug manufacturers are required to make available to opioid 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,” the FDA said.

When finalized later this year, coupled with the Opioid Analgesic Risk Evaluation and Mitigation Strategy, 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. For the first time, the FDA is requiring that the guidance be offered to healthcare professionals who are involved in the management of patients with pain, including nurses and pharmacists, in addition to prescribers.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“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. The Blueprint is one tool for achieving these goals,” he added.

Dr Gottlieb said the FDA will 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.”

According to the US Centers for Disease Control and Prevention, opioids — including prescription opioids, heroin, and fentanyl — killed more than 42,000 people in 2016, more than any year on record. Forty percent of all opioid overdose deaths involve a prescription opioid.

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