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Regulatory Focus™ > News Articles > FDA Blueprint for Opioid Education Shifts Focus to Pain Patients

FDA Blueprint for Opioid Education Shifts Focus to Pain Patients

Posted 09 May 2017 | By Michael Mezher 

FDA Blueprint for Opioid Education Shifts Focus to Pain Patients

As the US Food and Drug Administration (FDA) weighs its options for improving healthcare provider training and education on prescribing opioids, the agency is proposing changes to its blueprint for opioid prescriber education.

In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers.

Under the REMS, the training must be provided by accredited providers and cover all elements of the agency's Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. However, while the agency set goals for prescriber participation, prescribers were not required under the REMS to go through with the training.

On Tuesday, FDA kicked off a two-day public workshop to gather stakeholder input on how to improve opioid prescriber education, including the possibility for making opioid or pain management training necessary going forward.

Alongside the public workshop, FDA released proposed changes to its education blueprint, which incorporate recommendations made by the agency's Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee in May 2016.

The key changes reveal a shift from focusing on the risks and use of ER/LA opioids to a more holistic discussion of pain management, including methods of assessing patient pain, and the use of nonpharmacological treatments and non-opioid analgesics.

While FDA says the blueprint is not up for discussion at the public workshop, the agency says it hopes the blueprint will "provide important context for the public workshop's discussion."

The agency is also considering expanding the REMS to include immediate-release opioid formulations, which are not currently covered.

Draft Revised Blueprint, Federal Register, Public Workshop


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Tags: Opioids