jueves, 1 de febrero de 2018

FDA takes new steps to help mitigate overprescribing of opioid medications as effort to reduce rates of new addiction - Drug Information Update

The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA

On January 30, 2018, 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.

For more information, please visit: Opioid Blueprint

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