FDA expand REMS education program in effort against opioid crisis

pharmafile | September 19, 2018 | News story | Research and Development FDA, IR, opioid crisis, opioids, rems 

The US Food and Drug Administration is set to introduce a requirement that all healthcare providers be offered educational training in pain management and safe opioid prescribing under a major expansion of the agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) programme.

Furthermore, while previously the REMS program had only applied to long acting (ER/LA) opioid analgesics, the program is now set to be expanded to include immediate release (IR) opioids such as hydrocodone, oxycodone and morphine.

As expanded upon by FDA commissioner Scott Gottlieb: “Many people who become addicted to opioids will have their first exposure in the medical setting. Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements.”

First established in 2012, the REMS program required manufacturers of ER/LA opioids to pay for continuing education programs for prescribers only.  The expanded program will thus require manufacturers of both IR and ER/LA opioids to pay for education programmes for all healthcare providers. Nevertheless in both cases the training is not mandatory.

The FDA expanded on the move in noting that: “The agency believes that all health care providers involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight”

Louis Goss

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