The FDA’s new opioids Risk Evaluation and Mitigation Strategy (REMS) plan offers training to pharmacists and nurses for the first time, and adds new labeling for all opioids.

The agency’s final Opioid Analgesic REMS includes several measures to help better communicate the serious risks about the use of opioid painkillers to patients and health care professionals, including pharmacists.

Notably, the new REMS subjects immediate-release opioids analgesics—which account for around 90% of prescribed opioids—to a more stringent set of requirements as well as adds new labeling for all opioids, says FDA Commissioner Scott Gottlieb, MD, in a statement.

The new labeling includes information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections of labeling and strongly encourages providers to complete a REMS-compliant education program. The labeling also emphasizes to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists.

In addition, the expanded REMS requires that 347 opioid analgesics intended for outpatient use be subject to REMS, versus the 62 that were previously required.

The new REMS requires that the education for pharmacists, nurses, and other healthcare professionals cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain.

“Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients,” Gottlieb says.

The FDA believes that all healthcare 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,” Lyndsay Meyer, an FDA spokesperson, tells Drug Topics.

The FDA’s goal is to reduce unnecessary and/or inappropriate exposure to opioids by making certain that prescribers are properly informed about appropriate prescribing recommendations, that providers understand how to identify abuse by individual patients, and know how to get patients with opioid use disorder into treatment, Meyer says.

“The crisis of opioid addiction is a public health tragedy of enormous proportions. The FDA’s goal is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of opioid analgesics, while maintaining patient access to pain medications,” she says.

Continuing education training under the modified REMS will be available to health care providers by March 2019.

There is no mandatory federal requirement that prescribers, pharmacists, or other healthcare professionals take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients, according to Meyer.

“However,” she adds, “the FDA’s Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for healthcare providers and how the agency would pursue such a goal.”

This is a “can of worms”… The new REMS requires that the education for pharmacists, nurses, and other healthcare professionals cover broader information about appropriate pain management

If you notice that prescribers are not included in this statement, is the FDA trying to impose some reasoning on healthcare professionals that dispense and/or administer opiates to pts become the intermediary to “monitor” the prescribing of opiates to pts and perhaps become an “obstacle” between the prescriber and the pt  and the pt getting the opiates that have been prescribed to them ?

Could this be another “CDC guideline” type play by a federal agency since  There is no mandatory federal requirement that prescribers, pharmacists, or other healthcare professionals take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients, according to Meyer.

Is this something for the DEA to ‘hang their hat on” to go after prescribers and pharmacist that have not completed the course to accuse them of inappropriate “corresponding responsibility” because of their failure to take the course that is not mandatory ?