For the second time in six years, FDA has received a clear directive from its external experts that opioid prescriber education should be mandatory, not voluntary, under the Risk Evaluation and Mitigation Strategy for extended-release/long-acting products.

On May 4, all 30 members of two advisory committees – Drug Safety and Risk Management, and Anesthetic and Analgesic Drug Products – voted in favor of modifying the REMS rather than continuing the risk management plan as is or eliminating it entirely.

Panelists were uniform in their support for adding immediate-release opioid products to the REMS, and all but one of the panelists favored making prescriber education mandatory under the risk management plan.

However, most favored linking the education mandate to Drug Enforcement Administration registration and renewal or state medical board licensing. They said a closed distribution system – characteristic of some REMS with highly restrictive elements to assure safe use – would be more challenging due to concerns that it would be too burdensome in light of the large number of opioid prescribers and prescriptions dispensed annually.

Voluntary Program Not Working

The cornerstone of the current REMS, approved in 2012, is voluntary prescriber education that is funded by ER/LA opioid product sponsors through grants to continuing education providers.

FDA approved a voluntary education program over the objections of the majority of advisory committee members at a July 2010 meeting, who wanted to see mandatory training Also see "FDA Opioid REMS Proposal Leaves Advisory Panel Wanting More - i.e. Mandatory Training" - Pink Sheet, 23 July, 2010.. However, the number of ER/LA opioid prescribers who completed voluntary training by the education program's two-year mark was substantially below the target of 80,000 ([A#14160429003]).

In addition, shortcomings in the REMS assessments made it difficult to ascertain whether the education program was having any impact on prescribing behaviors or safety outcomes ([A#14160427001]).

Panelists were clear in their view that the voluntary education program is not working. Elaine Morrato, a drug safety and health outcomes researcher at the University of Colorado, was in the minority in favoring voluntary education during the 2010 committee meeting.

"I was concerned about the potential burden it might place but also the precedent-setting nature," she said of mandatory education. In addition, she was concerned that a "simple solution" like linkage to DEA licensure might take too long.

However, given the prescriber completion results in the current voluntary program, "I've come to the resolution that it really does need to be mandatory."

University of Washington epidemiologist James Floyd said prescriber education under the REMS "has the potential to be effective with encouraging safe prescribing." However, if it is to have "any chance of being effective it must be mandatory, whatever the mechanisms."

Floyd said he favored linking mandatory education with DEA registration, but "even if that's not possible I do still think that this needs to be a mandatory education component."

The Obama Administration and FDA have supported linking mandatory education with DEA licensure but said it would require congressional action.

David Craig, a clinical pharmacy specialist at the Moffitt Cancer Center in Tampa, said he favored mandatory education at the 2010 meeting. This time around, however, he was the lone voice in support of voluntary education.

Craig noted that the majority of people who abuse opioids are not patients who are prescribed opioids, "so targeting prescribers just to get at that problem won't work." In addition, the majority of patients who die from opioid overdoses are not prescribed the drug. "So opioid REMs will have no effect on those two, in my personal opinion," he said.

"Mandating pain education I think makes more sense," he said.

Tailored Education, Blueprint Revisions

In addition to making education mandatory, panelists recommended tailoring education according to medical specialty and extending training beyond prescribers to include all members of the health care team.

They also called on FDA to revise its educational blueprint to include general concepts related to pain management, not just opioid management.

"If you separate the issue of opioids from the driver, which is pain, you will fail," said Chester Buckenmeir, a pain management specialist at the Uniformed Services University in Bethesda, MD.

FDA's blueprint also should reflect the recently released Centers for Disease Control and Prevention guidelines on opioid prescribing, committee members said ([A#14160315007]).

In favoring the addition of IR products to the REMS, the panelists backed a proposal that would exponentially increase the risk management program's reach in terms of prescribers and prescriptions Also see "FDA's Opioid REMS Review Puts Brakes On Mandatory Education Push" - Pink Sheet, 27 April, 2016..

Panelists also said better objective measures were needed to assess the effectiveness of the REMS.

Committee members said they could not determine from the survey and surveillance data provided by the REMS Product Companies whether the risk management program was meeting its goal of reducing serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse, or whether it was assuring safe use of the products. They generally agreed, however, that the REMS was not unduly burdensome to patient access.

"We clearly need a better evaluation strategy to figure out whether this is worth the money," said Niteesh Choudhry, a health services researcher at Harvard.

Opioid REMS Prescriber Education Should Be Mandatory, FDA Panel Says

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