Sponsors of long-acting/extended release opioids are to submit their first assessment of prescribers’ understanding of the risks associated with the drugs by July 9, 2015, three years after Risk Evaluation and Mitigation Strategies for the products will have been operating and at a point when 25% of the drugs’ prescribers are expected to have received special training.

The first assessment of patient’s understanding about the drugs’ risks will be due a year earlier. Initial assessments, due Dec. 9, 2012 and July 9, 2013, will focus on progress in putting the REMS in place.

The changing nature of the REMS assessment, which evaluates whether the REMS’ goal is being met at year two, reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put its components in place.

Opioid REMS Coverage

This issue of the “The Pink Sheet” has in-depth coverage of the finalized REMS for long-acting opioids, including:

Also see "Opioid Training Syllabus Increases Emphasis On Patient Monitoring In Final REMS Blueprint" - Pink Sheet, 16 July, 2012.
Also see "Mandatory Training For Opioid Prescribers Remains Stuck On Drawing Board" - Pink Sheet, 16 July, 2012.
Also see "OxyContin Abuse-Deterrent Formulation Has Addicts Switching To Heroin" - Pink Sheet, 16 July, 2012.
Also see "One-Page MedGuide For Long-acting Opioids Sets Stage For Retooling MedGuide Format" - Pink Sheet, 16 July, 2012.
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Also see "Long-Acting Opioid REMS Tally: FDA Lists 12 Brand, 23 Generic" - Pink Sheet, 16 July, 2012.

It also provides more time for the psychometric work needed to prepare surveys that provide accurate evaluations of patient and prescriber knowledge. Limited time for that work was a complaint of drug companies during a recent workshop with FDA Also see "REMS Clock Ticking: Sponsors Grapple With Assessment Time Constraints" - Pink Sheet, 9 July, 2012..

FDA approved individual REMS for 12 brand and 23 generic LA/ER opioids July 9 to institute a class-wide effort aimed at reducing misuse and abuse of the narcotic pain killers.

To facilitate implementation of its requirements, a single, shared system known as the ER/LA Opioid REMS will fund prescriber training through the continuing medical education process and conduct the assessments of whether the REMS are meeting their goals.

That, FDA says in its approval letters to the sponsors, is “to ensure that the benefits of the drugs continue to outweigh the risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate prescribing, abuse and misuse.”

Each REMS consists of a Medication Guide and patient counseling form to educate patients about the risk of the drugs, a voluntary health care provider training program, letters to alert prescribers and their medical societies about the training and an assessment scheme.

Prescriber Education To Begin In Nine Months

The earlier look at patients’ risk comprehension, a staple of REMS comprehension, is indicative of the timeline for disseminating the REMS’ risk message.

Patients will receive revised Medication Guides with their prescriptions beginning Aug. 8 Also see "One-Page MedGuide For Long-acting Opioids Sets Stage For Retooling MedGuide Format" - Pink Sheet, 16 July, 2012..

But the voluntary training program for prescribers, designated as an Element To Assure Safe Use, is still in development, with a launch deadline of March 1, 2013 Also see "Opioid Training Syllabus Increases Emphasis On Patient Monitoring In Final REMS Blueprint" - Pink Sheet, 16 July, 2012..

Anatomy Of The REMS For Long-acting Opioids

The agency gives sponsors performance goals of educating 80,000 prescribers (25% of the 320,000 who wrote a prescription for an ER/LA opioid in 2011) within two years of the training program’s start-up; 160,000 (50% of the prescriber base) within three years and 192,000 (60% of the subscriber base) within four years.

Those goals are more lenient than the ones proposed by FDA when it informed drug companies about the REMS’ content in April 2011. At that time, the agency had in mind that 50% of prescribers would be trained within six months and 70% within 12 months, but suggested consultation with CME providers “to determine what can realistically be achieved,” a consultation that apparently reduced FDA expectations Also see "REMS Assessments For Opioids Will Require Data From Across Health System" - Pink Sheet, 25 April, 2011..

Despite the timeline change for prescriber education, FDA retains its proposal for assessment of the REMS’ effectiveness at six months, 12 months and yearly thereafter. Assessments are to conclude no earlier than 60 days before their due date.

Initial Assessment: Program Development

The early assessments will focus on progress toward instituting, developing and starting the training courses. The first evaluation, due Jan. 9, 2013, must provide a status report on developing the CME training, including a list of those selected to conduct the training, which will be funded but not conducted by ER/LA Opioid REMS, when the training will begin and how many prescribers are expected to be trained by each course; a status report on efforts to select contractors to evaluate prescribers’ long-term retention of knowledge and changes in their prescribing behavior – to be conducted six months to a year after completion of the training; and the number of letters sent to prescribers and professional organizations to alert them about the educational opportunities.

The second assessment is due July 9, 2013, which is only three months after the educational courses are expected to begin. It asks for the number of those who have participated in the training or are expected to participate, but otherwise again focuses on the status of the training program, distribution of letters to alert physicians of its existence and the status of the prescriber evaluation program.

Two-Year Mark: Impact On Drug Use

It is at year two, July 9, 2014, when an assessment will first look at the REMS’ influence on use of the LA/ER opioid drugs. The sponsors are to provide surveillance information on changes in abuse, misuse, overdose, addiction and death for different risk groups, such as teens and chronic abusers, and different centers, such as emergency rooms and addiction treatment centers. The information is to be drug-specific whenever possible.

Training Course Audits

The ER/LA Opioid REMS will ensure that independent audits are conducted to determine whether training courses for opioid prescribers comply with FDA’s Blueprint for Prescriber Education. The factors to be assessed are:

Whether the content covers all elements of the blueprint
Whether instruments used to assess prescribers’ post-course knowledge measure knowledge about all sections of the blueprint
Whether the training was conducted in accordance with the Accreditation Council for Continuing Medication Education standards or appropriate standards for accreditation bodies

Patient comprehension of the drugs’ risks is to be assessed at this time. Prescribers’ risk knowledge need not be assessed, but assessment of drug utilization will include evaluation of prescribing patterns, prescriptions to non-opioid tolerant patients and excessive prescriptions for early refills. The assessment will provide the first count of trained prescribers, although there will not yet be a threshold for success in this area.

At this point, FDA says the assessment should look at whether the risks mentioned in the labeling are being mitigated and whether the goals or the REMS should be modified.

The agency also wants an evaluation of changes in patient access to the narcotic products, but does not specify what information will make this possible.

To ensure the quality of prescriber education, FDA calls for sponsors to submit independent audits of educational materials used by the CME providers in their courses. The audits are required for a random sample of at least 10% of the training funded by the ER/LA Opioid REMS and other courses that comply with FDA’s Blueprint for Prescriber Education and will be counted toward the REMS’ prescriber training goals Also see "Opioid Training Syllabus Increases Emphasis On Patient Monitoring In Final REMS Blueprint" - Pink Sheet, 16 July, 2012..

It is not until the fourth go-round, at July 9, 2015, that the assessment will evaluate prescriber understanding. That will be two-plus years after the CME training is to begin. This will involve comparing the awareness and understanding of prescribers who have taken the REMS-compliant training with those who have not, and an evaluation of prescribers’ knowledge retention and practice changes six months to one year after they complete the training.

The other components of the assessment will be similar to those in the third assessment.

Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment

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