How Will the REMS Affect Pain Care?

Aaron Gilson, MS, MSSW, PhD


June 04, 2010


How will the FDA's upcoming REMS plan affect day-to-day neurology practice and prescribing?

Response from Aaron Gilson, MS, MSSW, PhD
Senior Scientist, Paul P. Carbone Comprehensive Cancer Center, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin

In February 2008, the US Food and Drug Administration (FDA) was given the legal authority to require, when considered necessary, pharmaceutical manufacturers to adopt a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a medication outweigh its risks.[1] On April 20, 2009, the FDA introduced the idea of a class-wide REMS for 24 long-acting or extended-release opioid products.[2] All identified products are classified as Schedule II medications indicated for the treatment of moderate to severe pain. The intention of a REMS is to ensure that the benefits of these products continue to outweigh the risks for misuse, abuse, accidental or intentional overdose, and use in opioid-nontolerant or improperly selected patients. The FDA, however, remains legally obligated to authorize the REMS "without unduly burdening the healthcare system or reducing patient access to these medications."[2] Consequently, the REMS must be both effective (eg, reduces nonmedical opioid use) and safe (eg, does not restrict medication access and impede patient care).

The FDA initially proposed a number of characteristics for the REMS that represent "Elements to Assure Safe Use" (ETASU)[2] and are defined in statute to signify methods for safe use.[3] A central ETASU characteristic is a requirement for both education and some sort of certification process for all practitioners who prescribe, dispense, or administer the relevant opioids. Another general requisite involves patient education, which could include universal use of a prescriber/patient agreement (which every patient must sign before receiving a prescription) and even enrollment into a central registry. An additional contemplated feature is the requirement to dispense medications to patients only in certain healthcare settings.

Although the final ETASU characteristics have yet to be formalized, it remains imperative for the FDA to consider possible unintended effects. As research on prescription monitoring programs has demonstrated, imposing onerous requirements with respect to certain medications can lead many clinicians to prescribe other products.[4] Some practitioners may avoid the education/certification process, and because they will be unable to prescribe these products, they will be less able to treat patients with severe pain. Also, the medical use of short-acting opioids not covered by the REMS (eg, hydrocodone combination products) may increase. Researchers already have recognized the potential for such a "squeezing-the-balloon" effect.[5,6]

Federal efforts are critical for managing the nonmedical use of prescription opioids. The FDA, therefore, must endeavor to implement a program that has the most favorable consequences for the dual public health concerns of abuse/diversion and medication access for patient pain care.[7] As part of this process, the FDA has an open docket until October 2010, to which comments can be submitted that the FDA will consider when making its final determinations. If you would like to provide the FDA with feedback regarding REMS, go to, enter the ID keyword "FDA-2009-N-0143-1061," and insert your comment. Yours could be an integral voice in helping shape a national drug control program that can effectively reduce one possible source of abuse and diversion while maintaining legitimate access to patients who require such treatment.


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