Mitigating the Safety Risks of Drugs With a Focus on Opioids: Are Risk Evaluation and Mitigation Strategies the Answer?

Abstract

Approximately 40% of all newly approved drugs are subject to safety restrictions inclusive of Risk Evaluation and Mitigation Strategies (REMS), which were created with the US Food and Drug Administration Amendments Act of 2007. This law expanded Food and Drug Administration (FDA) authority to require REMS of manufacturers but left implementation to the FDA. As a result, the potential access to medications that are effective but not without safety concerns has improved, yet the converse is also true because access may be restricted due to REMS requirements (eg, physician or patient registration). With the July 2012 reauthorization of the Prescription Drug User Fee Act, the FDA was given additional authorities and mandates for enhancing and modernizing the drug safety system-specifically, measuring the effectiveness of REMS as well as standardizing and better integrating REMS into the overall health care system. So, are REMS, which were conceived as a tool to improve medication safety, working? Specifically, are REMS achieving their intended outcomes (mitigating safety risks of effective drugs) without causing unintended consequences (creating a burden to the health care system and physicians and/or diminishing patient access to drugs)? Sitting squarely in the crosshairs, the approved shared REMS for extended-release/long-acting opioid analgesics provide a lens through which this question can be examined. This article discusses the current status, stakeholders, and key policy issues for clinicians with a focus on the shared REMS for opioids, as well as the anticipated role of clinicians in optimizing patient care in the new world of REMS.

Clinical Practice Guidelines for Pain Management in Acute Musculoskeletal Injury

“…Strategies can include medication guides for patients, clinician education, and physician certification. 316 Both immediate-release and extended-release opioids are now subject to these regulations. 317 Thus, manufacturers are required to fund continuing education regarding opioid prescribing.…”

SCOPEof Pain: An Evaluation of an Opioid Risk Evaluation and Mitigation Strategy Continuing Education Program

“…In July 2012, the US Food and Drug Administration (FDA) approved a single shared Risk Evaluation and Mitigation Strategy (REMS) required of manufacturers of extended-release/long-acting (ER/LA) opioid analgesics to promote safe use of these medications [ 32 ]. While most FDA-mandated REMS programs include medication guides and communication plans and are associated with a single medication, this REMS requires all manufacturers to jointly fund accredited continuing education for the approximately 320,000 ER/LA opioid prescribers in the United States [ 33 ]. The FDA created the Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (“FDA Blueprint”) to define the content that must be included in REMS educational programs [ 34 , 35 ].…”

Targeting practitioners: A review of guidelines, training, and policy in pain management

“…It is important to note that REMS requirements mandate that drug manufacturers produce educational materials for specified products; however, there is no accompanying mandate to ensure dissemination of these educational products amongst prescribing physicians. As such, prior REMS programs have suffered low physician participation rates and failed to demonstrate desired effects on prescribers’ knowledge ( Brooks, 2014 ; FDA, 2014 ; Woodcock, 2009 ). In response, the ER/LA REMS program was the first to leverage prescriber trainings offered through existing, accredited continuing education (CE) providers ( Center for Health Policy, 2015 ).…”