Maximizing REMS potential

While the Risk Evaluation and Mitigation Strategies program has come under fire for its inefficiencies, all is not yet lost.

Standardization, streamlined processes, and technology - all three are fundamental strategies for eliminating many of the complexities that plague the healthcare industry today. The Risk Evaluation and Mitigation Strategies (REMS) program is one FDA initiative that has taken center stage recently because of its inherent flaws in each of these areas.

Originally designed as a proactive method for addressing drug safety and postmarketing surveillance of medication safety, REMS has received ample criticism of its complicated processes, lack of standardization, and negative impact on pharmacy workflows and medication management. The need to address specific workflow challenges has been cited as a top priority, and the American Pharmacist Association (APhA) has emphasized the need for a "standardized, system-based process that is user-friendly, seamless, and integrated into the workflow of prescribers and pharmacists."

Flawed technology

Also, in light of the fact that some REMS will require action by the prescriber, patient, and pharmacist, there is often no way to know whether all REMS criteria have been met before he tries to fill a prescription, Mattingly said, noting that he often does not learn whether there are additional requirements until he tries to adjudicate the claim.

APhA has identified technology as a critical element to future success. Specifically, having REMS information centralized in a data repository to index drugs with REMS and medication guides will help workflow complexities by allowing convenient access to requirements.

This could be accomplished by means of electronic drug information publishers, whose services are already used by the vast majority of retail and hospital pharmacies. Indeed, true workflow savings will be realized when REMS information is available in a pharmacy management system, enabling identification of requirements when a prescription is being processed without requiring the pharmacist to exit the system.

Need for standardization

FDA has taken some steps in recent years to provide relief in the face of a growing list of medications requiring REMS action. One key initiative is the introduction of a standardized format for REMS that now provides guidance to manufacturers.

The rapid growth of medications requiring REMS has also been curtailed. At one point, the list of REMS-approved drugs had reached upwards of 160, with some requiring only a medication guide as part of the required action.

Because the requirement for medication guides is met through other FDA standards, the decision was made to remove those medications from the REMS list, bringing the current number to 94 total REMS programs, with 26 of those that have specific Elements to Assure Safe Use (ETASU). Posing the greatest challenge to compliance, ETASU is a restrictive element of REMS, controlling access to a drug that may be deemed high risk due to its potential for adverse events.

More action needed

These steps are a positive start, although the hefty workflow challenges still must be addressed. In addition to the identified benefits of advanced technology and automation, APhA has made a number of other recommendations.

APhA has outlined a plan of action that includes a tiered system based on the number of REMS requirements for a product and the types of risk targeted.

Along with suggesting pilot tests of all approved REMS programs, the plan highlighted the necessity for defined outcomes that are monitored to accurately measure the effectiveness of REMS programs in mitigating risk and improving quality of care.

Consistent compliance with REMS requirements might be achieved with a solid technology infrastructure in place to complement these actions. If REMS information and alerts could be integrated with comprehensive drug information references and decision support tools, the end result would be a reduction in adverse events and improved patient safety - the primary goal of the program.

Industry professionals overwhelmingly agree that an optimum balance can be achieved between regulating pharmaceuticals and ensuring efficient access to necessary medications. Looking ahead, a collaborative approach among all stakeholders is necessary to ensure that REMS reaches its full potential.

Scot Walker, PharmD, MS, BCPS, BCACP is senior director, Content Development, Facts & Comparisons, Wolters Kluwer Health. E-mail him at

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