Meeting REMS head on

July 1, 2011

Standardization, streamlined processes and technology hold the keys.

The Risk Evaluation and Mitigation Strategies (REMS) program has taken center stage recently as the Food and Drug Administration (FDA), pharmacies and healthcare providers seek ways to improve and streamline its administration. Many believe that the FDA's original intent with REMS — to provide a proactive method for addressing drug safety and post-marketing surveillance of medication safety — is being hampered by its own inherent complexities and lack of standardization.

The outcome of a 2010 FDA meeting regarding REMS revealed that the agency, pharmacists and providers currently agree on two things: (1) achieving the goals of the REMS program is vital; and (2) the program as it currently exists is confusing and costly and places too great a burden on those charged with carrying out its requirements.

There is an urgent need to address these issues. The REMS program is expanding at a rapid pace, from 60 medications requiring REMS in 2009 to 130 in early 2011. As a result, according to the American Society of Health-System Pharmacists (ASHP), it has evolved into “a system that requires us to move around tens of thousands of pieces of paper between hospitals and health systems and providers in the community.”

It's not just the number of drugs that creates challenges. It is also the lack of standardization. Development of REMS is completed independently by each manufacturer and submitted to the FDA. The inherent problem with this process is that the elements of each program could vary significantly.

According to a white paper from the American Pharmacist Association (APhA), “the growing number of disparate programs leads to administrative, logistical and workflow challenges for the healthcare system. The inconsistency that results from such 'silo' programs leads to provider confusion, administrative inefficiencies in implementation, workflow inefficiencies and burdens on the healthcare system.”

Alongside the complexities created by the lack of standardization, one of the most significant concerns has been the ability of hospitals to ensure patient access to needed medications while still policing the process. Access is also impacted by REMS restrictions that limit prescribing to certain specialists or dispensing by specialty pharmacies, which make it difficult for hospitals to obtain needed medications and increase costs. Finally, there are obstacles to sharing REMS information between the inpatient and outpatient settings.

Workflow challenges have been costly because monitoring programs often require double and triple documentation, with redundant information added to medical charts, pharmacy records and the REMS database. Even in cases where an electronic medical record (EMR) is used, the information must still be entered separately into the REMS database. If the patient is on more than one medication with a REMS requirement, the amount of documentation increases exponentially. Hospitals in particular struggle with the logistics of complying with REMS that require distribution of medication guides.

The FDA took its first steps in responding to industry concerns by issuing draft guidance in February that called for the elimination of medication guides from REMS in certain cases, including when medications are dispensed in the inpatient setting. It has also introduced a standardized format for REMS programs.
While these are positive first steps, the overriding burden of workflow challenges associated with compliance has not been addressed. For example, APhA points to the need for a “standardized, system-based process that is user friendly, seamless and integrated into the workflow of prescribers and pharmacists.”

The organization went on to outline a plan of action that included a tiered system based on the degree of intensity and the types of risk targeted, as well as pilot testing of all approved REMS programs. It also recommended that outcomes be prospectively defined and monitored for effectiveness at mitigating identified risks, as well as their impact on quality of care.

One area where technology — specifically electronic drug information publishers — can deliver immediate relief is in the centralization of REMS information by providing a consolidated reference indexing all drugs with REMS and medication guides.

For maximum value and end-user adoption, this information could be integrated with comprehensive drug information references and an array of decision support tools. When combined, the end result would be a reduction in adverse events and improved safety and care outcomes — the primary objectives of the REMS program.

Looking ahead, the ability to resolve REMS compliance issues still plaguing the industry will hinge on successful collaboration between all stakeholders. Collaborative efforts alongside a solid strategy that leverages the promise of technology can result in a streamlined program that will be embraced by pharmacists and prescribers.

Scot Walker, PharmD, MS, BCPS,
is clinical director of
Facts & Comparisons,
part of Wolters Kluwer Health
For more information on
Wolters Kluwer solutions:

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