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Thought Leaders: E-prescribing/Rx Management

Meeting REMS head on T

Standardization, streamlined processes and technology hold the keys. By Scot Walk er, PharmD, MS, BCPS

he Risk Evaluation and Mitigation Strategies (REMS) program has taken center stage recently as the Food and Drug Administration (FDA), pharma- cies 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

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

FDA meeting regard- ing 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 confus-

ing 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, ac- cording 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 signifi cantly. According to a white paper from the American Pharma- cist Association (APhA), “the growing number of disparate programs leads to administrative, logistical and workfl ow challenges for the healthcare system. The inconsistency that results from such ‘silo’ programs leads to provider confusion, administrative ineffi ciencies in implementation, workfl ow inef- fi ciencies and burdens on the healthcare system.” Alongside the complexities created by the lack of standard- ization, one of the most signifi cant 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 diffi cult for hospitals to obtain needed medications and increase costs.

34 July 2011

Finally, there are obstacles to sharing REMS information between the inpatient and outpatient settings. Workfl ow 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 elec- tronic 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 fi rst 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 inpa- tient setting. It has also introduced a standardized format for REMS programs.

While these are positive fi rst steps, the overriding burden

of workfl ow 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 workfl ow 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 pro- spectively defi ned and monitored for effectiveness at mitigating identifi ed risks, as well as their impact on quality of care. One area where technology – specifi cally 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 informa- tion could be integrated with comprehensive drug informa- tion 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 ef- forts alongside a solid strategy that leverages the promise of technology can result in a streamlined program that will be embraced by pharmacists and prescribers.


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