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BioPharma: Efforts Under Way to Make REMS More Efficient

HIT Perspectives Biopharma Insights – June 2015

Efforts Under Way to Make REMS More Efficient and Less Burdensome

By Brian Bamberger,  Health Sciences Practice Lead

The Food and Drug Administration (FDA) requires the use of REMS – risk evaluation and mitigation strategies – to manage the risks of certain drugs or biological products to ensure that their benefits outweigh risks. Look for the nature of REMS programs to start changing due to efforts aimed at increasing REMS’ efficiency by making them part of the electronic prescribing (ePrescribing) work flow.

Today, REMS include complex processes for educating patients and physicians about a drug’s safety and various criteria prescribers must meet to ensure safe use, such as physician certification in order to prescribe the drug, patient enrollment in a central registry, and restricted distribution of the drug to certain specialty pharmacies. Assessments, reports and audits must be done periodically and provided to the FDA and the drug’s manufacturer. Currently, this involves time-consuming, labor-intensive paper/phone/fax-based processes outside the work flow of physicians and pharmacies. REMS processes are similarly burdensome for pharmaceutical manufacturers.

Recognizing the burden and inefficiency of current REMS processes, pharmaceutical manufacturers, the FDA and the pharmacy services industry have banded together in fledgling efforts to streamline REMS processes and bring them into the digital age. Considerable work currently is focused on standardizing and integrating REMS solutions into electronic health records (EHRs) through ePrescribing electronic transaction standards. Most physicians are ePrescribing these days, and EHRs are the ePrescribing vehicle for the vast majority of ePrescribers.

In fact, a REMS transaction standard was discussed at the May meeting of the National Council for Prescription Drug Programs (NCPDP), which develops and maintains a number of standards related to ePrescribing. The proposed standard would enable automated communication through the EHR between the health care provider and REMS administrator (manufacturer or outsourced). Improved communication among the parties involved will reduce administrative overhead and improve the quality of REMS processes.

To assist adoption and transaction approval by NCPDP, we believe a pilot is in order to move the process along. Even small pilots can yield valuable results. Point-of-Care Partners has extensive experience in piloting new ePrescribing transactions. Call us or drop us an email to discuss the possibilities.