BETHESDA, MD 08 Aug 2013—Risk evaluation and mitigation strategy (REMS) programs have generally existed outside of normal health care delivery systems, but it's time to merge the two, say pharmacists and other health care providers.
With the increased use of electronic data exchange in health care delivery, "the conditions are becoming more favorable for the integration of REMS into the health care system," said JoAnn Stubbings, clinical associate professor at the University of Illinois at Chicago College of Pharmacy.
Stubbings was 1 of about 40 panelists at FDA's July 25–26 public meeting on the standardization and evaluation of REMS programs. She said her 495-bed hospital has incorporated into its electronic medical records and pharmacy systems the REMS programs for erythropoiesis-stimulating agents, clozapine, and lenalidomide.
She said benefits of this process include the verification and documentation of required REMS elements by prescribers and pharmacy staff and the ability to ensure that patients have appropriate access to their medications during care transitions.
"The health care system is evolving into an integrated model," Stubbings said. "I believe that REMS could be part of this integrated model."
For this to happen, REMS program elements need to be standardized, FDA and many panelists agreed.
Standardization of REMS programs is also a legislative priority. The 2013–17 reauthorization of the Prescription Drug User Fee Act requires FDA to work with stakeholders to standardize REMS programs in ways that reduce their burden on the health care delivery system.
FDA analyst Adam Kroetsch said FDA wants REMS programs to be "compatible with established systems for procurement, distribution, and dispensing."
He said some variation in REMS programs is necessary, but some is not, and the latter processes may be good targets for standardization.
For example, he said, many REMS programs use similar enrollment forms and educational materials but call them by different names, which has created a "very confusing" situation for users and also hampers standardization.
He also said FDA has created unnecessary complexity by using "regulatory terms" such as ETASU, short for "elements to assure safe use," when describing REMS programs. He said this type of language provides no useful information about how REMS programs actually work.
"We're going to try to steer clear of that terminology" in the future, Kroetsch said.
He said FDA is currently characterizing existing REMS programs to identify best practices for standardization and make the programs "more effective and less burdensome."
Kroetsch said FDA is "very interested" in translating REMS program elements into Structured Product Labeling (SPL) format, the document markup standard already used in drug labeling.
Gerald K. McEvoy, ASHP's assistant vice president for drug information, said ASHP "clearly supports the leveraging of SPL as a means for standardizing REMS data."
McEvoy volunteers as the leader of the National Council for Prescription Drug Programs (NCPDP) task group on REMS SPL requirements. The group's goal is to create a data structure within SPL that allows the timely and meaningful electronic transmission and translation of the data within systems used for the prescribing, approval, coverage, compliance, dispensing, monitoring, and reporting of prescription drug data.
"REMS information could be extracted easily, automatically, and electronically from an SPL document," McEvoy said. "Patients and their safety as well as timely access to REMS [drugs] are the most important reasons to standardize REMS information via SPL."
McEvoy said REMS programs aren't currently required to conform to data standards. Although many REMS program documents exist in electronic form, most consist of PDF or word processing program files. Nothing electronically connects the content of REMS programs to the labeling for the drugs themselves.
NCPDP envisions the federal government's DailyMed system, which uses SPL, as the central repository for REMS program data. Drug manufacturers already submit SPL data to DailyMed; at the end of July, the database included information on more than 52,000 prescription and nonprescription drug products.
McEvoy said that one of the first steps that could be taken to incorporate REMS programs into DailyMed is to simply add an identifier that the drug is subject to a REMS program.
He said that medication guides are the only components of any REMS programs that are currently coded into the DailyMed database.
Many meeting attendees described the effects of current REMS programs on workflow patterns in pharmacies and elsewhere.
Kaiser Permanente drug information pharmacist Doug Monroe called for the elimination of specialty distribution networks that prevent Kaiser and other closed systems from obtaining certain drugs that have a REMS program.
Jim DeVita, director of quality assurance and patient safety for CVS Caremark, said REMS programs require community pharmacies to enter the same data into multiple computer systems, which unnecessarily adds to the time it takes for patients to receive their medications.
David Chen, ASHP's director of pharmacy practice sections, likewise said that the lack of standardization within REMS programs "results in large amounts of duplication within health systems."
Chen said ASHP members are concerned that REMS programs adversely affect "the already limited time that pharmacists have to care for and ensure the safety of their patients."
"Members tell us they've had to dedicate significant resources to REMS," he said.
REMS program requirements that shut out hospitals, use alternative supply channels, or force patients to bring in their own medications during a hospital stay decrease patient safety by operating outside of established procedures, Chen said.
Representatives from several pharmacy organizations also said that requiring individual pharmacists to undergo special certification before dispensing a drug with a REMS program is unnecessary.
The panelists said that today's pharmacists are already qualified to dispense REMS drugs because pharmacists are highly trained experts who routinely manage complex drug therapy for patients.
FDA officials said they will take into account the meeting participants' concerns when the agency prepares a report outlining its next steps toward REMS program standardization. Public comments can be submitted at any time to docket FDA–2013–N–0502 at regulations.gov, but comments must be received by September 16 to be addressed in the report.