In June 2015, FDA updated and streamlined its online resource for all approved Risk Evaluation and Mitigation Strategies (REMS). REMS programs target drugs with serious known risk profiles so that these risks can be balanced carefully with their therapeutic benefits. A total of 82 REMS programs exist, including some classwide programs.
FDA’s Theresa Toigo, BSPharm, MBA, oversees centerwide REMS projects in her capacity as Center for Drug Evaluation and Research (CDER) Associate Director for Drug Safety Operations. Toigo acknowledged that the previous version of the site had its issues. “What we heard from stakeholders was that the site was complicated, difficult to navigate, and was not very user friendly. Most importantly, it was hard to figure out what the different requirements were for patients, prescribers, and pharmacists,” said Toigo.
LCDR Amy Ramanadham, PharmD, MS, U.S. Public Health Service, assisted Toigo and others, including FDA CDER’s Office of Medication Error Prevention and Risk Management, in the creation of the site. Ramanadham added, “When we were designing this site, our guiding principle was to give users relevant information quickly. Every program has a build-out page that describes what you need to do as either a patient, prescriber, or pharmacist. And those are summarized into an easy-to-use table at the top of the page.”
Marcie Bough, PharmD, Executive Director of the Montana Board of Pharmacy, formerly served as APhA’s Senior Director of Government Affairs and worked closely with the FDA on REMS programs. She said the updates “reflect the importance of APhA’s advocacy efforts and publications of the 2009 and 2011 REMS white papers” and should make complying with REMS easier for frontline providers.
“One of the great improvements to the FDA’s resources for health care providers is a central location with all of the information that pharmacists, physicians, and other providers need to implement REMS programs on behalf of their patients,” said Bough. “This is a hub of information that breaks down specifics and directs users toward what they need to do in order to prescribe or dispense medications with REMS requirements.”
The old website listed full REMS documents by drug, but only contained one link with a large PDF document of all the approved labeling—which included the REMS information. Said Bough, “Frontline providers had to wade through this information, and there was no distinction between what should be read by prescribers or by pharmacists or by patients. Now, these lines are clearly drawn, and many separate documents are included.”
Bough added that REMS programs are more than just patient safety paperwork; they can be a valuable opportunity for pharmacists to counsel.
“Use this as an opportunity to have the dialogue with the patient,” said Bough. “Ultimately, it can become a greater dialogue about medication reconciliation, or medication therapy management activities. REMS can be the tool that helps start that dialogue.”
Toigo added that pharmacists should be direct about the dangers of the drug in this dialogue, as it is in the patient’s best interest. “Prior to dispensing, a REMS may require a pharmacist to counsel on the serious risk associated with the drug,” she said. “That counseling is intended to help the patient mitigate and avoid this risk.”
Toigo and Ramanadham said that FDA will continue to build on improvements to the website, especially with the goal of making REMS programs less arduous.
“What we’ve heard from pharmacists is a request for more standardization,” said Toigo. “They would like all forms for REMS to be similar and accessible in one place. The site takes a step in the direction that pharmacists want, but you still have to go to a separate outside site hosted by the drug’s manufacturer to enroll patients.”
“A future state of REMS we are working toward is if requirements were integrated into pharmacy management systems, where pharmacists would not have to leave the system to verify it,” said Ramanadham. “For busy pharmacists, if REMS were integrated that way, without multiple steps, that would be ideal.”
Seeking more feedback, FDA is holding a public meeting about REMS at its White Oak Campus in Silver Spring, MD, on October 5–6, 2015. FDA panelists, including frontline physician and pharmacist providers, will present their experiences. Comments from pharmacists and the general public are welcomed.