Sunday, August 8, 2010

Improving Automation of REMS

iReminder, a healthcare technology company focused on increasing medication compliance, is calling for the greater automation of “Risk Evaluation and Mitigation Strategies” (REMS) programs. Jean Steckler, Senior Vice President, speaking at an FDA public meeting on REMS, advised pharmaceutical manufacturers and the FDA on how automation should be used to improve patient communications, prescriber and pharmacy access status, and provide patients with reminders for laboratory test requirements.

Many of the speakers at the public meeting, called for greater efficiencies in administering REMS programs for both prescribers and pharmacies. The challenge facing the FDA is to find the right balance between designing REMS templates for different classes of drugs and accommodating drug specific risk profiles.

Since patient medication treatment decisions are not made in isolation and are based on the patient’s aggregated risk profiles, Steckler recommends automating patient communications and reminders regarding protocol requirements.

“We know from research on memory that one day after information is presented, people remember only 20 percent of what they have learned,” Steckler noted. She pointed out that patients have different optimal learning styles in terms of visual and auditory, but it has been found that individuals learn best through interaction and by restating their understanding of their risk profiles.

“Despite the collective best efforts of pharmaceutical manufacturers and the FDA to design readable and culturally appropriate Medication Guides, these guides are typically quickly discarded by patients,” Steckler added.

Steckler proposed a methodology to simplify and provide consistent patient communications across all stakeholders such as with patients, prescribers, pharmacy chains, and independent pharmacies. Specifically, she recommends sending IVR, email, and SMS reminders to patients for upcoming laboratory testing and refill dates, sending automatic alerts to healthcare providers and pharmacies when patients report that they will not comply with laboratory testing or pick up their refills, and to distribute Medication Guides electronically to patients.

A new whitepaper “Risk Mitigation Regulation and Compliance Review” published by iReminder LLC provides guidance on meeting FDA requirements as set forth in the FDA Amendments Act of 2007for products with known or potential risks.

To download the whitepaper on REMS, go to To contact Jean Steckler email