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iReminder Calls for Greater Automation of Risk Evaluation and Mitigation Strategies (REMS) Programs Urges adoption of simple and consistent communications in a presentation at the FDA WESTFIELD, NJ [August 3, 2010] iReminder, a healthcare technology company focused on increasing medication compliance, called for greater automation of Risk Evaluation and Mitigation Strategies (REMS) programs. Speaking at the FDA public meeting on REMS, Jean Steckler, senior vice president, advised pharmaceutical manufacturers and the FDA how automation can improve patient communications, prescriber and pharmacy access status, and patient reminders for laboratory test requirements. Dr. Woodcock, a director at the FDA Center for Drug Evaluation and Research (CDER), challenged participants to consider remodeling REMS as the FDA simultaneously constructs REMS programs. Many of the speakers at the public meeting, called for greater efficiencies in administering REMS programs for both the 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 patients' aggregated risk profiles, Steckler recommended automating patient communications and reminders regarding protocol requirements. "We know from research on memory that one day after information is presented to them, people remember only 20% of what they learned," Steckler noted. She pointed out that patients have different optimal learning styles: visual, auditory and those who learn best through interaction, such as restating back 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: patients, prescribers, pharmacy chains and independent pharmacies. Specifically, she recommended sending IVR, email and SMS reminders to patients for upcoming laboratory testing and refill dates, sending automatic alerts to health care providers (HCPs) and pharmacies when patients report that they will not comply with laboratory testing or pick up their refills, and electronic distribution of Medication Guides to patients. Pharmaceutical brand teams, managed care organizations and pharmacies can download iReminder's white paper on REMS at http://ireminder.com/research/white-papers. A full transcript of the presentation also is available there. =========================================================================== iReminder, LLC Additional Resources: A video of the presentation can be viewed at:
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