FDA regulations regarding risk management have been growing since Thalidomide was found to cause birth defects. The passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA) mandated enforceable guidelines referred to as Risk Evaluation and Mitigation Strategies (REMS). Designed and implemented properly, a REMS program both protects patients from known or potential serious risks, and offers an economic upside to the biopharmaceutical business.

Several REMS components include commonly used communications tools, such as Patient Package Inserts (PPI), Medication Guides, and Dear Doctor/Dear Pharmacist letters. Other elements may also include HCP (Health Care Providers) and pharmacist education, restrictive distribution, dispenser and patient registries, and required patient laboratory testing.

To maximize patient benefit as well as HCP and pharmacy efficiencies, automation within and across systems is required. For more complex REMS systems, automation will improve patient, HCP and pharmacy compliance. Examples include:

• Automated IVR, email, SMS reminders to patients to remind them of upcoming laboratory testing and refill dates
• Automated alerts to HCP and pharmacies when patients report that they will not comply with laboratory testing or refill pick ups
• Automated distribution and printing of Medication Guides at the pharmacy and HCP office
• Online access for: pharmacies to determine certification status of HCPs, prescribers to determine certification status of pharmacies, wholesalers to determine certification status of pharmacies, HCP and pharmacy training and certification
•  Online storage of HCP and Patient Agreement documentation

Much of current record keeping is paper‐based, providing gross inefficiencies and poor transparency for all stakeholders. These problems will be resolved as the FDA approves previously paper‐based REMS processes.

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June 2010, written by Jean Steckler, Senior Vice President of www.ireminder.com