Risk Minimization Action Plans (Risk MAPs)

No one benefits from drug underutilization or from patient adverse events brought on by improper drug use — not the patient, not the drug manufacturer, not the payor, not the prescribing physician.

At ParagonRx^®, one of our major services is to assist pharmaceutical and biotech companies in helping to ensure that their drugs receive proper usage to benefit the appropriate patient population while reducing adverse events as much as possible. We accomplish this through cooperatively designed Risk Minimization Action Plans, usually begun during late stage drug development, that meet or exceed what the FDA will require for drug approval.

ParagonRx^® has benchmarked practices in other industries and disciplines as well as evolved and published A Framework for Pharmaceutical Risk Management. This allows the incorporation of insights from engineering, process improvement, adult learning, and disease management. The resulting approach overcomes inappropriate underuse through effective education rather than imposing restrictions that interfere with care.

See our Risk Management service pages for more details.