WEBINAR | REMS Technology Innovation: Reducing Prescriber and Pharmacy Burden

Name: WEBINAR | REMS Technology Innovation: Reducing Prescriber and Pharmacy Burden
Start: 2025-01-23
End: 2025-01-23

Examine the REMS Health IT projects that are underway to address prescriber and pharmacy stakeholder burden and ensure a more integrated, automated and aligned REMS implementation system approach.

January 23, 2025

Risk Evaluation and Mitigation Strategy (REMS) programs were introduced as part of the 2007 FDA Administrations Amendment Act and may be used for certain drugs that have serious safety concerns to help ensure their benefits outweigh their risks.

If required, pharmaceutical companies must establish a REMS program by; (1) agreeing the goal and program requirements with FDA, (2) establishing REMS implementation systems for stakeholders to conduct their required activities, and (3) submitting REMS assessments to FDA.

REMS programs often require stakeholders (patients, prescribers, and pharmacists) to complete transactions within the REMS implementation system to ensure that REMS activities have been fulfilled before the drug can be prescribed and/or dispensed. This activity is often performed outside of traditional healthcare workflow and systems, and therefore may increase stakeholder burden for participating in REMS programs.

Pharmaceutical companies, FDA, and REMS industry partners have recently been focused on addressing REMS stakeholder burden concerns through a variety of initiatives.

During this webinar we will examine a solution to address pharmacy REMS stakeholder burden sponsored by an NCPDP grant; that will move the industry towards a more integrated, automated and aligned REMS implementation system approach.

In this webinar, attendees will learn:

How REMS industry partners are collaborating to utilize health information technology standards to simplify REMS program implementations and reduce stakeholder burden.