REMS Technology Innovation: Reducing Prescriber and Pharmacy Burden

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 to the goal and program requirements set by the US Food and Drug Administration (FDA), (2) establishing REMS implementation systems for stakeholders to conduct their required activities and (3) submitting REMS assessments to FDA.

REMS programs often require REMS 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 focused on addressing REMS stakeholder burden concerns through a variety of initiatives.

In this webinar, the expert speakers will examine the different REMS Health IT projects that are underway to address prescriber and pharmacy REMS stakeholder burden and look towards a more integrated, automated and aligned REMS implementation system approach.

Register for this webinar today to understand the evolving landscape of REMS programs and explore innovative health IT projects that are aimed at reducing the burden on prescribers and pharmacists.

Speakers

Justin Wilson, Executive Director, Global Risk Management & REMS Technology Lead, Syneos Health

Justin Wilson is an Executive Director of Software Development and Technology with over 20 years of experience in the healthcare industry, building innovative technologies to drive operational excellence and increase speed, efficiency and quality.

In his role at Syneos Health, Justin is leading the ongoing development of REMS’ end-to-end technology solutions, is responsible for overseeing strategic planning for the technology area of REMS, delivering the REMS programs and leading the internal and external vendors and partners in technology.

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Brent Weyers, Director, Global Risk Management & REMS Implementation, Syneos Health

Brent Weyers brings more than 15 years’ experience in technology, implementations and lifecycle support for Risk Evaluation and Mitigation Strategy (REMS) programs to his role on the Global Risk Management and REMS Implementation team at Syneos Health.

Prior to joining Syneos Health in 2021, Brent spent 11 years at McKesson, where he was largely responsible for providing client strategic oversight and support for multiple REMS and patient assistance programs.

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Matt Wright, Director, Specialty Pharmacovigilance and Product Safety, CVS Specialty

With 20 years of experience in pharmacy technology and training, Matt Wright has spent the last nine years in pharmacy technology support and services at CVS Specialty, which provides specialty pharmacy services for patients who require treatment for rare or complex conditions.

Previously, Matt served as Pharmacy Integration Business Lead for New Albertsons and was responsible for the food and drug retailer’s proprietary Pharmacy Management application.

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Jeff Deitch, CEO, InfoWerks Data Services

With 25 years of experience in pharmacy technology, Jeff Deitch co-founded InfoWerks Data Services in 1997 to deliver data management solutions tailored to the healthcare industry, including new software systems, archive data and provide robust data aggregation and analytics.

Jeff was pivotal in pioneering pharmacy information technology — his innovative code revolutionized the conversion of patient data from outdated systems to modern platforms, allowing pharmacies to transport their invaluable customer databases.

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J.W. Hill, MBAHCM, Executive Director, NCPDP Foundation

J.W. Hill brings over 35 years of experience in the healthcare industry to the NCPDP Foundation and ensures strategic alignment with industry trends in standards development. With expansive knowledge of the industry and NCPDP Standards, Mr. Hill has a keen ability to identify projects that support the Foundation’s strategic initiatives such as patient safety. Mr. Hill recognized the potential to reduce the burden of current REMS processes by using NCPDP’s SCRIPT Standard which is already supporting REMS transactions.

Mr. Hill is a recognized leader in the industry serving as a board member of PQA, and has been involved in ASAE, AMCP and PBMI. He is a published author in Chain Drug Review and Executive Insight, and has represented healthcare organizations in Washington, D.C.

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