REMS

The goals of Risk Evaluation & Mitigation Strategies (REMS) and restricted distribution programs within pharmaceutical distribution channels are to protect patients from known or potential serious risks through efforts to ensure safe use of products, reduce diversion and prevent abuse. Meeting compliance objectives requires real-time monitoring for distribution and sales at all levels of stocking, selling, prescribing and dispensing.

The most rigorous REMS guidelines proposed by the FDA are tighter supply chain controls for long-acting and extended-release Class II Opioids with a deadline in the near future. Although the requirements will vary by class or by specific drug, the CII Opioids are among the first drugs to require this type of program and will likely become the model for all future restricted distribution programs.

The ValueTrak Data & Services Platform delivers manufacturers the data, analytics and reporting tools to meet the new government requirements. ValueCentric’s management of the authorized distributor and pharmacy network, linked to real-time data capture, exception alerts, stakeholder enrollments, and supply chain oversight for Mass Balancing, enables manufacturers to address the new FDA Guidance. The ValueTrak REMS is designed to work in conjunction with a REMS authorization system (safety adjudication) along with subsequent and periodic FDA level reporting.