RMP and REMS: The Most Stringent Risk Minimization Measures – Restricted Distribution


The past two decades have seen a fundamental “swing of the pendulum” where regulatory agencies have increasingly scrutinized the patient safety risks associated with medications. This has led to a rising number of Risk Minimization commitments regulators are requiring from pharma and biotech companies. To handle tasks of tracking and managing Risk Management activities and commitments, many companies initially turn to applications such as SharePoint, email, spreadsheets, and/or homegrown systems only to discover the overload of manual activity required from these systems. Due to this volume, companies have become increasingly overwhelmed and are in need of an efficient means to track and manage Risk Minimization requirements around the globe.

Purpose of Restricted Distribution

The most stringent– and therefore the most burdensome– Risk Minimization activities to manage, are Controlled Access and/or Restricted Distribution Programs. To ensure safe and appropriate use, the Risk Minimization measures of these programs gate access to therapies. This restriction to access involves one or several stakeholders, including health care providers, pharmacists, and patients. To demonstrate their compliance, pharma and biotech companies responsible for these programs must track the metrics associated with Restricted Distribution activities, placing even greater burden on teams to manage. REMS teams must ensure their Restrictive Distribution Programs do not overburden their organization, or the healthcare system at large – a challenge particularly for teams using manual processes and systems.

How do we track data to demonstrate compliance?

Digital technologies fundamentally shift the balance, meeting the need to have controls or “gates” in place to ensure safe use of the product without overburdening the system. Digitizing the holistic tracking of the data and the managed risks is the most efficient and effective way for all parties to demonstrate their compliance in accordance with the established commitments. Moreover, the transparency in the communication of these commitments alone promotes proactive identification and mitigation of risks before they escalate. Digital technologies present a huge opportunity within REMS programs to integrate the strategy, activities, and the collected data cross-functionally to demonstrate overall compliance.

Orbit facilitates activities automatically

Orbit’s strategy aligns all the stakeholders, with the appropriate systems in place to effectively track and manage the end-to-end process. The data collection is purposeful and simple – what is the data we need to collect that is going to affect our ability to evaluate program effectiveness? how can we strategically track and manage compliance commitments to streamline the various handoffs for better communication, compliance, and management? This continuous monitoring serves the industry and opens more opportunities for patient access while effectively managing the added variables.

Within the highest degree of REMS, there is the consistent need to provide access and manage the risk in the least burdensome yet most effective way. Orbit does that with its systematic approach. Consider the benefits of centralizing everything in one platform, from planning to the dissemination of Risk Minimization Measures, through to the back end of program effectiveness. It connects the people, the processes, and the systems that help facilitate the balance companies are trying to strike between ensuring patient access while maintaining appropriate controls.