All news

Revving Up for REMS - Part 3

(Third of a three part series)

Part 3: Implementing a REMS Management System

In addition to creating and implementing their Risk Evaluation and Mitigation Strategy (REMS),[1] pharmaceutical companies are also responsible for training healthcare providers and patients in the REMS’ elements and registering, monitoring, tracking, reporting, and evaluating data about those who have been trained, the effectiveness of REMS activities and events, and other necessary documentation. Implementing risk mitigation strategies and demonstrating compliance with the REMS can mean a mountain of educational materials, documentation, and reports.[2]

In each REMS document, the company must follow FDA-mandated guidelines in describing how it intends to manage the drug’s safety issues. If the REMS document is approved by the FDA, the company will then need to train staff, healthcare providers, and patients in the document’s provisions. The company will also need to track data on each REMS component for compliance.

To manage those data, many pharmaceutical brand marketers are likely to also become intimately familiar with a Learning Management System, or LMS, a software application specifically designed for the administration, documentation, tracking, and reporting of training activities and content.[3] Some pharmaceutical companies are already employing an LMS to manage their routine training needs. A REMS involves lots of training, tracking, reporting, and rich, robust content, which is where the LMS methodology can shine.

According to Bruce Bellande, PhD, chief education officer and chief compliance office for DWA Healthcare Communications Group (Bruce_Bellande@dwahcg.com), an LMS adapted into a custom-designed REMS Management System, or RMS, can be ideally suited to managing the training opportunities that are required to address specific audience needs, and to facilitating the development of additional targeted resources to address any strategic gaps that may surface. Why? Because the most robust systems can

  • Centralize and automate administration
  • Use self-service and self-guided services
  • Assemble and deliver learning content rapidly
  • Consolidate training initiatives on a scalable Web-based platform
  • Support portability and standards
  • Personalize content
  • Enable knowledge reuse

The custom-designed REMS Management System, or RMS, can support

  • REMS programs with online distribution and documentation of compliance with healthcare professionals
  • Drug safety training for employees and external partners
  • Centralized management of safety surveillance programs
  • Tailored programs to meet global regulatory compliance

Features can include

  • 24/7 online access to learning materials, content, and services
  • Online capabilities to view progress of groups and individuals
  • Client-specific portal/dashboards with the opportunity to brand at highest participation level
  • Client-specific reporting tool for administrators on-demand
  • Client-specific reporting back to client systems as needed
  • Collaborative areas such as e-learning for clients and learners

Bellande cautions that researching the system is of key importance before purchase because of the variety of features and configurations offered by competing LMS products. Not all REMS will be managed the same way, so evaluating the what, when, why, and how of documentation needs is essential before considering various LMS systems.

Summary

Marketers as communicators have a key role to play in the development and implementation of REMS. They must ensure that the brand marketing message and strategy are both reflected in the REMS and implemented in concordance with the REMS throughout the lifecycle of the product. Maximizing the marketing benefits of REMS and mitigating their potentially negative impact on the drug’s market are essential to ensuring the successful commercialization of high-risk, high-benefit pharmaceuticals.

References

  1. Food and Drug Administration Amendments Act of 2007. Public Law 110-85. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugand
    CosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrug
    AdministrationAmendmentsActof2007/FullTextofFDAAALaw/default.htm
  2. Jambulingam T. Roadmap for REMS. PharmExec. July 1, 2010; http://pharmexec.findpharma.com/pharmexec/Regulatory/Road-Map-for-REMS/ArticleStandard/Article/detail/678715?contextCategoryId=43767.
  3. Ellis RK. Field guide to learning management systems.  http://www.astd.org/NR/rdonlyres/12ECDB99-3B91-403E-9B15-7E597444645D/23395/LMS_fieldguide_20091.pdf. Accessed November 4, 2010.

          Read more about REMS in Part 1: A REMS Primer, and Part 2: What REMS Can Mean for Marketers.


          ©2011 Avant Healthcare Marketing, Inc.