Guidance on Post-Market Risk Evaluation and Mitigation Strategies (REMS)

In 2007, an amendment to the United States Food and Drug Administration (FDA) Act gave the FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from any applicable pharmaceutical manufacturers. A REMS ensures that potential risks in any pharmaceutical or biological product are mitigated as much as possible, that those risks are communicated to users and dispensers of the product, and inherently, that the benefits outweigh any potential risk. In 2009, the FDA issued a draft guidance on REMS, providing a description of an effective REMS, detailing what content is included, the format, supporting documentation, and how to communicate with the FDA about a REMS.

Impact

The Food and Drug Administration presides over all drug approvals in the United States. In addition, because many organizations have international supply chains, the FDA can affect world-wide businesses. The REMS guidelines are applicable to any drug or other biological product that is sold for human consumption in the United States. Those pharmaceuticals approved before the release of the official guidance on REMS are deemed to still have an effective REMS in place, and would need to provide evidence of this for further drug approvals going forward.

Challenge

Required REMS are subject to inspection and are therefore enforceable by the FDA. The lack of an efficient, effective risk strategy can result in a lack of product approvals and product recalls. From the FDA, REMS components include: medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission. There is a two part challenge to creating an effective REMS – first in successfully identifying all potential risk in a drug, and secondly in creating an effective communication plan around those risks. Lack of a consistent, standard format for quality risk identification, analysis and mitigation can lead to undesirable events, unsafe products and processes and inefficient REMS.

The Dyadem Solution

The Stature enterprise risk management solution can assist with all aspects of a Risk Evaluation and Mitigation Strategy, ensuring that any potential risk is properly identified, analyzed, measured and mitigated. Stature can provide your organization with a common risk framework, ensuring that everyone is speaking the same risk language, while significantly reducing risk management effort and cost and ensuring that there is always clear visibility to the risks that could impact patient safety and your business. The Stature Risk Management, Management of Change and Incident Management modules support multiple workflows that can be configured to any corporate standard and provide a global risk register of all risks across the organization. By allowing you to view risk holistically from the start, Stature can help ensure potential risk is addressed efficiently and effectively, helping to establish and communicate effective REMS for any product.