ISMP Partners with FDA to Enhance Medication Error Prevention Strategies

In a significant move to strengthen patient safety, the Institute for Safe Medication Practices (ISMP), which operates under ECRI, has been awarded a pivotal contract by the U.S. Food and Drug Administration (FDA). This agreement focuses on advancing medication error prevention by providing expert insights and data-driven analysis that will empower the FDA to identify and mitigate the risks associated with medication errors.

The Collaboration Framework

The foundation of this collaboration lies in ISMP's expertise in postmarket surveillance and its ability to identify potential catalysts contributing to medication errors. Under the terms of the agreement, ISMP will work closely with the FDA's Center for Drug Evaluation and Research (CDER) to achieve several objectives:

1. Access to Anonymous Reports: ISMP will furnish the FDA with access to anonymous reports generated from its national reporting programs, enhancing the agency's understanding of real-world medication errors.
2. Thematic Report Analysis: Detailed report analysis will be conducted to assist the FDA in evaluating product safety comprehensively.
3. Expert Consultation: ISMP will provide consultancy services focusing on identifying medication error risks and formulating effective mitigation strategies.
4. Tailored Surveillance Reports: Customized reports will be generated in response to emerging safety concerns, addressing new risks as they arise.
5. Alert System for Emerging Issues: ISMP will keep the FDA informed about emerging medication safety concerns and troubling trends, enabling timely interventions.

Voices from Leadership

ISMP President Rita K. Jew expressed the organization’s commitment to the FDA's mission, stating, "For years, ISMP has served as the unofficial 'eyes and ears' of the FDA regarding medication safety. We are honored to support the FDA by sharing our expertise to identify risks early and guide effective system-based prevention strategies across various healthcare settings."

On a similar note, Dr. Marcus Schabacker, CEO of ECRI, emphasized the critical nature of preventing medication errors stating, "Medication errors are among the most persistent and preventable threats to patient safety. Addressing these errors requires a dedicated culture of vigilance, supported by data-driven insights, and collaboration across the healthcare landscape, including federal bodies like the FDA."

ISMP's Legacy and Expertise in Medication Safety

With extensive experience in medication safety, ISMP operates the only voluntary practitioner-based reporting system in the U.S., facilitating crucial insights through its National Medication Errors Reporting Program, alongside specialized programs focused on vaccine and consumer medication errors. Recently, the organization launched the first statewide community pharmacy medication error reporting program in California, showcasing its innovative approach to enhancing medication safety.

For over three decades, ISMP has been recognized as a leading force in advocating for essential changes in clinical practices and public policies regarding medication safety. After becoming part of ECRI in 2020, ISMP has further solidified its role in advancing safe, evidence-based healthcare.

Foundation of Trust

As a nonprofit organization, ISMP operates without any advertising revenues. It relies entirely on charitable donations, educational grants, and volunteer efforts. This model ensures its altruistic mission to protect patients from medication errors remains uncompromised.

For those interested in learning more about ISMP's work or the resources it provides for medication safety, detailed information can be found on ISMP's official website: ISMP Website.

In summary, the partnership between ISMP and the FDA represents a proactive approach toward enhancing medication safety and minimizing the risks associated with medication errors, ultimately impacting the healthcare community positively.