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ISMP Awarded FDA Contract to Support Medication Error Prevention

ECRI Corporate Logo (PRNewsfoto/ECRI)

News provided by

Institute for Safe Medication Practices

Oct 21, 2025, 11:32 ET

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WILLOW GROVE, Pa., Oct. 21, 2025 /PRNewswire/ -- The Institute for Safe Medication Practices (ISMP), an ECRI company, has been awarded a contract from the U.S. Food and Drug Administration (FDA) to provide expert analysis and data-driven insights that will strengthen the agency's ability to identify and reduce the risk of medication errors.

Under the agreement, ISMP will collaborate with FDA's Center for Drug Evaluation and Research (CDER) to advance postmarket surveillance, identify potential causes and contributing factors of medication errors, and help develop strategies to prevent patient harm.

ISMP's services to the FDA will include:

  • Access to anonymous reports from ISMP's national reporting programs
  • In-depth report analysis to assist FDA in evaluating product safety
  • Expert consultation on medication error risk identification and mitigation strategies
  • Customized surveillance reports in response to emerging safety concerns
  • Alerting FDA about emerging medication safety issues and concerning trends

"For years, ISMP has served as the unofficial 'eyes and ears' of the FDA with regards to medication safety," said Rita K. Jew, PharmD, MBA, BCPPS, FASHP, president of ISMP. "We are honored to further support FDA's mission by sharing our expertise in identifying risks early and guiding effective, system-based prevention strategies across care settings."

ISMP's interdisciplinary team of pharmacists, nurses, and clinicians—in addition to subject matter experts from ECRI—has deep experience in developing actionable recommendations that have informed national safety standards. Together, ISMP and ECRI have decades of experience in medication and patient safety, and the ECRI and ISMP Patient Safety Organization (PSO) helps drive improvements using healthcare's largest adverse event dataset.

"Medication errors remain one of the most persistent and preventable sources of harm in healthcare," said Marcus Schabacker, MD, PhD, president and CEO of ECRI. "Preventing these errors demands a culture of vigilance, powered by data-driven insights and cross-industry collaborations including the FDA and patient safety leaders like ECRI and ISMP. We are proud to continue our legacy as a partner to the FDA in improving the safety of healthcare."

ISMP operates the only U.S. voluntary practitioner-based reporting system, the ISMP National Medication Errors Reporting Program, as well as the ISMP National Vaccine Errors Reporting Program and the ISMP Consumer Medication Errors Reporting Program. ISMP also recently built the first state community pharmacy error reporting program in California. The real-time information gained from those programs provides critical medication safety insights that help the entire healthcare community. For more on ISMP's error reporting programs, visit: Report An Error

About the Institute for Safe Medication Practices

The Institute for Safe Medication Practices (ISMP) is the nation's first 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information. For more than 30 years, it also has served as a vital force for progress. ISMP's advocacy work alone has resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging. Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP was acquired by ECRI, a global organization advancing safe, evidence-based healthcare. The ECRI and the ISMP PSO is a federally certified patient safety organization by the U.S. Department of Health and Human Services. As a watchdog organization, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its lifesaving work. Visit www.ismp.org and follow @ismp_org to learn more.

SOURCE Institute for Safe Medication Practices

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