ISMP Partners with FDA to Enhance Medication Safety Standards
ISMP Collaborates with FDA to Bolster Medication Safety
WILLOW GROVE, Pa. — The Institute for Safe Medication Practices (ISMP), an esteemed ECRI company, is thrilled to announce a significant partnership with the U.S. Food and Drug Administration (FDA). This collaboration aims to strengthen the ability of the FDA to recognize and mitigate the risks associated with medication errors through meticulous analysis and data-driven insights.
Enhancing Surveillance of Medication Errors
Under this new agreement, ISMP will work closely with the FDA's Center for Drug Evaluation and Research (CDER). Together, they will focus on advancing postmarket surveillance, identifying root causes and potential risk factors linked to medication errors, while also developing effective prevention strategies to safeguard patients.
Key Services Offered by ISMP
ISMP will provide several critical services to support the FDA, including:
- Access to anonymized reports generated from ISMP's extensive national reporting programs.
- In-depth analysis reports aimed at evaluating product safety comprehensively.
- Expert consultation on identifying medication error risks and creating mitigation strategies.
- Tailored surveillance reports in response to emerging medication safety concerns.
- Proactive notifications to the FDA regarding new medication safety issues and concerning trends.
Leadership Insights on Medication Safety
"For years, ISMP has been recognized as the unofficial watchdog for the FDA in terms of medication safety," stated Rita K. Jew, PharmD, MBA, BCPPS, FASHP, who serves as the president of ISMP. "We are honored to enhance our support for the FDA's mission by sharing our expertise in early risk identification and effective, systems-based prevention strategies across various healthcare settings.”
The Expertise Behind ISMP
ISMP boasts a dedicated interdisciplinary team composed of pharmacists, nurses, and clinicians, alongside subject matter experts from ECRI. This dynamic team has substantial experience in establishing actionable recommendations that inform national safety standards. With decades of combined expertise in medication and patient safety, ISMP and ECRI are champions for advancements in healthcare, backed by the largest dataset of adverse events in the industry.
Addressing Medication Errors in Healthcare
“Medication errors continue to be one of the most prevalent and preventable sources of harm within healthcare systems,” remarked Marcus Schabacker, MD, PhD, president and CEO of ECRI. “Stopping these errors requires a culture of vigilance, informed by data-driven insights and collaborations across the industry, including with the FDA and trusted partners like ISMP and ECRI. We are proud to maintain our role as partners with the FDA in enhancing healthcare safety.”
Revolutionizing Medication Error Reporting
ISMP operates the only voluntary practitioner-based reporting system in the United States, known as the ISMP National Medication Errors Reporting Program. Additionally, it oversees the ISMP National Vaccine Errors Reporting Program and the ISMP Consumer Medication Errors Reporting Program. A recent highlight includes the establishment of California's first community pharmacy error reporting initiative. The instant feedback gathered from these programs delivers vital medication safety intelligence that benefits the broader healthcare community.
About ISMP
The Institute for Safe Medication Practices (ISMP) stands as the nation's pioneering 501(c)(3) nonprofit organization solely dedicated to preventing medication errors. With over three decades of impactful service, ISMP is lauded for its comprehensive medication safety resources and advocacy efforts, prompting critical advancements in clinical practices, public policies, and drug packaging. Known for operating the only national voluntary reporting program for medication errors, ISMP also disseminates timely information through newsletters that are trusted by healthcare professionals globally. Following its acquisition by ECRI in 2020, ISMP continues to enhance its mission within evidence-based healthcare, as a federally certified patient safety organization by the U.S. Department of Health and Human Services. As a proud advocacy group, ISMP functions without advertising revenue, relying entirely on charitable donations and grants to support its essential work.
Frequently Asked Questions
What is the purpose of ISMP's contract with the FDA?
The contract aims to provide expert analysis and insights to help the FDA identify and mitigate medication errors, enhancing patient safety.
What specific services will ISMP offer under this partnership?
ISMP will offer access to reporting data, analysis of safety concerns, expert consultations, and alerts on emerging medication safety issues.
Who are the key leaders involved in this collaboration?
Rita K. Jew, president of ISMP, and Marcus Schabacker, president and CEO of ECRI, are notable figures emphasizing the importance of this initiative.
How does ISMP contribute to medication safety?
ISMP operates national reporting programs and educational initiatives, helping to implement improvements in medication practices across healthcare settings.
What resources does ISMP provide to healthcare professionals?
ISMP offers various resources including newsletters with real-time error information, reporting tools, educational programs, and guidelines aimed at enhancing medication safety.
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