Angels for Change is proud to announce a significant milestone in Project PROTECT, which aims to anticipate and mitigate critical U.S. drug shortages of essential medicines through non-profit partnership.
Fagron Sterile Services US (FSS), a subsidiary of Fagron, recipient of the 2023 Project PROTECT grant and a leader in the 503B outsourcing industry, has completed the Preparation and Protective phases for preservative-free Dextrose 70% injection solution, an essential medication for hydration and blood sugar control.
This achievement is especially significant in light of the recent flooding and damage to Baxter's North Cove manufacturing site due to Hurricane Helene. The resulting supply shortages prompted the U.S. Food and Drug Administration to include Dextrose on its drug shortage list as of October 12, 2024. However, with the strategic preparations made through Project PROTECT, Dextrose will remain accessible to vulnerable patients, especially PICU and NICU babies, amid these supply chain disruptions.
As a leading 503B outsourcing company, FSS takes a pivotal role in bridging the healthcare supply chain gap. "By securing a supply of Dextrose, we underscore our commitment to Angels for Change, our customers, and most importantly, the patients they serve, addressing the concerns surrounding this drug shortage," said Ray Dixon, Senior Vice President of Commercial at Fagron Sterile Services.
Launched in 2022, Project PROTECT is Angels for Change's proactive approach to build resilience in the U.S. healthcare supply chain. It establishes additional onshore 503B manufacturing of essential medicines at risk of shortage, before shortages occur, ensuring additional onshore supply during disruptions.
One focal point of Project PROTECT has been preventing impact from Total Parental Nutrition (TPN) related pharmacy shortages. This focus is a result of deep collaboration with Children's Hospital Association (CHA) and Angels for Change. Through funding grants and strategic partnerships, Project PROTECT empowers manufacturers like Fagron to ensure the availability of critical medications before disruptions arise, reassuring the public about the preparedness for potential disruptions.
Shabnam Gaskari, PharmD, Chief Pharmacy Officer at Stanford Medicine Children's Health says, "This partnership is essential in safeguarding our most vulnerable patients, pediatric populations, from the impact of drug shortages. The collaboration between Angels for Change, Fagron, and the Children's Hospital Association exemplifies how proactive, strategic initiatives can transform health care delivery, empowering us to meet pediatric patient needs more effectively during challenging times."
Of the 9 medicines awarded PROTECT grants by Angels for Change, 33% have been added to the FDA shortage list. The Project PROTECT model has again succeeded by limiting the patient impact of shortages for the Dextrose disruption. Previously PROTECT ensured access to 750,000 shortage treatments for patients, mostly children.
"Our partnerships with trusted organizations like CHA and Fagron, are preventing disruptions in care for our nation's most vulnerable patients. I would like to thank them for their commitment to patient care. On average, it takes 12 months to move a PROTECT medicine from selection to production. This vital work is building the supply chain of the future. We must value this work and accelerate it to ensure access to care" said Laura Bray, founder and Chief Change Maker at Angels for Change.
Fagron's Role in Proactive Patient Protection:
As part of this strategic partnership, FSS's production readiness for Dextrose addresses potential supply gaps stemming from anticipated disruptions, including seasonal and environmental impacts on significant suppliers. Its proactive approach to providing essential Dextrose supply demonstrates the power of a patient-centered strategy in preventing healthcare crises and underscores Fagron's commitment to public health and wellbeing. This strong partnership between Fagron and Angels for Change instills confidence in the public about the proactive approach to healthcare and medication availability.
"Fagron, through FSS and Fagron's other companies in the United States and abroad, remains committed to quality and safety within pharmaceutical compounding. Through our partnership with Angels for Change, we are proactively securing essential medications for healthcare providers across the country," said Jason McGuire, Senior Vice President of Operations at Fagron Sterile Services, emphasizing Fagron's commitment to patient care and healthcare.
Children's Hospital Association's Role in Safeguarding Pediatric Health Amid Drug Shortages:
The Children's Hospital Association (CHA) has been instrumental in addressing the recent hurricane-related shortages, focusing on critical needs for hydration and TPN management in pediatric care. Working closely with Angels for Change and Project PROTECT, CHA has mobilized resources and advocated for rapid response strategies to mitigate the shortage's impact on children nationwide. Leveraging its network of over 200 children's hospitals, CHA has prioritized essential needs of pediatric patients, coordinating with healthcare providers and policymakers to secure a reliable drug supply for children.
"Because children are disproportionately impacted by drug shortages and have unique pharmaceutical needs, collaborating in projects like this to raise awareness and advance work on supporting children's health is a high priority," said Terri Lyle Wilson, Vice President of Pharmacy at Children's Hospital Association.
About Project PROTECT:
Project PROTECT is a scalable program that provides grants to 503B outsourcing facilities. Its goal is to ensure the continuous availability and supply of over 100 essential medications vulnerable to shortages. This award-winning program enhances supply chain resilience and supports patient care nationwide.
For more information please visit, www.angelsforchange.org
