United States Pharmacopeia Statement: Angels for Change, USP and Vizient collaborate to characterize and quantify supply chain risk for drugs to improve pediatric oncology patient access to quality medicines

Rockville, MD, May 13, 2021 - USP, Vizient and Angels for Change collaborated to develop a predictive model focused on improving supply chain resilience for 17 critical pediatric oncology drugs. Pediatric oncology drugs have been at high risk of shortage  for a long-time: 13 of the drugs examined have experienced shortages in the last 3 years, with each shortage lasting for ~3 years; the average drug shortage lasts 2 years. Many of the drugs examined do not have clinical substitutes.  

“Pediatric oncology drugs have long been at high risk of shortage and this has impacted hospital costs and led to adverse patient outcomes. The Drug Supply Resiliency Model, which builds on the Pediatric Drug Shortage Project implemented by CHA and Vizient, helps us quantify the root causes and further identify solutions as we work to eliminate pediatric drug shortages,” said Terri Wilson, Director, Supply Chain Services – Pharmacy at Children’s Hospital Association, who served as an advisor on this project.  

USP’s graph-based data capability, the Medicine Supply Map, served as the foundation for the analysis of the 17 drugs. The capability aggregates over 200 million datapoints and 20+ data sources from USP, FDA, CMS, European Medicines Agency and private sector sources. The goal of this capability is to identify, characterize and quantify risk in the upstream pharmaceutical supply chain. The Drug Supply Resilience Model is one application of the Medicine Supply Map. This model quantifies the supply chain resilience of a specific drug compared to the supply chain resilience of the average generic  drug. The various validated factors are captured in a scorecard and include quality, geographic concentration, price, market competitiveness, and manufacturing complexity.”

“Understanding upstream supply chain risk is important for governments, GPOs and manufacturers to prioritize investments in improving the resiliency of the supply chain. Data on the medicine supply chain is fragmented, but private sector collaborations such as this can bring together a more complete picture and help governments, GPOs, manufacturers and other stakeholders work together to improve the resiliency of the supply chain and prevent patients from experiencing drug shortages,” said Stephen Schondelmeyer, co-Principal Investigator of the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Diseases Research and Policy (CIDRAP). Dr. Schondelmeyer also served as an advisor on the predictive modeling project.

The model that USP, Angels for Change and Vizient built to identify shortages of critical pediatric oncology drugs exemplifies how private sector collaboration can unlock insights into the supply chain. The organizations brought together fragmented expertise and data, with the goal of producing insights that will help prevent or mitigate the impact of supply interruptions on providers and patients.  

  • Angels for Change, a non-profit patient advocacy group dedicated to ending drug shortages in pediatric oncology, identified the 17 drugs for the pilot, in consultation with clinical experts.   
  • USP developed the model and contributed upstream supply chain data. USP brings insights into the upstream supply chain to the Medicine Supply Map. It leverages insights from ~22,000 locations where USP standards are used and USP’s on-the-ground presence in global manufacturing hubs like India, China, Europe and the United States.   
  • Vizient, the nation’s largest group purchasing organization, supports members with a focused mission to end drug shortages. Beginning with the identification of essential medications for which supply disruption would impact a hospital's ability to deliver care, Vizient addresses drug shortages through key initiatives including the Novaplus Enhanced Supply program that encourages additional production of essential medications, and the Pediatric Drug Shortage project, developed in collaboration with Children’s Hospital Association, that addresses essential medications specific to pediatric care.  Vizient provided expertise and contributed downstream demand data.

A paper will be made publicly available that describes the insights gained from this work on the supply chain resilience of pediatric oncology drugs. USP also welcomes input from additional stakeholders on the model’s application to other public health use cases. For more information, contact Vimala Raghavendran, Senior Director of USP’s Pharmaceutical Supply Chain Center at VAR@usp.org.