Rockville, Md., July 21, 2023 – The U.S. Pharmacopeia (USP) issued the following statement from Vimala Raghavendran, Vice President for Informatics Product Development in response to the tornado damage sustained by Pfizer Inc.'s North Carolina facility on July 19.
“USP is saddened to hear of the tornado that affected central North Carolina yesterday, which resulted in damage to a Pfizer facility that produces medicines for U.S. patients and is an important supplier of sterile injectables. Our thoughts are with those who suffered injury or damage from the destructive event and we stand ready to support Pfizer and others involved in the responding to the rebuilding effort. We commend Pfizer for its contributions to bolstering the supply of essential medicines in the U.S. through this facility and hope for a swift recovery.
“Tragedies like this underscore the need for an early warning system to help identify critical medicines at risk for shortage. This is why USP is pleased to support the Mapping America’s Pharmaceutical Supply (MAPS) Act (S. 2364), co-sponsored by Senators Gary Peters (D-MI), Mike Braun (R-IN) and James Lankford (R-OK), which will facilitate a robust mapping of the medicines supply chain to provide a greater understanding of where active pharmaceutical ingredients and key starting materials are produced. This information can help target and inform responses – including to potential supply chain disruption events such as this weather event – to help mitigate drug shortages and make policy reforms and U.S. government investments to enhance resilience.
“Although the damage to Pfizer’s facility and the effect on operations and the supply chain are still being assessed, USP’s analysis of available data through the Medicine Supply Map identified more than 150 medications made at the facility, about half of which our analysis shows are on the FDA essential medicines list. Our review also shows that many of the products manufactured at this location have been in shortage recently and were already at risk for shortage before the tornado occurred.
“Leveraging insights from USP’s Medicine Supply Map, our analysis indicates that many of the medicines made at this facility are electrolytes, such as potassium chloride and magnesium sulfate, which are used for conditions such as severe dehydration, cardiac arrest and metabolic acidosis, including diabetic ketoacidosis. The USP Medicine Supply Map shows that these electrolytes had an average Vulnerability Score of 92% prior to the tornado. The high vulnerability score indicates that these products are approximately five times more likely to be in shortage compared to all other medicines tracked by USP’s Medicine Supply Map.
“Our data indicates that this facility also manufactures a large number of anesthetics and analgesics, used in hospital settings to control pain, with average vulnerability scores of 95% and 94% respectively. Our analysis also finds that some of these drugs are controlled substances, such as morphine and fentanyl, used for pain management in oncology or in acute care settings.
“Many of the medicines made at this facility are sterile injectables, which are complicated to manufacture and often low in price. Injectable medicines often undergo a manufacturing process called lyophilization, which is expensive and complex, and therefore medicines made with this process have lower supply chain resilience. Manufacturing complexity and low price are two of four main factors correlated with shortage risk, according to USP’s analysis. Other factors include manufacturing quality issues and geographic concentration of manufacturing. The combination of these factors is used to calculate the USP Vulnerability Score.
“The significant damage affecting this important pharmaceutical facility in the U.S. represents another potential challenge to the resilience of the medicines supply chain. There are currently more than 300 medicines in shortage according to the American Society of Health-System Pharmacists. Severe climate events, such as this tornado and the severe weather system currently affecting much of the U.S., are expected to increase in frequency and location. In addition to climate events, sociopolitical tensions and public health emergencies can also lead to plant closures and shortages.”