Countries around the world continue to be impacted by record breaking climate events. Extreme weather has impacted major hubs where U.S. medicine is made, including India, China and Italy. Most recently, all factories in 19 cities and prefectures in Sichuan province in China have been shut down for six days because of power shortages amid the most extreme heat wave the region has faced in six decades.
As reported in this recent New York Times article, demand for power amid the intense heat wave has forced Chinese leaders to close factories for a wide range of industries. The report gave examples of the impact on the automotive and tech industries. However, the heat related closures also directly affect the pharmaceutical industry and pose risks for U.S. patients’ access to several critical medications.
The U.S. Pharmacopeia Medicine Supply Map has identified 48 U.S. approved prescription drug products and four active pharmaceutical ingredients (APIs) made in the impacted Sichuan Province. These are primarily antibiotics and include daptomycin, an antibacterial that is used to treat skin conditions, already in shortage. There are U.S. suppliers of daptomycin API in Chengdu in the Sichuan Province, but also in Italy and Denmark, areas that are also experiencing extreme heat and drought events, as well as other parts of China. Two drug products on the FDA Essential Medicines List – octreotide injectable and ticagrelor tablets – are also approved for manufacture in Sichuan province.
However, to really understand if the Sichuan province shutdowns pose a material risk to the U.S. medicine supply, we need to know how much volume is made in the region. Some of this information is available commercially, but is expensive to access. We also don’t know how many key starting materials (KSM), critical components of APIs, are made in the impacted regions. To our knowledge, there is very little information about what KSMs are important to the U.S. medicine supply, let alone knowledge about where these critical ingredients are made.
Without visibility into the pharmaceutical supply chain, it is difficult for U.S. policymakers to make informed decisions about preparedness planning, for manufacturers to decide whether to increase production or shore up raw material inventory, or for hospitals and group purchasing organizations to know how to bolster or preserve supply of critical medicines to protect patient care. The USP Medicine Supply Map can provide insight into risks from geographic concentration of key drug ingredients and medicines, as well as the impact from other factors like price, complexity of the product, and competition that can inform those decisions.
Severe climate events are expected to increase in frequency and location, and they are just one of many different causes of disruptions. Sociopolitical tensions and public health emergencies can also lead to plant closures and shortages. Thankfully, China’s current heatwave is expected to end soon. Manufacturers typically keep multiple months of API supply on hand, so the shutdown is unlikely to have a significant impact right away. However, if another heat wave or extreme climate event forces similar closures, the U.S. must evaluate the impact on its pharmaceutical supply chain and should take steps to diversify the number of suppliers of essential impact to minimize the risk to patients.