A new US government report characterizes risks in the 100-day supply chains of 143 essential prescription drugs, including 86 priority drugs deemed critical to the health of Americans. The vulnerability of these supply chains, which underlies drug shortages, has been exposed by the pandemic and other recent natural disasters, such as hurricanes in Puerto Rico.
The US Office of the Assistant Secretary for Preparedness and Response (ASPR) released the nation's first Essential Medicines Supply Chain and Manufacturing Resilience Assessment this week in response to a February 2021 White House executive order. ASPR is part of the US Department of Health and Human Services.
"A resilient and robust U.S. supply chain can ensure that essential medicines are available in the event of a pandemic or crisis as well as for typical acute patient care," the report authors wrote. "The reliable availability of these medicines can help to alleviate strains on hospital resources, resulting in more lives saved and improved patient care."
Actions needed to cut US reliance on foreign drug makers
The ASPR report features case studies and an action plan to address these risks. The plan stresses quality, diversification, redundancy, and reduction of US reliance on foreign drug makers.
Specifically, it urges anticipation of shortages using a centralized "control tower" platform using integrated data and supply-chain business metric networks. This would allow preparation of stockpiles, establishment of multiple sourcing options and contingency plans, and maintenance of a strong workforce and robust distribution capabilities.
Among the challenges to accomplish this goal are:
- Lack of data sharing, integration, standardization, communication, and transparency across the drug supply chain
- Need to reform procurement and purchasing practices that promote quality and supply-chain resilience rather than just the least expensive product
- Incentives to work with nearby, friendly countries to move production closer to the United States (ie, nearshoring)
- Need for a global supply chain map for critical medications, pinpointing source location, volume, and number of facilities involved in production of active pharmaceutical ingredients (APIs), finished-dose forms, and related supplies, such as syringes, needles, filters, and vials
- Lack of clearly defined roles for federal agencies, including the Food and Drug Administration (FDA), the Federal Emergency Management Agency (FEMA), and the Centers for Disease Control & Prevention (CDC), in ensuring a sustainable drug supply
- Vulnerable physical and cyber security measures throughout the supply drug chain
- Need to create a comprehensive set of priorities and logistical plans for addressing drug shortages when they to occur
"The strategies outlined in this report aim to move toward a more coordinated and prepared pharmaceutical supply chain," the report authors wrote. "The result—the more reliable availability of medicines when and where they are needed—can strengthen the United States' ability not only to respond to crisis- or market-based demand fluctuations but also to ensure economic and national security."
RDSP's resilient drug supply map
Most of the recommendations of the ASPR report are on target, said Stephen Schondelmeyer, PharmD, PhD, coinvestigator of the Resilient Drug Supply Project (RDSP), part of the Center for Infectious Disease Research and Policy at the University of Minnesota
"We have already taken actions to address many of those needs and challenges," he said. For example, since 2018, we have been building a map of the upstream supply chain for drug products on the US market. This supply map includes not only the 86 priority drugs listed by ASPR, but nearly all generics and most brand-name prescription drug products."
The RDSP drug supply map contains information from more than 60 databases collected from government entities, commercial sources, and private businesses. These datasets are carefully curated, standardized, and integrated to ensure valid linkages of data for each drug throughout the entire drug supply chain.
Among the data in the supply map is the company name and geographic location where the drug’s active APIs and finished product are made. This country-of-origin information is then linked to the US drug sponsor and to the specific drug product marketed in the United States. The map also includes information on FDA regulatory actions related to importation, facility inspection, drug master files for API production, bioequivalence, and approved labeling.
RDSP tracks global product demand, supply disruptions, and systemic vulnerabilities in the drug supply chain. Through evidence-based predictive models and algorithms as well as incorporation of information from current market events, the design evolves and adapts to changing situations.
Situational analyses focus on bottlenecks in the upstream drug supply chain and the many organizations that contract to manufacture drug products. Among the considered market factors are quality problems and recalls, shipping delays, raw material shortages, and geopolitical and economic issues. The RDSP model also incorporates data on weather patterns, critical infrastructure such as electrical and nuclear power plants, and geopolitical risk factors.
"Working alone, neither the FDA nor individual stakeholders such as manufacturers and wholesalers can have a comprehensive view of the upstream drug supply chain for the US market," Schondelmeyer said.
He added that stakeholders and policymakers can use the market-wide RDSP map to ensure visibility into the upstream US drug market. This tool can bring to life the recommendations in the ASPR report and strengthen the reliability and quality of the US drug supply.
"Widespread and timely access to drug therapy depends on a robust competitive market and a resilient drug supply chain so that Americans will have necessary prescription drugs when and where they are needed," Schondelmeyer said. "Ensuring the supply of drugs that Americans need is a critical infrastructure issue that has public health, economic, and national security implications."