Many people trying to fill a routine prescription or treat an ailment during this harsh cold and flu season are discovering it is not as convenient as dropping by their local pharmacy. Amoxicillin, Tamiflu, and Adderall are just some of the drugs in short supply now, leading people to hunt them down across cities, go without them for days, or search for an alternative treatment. While these shortages may be an annoyance for some, they could be harmful for many — possibly risking the health and lives of people across the country.  

Although the COVID-19 pandemic led to early shortages of certain medical devices, supplies, and drugs, why is the country still facing such shortages?  

Medical product supply chain disruptions are not new; they are a decades-long problem. While shortages of drugs and medical devices are life-threatening for some, they also have systemic effects. Shortages increase pressure on manufacturers and suppliers to meet unpredicted surges in demand, and they compromise the entire U.S. health care system — costing millions of dollars per year.  

“Disruptions in medical product supply chains have greater implications than making people wait for a new television set. They have the potential to seriously compromise patient care,” said Wallace J. Hopp, distinguished professor of business and engineering at the University of Michigan, and chair of the committee that wrote the consensus report, Building Resilience into the Nation’s Medical Product Supply Chains.  

New resources developed from the National Academies report offer a better understanding of the issue, as well as insights into how medical product supply chains work, what continues to lead to failures, and the ultimate effects of medical product shortages. These resources also explain measures that should be taken to build more resilient supply chains that protect against future disruptions — including enhancing public awareness of supply chain risks, implementing mitigation strategies to reduce the risk and magnitude of disruptive events, enacting preparedness actions to prevent or reduce shortages, and applying response measures to minimize harm or resolve shortages. 

A Complex Chain 

Medical product supply chains vary considerably for different drugs and medical devices, but all are multistage, global systems that involve people, production processes, technologies, and policies. Given these variations, the steps that should be taken to increase the resilience of supply chains for medical products vary, too. 

For example, when COVID-19 surged in 2020, the resulting shortage of N95 respirator face masks in the U.S. highlighted the complexities of global medical product supply chains, as well as the need for serious modifications to ensure public health and safety.  

Real World Effect: The N95 Respirator Shortage 

COVID-19 led to an increase in demand for N95 respirator face masks while at the same time limiting the ability to ramp up supply. Immediately prior to the pandemic, the United States had been using about 50 million N95s per year, but in 2020 that figure soared to about 560 million. With few N95s made domestically, half of the world’s supply came from China.  

Early in the pandemic, lockdowns in China limited its ability to ramp up supply, and it banned exports to other countries. The U.S. government tried to spur domestic production by ordering 500 million masks and attempted to reduce demand by recommending that N95s be sterilized and reused. However, no formal coordination was established, leaving federal agencies, states, hospitals, and individuals to compete for limited resources. Price gouging was common, and restrictions on sales and advertising prevented companies from reaching consumers. 

In August 2022, the U.S. Food and Drug Administration was able to remove N95s from the agency’s medical device shortage list as demand fell and supply rose — partly as a result of increased domestic manufacturing. 

What Leads to Failures in Medical Product Supply Chains?  

The pandemic is an obvious example of how problems caused by a crisis can drive up demand or trigger a disruption in production or delivery. Natural disasters or manufacturing process problems can also disrupt medical product supply chains in various ways. For example, a surge in consumer needs can drive demand for a product well above normal levels for an extended period. A power outage or lack of workers could reduce manufacturing output. Coordination failures — such as those resulting from political crises, social disruptions, or communication breakdowns during a natural disaster — can cause shortages even when total supply is sufficient to meet total demand. Several of these triggers led to a shortage of saline solution, which continues today. 

Real World Effect: Saline Solution Shortages 

A large hospital can use hundreds to thousands of IV saline bags each day to maintain or replace patients’ fluids and carry medications into their bloodstreams. Though their components are simple, the products are complex to manufacture, expensive to ship, and difficult to stockpile. Production of one batch of saline involves a 10-day, 29-step process that includes 350 regulatory checks.  

Saline shortages go as far back as 2013 when several product recalls occurred during a difficult flu season. In 2017, Hurricane Maria hit Puerto Rico and cut off power to a major manufacturer for four months, crippling saline production. The manufacturer was responsible for roughly 43 percent of IV saline solutions used in the U.S., and other companies could not make up the difference. Another bad flu season the same year compounded the shortages. Hospitals were forced to delay elective procedures, and some providers began hoarding IV bags.  

To help address the shortage, FDA allowed saline imports from other countries. The U.S. manufacturer invested $1 billion in its manufacturing network and now stores its finished product on the U.S. mainland instead of Puerto Rico. Regardless of these efforts, saline remains on the FDA shortage list, requiring continued rationing. 

Building Resilient Medical Product Supply Chains 

By definition, a resilient supply chain should have the capacity to reliably supply medical products under normal conditions as well as protect public health and safety in emergencies. Achieving these standards means implementing safeguards and multiple layers of protection against disruptions and shortages.  

One of the first steps is building awareness of risks involved in medical product supply chains. This includes making information on sourcing, quality, volume, and capacity for all medical products publicly available and establishing a public database of medical product supply chain information that health systems could access to make better purchasing decisions.  

Creating a public database resonates with committee member W. Craig Vanderwagen, former assistant secretary for preparedness and response and the lead federal health official for several disasters, including hurricanes Katrina and Rita where he served as the commander of public health and medical response. 

“Without data and evidence, it’s almost impossible to rationally approach the notion of how we’re going to mitigate, prepare, and respond,” Vanderwagen said. 

Additional actions that could be taken to bolster medical product supply chains include resilience contracting by health systems, modernizing and optimizing inventory stockpiling management, and cultivating capacity buffering for medical products critical to the supply chain.  

After a crisis or natural disaster, measures could also be taken to minimize harm and resolve the shortage in a timely manner. Major medical product producers could negotiate a treaty prohibiting export bans and restrictions, and a working group of key stakeholders could examine and identify effective last-mile strategies. 

Importantly, to make the medical product supply chain more secure and the American public safer, all these measures and more will have to integrate seamlessly under a sound, cost-effective strategy that includes ongoing analysis and evaluation.  

“There is no one-size-fits-all strategy,” said Ozlem Ergun, professor of mechanical and industrial engineering at Northeastern University College of Engineering and a committee member. “The key challenge is to match measures to products in a cost-effective manner.” 

Learn more about medical product supply chains and visit our interactive site.