Medication Shortages Are the Next Crisis
The frequency of alerts and the number of drugs in undersupply are shocking developments in a rich country.
Widespread critical-medication shortages are the next big crisis of the coronavirus pandemic. Some hospitals, including in New York, are running low on paralytic agents that are needed to safely intubate patients. Steve Corwin, the president and CEO of New York–Presbyterian, recently noted on MSNBC that his hospital is even running short on solutions needed for dialysis. I am fortunate to work in the emergency department of one of the best-resourced hospitals in the country, Brigham and Women’s Hospital in Massachusetts. But already, when I order intravenous fentanyl, which doctors use to minimize pain and keep patients breathing safely and comfortably while on mechanical ventilators, an alert pops up reminding me that there’s a national shortage. Am I sure I want to use this medication? Of course I’m sure. The frequency of alerts and the number of drugs in undersupply are shocking developments in a rich country.
Throughout the pandemic, the United States has been playing catch-up. We’re still not testing enough, even though public-health officials saw that problem coming from miles away. Hospitals continue to run low on personal protective equipment. It is too soon to know whether 11th-hour attempts to increase those supplies will succeed. Too many lives hang in the balance to play wait-and-see with our medications too.
In addition to drugs for patients on mechanical ventilators, including sedatives such as etomidate, paralytics, and pain meds, we also need to fast-track the production of antibiotics such as azithromycin, cefepime, and others that we use to treat pneumonia. We need a steady supply of hydroxychloroquine, although not for patients with COVID-19—no compelling evidence shows that it actually benefits those with the virus. Yet because many are using it for the coronavirus, we are now low on the drug for patients with conditions it’s known to help, such as lupus and rheumatoid arthritis.
Here are steps the federal government can take now to make sure that hospitals are well stocked during the pandemic and after it passes, when doctors turn to operations delayed by the COVID-19 surge. First, it needs to improve data collection to track how manufacturing capacity is stacking up against medical demand. Then, it needs to compel pharmaceutical companies and their suppliers to accelerate the production of needed drugs.
The data infrastructure is already in place. For some 20 years, the FDA has run a drug-shortage tracking program. In 2011, in response to a deficit of cancer treatments, anesthesia, and other critical-care medications, President Barack Obama issued an executive order urging drug manufacturers to report supply issues early so that any bottlenecks in production could be addressed in a timely way.
The FDA should build on this program by requiring drug manufacturers to disclose the companies that make their ingredients. Right now, this disclosure is voluntary. The FDA would then need to take tracking a step further and demand that suppliers of ingredients also release production information. Although obtaining this kind of authority may require a change in executive rules at the FDA or a presidential executive order, it is worthwhile. By knowing where companies get their essential compounds, the FDA can keep tabs on the supply of ingredients, identify any production hiccups early, and guarantee that the ingredients are reserved for medical use. Some reagents needed to make vital medications, for example, are also used in cosmetics and other nonessential products.
State and federal officials can already anticipate equipment and staffing shortfalls at hospitals by looking at the Centers for Disease Control and Prevention’s records on caseloads and capacity. But expanding the system to allow hospitals to report the undersupply of medications as well will help public-health officials know when and if it is prudent for the government to step in to direct deliveries, prioritizing areas of maximal need and anticipating other shortages before they become critical.
More robust tracking will help the White House wield the Defense Production Act to its fullest extent and in the most effective way. Although in normal times the government is not involved in the distribution of drugs, these are not normal times. The president should therefore use the DPA’s allocation authority to direct private companies to sell and ship drug ingredients only to priority users. Companies including Amazon are already voluntarily prioritizing the sale of supplies such as hand sanitizer to hospitals. But if medical-ingredient companies sell to producers of nonessential products such as skin care instead of to drug manufacturers, the government should coerce them to act. If domestic companies increase production of these active chemical substances, the U.S. will also be less reliant on manufacturers in China, which are of course outside the authority of the DPA and therefore can’t be forced to respond to the needs of American hospitals. And finally, the White House should use DPA authority to direct manufacturers to sell medications to hospitals or regions most in need according to expanded CDC reports.
If the president is reluctant to continually use the DPA, the government can also compel companies to fill the medication gap in other ways. Recently, for example, the FDA issued guidelines to allow compounding pharmacies, which typically fill prescriptions only for individuals, to temporarily fill them for hospitals. Money can always incentivize companies to speed up production too. The Department of Health and Human Services and the Centers for Medicaid and Medicare Services can temporarily offer higher payments for medications, including generics. Better financial margins will spur manufacturers to make these drugs more quickly.
Finally, after improving the tracking of drugs and increasing production, the government should make sure that hospitals don’t face scarcity again in the near future. It can do that by replenishing the Strategic National Stockpile now with medicine that doctors use in treating the coronavirus, as the pandemic will likely be here for many more months before a vaccine is available.
Doctors are only as good as our teams, our equipment, and our medicines. If we get the PPE we need, our teams will stay safe. If we receive much-needed equipment—tests, ventilators, IV pumps—in time, fewer of our patients will die needlessly. But if we can’t provide medications that make what we do effective, all our efforts will be for naught.