Editor’s Note: Dr. Megan Ranney is the deputy dean at the School of Public Health at Brown University and a professor of emergency medicine at the university’s Warren Alpert Medical School. The views expressed in this commentary are her own. Read more opinion on CNN.
Remember the shortages of personal protective equipment in March 2020? Now it’s medications for kids.
Around Halloween, some manufacturers began reporting shortages of the liquid (pediatric) formulations of amoxicillin, an antibiotic used for everything from strep throat to ear infections.
Over the last few weeks, shortages of other antibiotics have emerged, particularly for pediatric formulations. We’re also seeing new reports of shortages of oseltamivir (Tamiflu), used to prevent hospitalizations from the flu, and some formulations of albuterol, used to treat asthma and wheezing.
Now my health care colleagues across the country — in areas ranging from Texas to rural Oregon, from Southern California to my home state of Rhode Island — are reporting that they simply can’t find pediatric versions of multiple common medications.
I’m hearing about pharmacists coming in early and staying late to try to get their hands on limited supplies. Some physicians tell me that they are sending patients home with printed versions of several different antibiotic prescriptions, just in case the first one is out of stock.
Unfortunately, according to the American Society of Health-System Pharmacists’ website, there is neither a stated reason for, nor an anticipated resolution of, the shortages in many of these medications. For example, for oral amoxicillin, three of the five manufacturers “did not provide a reason” for the shortages, and one “refuses to provide availability information,” the site said. (The US Food and Drug Administration and some manufacturers have pointed to an increased demand for amoxicillin due to the number of respiratory illnesses this season.)
What the heck is going on, and what can we do to fix it?
Of course, these shortages are partly due to demand. Our country has seen an unprecedented number of cases of respiratory syncytial virus, known as RSV, and influenza for this time of year, and these viral illnesses are often complicated by superimposed bacterial infections.
We also know that health care providers have a bad habit of prescribing antibiotics when they’re not indicated, especially when they’re pressed for time, as most are right now. (Antibiotics treat specific bacterial infections but don’t do a thing for a virus and can cause more harm than good when prescribed inappropriately.)
The problem is bigger than prescribing practices and increased demand though. It is also bigger than just pediatric medications. According to the FDA webpage, there are currently more than 120 medications — ranging from amoxicillin and albuterol to a non-insulin diabetes medication known as semaglutide to basic intravenous fluids such as sodium chloride — that are unavailable or in short supply in the United States.
Many of these 120-plus medications are ones that kids depend on for the likes of diabetes and attention deficit disorder. As an emergency physician, I’ve also been dealing with shortages of lifesaving drugs for seizures, hypoglycemia and anaphylaxis for months.
Out of fairness, the FDA has been working on this issue for years. The Drug Shortage Staff was established in 1999. A presidential executive order in 2011 and a 2018 interagency task force led to updated and expanded capacity. Thanks in part to these efforts and new mitigation strategies funded by the 2020 CARES Act, they averted hundreds of drug shortages last year.
Despite the best efforts to address root causes, we still have a dysfunctional, opaque medical supply chain. There is still no easy way to scale up production to meet excess demand. And there remains a limited profit motive to do better, particularly for low-cost medications such as amoxicillin.
As I learned all too well when fighting PPE shortages, making medications and medical-grade products is difficult even in the best of times. When an ingredient goes into short supply, when demand increases (either because of real increases in demand or because of perceived need due to media coverage), when workers get sick or when a single manufacturer goes down — the system falls apart.
When preferred medications aren’t available, doctors have to turn to second-line or alternative medications (which might be stronger, weaker or just work in a different way). This swap then causes its own cascade of problems. Using second-line medications puts patient safety at risk as physicians, nurses and pharmacists try to calculate dosages on the fly.
Second-line antibiotics may worsen existing antibiotic resistance patterns; second-line versions of other drugs may be less effective. And these shortages create more work for already overstressed, burned-out pharmacists, physicians and nurses.
Unfortunately, the patients who are least able to cope with unpredictable access to prescribed medications are also most likely to be affected by these shortages.
Children need precise dosing. People on Medicaid have more restrictive coverage of second-line drugs, can rarely pay out of pocket for what the pharmacy has on hand and may have neither the time nor transportation to travel from pharmacy to pharmacy looking for one that has adequate supply.
Nursing homes and jails don’t have the finances or capability to contract with new suppliers on a dime. And non-English-speaking patients face extra barriers in figuring out their options. As pharmacist Kerry LaPlante, a past president of the Society of Infectious Diseases Pharmacists, reminded me, “Access is key.”
There are some promising solutions on the horizon. For example, Mark Cuban’s company, CostPlus Drug Co., is creating a new facility to permit quick upscaling of manufacturing in the face of generic drug shortages. The startup Civica Rx is already partnering with hospitals to create dependable supply chains of generic injectables by treating these medications like a public good.
Unfortunately, these solutions are not coming soon enough for those of us with sick family members or those of us trying to take care of people who are sick.
“The system is so broken. I see it as a physician, as a mom, and as a patient. All. The. Time,” Dr. Joanna Bisgrove, a family physician who sits on the American Medical Association’s Council on Science and Public Health, shared with me on Facebook.
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In this country, we continually forget that the profit motive is not sufficient for the public’s health. The answer, of course, is not to stock up on antibiotics like we did with hand sanitizer but rather to advocate for and create better systems — and to support the government and private companies in doing so.
In the meantime, this winter, our best hope is simply not to get sick. Get your flu shot and bivalent Covid-19 booster if you haven’t done so already, mask up indoors and wash your hands.