Baby with Respiratory Syncytial Virus (RSV) in hospital.
In the U.S., all but 6 states are currently experiencing “high” or “very high” respiratory virus levels. The nation is faced with a so-called “tripledemic” of ongoing Covid-19, which is leading to increases in hospitalizations once again in certain areas; influenza, which has re-emerged in full fury nationwide after a two year absence; and respiratory syncytial virus (RSV), which is already nearing seasonal peak levels in a growing number of regions of the country.
As a result, there are acute shortages of a number of over-the-counter (OTC) medicines used for symptomatic relief, such as the children’s medications liquid acetaminophen and ibuprofen.
Record levels of illnesses have also caused a spike in demand for amoxicillin. This has resulted in an acute shortage of the antibiotic, which is widely used for the treatment of bacterial upper and lower respiratory infections in, among others, the pediatric population.
Some of this excess demand may actually be inappropriate, as amoxicillin is indicated for bacterial infections, not viral ones. Nonetheless, across the country multiple strains of streptococcus infections are being reported at elevated levels. And, some viral infections can lead to secondary bacterial infections over time.
Dr. Megan Ranney reports that besides amoxicillin, shortages of other antibiotics have emerged, especially pediatric formulations.
The root causes of all these shortages are manifold. Solutions in the short term are hard to come by, given the profound dysfunctionality that persists in the drug supply chain.
According to the Food and Drug Administration (FDA), “drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations.”
Conspicuously absent in the list of factors mentioned by FDA are difficulties in acquiring raw materials, manufacturing problems, regulatory issues, business decisions, and disturbances within the supply chain.
Among the business decisions that can contribute to shortages of generic drugs is the discontinuation of older, off-patent drugs in favor of newer, branded, and more profitable ones.
Both generic and branded drug manufacturers must provide FDA information on supply disruptions, and the agency works closely with them to prevent or reduce their impact. However, until now, companies have not been obligated to report steep rises in demand to the agency. Valerie Jensen, the associate director of the FDA’s Drug Shortage Staff, is calling on companies to report such demand increases.
It’s important to keep things in perspective and not place undue blame on issues such as the Covid-19 pandemic, lockdowns in China where some of the drug manufacturing plants are located, or the Biden Administration for that matter.
Indeed, shortages of critical generic drugs – both prescription and OTC – have plagued the U.S. for many years. In fact, shortages were worse 12 years ago than they are today. At present, the FDA maintains a list of 123 drugs in short supply. In 2010, the FDA reported 178 drug shortages. Back then, shortages were reported in cancer drugs, anesthetics used in surgery, and in a large number of medicines that are given intravenously. Like today, one of the driving factors was inadequate supply of raw materials.
There are several initiatives underway in both the private and public sector to comprehensively address certain drug shortages. For instance, Mark Cuban’s Cost Plus Drug Company is pursuing the production of low-cost prescription drugs that are considered most commonly in short supply. These are mostly for in-hospital and in-clinic use, and none are OTC medications.
Cuban’s company is currently in conversations with hospitals around the nation to identify the most common drug shortages. The manufacturing facility – where the Cost Plus Drug Company will manufacture these drugs – is expected to be up and running in early 2023.
Meanwhile, public agencies and legislators are pushing for a resolution of the amoxicillin problem. The FDA, for example, is urging compounding pharmacies to produce the drug. Pharmacists looking to help their patients get access to this drug can reference an FDA guidance document.
Also, in a bipartisan effort with several of her colleagues, Senator Amy Klobuchar (D-MN) want the White House to soon convene its Drug Shortage Task Force to address the amoxicillin issue.
Ultimately, however, piecemeal changes aren’t the answer. A structural solution must be found to all shortages, perhaps based on the public-private partnership, which the White House unveiled in June of 2021.
It appears that the established consortium for domestic essential drugs production is still in fact-finding mode. The Department of Health and Human Services has tasked the National Forum to Secure America’s Supply Chain for Essential Medicines to select a list of critical drugs – which include acetaminophen, ibuprofen, and amoxicillin – drawn from the FDA’s essential drug list. At the same time, the Forum is developing “strategies to overcome current pharmaceutical supply chain challenges and constraints.”
Further, the federal government is committing around $60 million to research new technologies to boost domestic active pharmaceutical ingredient or API production.
While the consortium has laudable goals, frankly $60 million is a pittance in light of the enormity of the problem.
Drug shortages are a persistent public health issue in the U.S. And, there are no easy fixes. There is no facile method to scale up production to meet periodic sharp increases in demand, like the one occurring at the moment as a consequence of the “tripledemic.” And there remains a limited profit motive to do so, particularly for low-cost generics.