In the United States, 6 states are recently experiencing “high” or “very high” degrees of respiratory viruses. increased hospitalizations in some areas; the flu, which reappeared with total fury in the country after two years of absence; and respiratory syncytial virus (RSV), which is already reaching seasonal peaks in an increasing number of parts of the country.
As a result, there is a severe shortage of several over-the-counter (OTC) medications that are used to relieve symptoms, such as children’s medications, liquid acetaminophen, and ibuprofen.
Record degrees of the disease have also caused an increase in demand for amoxicillin. This has led to an acute shortage of the antibiotic, which is widely used for the treatment of bacterial infections of the upper and lower respiratory tract, among others, in the pediatric population.
Some of this excess demand would possibly be inappropriate, as amoxicillin is indicated for bacterial and non-viral infections. However, across the country, several strains of strep infections are reported at the highest levels. Bacterial infections over time.
Dr. Megan Ranney reports that in addition to amoxicillin, there has been a shortage of antibiotics, especially pediatric formulations.
The fundamental reasons for all this shortage are manifold. Short-term answers are hard to find, given the deep dysfunctions that persist in the chain of origin of medicines.
According to the Food and Drug Administration (FDA), “drug shortages can occur for many reasons, in addition to production and quality issues, delays and disruptions. “
Raw procurement difficulties, production issues, regulatory issues, business decisions, and supply chain disruptions are conspicuous by their absence from the list of points discussed by the FDA.
Among the business decisions that may contribute to generic drug shortages is the discontinuation of older, non-patented drugs in favor of newer, brand-name, and more successful drugs.
Generic and brand-name drug brands will have to provide the FDA with data on source disruptions, and the company works heavily with them to save it or reduce its impact. However, until now, companies were not required to report giant increases in demand to the firm. Valerie Jensen, the FDA’s associate director of staff for drug shortage rate, is asking companies to report those increases in demand.
It is vital to keep things going and not unduly blame problems such as the covid-19 pandemic, the lockdowns in China, where some of the drug production plants are located, or Biden’s management.
In fact, shortages of critical generic drugs, whether prescription or over-the-counter, have affected the U. S. It was in the U. S. for many years. In fact, shortages were worse 12 years ago than they are today. Currently, the FDA maintains a list of 123 drugs in short supply. In 2010, the FDA reported shortages of 178 drugs. At that time, shortages of anti-cancer drugs, anesthetics used in surgery, and a large number of intravenous drugs were reported. Today, one of the points to be resolved was the inadequate source of raw materials.
Several projects are underway in the private and public sectors to comprehensively address some of the drug shortages. For example, Mark Cuban’s Cost Plus Drug Company continues to produce cheap prescription drugs that are considered to be in full short supply. These are primarily intended for hospital and clinical use, and none are an over-the-counter medication.
The Cuban company is recently in talks with hospitals across the country to identify shortages of most common medicines. The production plant, where Cost Plus Drug Company will manufacture those drugs, is expected to be operational in early 2023.
Meanwhile, public bodies and legislators are pushing for a fix to the amoxicillin problem. The FDA, for example, urges compounding pharmacies to produce the drug. Pharmacists to help their patients access this drug can consult an FDA guidance document.
In addition, in a bipartisan effort with several of her colleagues, Sen. Amy Klobuchar (D-MN) needs the White House to convene her drug shortage task force soon to address the amoxicillin problem.
Ultimately, however, gradual adjustments are not the answer. A structural solution to all shortcomings will need to be discovered, perhaps on the basis of the public-private partnership, which the White House presented in June 2021.
It seems that the consortium established for domestic drug production is still in research mode. The Department of Health and Human Services commissioned the U. S. National Forum to Secure the Essential Medicines Supply Chain with Essential Medicines. A list of drugs, which come with acetaminophen, ibuprofen, and amoxicillin, be established from the FDA’s drug list. At the same time, the Forum presents “strategies to succeed over demanding situations and constraints in the pharmaceutical supply chain. “
In addition, the federal government is allocating approximately $60 million to new technologies to stimulate domestic production of active pharmaceutical ingredients, or APIs.
While the consortium has laudable goals, frankly $60 million, that’s a negligible amount of cash for the enormity of the problem.
Drug shortages are a persistent public health challenge in the United States. And there are no simple solutions. There is no simple way to increase production to meet the periodic sharp increases in demand, such as the one that is occurring lately in the wake of the “triple epidemic”. Generic.
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