Generic drug shortages cause problems for hospitals and doctors.
Shortages of Generic Drugs Pose Challenges for U.S. Hospitals
Many U.S. hospitals and treatment facilities are currently facing shortages of generic drugs, which are the more affordable alternatives to brand-name medications. This growing problem could potentially force doctors to make difficult decisions regarding prescriptions for ADHD treatments, antibiotics, children’s acetaminophen, and other medications that are in short supply.
There are several factors contributing to the shortage of generic drugs and prescription medications in general. One of the main reasons is the decline in the number of drug manufacturers in the United States that produce generics. Additionally, the global supply chain has become overly complicated due to the lingering effects of the coronavirus pandemic, leaving some patients struggling to access life-saving medications. Furthermore, government policies aimed at lowering drug costs may be unintentionally exacerbating the problem.
Shortages Extend Beyond Commonly Used Pharmaceuticals
The shortage of generic drugs is not limited to widely used pharmaceuticals like the antibiotic amoxicillin. Cancer drugs such as carboplatin, cisplatin, and doxorubicin are also experiencing a shortage in supply.
A recent survey conducted by the National Comprehensive Cancer Network revealed that over 90% of cancer centers have faced difficulties in obtaining enough carboplatin, a chemotherapy drug used to treat various types of cancer including ovarian, lung, and breast cancer.
The American Society of Health-System Pharmacists has listed over 240 drugs that are currently in short supply. A poll conducted by the organization found that nearly one-third of hospitals are rationing or delaying the prescription of medications. Almost all of the 1,100 hospitals surveyed reported struggling with some degree of drug shortage.
Generic drugs are particularly vulnerable to shortages, accounting for over 70% of all drug shortages according to the Food and Drug Administration (FDA). ASHP CEO Paul Abramowitz has expressed concern about the lack of alternatives for affected drugs, which puts patients at risk.
A study published in the Journal of the American Medical Association found that a shortage of norepinephrine, a drug used to treat septic shock, resulted in an increase in patient deaths.
Causes and Implications of the Shortage
Defining a shortage is not straightforward. The FDA defines a shortage as a situation where the total supply of all versions of a commercially available product cannot meet the current demand. However, the duration of the shortage is not taken into account. A drug that falls short of demand for a few days may not be considered a shortage.
Geoffrey Joyce, director of health policy at the University of Southern California Schaeffer Center, emphasizes that the drug shortage problem is not transient but rather an ongoing issue. While drug shortages have been a concern for over a decade, the pandemic has exacerbated the problem.
During the pandemic, factory shutdowns in China, a major supplier of basic ingredients for pharmaceuticals and generics, disrupted the supply chain. India, a significant manufacturer of generics, also restricted exports to ensure domestic availability. These factors have contributed to the exaggeration of drug shortages.
Quality problems also contribute to the shortage. For instance, the FDA discovered significant quality violations at an Intas Pharmaceuticals plant in India, which produces about half of the cisplatin supplied to the U.S. The resulting shutdown of the plant led to a scarcity of the cancer drug in the country.
Market failure is another underlying issue. While newer patented drugs yield substantial profits, the profit margins for generic drugs are slim, regardless of their importance in treatment. Drug manufacturers and the supply chain prioritize return on investment, which can lead to a lack of production for generic drugs.
In response to the shortage, California passed a law allowing the state to partner with drug manufacturers to produce generic drugs. The state has already contracted with generic drug company Civica to produce insulin. While California expects this effort to be profitable, taxpayers may bear some of the costs.
Government policies have also been identified as a driver of shortages. Federal law requires drugmakers to issue rebates for generic drugs purchased by Medicaid, and manufacturers must provide price discounts for generic drugs included on the Federal Supply Schedule. Some argue that these policies impose further price concessions on already low-priced generic drugs, potentially exacerbating shortages.
Future Outlook
Unfortunately, it is expected that reports of potential and actual drug shortages will continue to increase in the coming months and years, according to the FDA. This ongoing issue poses significant challenges for healthcare providers and patients alike.
Source: The Washington Examiner
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