Drug Shortages vs. Public Health Crisis

Meeting for generic medications, low-profit boundaries, and low making facilities have all performed to remedy shortages in the United States.

When modern generic drugs enter the market, the presence of the original product can force market opponents to drop their prices to compete. Sometimes, these prices are reduced so low that it negatively affects profit margins.

The resulting low-profit edges drive companies to seek the least costly suppliers, often to China and India, where state government may not be as powerful as in the United States.

This can result in poor-quality goods and quality-related recalls. This model is not sustainable long term, and a company can often be forced to sell its product at unrealistically low prices or drop out of the generics market.

Those living in the generics market find that there are few means to maintain or upgrade production facilities, buy quality active pharmaceutical components from reliable suppliers, or ensure that business continuity plans, excess manufacturing capacity, and well-stocked inventories are available to prevent shortages in the event of a natural catastrophe.

When companies leave the market, the resulting reduction in competition and a shortage of stores shifts the pendulum the opposite way to the few remaining businesses that can increase prices and take advantage of a higher demand for these drugs. Meantime, US factories have not been improved to include enhanced quality systems, which results in shortages at domestic plants.

Medicine deficiencies have become moderately of a phenomenon over the past 15 years, tripling from 61 shortages in 2005 to 178 in 2010. This spike occurred in an analysis by the Obama administration, which concluded that the shortage problem is complex and stems from an economic, legal, regulatory, policy, and clinical decisions that are strongly interconnected.

Medications Changed by Shortages

More than 200 drugs have been listed on the FDA (Food and Drug Administration) and the American Society of Health-System Pharmacists’ drug shortage lists. Among these are sterile injectable drugs and critical drugs, such as those used in oncology.

Besides, many life-saving products usually used in surgeries and hospital crisis rooms, such as anesthesia medications, antibiotics, pain management medications, nutrition and electrolyte products, and chemotherapy agents, have all endured shortages. Even the sterile saline solution used to administer medications intravenously has been in short supply.

The most challenging medicine shortages are:

• pain treatment injectables
• saline (as intravenous therapy [IV], rehydrating patients, and wound cleaning)
• sodium bicarbonate for oral or parenteral (injection) therapy
• sterile water (for IV use)
• epinephrine (for acute anaphylactic reactions)
• dextrose (for calories and water for nutrition and hydration)

Price Gouging as a Result

An unfortunate result of drug shortages is that some drug wholesalers capitalized on the supply-and-demand perspective and raised prices for their goods to take account of the situation. One part of this was when a leukemia drug with a typical per vial contract price of about $12 was being sold for $990. Another shortage-related development occurred when a high blood pressure medicine regularly priced at $26 was being sold at $1200.

There are many causes and workable solutions to this summons. Addressing this significant public health problem requires the urgent attention of the pharma industry, other stakeholders, and government officials.

Executive Order

The Obama government request resulted in an executive order directed at the FDA and Department of Justice to reduce drug shortages, protect consumers, and prevent price gouging. Among the suggestions made were for early warning of potential drug shortages to help the FDA work with companies, hospitals, physicians, and patients to prevent or mitigate deficiencies before a crisis happens.

Nowadays, federal law needs drug companies to inform the FDA when the production of critical medicine is being stopped. The president’s order also requested the FDA to broaden its reporting of potential shortages of certain medical drugs. Additionally, the administrative law requires the FDA to expand its efforts to expedite the review of new manufacturing sites, drug suppliers, and manufacturing changes to prevent shortages.