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Generic injectable drugs can cause shortages due to high manufacturing costs and low profit margins.
Drug manufacturers and large pharmacies have come under heavy scrutiny due to ever-increasing drug costs. However, certain drugs are priced too low and could lead to shortages, The New York Times reports.
Generic injectable drugs given in the physician’s office or the hospital are the most susceptible to shortages.
When these drugs, such as anticancer agents, heart attack medications, and anesthetics, are in short supply, it can cause delays in proper care and alternatives, if any, are used.
According to the article, during a morphine shortage in 2011, there were 2 fatalities from accidental dosing of hydromorphone. Hydromorphone is approximately 7 times more powerful. Currently, generic injectable nitroglycerin used for serious heart attacks is in short supply.
In recent studies, researchers have found that emergency and critical care drugs, such as pain medications, sedatives, electrolyte solutions, antibiotics, antidotes, and drugs that undo the effects of anesthesia are in short supply, according to the article.
Researchers also found that 10% of drugs in short supply have no valid substitutes. Since these shortages can last at least 9 months, they can affect the health of many patients that require the drugs.
In general, generic injectable drugs are likely to be susceptible to shortages because of high manufacturing costs and little profit margins. Purchasing organizations also drive the costs down since they direct large volumes to a few manufacturers that are the least expensive.
According to the article, a majority of generic injectable drugs are produced at 3 or fewer companies, so if there is a problem at 1 company, the supply of many drugs is threatened. Due to a low profit margin, these companies do not have any backup plants or production lines, which causes shortages if there is a problem.
Generic injectable drugs are also more expensive to produce since they have to be created in a sterile facility due to injection into the spine, blood, or eye and because they do not pass through the digestive system that offers some protection from bacteria.
To combat drug shortages, the FDA put a law into place in 2012 and the number of shortages has decreased. The FDA avoided 80% of potential shortages through accelerating approval for substitutes, helping manufacturers understand how to overcome shortages, and helping them create solutions to purify drugs contaminated from production.
However, shortages are still increasing due to the low cost of the drugs and growing costs for certain generic injectables could potentially lead to less shortages, the article concluded.