Several reports have recently highlighted the fact that hospitals throughout the U.S. are running out of key drugs, including anesthetics needed in surgeries, chemotherapy drugs needed to treat cancer, and common antibiotics required to treat a multitude of diseases.
The drug shortages are causing hospitals and in turn their patients to pay higher prices to get the short supply of drugs needed for their care, and in many cases are causing doctors and hospitals to turn to alternative or older treatments when the needed prescription medications are simply not available.
This has reportedly resulted in serious side effects, and in some cases, death, with a survey of 1,800 health care professionals conducted in the Fall finding that one in four health care professionals reported having had patients who experienced adverse events due to the medication shortage.
“These are the worst shortages I have ever seen,” said Thomas Wheeler, a hospital pharmacist for three decades and director of pharmacy for Advocate Illinois Masonic Medical Center on Chicago’s North Side, as reported in an article by Bruce Japsen, Health Reporter for the Chicago Tribune, published February 19 in the Los Angeles Times. “The most troubling aspect is that it is critical drugs for which there are limited alternatives,” Wheeler continued. “Many are involved in cancer care and surgery.”
According to the American Society of Health-System Pharmacists, about 150 drugs are now in short supply. This is triple the number in short supply just five years ago. About 60 of the drugs currently in short supply are considered by federal health officials as “medically necessary,” including prescription medicines used to treat or prevent serious diseases or medical conditions.
Why is this happening?
Many theories and explanations have been advanced. According to the LA times article, part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies that have failed to comply with Federal Government safety requirements. This has caused stoppages in manufacturing until compliance is established, with corresponding interruptions and delays in the supply chain, due to the long lead times required to manufacture a pharmaceutical after production has stopped.
Some of the issues causing the FDA to step up quality control enforcement against pharmaceutical companies stem from previously reported serious health risks arising from low cost/ low quality ingredients being imported from places like China.
Consolidation in the pharmaceutical industry, which leaves fewer companies making drugs, has exacerbated the problem, according to the LA Times. When quality issues or other reasons limit supply by any one of the remaining drug producers, there are fewer other companies to pick up the slack, with resulting greater disruptions to the supply chain.
In addition, and significantly, the profit motive has played a role in creating current drug shortages. Some drug companies have exited the business of making older, generic drugs, which typically aren’t as profitable as newer brand-name medicines. Certain major drug companies have recently announced moves to increase profits by cutting back on research & development for new drugs and moving production to low wage countries overseas when patent protection lapses for existing drugs. And, according to U.S. Senator Amy Klobuchar, some companies simply stopped the production of low priced generic drugs in an effort to make more money by producing and selling brand name drugs. This has limited the supply of many commonly used and needed antiobiotics, list of which is contained in the LA Times article..
Another exacerbating factor is that pharmaceutical companies have not been required by law to alert the FDA when they decide to stop making a medication or expect a shortage in supply to occur, according to Bona Benjamin, director of medication use quality improvement at the American Society of Health System Pharmacists, as reported in “Growing Shortage of Some Rx Drugs” by WebMD.com
“This can result in health care professionals not having adequate notice to find a viable alternative to a patient’s current medication, putting patients at risk for side effects, which can be serious in some cases,” according to R. Elizabeth C. Kitchen, medical writer for Yahoo Health News.
Senator Klobuchar has co–introduced the Life Saving Medications Act to address this problem. The proposed legislation would require drug manufactures to give the FDA an early notification if they’re running low on a particular drug. “That way,” she said, “the FDA can start working on finding drugs from another manufacture and if nothing is found in the United States, to re–import drugs from safe places like Canada because the last thing that should happen to a patient is that they find out the day before they have a treatment for cancer that the drug is unavailable.”
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See Also » The website of the U.S. Food and Drug Administration (FDA) on Drug Shortages.
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