The drug shortages that have been plaguing the U.S. show no signs of going away anytime soon.
The problem peaked in 2011, when a record 251 drugs were declared in short supply. This year, slightly more than 100 were placed on the list, and workers say the battle to keep pharmacy shelves stocked continues.
According to the Food and Drug Administration, the number of drug shortages has increased nearly 300% since 2005.
More than half of the drugs on the shortage list are considered critical — meaning they have no alternative. The drugs most often in short supply include chemotherapy drugs for cancer, antibiotics for severe infections and anesthetics for surgery.
Some of the drugs on the list, such as the amphetamine mixed salts used to treat ADHD or attention-deficit and hyperactivity disorder, have been on the list for a year or more.
In a dozen cases over the past two years, the crisis has become so drastic that the FDA has resorted to importing vital drugs from foreign suppliers.
It’s even come down to rationing as a means of addressing the shortage, which health care workers say has ceased to be a temporary emergency and is now a fact of life.
In desperation, they are resorting to treating patients with less effective alternative medicines and using expired drugs.
(Hey guys, this is America, last time I checked. Or are we becoming a third world country?)
The shortage has prompted Congressional hearings, a presidential order and pledges by generic drug makers to communicate better with federal regulators.
Meanwhile, back on the home front, drug shortages have numerous implications for hospitals, healthcare providers and patients.
These include adversely affecting choices for drug therapy, delaying medication therapies or treatments, escalating costs of product and resources to manage shortages, and increasing risk for medication errors and potentially fatal patient outcomes.
There’s also an emotional component to the drug shortages of frustration, anger, anxiety, and mistrust that results in strained relationships between the providers and manufacturers, pharmacy and prescribers, patients and providers.
It’s come down to health care workers around the country using expired drugs or less effective alternatives when a critical medicine can’t be found. The shortages of generic drugs also drive up the cost of care when doctors have to use a more expensive drug instead.
“When you can’t treat basic things — cardiac arrest, pain management, seizures — you’re in trouble,” said Dr. Carol Cunningham, the state medical director for the Ohio Department of Public Safety’s emergency services division.
“When you only have five tools in your toolbox and three of them are gone, what do you do?”
The (sort of) encouraging news is that more than 150 new shortages have been prevented this year.
And the scary news is: that these drug shortages have forced the F.D.A. to make some tough choices. Like allowing manufacturers to sell drugs that most likely would have been recalled if it were not for the crisis.
Last year, for example, the agency allowed the manufacturer American Regent to sell a drug used during chemotherapy that was found to contain glass particles. Doctors and nurses were instructed to filter the drug, sodium thiosulfate, before administering it to patients!
In a recent report, The House Oversight Committee claimed the FDA — the very agency tasked with dealing with shortages — is partly to blame for the shortage situation.
“The FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs,” according to the House report.
In turn, the FDA claims “What has changed is that there is an aging manufacturing infrastructure, and there are serious quality problems that have required companies to close down to fix the problems.”
But, the factors that contribute to drug shortages are complex and multidimensional.
They can occur for a variety of reasons found throughout the supply chain such as:
1. Shifts in clinical practices…
2. Wholesaler and pharmacy inventory control…
3. Raw material shortages…
4. Changes in hospital and pharmacy contractual relationships with suppliers and wholesalers…
5. Adherence to distribution protocols mandated by the FDA…
6. Individual company decisions to discontinue specific medicines…
7. Natural disasters…
8. Manufacturing challenges.
President Obama’s executive order has instructed the FDA to do 3 things: “broaden reporting of potential shortages of certain prescription drugs, speed reviews of applications to begin or alter production of these drugs and provide more information to the Justice Department about possible instances of collusion or price gouging.”
But, all that being said; until federal regulators can bolster the supply chain without compromising quality, we can’t be assured of reliable access to safe medicines.
To see exactly which drugs are in short supply, according to the FDA, go to: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
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