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Drug Shortages: A Deadly Problem With No Cure in Sight
News of a shortage tends to get the public's attention. If gasoline or jobs or milk were in short supply, we'd all know about it. But unknown to most Americans, the country is now in the grips of a life-threatening drug shortage. Medical professionals are quite aware of it, however, and they're deeply concerned.
So is the Food and Drug Administration. Unfortunately, the FDA's hands are pretty much tied when it comes to taking steps that could ease this crisis. It's powerless to demand that a drug company produce a particular medication simply because it's becoming dangerously unavailable.
How bad is this situation? A recent survey of health care professionals found the U.S. is experiencing drug shortages of "epic proportion that are often associated with third-world countries." This unprecedented, and growing, shortage of critically important medications is affecting care and endangering patients' lives.
But when it comes to a company's business decisions, the FDA has no authority. Some companies have decided it's not worth their trouble to produce a certain drug anymore. Such was the case when Teva decided to discontinue the widely used anesthetic propofol. Basically, Teva said it's too hard to make and barely profitable.
A recent trend concerns discontinuation of older products that aren't as profitable as newer ones or that have to regain FDA approvals -- a resource-intensive process. Others simply take lower precedent in production over more profitable drugs.
"Right now we just don't have any authority at all to require companies to increase production or to require other firms to come on the market," Jensen says. FDA also can't require firms to continue making a product, and drugmakers aren't required to report shortages or discontinuations, except for sole manufacturers in certain circumstances.
"We would like to have them report on all discontinuations and shortages, but that's not something we can require, just encourage them to do," Jensen says. She explains that early notifications from manufacturers on issues that could cause shortages have been most helpful because, she says, "many times we can resolve the issue before it becomes a shortage."
Originally posted by RainTurtle
At my place of employment, it has been tough for us to get certain antibiotics. It seems like antibiotics would be the one type of medication that they would make plenty of.
Originally posted by NorEaster
The Congress and the President aren't the ones in control of the impact of the new healthcare laws. This belongs to policy bureaucrats, and the implementation will involve thousands of pages of regulations and (no doubt) loopholes. A magazine article like the one I linked in the OP could be just a magazine article. Then again, it could be a heads up to an Executive Branch policy chief that such shortages could very easily become the "new normal" - just as the big business sector has been giving the same heads up that double digit unemployment could easily become the "new normal" if true finacial reform ends up being "improperly implemented" at the policy level. Hell, maybe there's never any such thing as collusion or conspiracy, and maybe trillions of dollars isn't enough money to make people do terrible things?
In an unintended consequence of the new health care law, drug companies have begun notifying children’s hospitals around the country that they no longer qualify for large discounts on drugs used to treat rare medical conditions.
As a result, prices are going up for these specialized “orphan drugs,” some of which are also used to treat more common conditions.
Over the last 18 years, Congress has required drug manufacturers to provide discounts to a variety of health care providers, including community health centers, AIDS clinics and hospitals that care for large numbers of low-income people.
Several years ago, Congress broadened the program to include children’s hospitals. But this year Congress, in revising the drug discount program as part of the new health care law, blocked these hospitals from continuing to receive price cuts on orphan drugs intended for treatment of diseases affecting fewer than 200,000 people in the United States.
Originally posted by Mountainmeg
Not a good scenario. That healthcare bill is just a vortex of unknowns. Congress has no clue what they voted on. And now we're starting to see the effects of is. The most recent wickedness from this bill was the loss of orphan drug discounts for children's hospitals. Now discounts are "not allowed" by Obamacare. Hmmm, wonder how that got in there?
In an unintended consequence of the new health care law, drug companies have begun notifying children’s hospitals around the country that they no longer qualify for large discounts on drugs used to treat rare medical conditions.
As a result, prices are going up for these specialized “orphan drugs,” some of which are also used to treat more common conditions.
Over the last 18 years, Congress has required drug manufacturers to provide discounts to a variety of health care providers, including community health centers, AIDS clinics and hospitals that care for large numbers of low-income people.
Several years ago, Congress broadened the program to include children’s hospitals. But this year Congress, in revising the drug discount program as part of the new health care law, blocked these hospitals from continuing to receive price cuts on orphan drugs intended for treatment of diseases affecting fewer than 200,000 people in the United States.
www.nytimes.com...
Survey: 99.5 percent of hospitals affected Among the findings from AHA’s online survey that drew responses from 820 of the nation’s 5,100 hospitals: 99.5 percent of hospitals reported one or more drug shortages in the last six months, and nearly half reported shortages of 21 or more drugs. Some 82 percent of those hospitals said they’ve delayed patient treatment because of shortages, or have been unable to treat patients as recommended.
The issue will be resolved when Medicare no longer pays for the drugs needed to save lives. No shortages then. And the patients will be gone as well. Seems this resolves two issues at once!