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Officials at at least one U.S. hospital admit they've discarded the scarce cancer drug doxorubicin in order to comply with strict regulations for storage and sterility.
Mounting shortages of crucial drugs are creating a new dilemma for the nation’s hospital pharmacists, who say they find themselves caught between breaking government rules for storage and safety -- or throwing away vital and lifesaving medications.
At one hospital in Florida, officials acknowledge they’ve discarded the scarce cancer drug doxorubicin, even as patients nationwide clamor for treatment.
“I’d never want to take a chance with not following the rules,” said Alan K. Knudsen, director of pharmacy legal services for Shands HealthCare at the University of Florida in Gainesville. “I wish I didn't have to throw it out."
Others, however, admit they’re bucking regulations imposed by federal agencies, including the Centers for Medicare & Medicaid Services, in the interest of patient care, as long as they have strong scientific evidence that the drugs are still safe.
"With the medications in very high need, we are using it," said Thomas Burnakis, coordinator of pharmacy clinical services at Baptist Medical Center in Jacksonville, Fla. It would gall him, for instance, to toss midazolam, a widely-used anesthetic known as Versed that has been in short supply for months, simply because it exceeded arbitrary storage limits.
“I am not throwing out the rest of that Versed,” he said.
And in the eyes of some patient care experts, he shouldn’t have to.
Organizations such as the Institute for Safe Medication Practices and the American Society of Health-System Pharmacists are raising questions about federal rules they believe exacerbate a crisis that saw 267 drugs in shortage last year, up from 211 the year before, the most in U.S. history.
“It’s really a major issue,” said ISMP president Michael R. Cohen. “It’s a waste of money and it’s a waste of drugs in short supply.”
Most drugs, including those in shortage, have specific requirements for handling that limit how long and in what manner they are stored or how quickly they must be used after they're opened, industry experts say. Some must be refrigerated; others must be used within 24 hours after opening, or even immediately.
Those requirements should be listed in the official prescribing information package inserts that are approved by the federal Food and Drug Administration when a drug is cleared. But the directions may be incomplete or outdated. It can be costly and time-consuming to seek new FDA label approval, so updated science often doesn't make it into the inserts.
ISMP officials contend that pharmacists are hamstrung by Medicare regulations that require them to follow only the manufacturers’ package instructions for storage and use of medication, even when it's not current -- and even when there’s valid new scientific information available.
For instance, take the widely-used neuro-muscular blocker succinylcholine, which has been in shortage off and on for more than a year.
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Should medications be discarded when they exceed the storage limit, even if there's a shortage?
"The manufacturer says it's good for two weeks outside the refrigerator, but the literature says it would be good for three weeks or a month," said Allen Vaida, executive vice president for the ISMP. "That period makes a big difference when you're talking about a drug shortage."
According to CMS interpretive guidelines for the agency's standard 482.25, “drugs and biologicals are stored in accordance with manufacturers’ directions and State and Federal Requirements.”
But a recent analysis conducted at Cedars-Sinai Medical Center in Los Angeles confirmed that directions for many of the drugs in shortage are flawed or lacking. Of 50 random drugs on the national shortage list, a third lacked basic information about compatibility with diluents and half lacked information about stability, storage and expiration dates after dilution, according to an ISMP report.
When pharmacists ask the manufacturers directly, the answers still may remain unclear, ISMP officials said. In that case, pharmacists often turn to recent studies or other accepted industry documents for guidance -- or they face trashing drugs based on falsely cautious parameters.
It's not clear what volume of drugs in shortage is being discarded. Officials with federal agencies including CMS and the Environmental Protection Agency say they don't keep those figures. Individual hospitals say they have no incentive to track them.
ISMP officials have launched a survey of the agency's members to determine the extent of the problem and to decide whether the group should petition CMS to relax the rule. Results are expected this month.
Dr. Patrick Conway, chief medical officer for CMS, says that the agency is willing to talk to ISMP about alternatives.
“The concern is that we don’t currently have another standard to apply,” Conway said. “The manufacturers’ label is a Food and Drug Administration-approved label.”
Hospitals found to violate storage and stability rules could face CMS fines or other sanctions.
Even when there are trusted regulations, such as the pharmaceutical compounding directions issued by the U.S. Pharmacopeia -- known as USP 797 -- being forced to toss limited drugs can put pharmacists in a quandary, said Bona Benjamin, ASHP’s director of medication-use quality improvement.
“In these situations, clinicians are likely to question whether there’s greater benefit or risk to the patient if medications that are scarce must be discarded,” she said, adding that ASHP officials support 797's science-based rules.
Other experts say they know some pharmacists are side-stepping requirements from the USP, the nonprofit organization that sets standards for drug safety and sterility, in order to conserve medications already in short supply.
“If I know I’ve got 10 single-dose vials to last me through the week, and 30 procedures, I have to make those 10 vials last,” said Gigi Davidson, a veterinary pharmacist at North Carolina State University who heads pharmacy compounding for the USP council of experts. “I am clearly stepping away from the standard when I make those choices.”
Pharmacists are repackaging drugs into smaller units, stretching the medications to serve more patients, even when the USP 797 rules warn that there's more risk of problems such as contamination and infection. The important thing is to make sure proper aseptic technique and procedures are followed, Davidson said.
“It makes me nervous, but it’s something I do with eyes wide open,” she added.
While the dilemma for the pharmacists is acute, some cancer patients believe there should be no question at all. Maggie Heim, 58, of Hermosa Beach, Calif., is a lawyer who was diagnosed in 2009 with stage 3 ovarian cancer.
She was prescribed the cancer drug Doxil, which has been in short supply since last year, particularly after a troubled contract manufacturer, Ben Venue Laboratories Inc., suspended operations last fall. She was placed on the Doxil waiting list arranged by Janssen Products LP, the Johnson & Johnson subsidiary that owns the drug's patent. She never received the medication, though, and had to be treated with a different protocol.
During her treatment, several other medications used to treat ovarian cancer were added to the drug shortage list.
“Give that I am fighting for my life, I would be very upset if I found out that a pharmacist was required to throw out a drug I needed that is in shortage,” said Heim, adding: “How could a pharmacist pour it down the drain when it is so needed to keep people alive?”
Some pharmacists refuse to take the risk. At Shands HealthCare, Knudsen, the pharmacy legal director, says rules are rules, even when drugs are in short supply. His hospital has been able to transfer doxorubicin patients safely to other drugs, he said.
"The Florida Board of Pharmacy and USP 797 rules were created to protect patients," Knudsen said. "Selectively choosing which rules to follow, particularly when alternatives to doxorubicin exist, seems risky."
Davidson agrees that standards should not be relaxed to accommodate the crisis of the moment.
"If it’s not drug shortages, it’s going to be something else,” she said.
At the same time, she understands the Catch-22 faced by a pharmacist who knows the drugs he discards could save someone’s life.
“Then I have to do some soul-searching,” she said. “Am I afraid of harming the patient, and that’s why I throw it away? Or am I afraid of regulatory authority?”
If it’s the latter, the pharmacist should seek guidance from the state board of pharmacy before tossing the medication, she said.
As far as experts can say, no hospital has yet faced sanctions for failing to discard drugs during the current shortages. “If someone comes in and surveys, there probably would be hell to pay,” said Burnakis, the Baptist Medical Center pharmacist.
But any sanctions, even in the case of patient harm, would have to be tempered with the reality of trying to salvage life-saving drugs in the midst of a crisis, Davidson said.
"If I were sitting on the jury and someone had to choose to stray from 797 to provide a needed drug to serve a child with cancer, I know exactly how as a juror I would vote."
What should happen to drugs that hit the manufacture's guideline for disposal? Tell us on Facebook.
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Leave a Comment:
Florida's governor Rick Scott's new plan to make himself another 500 million dollars.
That guy is a total screwball. He's a psychopathic serial fraudster.
Florida cannot wait to be rid of this idiot.
.
My hometown in NY is a better place in florda. And I grew up in the Bronx so you know thats saying something that doesn't matter to anyone here.
"With the medications in very high need, we are using it," said Thomas Burnakis, coordinator of pharmacy clinical services at Baptist Medical Center in Jacksonville, Fla. "
Be ready to get a call from the Obama Administration and perhaps lose your license.
A rule is a rule, and you're breaking a rule, and saving lives is no excuse.
PS - Request a jury trial - jurors with 'common sense' will never convict you.
Nice try in making it a Republican Governor's fault. These are FEDERAL not State regulations. The regulations are set up to create a situation of nearly zero risk, and if they are not followed by the hospitals or the suppliers, there are fines as well as the liability of being sued. Regulators will enforce by the book because they have no incentive to use common sense. If they "overlook" something, they are subject to dicipline (or maybe just another agency being created to do their job by the book).
So, now that you see the downside to Zero Risk regulation, can you see why it increases costs? It may be more PC to blame things on a Political Party or on Manufacturers, but those blamers are the same ones that applaud the level of regulation.
@Roy
+1
Could not have said that better myself! Rules > Saving Lives.
I travel from inpatient pharmacy to inpatient pharmacy all day long. Different regions. Different IDNs. They all basically say the same thing you did. The rules make absolutely no sense to the practical world, but breaking them is a career ender. Pharmacy technicians shake their heads and tell me they have to retire a perfectly good drug that "expired" a two days ago. The pharmacist knows this, but has to remain compliant.
The anesthesiologists are even worse. They get real emotional about how their patient safety is affected by the shortages. Was fentanyl listed here? They complain about that one too...
Better hope JCAHO doesn't catch them.
Anytime you begin the word with an F as in FDA something tells me these days especially that your are F&#ked. Another reason why Federal gov't is in way over their head. They can't manage anything because everything they do they is so regulated. If people in this county can't see what's going on here and continue our Gov't down this road, soon we will all be F@#ked.
That's the name of the game. Government regulation is all about wasteing time and money in the name of power and lazy bureaucrats who justify their fat salaries by looking for new ways to gum up economic activity. And the little people are the ones who generally end up getting shafted as a result.
Shortages? WHY?
Foolish money grabbers!
We should be pouring ourselves into production if they work.
Oh well, just too much money in cancer to cure it.
Why in the hell would you say something like that Roy Wilson? That just goes to show how little you know about our President. He makes critical decsions not blindly following rules unlike so many airhead Repubs.
You wish you could be a quarter the man he is.
Yet another glaring example how healthcare is taken out of the hands of those who spend their lives studying it (doctors, pharmacists, etc.). Instead, fear of being sued and arbitrary regulations take precedence. It's a shame that poor woman with Stage 3 ovarian cancer cannot receive her drug of choice, but its her blood-thirsty colleagues in private practice and in government that have screwed her.
I am waiting for the day when lawyers run out of people to sue and start litigation against each other.
We have drug shortages and unemployment. Employ the out of work to make drugs. Simple. Or is it? I have a feeling we're being held hostage by the pharmaceutical companies.
A few questions that should be answered:
1. Whom was in the room when the federal regulations were created? Big pharm? A czar? A donor?
2. Are the regulations based on when the drugs start to deteriorate or for another reason?
3. If these drugs are in a shortage, why do the drugs go to waste? Aren't they being used up? Can the hospitals trade the drugs between themselves per the need?
4. If the FDA is aware of the growing shortages in vital drugs, have they come out with any temporary revisions that will aid in the supply or flow of the drugs?
5. If we really are headed towards nationalized healthcare, are these drugs going to be more available, similarly available, less available, or even unavailable (due to cost, etc.)?
Those whom are complaining that there is too much Federal Regulations...I hope you or one of your family members are not the next one to die or greatly injured by EXPIRED medicine. FDA states to follow the manufactors label....Pharmaist calls Manufactor regarding expiration...no clear answer given. Manuafactor KNOWS the possiblities and limitations of their products...and they cannot give someone a straight answer. Oh, and research that saids a medicine is sitll good...check the funder for the research if it's the manufacture, it can be bias. So before you DAMN the government, be reminded that their are thousand more life saving drugs that this FDA regulation SAVE lives.
The pharmaceutical company suits don't care. They can control the supply and increase their profits at the same time. Hey, a few dead people are worth another billion in profit, right?
Someone should be Prosecuted and put in Jail. Life is Precious, period. If one person dies in Florida or anywhere people trying to benefit should be held accountable. WAKE UP AMERICA.
Mike C. They wouldn't think of situations like that. The might however, think that the current system is OK because it helps cover their anus from lawsuits, yet still increases production and manufacturing and shipping, thus making the recovery look better.
This is another, ANOTHER problem, with healthcare in this country, and why it costs so much to afford treatment. BS on the re-couping of monies spent in R+D. The costs of the finished products are from (example only....$1. to $600.) to the various dependants of said drug.
And these folks worked with the administration on Health Care. Yikes!
TaMonica, good lord, look at how rediculous the situation is WITH the overegulation now.
WHO? Regulations from your PRESIDENT and idiot advisors. If you vote for him take the consequences. Liberals do not do that since they are dumb @#@#@.
MGates73 "Why in the hell would you say something like that Roy Wilson? That just goes to show how little you know about our President. He makes critical decsions not blindly following rules unlike so many airhead Repubs."
He has to follow the same laws that everyone else does, even if he did sign them into law. While he's guilty of 'selective prosecution' in some cases (ignoring the laws against illegal immigration for example), he cannot arbitrarily change the letter of the law. He needs Congress to revise the law first, and then sign the revision.
Obama may think of himself as a 'Dictator' when it comes to arbitrarily changing laws, he is not.
Whaaaat ? Blaming Florida elected officials when the "regulations" were imposed by Federal Agencies ?
Wow, some folks will go to any lengths to shift the blame. Sounds like a Liberal "Truth Squad" talking point, or is that a Liberal "Attack anything - Blame someone else" policy.
Maybe we will see an article today on how the FDA is skirting their assigned "regulations" for providing safe food to the masses.
Ransom. Profits. Period.
Spin all you want about "government " regulation while you support deregulation of murderous tactics for your #1' God given righ't to make as much money any way you please.
Big pharma becoming the same as big oil? Without regulation thousands would be dead from bad drugs. Profits are all that matter to the big boys. The money spent on advertising is outrageous. You government haters are full of crap. Its the huge corporations that are killing you.
I've always wondered if the expiration dates are set way ahead of the actual date the drug expires in order to force people to buy more of the medications. We see this kind of business practice with electronics (built cheaply so they don't last long, thus forcing another purchase; or as with certain printers, their computers will make them inoperable unless a spare part is bought, even though the spare part actually still works), and pharmaceutical industry is clearly just as ruthless. Not too long ago there was a company with a monopoly on a drug that was so vital to some people's existence (and thus demand was so intense) that it tried charging something like $1500 a pop. Thankfully, some government entity stepped in.
Or perhaps, and I'd like to believe this version, the pharm companies set the expiration date well ahead of the date on which the drug would actually expire in order to be overly safe, in the same way we see with many foods, such as canned foods. Making a mistake on the expiration date in the other direction could lead to a company destabilizing class action.
As someone highly involved in the process of determining expiration dates... they are definitely NOT arbitrary!
Anyone who thinks that should sit down and read the regulations governing drug stability. When you can make sense of it and come up with the amount of work it takes to determine expiration dates, then you can complain about how easy and arbitrarily assigned the dates are, and why its a total conspiracy that the big "they" set the dates too short just to make more money.
I think it's funny that we are lamenting about the rule to throw away "perfectly good drugs" do to "govt regulation"
and we arent bellyaching about the PRIVATE INDUSTRIES who are simply choosing not to produce LIFE SAVING DRUGS because they dont make them ENOUGH profits (read: they do not create losses)
It's awesome that we are willing to overlook the greed that is costing lives...
but many here, wont waste a chance to lash out at the federal govt...who isnt creating the shortages to begin with, that are resulting in lives being put on the line.
thats the new american logic...and it's killing us.
He doesn't, you do, and the concept is a joke. Do you think Obama himself wrote all of these rules, and insisted they be implemented? Your ODS makes you look foolish.
Better yet, why don't we examine why the rules are as they are? Would you use over-age eggs? I wouldn't, so why insist on using out-of-date drugs? (though multiple 'use-by' dates is confusing, who wants to get sued for using stale drugs? I guarantee if your mama was sick, and got old drugs and died, you would sue their pants off!)
If there are issues with dating the age of safety on the drugs, ADDRESS THEM, instead of pointing fingers at the Feds, and screaming about how stupid they are. Examine how the rules came to be, and how to change them to mirror reality and SAFETY more closely.
Seriously, it's not that hard to not be an idiot.
If you think things are bad now, wait until Obamacare takes over the entire health care system. Government paper shufflers will run everything!
If you think there are drug shortages now, wait until the Federal Government starts dictating the prices to be paid for drugs. Why should pharma invest billions in a new drug? Why should they build more manufacturing plants?
Central Planning always fails. How was the healthcare in the USSR? When was the last time somebody flew to China to get an operation?
Wake up America! Repeal Obamacare.
One poster here compares expired drugs to leaving milk out for a couple hours. You might drink that milk and be fine, but ill patients with poor immune systems and compromized liver function are more suceptible to any bacteria or fungus that might have begun to develop.
Hospital pharmacists are preparing medications for desperately sick patients or those undergoing risky surgeries, so they have to be careful about how long any drugs have been open or on the shelf. But this article describes regulations that are not based on current science or medical research - so that's what needs to be updated.
Many drugs past their expiration date are still good, but they may be 90% - 95% effective instead of 100%, putting both the pharmacists and physicians at risk for lawsuits if something goes wrong with the treatment (e.g. bad side effects or ineffective) or surgery. Investigations may not be able to pinpoint the cause of the problems, but if the medication used was not handled according to strict regulations, that's where the blame will be (mis)placed.
Not only do I support the Healthcare Reform Act, but I wish it went several steps further towards instituting a modern single-payer system for Americans. Medical care should not be viewed as a regular commodity to be bought only by people who can afford expensive health insurance plans. Poor Americans should have equal and affordable access to decent medical care just as they're assured of clean water, clean air, and and basic safety precautions.
I get a good laugh out of the ignorant, ranting right-wingers who simply reject anything Obama supports, e.g. that doesn't fatten the wallets of the rich. I'll vote for Obama again this year and hope for a Democrat-run House and Senate (and more local democratic politicians) to fix the serious problems caused by the Bush administration. Racism and greed run deep in many Republicans.
Imright - LOL, we are talking about date expirations not restricting manufacturing.
Obviously date expiration, demand and manufacturing are interelated but who has the magic formula to accurately define it?
Seems like the biggest issue here is liability, and we all know that Americans are fond of law suits.
terryknight "Someone should be Prosecuted and put in Jail. Life is Precious, period. If one person dies in Florida or anywhere people trying to benefit should be held accountable. WAKE UP AMERICA."
Your point is unclear, but if you're saying that 'the law is the law', then does it make sense that 100 people die from lack of medicine, to 'protect' that one person who might have complications from an 'expired' drug?
The FDA rules say that drugs have to be discarded when they lose a small percentage of their effectiveness (say 5%). The drug may still perform its function in virtually 100% of the cases, but the arbitrary rule requires it to be discarded.
The other factor is the cost. Some of these drugs may cost $100s or more per dose, and discarding them results in the cost of discarding the drugs being built into the final cost - possibly requiring $Billions in extra costs that the consumer ends up paying for.
Common sense and 'government rules' seldom combine effectively.
right...a lot of these regulations have existed for years. They have been put in place during conservative and liberal administrations. They were put in place to protect the patients from compromised pharmaceuticals. At the time no one saw the looming shortages, nor could they forsee the new data establishing a longer life for the drugs.
The manufacturer should know more about the meds than anyone else, they should be providing updated shelf life information. It is a reasonable regulation that the user should follow the manufacturer's instructions. The problem seems to be lack of incentive to update shelf life and storage instructions on the part of the manufacturer and lack of flexibility to changing situations on the part of the FDA.
Only a rabid ignoramus would blame this on Obama.
Fred Evil "Obama may think of himself as a 'Dictator' ..........He doesn't, you do, and the concept is a joke. Do you think Obama himself wrote all of these rules, and insisted they be implemented?"
Thanks for the 'promotion' - I hereby 'dictate' that people use common sense when making a post. lol
When you're the person in charge, you are responsible for the results. How often has Obama 'blamed Bush' for what happened when he was President, whether Bush personally did anything wrong or not?
In 2008, Obama said "Elect me - I know how to fix our problems". He has failed by all objective standards.
I work for a biomedical company and often we find ourselves in back-order situations. It's not pharmaceuticals but it's close enough that I can tell you that often times the manufacturer simply cannot make enough of a product to meet the demands of hospitals. Often it comes down to the raw materials that are needed to make it also being in short supply, other times it's because the process to manufacture the item is difficult and entire batches need to be re-worked or discarded. So it's not likely that Pharma is creating shortage on purpose to drive up profits. The price is the same for the drug regardless, hospitals pay what they are told they have to pay, doctors don't really take price into consideration when prescribing drugs. So during shortages, the drug companies lose money because they can't sell as much as they would like to.
One of the reasons I can think of why they have expiring products on the shelf when the product is in high demand might be because when the maufacturer is faced with back-orders, they may offer short dated products to the hospital to help them service their patients. In otherwords, customer service at the manufacturer might call the hospital purchasing department and say "we see you have a backorder for ABC drug. We do not expect to have any available for serveral months, however we do have some product here that is expiring in 4 weeks, if you need and think you'll use it in time we can fill the order with that." In severe backorder situations they often will accept it knowing that it will likely be used before expiration. Obviously they don't always use all of it.
Roy - do you honestly believe that if Obama were became ill with a disease that could only be effectively treated by one of these drugs that are in short supply, that he would be treated like everyone else? If you do, then you are in la-la land. He would be at the top of the list to receive treatment. The drug manufacturers would probably ramp up production to make certain that he has everything he needs. The president and those in Congress don't follow the same rules as everyone else. If they did, a drug shortage would not be an issue.
It is very difficult to have the FDA approve any changes to a product insert. Many times initial expiration dating is extimated conservatively because the drug simply hasn't been around long enough at the initial launch date to know how it breaks down over time. The approval process for a new drug is tedious.
It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans.
The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.
The research-based pharmaceutical industry currently invests some US$12.6 billion a year in new drug development. Historically, the drug development figure doubles every five years.
When it takes this much time, money and red tape to bring a drug to market, the chances of a company voluntarily jumping through these same hoops to extend shelf life by 6 months is highly unlikely.
It is very difficult to have the FDA approve any changes to a product insert. Many times initial expiration dating is extimated conservatively because the drug simply hasn't been around long enough at the initial launch date to know how it breaks down over time. The approval process for a new drug is tedious.
It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans.
The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.
The research-based pharmaceutical industry currently invests some US$12.6 billion a year in new drug development. Historically, the drug development figure doubles every five years.
When it takes this much time, money and red tape to bring a drug to market, the chances of a company voluntarily jumping through these same hoops to extend shelf life by 6 months is highly unlikely.
This is not a liberal vs conservative issue but rather an example of how regulations can and need to be re-worked (not removed) in order to make them more effective and applied better. You folks who think that regulations are simply wrong. Regulations to PROTECT patients are never bad... as long as they are reviewed and re-evaluated in order to ensure their efficacy.
the question now becomes how much money must be spent on establishing a system to review and rework the regulations on these drugs? This would be an acceptable way to use taxpayer money...
Judge - These are federal regulations, not state. Not too good at reading comprehension, are you? For whatever reason, MSNBC decided to interview health care professionals in Florida. They could have interviewed pharmacists in NY, who would have said the same thing because they are bound by the same federal regulations. Would you have made disparaging comments about your own state?
Raymond - How about explaining to the rest of us how this is going to make money for the governor of Florida, especially since this is something the federal government is doing, not the state government. Oh, that's right. You went to the same school as Judge and are slow on reading comprehension.
We'll let you know when you do (surprise surprise, you twisted my words to mean something not intended).
I don't disagree with this statement, but it's hardly realistic given the vast territory and wide expanse of topics our government has been FORCED to regulate. Yes, I said FORCED to regulate. Why? Because businesses don't give a rat's tail about the safety of their products unless their feet are held to the fire. Without these rules in place, who knows how many people would get sick because the medicine made them worse, not better?
You're picking nits looking for ANYTHING to bash Obama over. It's your right, you can marginalize yourself however you want.
Only if you never intend to be fair about it. Was it jobs that was a problem (here they come!)? The economy (doing better!)? Or was it expired drugs (not an issue)? Please, stop making your ODS so obvious. You only undermine your own position.
Spot on, accurate and poignant.
ABCzyx "He has to follow the same laws that everyone else does, even if he did sign them into law....Roy - do you honestly believe that if Obama were became ill with a disease that could only be effectively treated by one of these drugs that are in short supply, that he would be treated like everyone else?"
Boy did you reach out into left-field to put that spin on my comment. I believe the topic was expiration dates on drugs, not Obama's personal health issues.
Fred Evil "Regulations to PROTECT patients are never bad... as long as they are reviewed and re-evaluated in order to ensure their efficacy..................Spot on, accurate and poignant."
Oh Really? So if the government passed a law that said "All drinking water must be 100% pure", even though the cost might go from one penny per gallon to $1 per gallon would be good (NEVER BAD)? Just think - it might save a few lives each year - even if it does cost the average family about $2,000 more per month.
Regulations need to balance the perceived costs/benefits, which is something the government seldom does when considering legislation to dictate how people have to live their lives.
The current topic about the shortage of critical drugs and the government imposing 'expiration dates' that may not balance the 'costs/benefits' is a prime example.
PS - Since this is 'front page news', Obama will likely give some 'waiver' to alleviate the problem, but what about the 99% of cases where the public never even knows about the foolish governmental 'regulations' and their impacts.
You love to be deliberately hyperbolic, huh?
Read that again, UNDERSTAND what it means, and then you will see why your response was unnecessary.
Don't worry!
Obamacare will fix everything!
I find it funny that while the article describing a difficult situation for pharmacists stuck in the middle of a conflict between manufacturing difficulties and pharmacy law, nearly all of the above posters tell a tale of a single political misanthrope purposefully causing this stressful situation. Whether it is Florida state or federal law seems irrelevant because both pieces of legislature were obviously written and put through proper congressional processes (involving several public service representatives voted into office by the popular vote of their respective constituencies) before ultimately being signed by the governor or president of THAT DATE (many years ago), and thus could not possibly be the single orchestrated efforts of any person in office today.
If you have suggestions to improve the USP guidelines; perhaps to amend with an exception due to shortage events, or exceptions due to multiple scientific literature sources, or even requirements for manufacturers to regularly review and update their storage parameters and stability information based on continuing scientific study; then I would urge you to contact your local / state / federal representatives to begin drafting amendments to these guidelines. The sooner that action is taken on the part of the citizens, the sooner the government can make amendments and corrections.
Nice reply Fred.
I find it extremely hard to believe that there are shortages of medications. I find it easier to believe that all this shortage nonsense is just another way the Big Wig Drug industry has found to jack up prices and thrive in greed greed greed and oh yes greed!!!
Shame on big pharma for risking people's lives for the love of Greed.
People before Profits.
And thats my opinion.
Nothing like an over regulated industry ham tied by litigation from the likes of John Edwards and his ilk driving up the costs beyond all reason.
Federal Govt setting price controls......
I'd cut production too...
Jello heads!
Sure JOE, let's totally deregulate the industry. I trust corporate America to always do the right thing. They would never dream of screwing the American public in the interests of making a few more billion, right Joe???
You might want to look back in history to a time when there was no FDA and the industry was rife with quacks. What do you do when there's an issue with regulations??? You fix it Joe, you don't trash the entire regulatory body.
Shall we ban the FAA, EPA and OSHA while we're at it? If you're the Righty that you sound like, chances are your answer is yes. No thanks, I like flying on aircraft that have been checked out by the FAA and I know the wings are safely bolted on. Taking a drug companies word just ain't good enough for me. Not like there's ever been any abuses by the drug industry. Ain't that so, Joe???
They already screw the American public by creating "shortages" to improve their bottom line and justify the high cost of medicine.
The FDA is a piece of sh|T ... there are drugs out there that are known to fight and cure cancer but they won't step in and have official testing conducted. They emailed me saying drugs needed a sponsor in order to get the testing needed to be "approved". Drugs that fight and cure cancer will never get the approval because of the lobbying of drug companies prevents it.
This is not only a medical industry problem; it is any industry that the government is involved in. Manufactures place ridiculous shelf lives to force industries to buy more of the item to make more money and the federal inspectors enforce it.
ExMilitary,
These are cancer fighting drugs that hospitals have. They have nothing to do with drug approval. For example, if they leave the bottle out of the refrigerator they have to toss it. It's a safety issue because bacteria could grow in the medicine. Would you drink milk that you'd left out for a couple hours?
Apparently your familiar with the term "Close enough for government work!"
Ozzie always checks the date on anything from his fridge, medicine cabinet, etc. If it's out of date, he tosses it and buys new like a good little ozzie boy. The gubmint bureaucrats always know best.
I am referring to drugs that aren't in the hospitals. Check out the lowdosenaltrexone.org website. Why hasn't this been approved?? Why, because its cheap, about a dollar a day and it CURES cancer at better rates than approved drugs and it cures other diseases that aren't addressed by current medicines.
Ozzie Boy
You sound like a complete lefty. I happen to be on the other side. I like the fact that the GOP tried to block Obamacare because it was written with the help of the health industry. And when you have an industry in business to make money you get over regulations that benefit those industries. There are soooo many issues in Obamacare that we haven't even begun to see yet that will cause more pain than they will help to reform. This drug isssue is a perfect example. If you read the article, it pretty much comes down to medicare and medicaid writing the rules. Which party has been trying to reform these institutions? The GOP. Which party refuses to reform them? Democrats. You talk about fixing the problem? Talk to your politicians on the left. More regulation doesn't help. Good regulations and oversight help.
Ok because the article isn't about that.
I looked up the pharmacokinetics and mechanism of action of naltrexone. I don't see how it can fight cancer and I've done cancer research. It's also been claimed to cure HIV and again, I don't see how that's possible and I've done HIV research too. I also hit the scientific journals and I can't find an experiment that supports what you're claiming. Check out http://www.sciencebasedmedicine.org/index.php/low-dose-naltrexone-bogus-or-cutting-edge-science/ for some information about this topic.
Joe, go read the article on MSNBC.com about S.C. Johnson selling hip implants overseas that were recalled after thousands failed in the US and then talk about deregulating the medical industry.
The lame-brained government has created these shortages by over regulation the suppliers of material to produce the drugs and now more stupid regulations to force hospitals to discard still usable and safe drugs creating even more shortages.
And some people actually believe the government is smart so they want more of it! The government has been known to operate on the 'mob principle' (the IQ of the stupidest member) ever since government was created. Everyone has been exposed to the TSA's stupidity. That's exactly what the rest of government is like.
We don't need MORE stupidity!
It's called the Healthcare Reform Act! "Obamacare" is the stupid GOP/TP code word that has nothing to do with the legislation. It is major reform. Obviously the Right wouldn't be so upset if it was not.
You clearly have zero knowledge of the drug industry. This has nothing to do with Healthcare reform. Expiration dates have long existed and have always been abided.
If you want to take and use expired medications for you and your family go right ahead. But don't ask a healthcare professional to do this because they would be clearly exposing themselves to litigation were there issues with medications they administered that were expired.
You appear as just another righty pretending to have knowledge of something you know nothing about. I work in the medical industry. Most of these regulations come from the insurers themselves. It's all about covering their own behinds and having every "i" dotted and "t" crossed and has a lot to do again with litigious matters. If you made your argument from that angle it would be far more sensible. Instead you chose a politic angle and fall back on the usual non-sensical talking points.
Pragmatic: "Would you drink milk that you'd left out for a couple hours?"
Yes, absolutely. Wonder how long some of the milk in sippy cups stay out of the fridge and gets ingested? Wonder what the manufacturer says about keep the bottle refrigerated? With all the money spent on testing today, you'd think we would be smart enough to conduct a series of tests to determine the point of no return on various medicines that need to be kept refrigerated. Also, if the refrigeration is necessary, why can't a specific dose be separated from the parent bottle which could then be returned to refrigeration?
Just sounds like there is too much bureaucracy and hooey surrounding this issue. Kind of reminds me of the gasoline pricing scam.
JH the GOP don't like Obamacare because it came from Obama. It doesn't matter that most of it has been on the GOP want list for the last 25 years. Now that Obama is on board in the name of non-partisanship those ideas are crap. Do you even see the irony that now that a Democrat is using the ideas that which the Republicans have wanted and loved, they now hate it. You never head anything about Romneycare until Obama used it as a model because it was mostly Rebulican ideas. Now Obama uses them and Romney "isn't a real conservative". Your being condtradictory out of pure spite. I believe the saying is "cutting off the nose to spite the face. Obama could do an about face and give the Republicans everything they ever wanted and they would still complain and hate it because it came from Obama the Democrat. Meanwhile Obama sells Democrats down the river in the spirit of "non-partisanship". He should have rammed Single Payer Health insurance down the throats of Republicans when he had the chance. You can scream Socialism all you want but the fact is the US is the only first world country not to have a free or low cost medical system. And meanwhile while the GOP screams Socialism the USA continues to drop in the ranks medical care and education to the level of third world nations. At least I find it a sad day that Doctors Without Borders who bring medical care to those who can't afford it in third world nations are now herere
O.K. you can scream against the "evil" regulations but when something bad happens because the saftey regulations aren't followed, I would wonder how many people would be screaming: " Why wasnt anything done about this?"
Ozzie Boy-2719086 "What do you do when there's an issue with regulations??? You fix it Joe, you don't trash the entire regulatory body."
Agreed. The regulations should offer some flexibility in 'emergencies'. Unfortunately, the 'brilliant' legislators that dreamed up the law probably didn't think of that - they seldom do in their zeal to 'regulate' everything.
As a recently retired home care hospice RN, I myself have destroyed 100's of 1,000's of dollars worth of medications, that were NEVER touched by the patient or their care givers. Lovenox, a blood thinner injected into the abdomen, cost about $100 per ingestion. Destroyed! Why because there is a law that states once a medication is delivered to the patients home, it cannot be returned to the pharmacy. Medications, I personally sign for but did not use for different reasons.
Also, patients who are nursing homes (Extended Care Facilities) or ECFs and are on Medicaid, are required by law, to receive vitamins and minerals, as "prevention measures." Now imagine, you are waiting for breakfast and a nurse puts a spoonful of applesauce with CRUSHED vitamins and minerals added, into your mouth. It is disgusting but it is the law. Nurses have to use ingenuity, to get patients, to take these medications. I wonder what drug company lined the pockets of the law makers, who thought that up? And then the patient begins to loose weight. Hospice is called in because the patient is considered terminal.
Once the patient is admitted to hospice, many of these "supplements" are stopped because it becomes a quality of life issue. Guess what? The patients start to eat and gain weight and feel better. I can remember having patients, on the hospice program and then discharged because they no longer were "actively dying. A few months go by and they start to loose weight again. It is a vicious and cruel circle.
That is what happens when politics mixes with the medical profession. There is so much waste because of government regulation, it is no wonder medical treatment is getting more and more expensive. Currently I have $1,000 worth of Lovenox sitting in my cupboard. Never been open and useless, because I cannot return it to the pharmacy. If I am able, I can find a group, such as Doctors Without Borders" or some other organization and donate the medication to them. People in third world countries are grateful to receive anything that will help them get well, even if the medication is stored in a clean cupboard in my home.
The medical field does need regulations by by whom?
Some Lame Name Here "JH the GOP don't like Obamacare because it came from Obama. It doesn't matter that most of it has been on the GOP want list for the last 25 years."
I doubt that the GOP has been insisting that the Catholic Church violate their deeply held religious beliefs against abortions and force them to offer contraceptives, including sterilizations and the 'morning after abortion pill'.
Lame Name
The American people don't like Obamacare. It did NOTHING to reduce the cost of healthcare in this country. It has layers and layers of crap that will continue to cause this exact problem. The objection to Obamacare is NOT President Obama, not his skin color, not his party, it is the POS bill itself. You far lefties and your stupid talking points about it just being about our President are wrong! How many wavers have already been granted? They are currently trying to get the "doctor fix" fixed in the payroll tax deduction talks. They scrapped the 1099 form regulation because it was so stupid. There are some parts in Obamacare that most everyone agrees with but there are many parts that are just not workable. That POS will NEVER reduce this countries money woes. It will take us to the poor house. You can bet your paycheck on that.
Socialism works fine, as the term is currently used. Small business owners and entrepreneurs tend to be middle class folk. In order to start their enterprises, they benefit from a strong social safety net. You are far less likely to take a risk if you are worried paying for your health is going to be an issue. It is no surprise that the more prosperous states within the US tend to be more socialist. A prime example is silicon valley; after the crash of 2000, engineers just started cashing their large unemployment checks and working for themselves. Many of today's successful Internet companies were formed during that time.
The so-called disagreement between today's Left and Right isn't about business vs. the poor. It's about the disagreement between the mega-rich and the middle class. The rich and Big Business don't want change or innovation, they have some nice cash cows and they have a good thing going. They don't want all those small business owners and inventors working for themselves. So insurance and services and everything should be provided by your employer.
It always surprises me that there are some people who have serious problems with the government taking away their freedom, but have no problem with businesses taking away freedom. Yes, there's the argument that you don't have to deal with a particular business. But then, you don't have to deal with a particular government either - you can always leave.
Then perhaps you should have supported Obama when he was trying to get it passed and helped him working reducing the cost to you. Instead, you helped almost every health insurance company write it so that it could do nearly nothing to stop their ability to gouge the American public. But no, it was all about freedom back then - freedom to charge you whatever they want and not allow you to refuse.
We far lefties hate Obamacare because it does very little to cut costs and does a lot to make it difficult to avoid costs. You got what you wanted into Obamacare. Why are you complaining now?
How could it NOT be "just about our President?" If it was about providing better and cheaper healthcare to the American people, you would have supported it.
JH-479998 "Lame Name The American people don't like Obamacare. It did NOTHING to reduce the cost of healthcare in this country."
In fact, the cost of healthcare increased dramatically because of the first few provisions that went into effect. Normally, health insurance goes up about 7% per year, but after Obamacare went into effect, the premiums went almost 20% shortly thereafter.
Just wait until the really expensive provisions go into effect - shortly AFTER the 2012 elections. By the way - if you don't buy government mandated health insurance soon, you will be fined and the IRS will come after you and attach any 'refunds' you might be entitled to, as well as your bank accounts.
Congratulations on that "Change we can Believe in" that you voted for.
By the way - there are some provisions that most Americans would agree with, such as eliminating the 'pre-existing conditions' clauses, but that didn't require a total takeover of control of the healthcare industry by government. The Administration requiring churches to offer 'contraceptive' coverage (including abortions and sterilizations) regardless of the core doctrines against such things, is a prime example of the government forcing THEIR version of morality on everyone.
As with most all, this isn't A or B; there's a midline not being seen.
I, too, have worked the medical field and some is profit based waste, some fear litigations brought against (that's actually a big one) and some overly cautionary. All need attended to and have been allowed to get out of hand by legislature, pure and simple, whether by being bought out or by sheer neglect.
Most cancer meds have enough ass that people on them are instructed to use their own toilets, etc... (I know... my mom took them with pancreatic cancer) and expiration dates on these are mostly bull, as the half lives are phenomenal. Cancer meds and others that aren't radioactive but stronger if stored properly can far outlive their expiration dates, but in order to make more $$, shorter dates applied.
Shortages are gambles with those that need vs. those producing; guess who's going to win in the end? The same that always win- those that buy our supposed representatives.
The big risk is the scum sucking lawyers, e.g. baddrug.com. If there is any variation from published specs, you can bet lawsuits will follow. That's a big part of the reason for the drug shortages in the first place.
Some of you will never get it because you only think in the extreme. Republicans are bad at communicating it and Democrats are only good at demagoging it but the reality is that deregulation is not an all or nothing thing. Yes we need regulations but we don't need them to the point that every little aspect of everything is controlled down to the minute detail at a cost to liberty and common sense. The EPA is the biggest target right now because it is being run by a radical left enviro nut case who don't give a crap about the American People but is instead using over regulation to pass a leftist, anti business, anti energy, anti jobs, anti poor and down right Nihilist agenda. They have the sheeple so convinced that they will fall over and die from cancer or emphysema or the world will be flooded if anything burnable is ignited. This is why we need to get regulations under control and get people like that out of power. Does it mean that we need to burn all the regulations? No of course not but we need to find a balance that works for all parties in America not just the agenda of one. The same thing goes for every other regulated entity. Review publicly and scientifically what is out there and repeal or change what doesn't work or is more burdensome than helpful. Don't toss it fix it.
Byron
Please tell all of us how the GOP could have helped write Obamacare. If I recall it was the fighting between the democrats that delayed Obama getting it done sooner. I also recall hearing that republicans were not allowed into major meetings to discuss the issues. The GOP were not allowed to help. So if anyone let the insurance companies help write the legislation it was the democrats. If you say that the insurance companie wrote it why the hell did only DEMOCRATS pass it?
It is NOT about our President, you are right that if it provided better and cheaper healthcare I would have supported it. But it doesn't do anything close to that so it really is about our stupid democrat leaders who allowed the insurance companies to screw us.
@Ozzie Boy-2719086
This is the ONLY argument the sheeple have and it is TOTAL BS. NO ONE has EVER said there should be no regulation at all. If you have to grossly exaggerate to make your argument it's pretty obvious you never had a valid complaint to begin with.
But I thought that by having government more involved with our healthcare system everything would get better!! Well, that's what the left thinks anyway. I can tell you this, it sure as hell is not any cheaper either!
Come on! Big Pharm doesn't want to cure cancer. It's much more profitable to simply treat it long-term.
Many medicines are sterilely packed. If they are opened in a doctor's office they can become contaminated. I do the same thing in cell research. If my growth media is exposed to the open air for even a second, it is considered no good. If I were to take that media and put it at human body temperature, I can say with near 100% certainty that it will be cloudy with bacteria within 8 hours!
There are a lot of bacterial species that can thrive even in a refrigerator. The way to prevent that is to issue single dose bottles or freezing. Some compounds can't be frozen. Often when you have drug shortages like this, the single dose bottles are gone and you just have the multi-dose bottles left, which are more economical. If doctors extracted the medicine in a sterile environment, it wouldn't be such a big deal. The problem is many do not have a sterile environment to extract single doses. They could, if it were economical to maintain such an environment versus buying fresh drugs.
What we need, is full coverage Medicare for all. So the blood sucking insurance companies could dry up and blow away. Getting them and their 12 million a year CEOs out of the mix would save us a fortune on health care. In the mean time Obamacare will be better for people than the nothing they had before.
ExMilitary - it sounds like your beef isnt specifically with GOVT itself, but with the fact that GOVT has been corrupted by lobbyists for Big Pharma.
The people we elect to congress and senate, they dont represent us...the represent the people who cut them the biggest checks and promise the sweetest "board of director" or "adviser" jobs once out of office...
so long as we favor the republican brand of govt, to the highest bidder goes my loyalty (and yes, plenty of democrats favor this too)...then we'll continue to remain screwed.
you'll note, there arent many (if any at all) republicans who favor campaign finance reform, and eliminating lobbyist influence...and most if not all, believe whole-heartedly that corporations ARE PEOPLE, and not only that...the are more important "people" that deserve a larger voice and control in congress.
ultimately, the FDA is staffed with folks who work for Big Pharma, and so long as that reality exists...we'll always be screwed.
Again, we need to create firewalls between the regulatory bodies and the industries they regulate.
let's simply kick the folks out of office, who dont agree with these realities...adn THEN you'll see change.
I dont understand the concept of eliminating govt, will somehow make things better?
Corporations and Industries, arent intersted in creating a better nation and helping the people of America, they are interested in profits - as evidence by refusing to produce drugs that dont deliver the big profits (even if they arent losses to the company).
It's apparent, saving lives is not the industry they are in...despite popular republican belief.
Skup - thanks for the morning chuckle. It's been a long time since I heard the phrase "close enough for government work"
This is why every school at every level is required to teach science courses no matter what major the student has adopted (I'm speaking specifically about college here). Science is pervasive in our lives and people need to understand it because of issues that WILL affect them at some point in their lives. Whether it is political issues that the person finds problems with or an individual health problem that would be easier to understand and therefore self-treat, regular people need to understand more complex scientific concepts. Unfortunately, as our education efficacy deteriorates so does the understanding of individuals who don't pursue a career in the science field. Those who are older are also unable to keep up with the advances that the scientific community has made in the past ( relatively very few) 20 years. It's no wonder most of these older people are right of the middle because they can't understand the issues that drive many liberals. I'm also not saying that all liberals understand scientific concepts that they need to and fight for. On the contrary, I concede that very few understand these things to the extent they should. However, they do understand that scientists and those that are high in the field know more about the issue at hand than they do and trust (for the most part) their opinions. Again, I don't believe in blind faith on these issues which require critical thinking but by cripes sake, at least look the sh*t up on a credible site (aka .org or .gov or .edu etc) before you spew nonsense on the internet and prove your wilfull ignorance!
Jessica, you said...
It is not the intent to eliminate government, but to reduce the influx of regulations that try to legislate every aspect of human endeavor. Think of your two comments above, a larger government will likely promote what you pointed out about the FDA.
No, a firewall is not a good thing, how do you enforce the regs?
What we need is a more efficient enforcement system and therein lies the "catch 22" dilema. The more regs, the more enforcers, the more taxpayer $$$ spent chasing down a myriad of growing conditions that may or may not be a problem. If obama can find 500 regs restricting economic growth, don't you think that there are a whole lot more out there?
For all of you anti-government cynics... This is not a liberal vs conservative issue (or a conspiracy) but rather an example of a regulation in dire need of being re-evaluated and reworked using the latest scientific data. Regulations to protect patients from the adverse effects of expired drugs or improperly stored drugs is NEVER a bad thing. Is their a system in place to re-evaluate regulations to make them more effective and efficient? If not then this would be a great use, in my opinion, of taxpayer money... patients, doctors, pharma and hospitals would ALL benefit from this.
In order for the US to remain a GREAT country then WE THE PEOPLE need to be involved. Cynicism, myopia, zenophobia and ignorance are NOT conducive to achieving this goal.
The government has now began their Hitler practices by eliminating the poor, the seniors, the disabled, and the sick.
If the hospitals are forced to toss out drugs needed to save lives, then the only option let for the person is death.
REVOLUTION 2012 When are the people going to wake up and say "ENOUGH to big government".
@flbikerchick
Yawn. Not much profit after their patents run out. A drug that cured cancer would be the single biggest money maker in the history of pharmaceuticals but you just keep on lapping up the BS your puppet masters dump in your trough. bahhh, bahhhhh
Mgates, you rambled, especially on critical thinking...
On the surface true, however the question it raises is what came first, the chicken or the egg? I would submit that k12 education has lost the focus on mastering the fundamentals early on and neglecting to change the focus over time for the individual to become an asset to the populace upon graduation.
Quite a chuckle here, how can you relate technology to social issues that are derived from interpersonal relationships over time? Does mastery or lack thereof over a cell phone create a mastery for understanding social issues?
Most will only be concerned about what will affect them personally and those they can empathize with. Very few will look down the road to study potential results of decisions made today. Especially if such decisions were not in their realm of personal experience.
Really only valid within the physical sciences that can prove if A & B occurs then the result is always C.
Hard to do this within the medical field (not everything is known) or socio-economic field which relies heavily on human nature (another more unknown than known).
I would question any scientists opinion outside of their field of endeavor who couldn't show how their field impacts the populace. Case in point would be the physicist michio kaku. Not only can he tie the benefits of science with socio-economics but he can do it in a manner that doesn't require a mensa IQ.
The operative word in your post is OPINION, which is what most blogs are based on.
Thats the problem with you GOPhers, you always blame the govt and there regulations of products and industrys,yet you havent the foggiest idea that these industrys write there own policys since they are the experts in these fields, govt passes policys and regulations that the industry writes, so if you have a problem blame the industry
The problem is the hospitals / pharmacies are overstocking of the pills (because pills are one way for them to make a profit (another is the crap they bill you for - like charing $ 4.00 for surgical gloves - when you can buy a box of a hundred for $12.00), let alone overcharging on the price. If the pills have expired, then they need to be pulled from the shelf and the shelf life needs to be reevaluated.
These "expired" pills should be held in storage for emergenices like a major natural diaster.
If people want to take expired pills, the pills should be sold for pennies on the dollar and the patients sign a waiver stating they know these pills might not be as effective. But the hospitals will just want to mix them them in with their stock and try to sell them as "new"
Hospitals should be using "FIFO" (first in - first out) in their inventory. But their accountants are using "LIFO" (last in - first out) so the cheaper pills (early stock) get sold at the higher price (newest stock).
The problem is people taking expired pills, having a bad reaction is nobody knows if it was a bad lot, expired pills or was the medicine needed further testing.
As to the "gubmet" bashing - it's amazing how people would rather trust the corporations (that they no say over and only care about profit) and not the government (where they do have a say - it's called elections)
And if you don't like what "big pharma" is doing - look at the politicans from your state and see if their getting money from pharma and then boot their ass out of office.
Corporation will sell this country out for a profit. And they have when they started "outsourcing" jobs to increase their bottom line. So I guess the corporations have pretty much said "F%^& the United States, our profits mean more to us"
Here's an idea; within a state, all pharmacies should keep an inventory of high-demand, low-supply drugs in their possession and when a drug has reached, say, 80% of its lifespan, that inventory should be added to a statewide pool of available drugs on the computer. When a dr./hospital needs that drug and it is not available locally, they go to the inventory and purchase it before it expires. As long as people keep listing and buying, it should shuffle the short-time meds out to those who need them before they expire. Now, of course, this isn't going to fix the planned shortages sponsored by Big Pharma...
S. Williams-430936 "Here's an idea;"
Any idea that requires a governmental entity to operate efficiently is doomed to failure. A private for-profit company is going to be 100 times more efficient at matching supply and demand than some bureaucrat.
Good thought, though.
@ex TeaParty Member
Ding, ding, ding...and we have a winner. The award for the stupidest post on the board goes to ex TeaParty Member (not to mention the award for the biggest BS in their screen name).
Blame the industry because the government puts them in charge? That somehow makes sense to you? The "industry" can write regulations until they're blue in the face and it won't mean jack shti if the government doesn't enact them. Durrrrr
AL-1735815 "Hospitals should be using "FIFO" (first in - first out) in their inventory. But their accountants are using "LIFO" (last in - first out) so the cheaper pills (early stock) get sold at the higher price (newest stock)."
Nonsense - hospitals are not so dumb as to use the newest first. FIFO & LIFO are merely accounting policies and have nothing to do with actual physical practices.
Tell that to the Marines and Blackwater. The only thing such absolute statements demonstrate is your utter bias on the topic.
How about instead of requiring hospitals to hang onto expired drugs that may be less effective and possibly hazardous, we address the PROBLEM instead of the symptom
-->WHY IS THERE A SHORTAGE IN THE FIRST PLACE
Answer: There are only a handful of producers making an important drug. Why, is there's not enough money in it? Or is it a patent owned by a pharmaceutical company that's trying to drive up the price by restricting supply?
Solution: Make a requirement that pharmaceutical designers may not also exclusively own the means of production. Have a few plants that also crank out the medications at a rate that shores up whatever the patent-holder's manufacturing isn't adequately covering and pay a royalty on utilizing the patent.
Don't worry!
Obamacare will fix everything!
Judy --
Are you saying that when a person gets Medicaid they have to give up their right to refuse medications?
Are you sure about that?
I find it funny that while the article describing a difficult situation for pharmacists stuck in the middle of a conflict between manufacturing difficulties and pharmacy law, nearly all of the above posters tell a tale of a single political misanthrope purposefully causing this stressful situation. Whether it is Florida state or federal law seems irrelevant because both pieces of legislature were obviously written and put through proper congressional processes (involving several public service representatives voted into office by the popular vote of their respective constituencies) before ultimately being signed by the governor or president of THAT DATE (many years ago), and thus could not possibly be the single orchestrated efforts of any person in office today.
If you have suggestions to improve the USP guidelines; perhaps to amend with an exception due to shortage events, or exceptions due to multiple scientific literature sources, or even requirements for manufacturers to regularly review and update their storage parameters and stability information based on continuing scientific study; then I would urge you to contact your local / state / federal representatives to begin drafting amendments to these guidelines. The sooner that action is taken on the part of the citizens, the sooner the government can make amendments and corrections.
As for "Big Pharma", few american industries are so heavily scrutinized for trying to turn a profit or further the science of their field. Patents for medications do not last forever. To fund continuing research into the drug in question, or other drugs that the company wishes to pursue, capital must be earned from the drugs the company currently sells. Drugs that are no longer under patent, and thus are available for generic manufacturing, obviously make less money than drugs under patent. To successfully stay in business (and thus creating new drugs and furthering the science of medicine) the company must earn enough capital to fund scientific efforts to stay on the cutting edge of the market, but also must not go bankrupt on court settlements from law suits. Law suits that would arise if they didn't set the parameters they set for storage and stability. Although independent scientific literature may suggest drugs are good outside of the manufacturer's requirements, these independent scientific organizations are not ultimately liable should harm come to the patient either from contamination, loss of efficacy of the drug, etc. Obviously the party most legally liable is going to have the most conservative set of regulations. Being the sole manufacturer of a drug product comes with its own problems, and any number of internal problems will disrupt supply, but the current economic model for drug companies dictate that they try to make as much money off of a drug under patent as possible, as well try to lose as little money to settlements as possible.
Situations such as these are difficult for everyone involved, but going around the circle pointing fingers is not progress. If you desire progress, become involved. Work with representatives.
Okay...you guys can have the soapbox back now. :)
Robobrain, that was probably the best stated comment I've heard on the subject.
Despite my numerous grammatical errors... :(
Malfeasence and manipulative process of PHARMA-gouging?How can these "mfgrs"not know what they are doing?We all know what THEY want and need.Jesus wept.
It is the Government that demands near zero risk in the regulations. Flexibility is not a viable option for regulators. You may like to blame others for these situations, but this is what the Government (and the voters) demand.
@ Roger-396420
Then why do the pharmaceuticals cost so much less just north and south of the border? You'd think that their costs of production would make it prohibitively expensive to offer something even like Viagra for as little as they do outside the US.
I seem to recall in my economics classes that monopolies/oligopolies have the ability to control the price of their products by restricting supply.
Do you not think that this could be one of those situations?
How come in such a "near zero risk" environment, drugs like generics aren't also as equally expensive as the brand name drugs?
Perhaps you may want to analyze things a bit further ^_^
The missing economic piece is the cost of drug companies to research as well as continuing research onto the properties and stability and storage instructions of their own product. This isn't a button factory, even if they make a product of a similar size. Drugs can be produced outside of the US at cheaper costs because the businesses that create those generic drugs dont have to:
1) Live up the very strict guidelines set by both the FDA as well as USP.
2) Pay out lawsuits to claimants.
3) Research new drugs (there is a reason most of these countries that can 'miraculously' manufacture drugs cheaply rarely reach the headlines about a drug design or breakthrough) as well as continue to research existing drugs.
4) Advertise (believe it or not EVERY company must advertise in some form or another to some audience in order to continue to sell product and thus remain in business)
It is easy to imagine evil people at the top creating all of the struggle for the people at the button. This goes for any system. After all, that has essentially been the story of humanity since the beginning. But never before in history have people been so capable of becoming informed, forming educated opinions, becoming involved in the law making processes. Yet we cannot destroy this architype of the rich fat-cat living it up on a mountain of butter and honey and expensive drugs while us underlings suffer needlessly. I would be lying to say I thought it was never the case in modern society...it obviously still is sometimes...but I would challenge everyone willing to regurgitate an opinion formed outside of their own mind to instead research and enlighten themselves of the subject first. Look at the problem from all of the perspectives possible (the patient, the doctor, the pharmacist, the hospital director, the drug companies, the government, the rules already enacted into law and WHY) and you might realize that not only is there not a single horrible do-badder, there couldn't even be one. The system is too large. I don't believe in well orchestrated failure, only because failure does not require orchestration...only success does.
You can thank Oamadon'tcare anti-health plan for this!
I'll buy it. Drug companies see an end to their huge profits so they are manufacturing drug shortages to increase demand and profits. Of course they won't be able to get away with it when the act goes into effect 2 years from now.
how so and where are your facts?? or you just a GOP=grumpy old people?
This policy has been in effect for decades. It has received more attention recently, is all.
Obama has nothing to do with it.
Drug shortage?!?!? Really??? Gee, I wonder who would profit from such an event? Lets see ... how about the jackasses that are causing the shortage to begin with!!! This is the one thing, if nothing else, that our supposed government leaders need to step in and put a halt to the BS!! There is NO reason this country should have ANY shortage and I see no reason why the pharmaceutical company's couldn't make the drug.
This country is so f*cked up!! Human life devalued, government corruption, monitoring the world while we have homeless people needing help, veterans who gave of themselves treated poorly - friggin disgusting.
We need socialized medicine....Why are corporations making money off of people and their health? This is one area I wouldlove the gov't to step in and take over. All US citizens should be able to go to the doctor
Price controls create shortages - a simple economic fact. If the price for generic drugs becomes too low to make it feasible to manufacture the stuff, production will eventually drop to zero, regardless of demand.
LoriLea66 I agree with you. Unfortunately the new "Health Care" law did nothing to help with that issue. It just directs more money to the insurance companies. At the end of the year all insurance companies should be taxed at 100% of their profits. They should not be able to pay anyone in the company more than $1 million per year inluding stocks and bonuses. Other than that, we'd all be better off paying into one big pool and having that pool payout to the doctors and hospitals.
LoriLea66---
There's a grand idea ... government oversight of all medical procedures. Because it's worked soooo well in the VA hospitals and on the Indian reservations.
Oh why can't there be a shortage of Viagra and Cialis? I bet that would get fixed REALLY fast......
LoriLea66, while I agree that every American should be able to go to the doctor, I wonder if you have ever had any experience with socialized medicine? My friend has, and is very grateful to have gotten her daughter back to America for treatment after how her daughter was "treated"
People, please stop bashing our country, educate yourselves, and then make a difference. Socialized medicine is not the magic answer. Something must be done, I don't know what it is, but I know that foreign country models are not it.
LoriLea66
Seriously? If someone told you to go to work today for no compensation just because it was for the good of "people and their health" would you? Would you work for nothing? I doubt it. Typical liberal mindset, let everyone else work for ME; just don't ask me to do the same for you.
Exmilitary - No one has a crystal ball in predicting when shortages occur, especially when a product has a shelf life for full effectiveness and liability plays a big role as well.
Socialized Medicine is sooooooo bad..... Then how come tens of THOUSANDS of Americans go to CANADA every year to get treated? and if for profit medicine is so good why do Thousands of Americans go to Thailand to get Surgery, I swear you GOPhers need to take your head out....... of the sand and quit spewing that Faux news BS...... Price controls lolololololol..... We are LAST in the Developed Nations in Medical Care
We simply need to split pharmaceutical developers and the means of production. Think of it like the medical/industrial equivalent of Glass-Steagall
At the very least, don't allow a pharmaceutical company to be the sole producer of the product that it created when it is designated as a life-saving product...maybe just do this across the board.
If the designers were required to license their patents to other producers and have no say on the rate of production...not only would prices normalize, but there would not be any monopoly power to create shortages such as this.
Separating the practices of drug research and drug manufacture is an excellent suggestion. After all, at one point historically we had to separate the fields of prescribing medicines (Medicine) and dispensing medicines (Pharmacy). If problems that have arisen warrant further separation within the latter profession you should pitch this idea to your government representative. As it goes around the legislative channels and is challenged by several others, it could mature into a realistic model for future pharmacy practice. We would simply need to ensure this model was robust enough to satisfy the needs of each business involved.
Just the first effects of Obama care and the Federal Govt. regs. on your life. Get ready its going to get much worst. Hope you like all that change you voted for when your loved ones are dying and can't get treatment.
Oh yes, this is the first effects. Because the law doesn't go into effect for another 2 years. These drugs are so powerful, they actually come from the future, albeit in limited supply because of Obamacare. Riiiiiight.
Bill I see you're playing stupid, and looks like you're winning!
According to the timeline, there are plenty of provisions of ObamaCare that are in effect, and more will be coming before 2014.
Look it up for yourself.
http://republicans.waysandmeans.house.gov/UploadedFiles/WM_hcr_timelinel.pdf
So maybe Bill isn't as out of touch as Pragmatic and rick would like to believe.
Um, Bill? Peoples loved ones are already dying and can't get treatment because it costs an insane amount of money. If they do get fixed then they lose their house to pay the bills and have to declare bankruptcy. Lovely system isn't it?
Dan,
I don't see anything that would cause drug shortages there that has already taken effect. Claiming that drug shortages are a result of something you don't like makes you as complicit in baseless rhetorical trickery as the people who claim the mild winter we've had is because of global warming. I could argue just as much that this is a result of Medicare Part D and more people having access to drugs, thus decreasing supply.
Mkay people, Obama has NOTHING to do with how drugs are regulated... The policies that the HOUSE (where the majority is Republican) passed does not go into effect for 2 more years. What is wrong with everyone? USE YOUR BRAIN!!!!!!!!
Dammed if you do Dammed if you don't no matter what you do the lawyers always make money. That's what it's all about ( sung to the tune " Hokey Pokey")
I read several years ago the military trashed expiration guidelines as most drugs last much longer then the labeled expiration date. This date is put on there by the drug companies not necessarily for safety, but for profit. High turnover means many more dollars to the drug manufacturers. Its time for HONEST dates to be put on labels.
Storage conditions are more often about safety and stability. If you were reading about how people were dying from taking their medications and then found out about lax rules in the storage and handling of drugs, you'd probably be blaming the drug companies for making insane profits killing people while the rules were lax.
dalenkat----- Perhaps you are referring to the Angolan or Egyptian Military because the US Military follows all Federal guidelines in reference to medication storage, proper usage and expiration dates. The US military health care system has always and will always follow established guidelines with regards to patient safety. Now you can say I read that somewhere. Thanks
WCF: It's so true... people always think because they read it, it must be true. Trusted sources... c'mon!
@dalenkat
BS. They put expiration dates on drugs because in 1979 the government told them they HAD TO. The expiration date is determined by the date at which the manufacturer can guarantee 100% effectiveness and safety. A drug past it's date may still work it just won't be 100%.
You can blame this on the evil corporations just like your puppet-masters want you to but it is just more of their garbage. This is another example of what you get when the government passes a regulation with no consideration for the unintended consequence.
Perhaps. then, there should be two expiration date given: one when the drug is no longer 100% effective and one when the drug drops below 90%(or some other limit) of effectiveness. In between, it would be the doctor's or pharmacist's decision.
Still bandaids over bullet wounds...we're not addressing why there's a shortage of a life-saving drug in the first place.
We cannot have a single pharmaceutical company able to single-handedly control the supply of any drug.
The shortage is artificial, there's nothing about the raw materials that are scarce, this is a case of a pharmaceutical company drumming up prices and reducing production rates to increase profit margins.
All we need to do is require that a pharmaceutical developer must lease their patents to multiple 3rd party producers for royalties but have no say in the rate of production. We could even have a few national subsidies for producers that can create a little downward pressure on prices for drugs that are necessary but are used to treat orphan-illnesses.
The best part, the more that pharmaceutical developers charge for the royalties, the more the producers will distribute in order to make up for it
Perscription drugs now kill more people than street drugs.
Well, if you listen to the commercials on TV - specifically to the side affects, no wonder people die from taking them. Some even list "possible death in rare cases" ... WTF is that all about? Money - profiting from the needless death of people seeking a longer life.
Ex,
The reality is that science doesn't totally understand how the body works and therefor, can not understand how a drug is going to affect every person. I can take a vitamin on an empty stomach while my wife can not; are the vitamins bad? No, I'm just different than she is. Any time we put something in our body that man has made, we stand the risk that we are going to react to it.
Years ago we were told to stop eating butter and change to margarine, which would be better for our heart. After a lot of study, we understand that this was wrong and the warnings from the government caused health problems for a many of people.
I understand there are many problems from pharma, but there are just as many problems with the way the government regulates drugs.
Facts please, not statements in a vacuum.
Maxbird. The prescription drugs you refer to are now street drugs. Kids stealing their parent's medications, and selling them, patients selling their drugs to make a buck so they can go out and buy "the good stuff' off the street..
The headline is misleading. Please read the article. The problem is not the rules -- nobody wants to take away rules that prevent hospitals from using expired and ineffective drugs. Do you want a pharmacy to sell ineffective drugs to you? The problem is the pharmiceutical industry who, even though they are making record profits, are too cheap to pay to label their drugs with the most accurate expiration dates. Please read the article and don't rely on misleading headlines.
Bingo!!!!!
Another solution is to have a national clearing house that list drugs that are reaching the end of self life. After all we have a very good inter net, why not use it?
The pharamuctical manufactures are supposed to do their homework and provide accurate information.
But they would rather make that big money, and who is to say that they are not lax.$$$$$$$$$$$$
Let's see if I have the gist of this article. Federal regulations prevent hospitals from profiting by passing off expired medications on unsuspecting patients.
Oh how horrible, we must eliminate these outrageous regulations immediately and then make sure the hospitals and doctors can't be sued for malpractice if someone dies because the medication was tainted, spoiled, or otherwise unsafe.
No, Will, the gist of the article is that people may be dying because medications have unrealistically short shelf lives on their labels.
If I read the article correctly the manufacturers determine the shelf life. I'm curious if they must prove this determination when getting drug approval or if they can simply state it. I assume they are paid when a drug is ordered. So enforcing a short shelf life would increase profits a lot. I think I need to do some research. All this 'drug shortage' stuff recently smells rotten to me.
in fact if you did some more research you would find who drafted the 1200+ pages of the the new health care act. let's see. 40-50 million new madatory insureds starting in 2014. Wonder exactly what price controls people are referring to as each time I go to renew brand prescriptions, or health care policy, costs have increased as much as 30% in just one year. when inflation is about 2-3%. How can that be? This is the case with so many complex regualtions. The industry to be regulated is the one that drafts the rules and lobbies for approval by legislative bodies.
The cost of health care has been increasing about 10% per year for a good long while now. Far past the rate of inflation. And I've read that you can expect an increase for 2012 to be between 5% and 10%, not 30%.
in 2010 my renewal for health policy jumped 31% which I paid until state insurance depts. across the country started investigation and I got a small rebate which was still an effective 28% jump. and one of he meds went up nearly 50%. You fail to take into account it is not just inflation. as many people, for whatever the reason, find they cannot afford a policy, the rest in the group must make up the difference and some like me are locked into the policy because there are preexisting conditions which made other polices even more expensive. as to rate of inflation or rates of increase in general for health care, it's the old adage, figures don't lie but liars do figure. You are talking about rates that are averaged and some products can go up and some down more than others to create that average. In fact, a 6'5" NFL quarterback can drown in water that is an average of only 4" deep so long as there is just enough water that is 7' deep.
A few interesting elements of this story: There is no solid information on shortages because hospitals have no incentive to collect the data; Drugs are being destroyed in one place that are in shortage in another; All the government is saying is to follow the manufacturers instructions regarding storage and disposal.
Clearly, there should be a process to track exactly how severe this problem is, how many drugs are destroyed, where and when. The idea of a clearinghouse should be explored so when drugs are not being used and are within a certain range of being expired that information should be available to other medical facilities who may need them. A payment or reciprocal compensation mechanism can be created as well. Finally, pharma makes enough money on these drugs to propose updated guidelines be approved by FDA to extend the storage and use of drugs as new information becomes available. Remember, however, that if storage and use time is extended, pharma will sell fewer drugs and make less money. It is in their interest to restrict the usable time for many drugs. As such information becomes available through the scientific community, FDA should be empowered to require manufacturers to update their instructions or show why doing so would be detrimental to patients.
Shortages are a mechanism to increase profits. Shortages have increased since affordable care became law and guaranteed certain services to all people. The spectra of artificially increased prices and manufactured shortages was why Part D specifically prohibited the government from negotiating drug prices with pharma. There is no doubt that manipulation of prices was what pharma threatened when the idea of price negotiation was considered.
A sure way to eliminate shortages is to pass a law that would terminate the patent on drugs which are in short supply if the patent-holder is unable to meet demand within a reasonable amount of time. The law would have to specify what constitutes a shortage and what time period would be allowed to correct the shortage before losing the patent protection.
Your solution would make sense if every single dose was EXACTLY the same. The way it works is that the FDA Approves a material as "safe and effective". When the material changes or degrades in some way, it is no longer the "approved" material. In order to assure that the material is the same, the companies study the degredation rate of the materials, and do a statistical analysis. To insure that there is near zero risk, they may be required to set an expiration where only 0.001% of the material is changed (something along the lines or 3 standard deviations from the mean). If you would wish to make that more lax (I am sure this would be a benefit to manufacturers), then you would have a higher incidence of medicines not having the expected strength or possible the expected safety. This is all well and good until you are the one getting the "bad" dose. The liability for both the manufacturer and the health care provider is too great to take that risk.
Robert- you can terminate the patent, but it would take years for a new manufacturer to be approved.
Roger: I might add to your last statement that it would be incredibly costly and wasteful to do so as well.
switch to per use payments. the drug mfgr's send the hospital the drugs but the hospital only pays for what it uses. If a drug needs to be flushed due to age then hospital doesnt have to pay for it. This makes the mfgr want the drug to last as long as it can and ensures that hospitals are stocked with only what they need so that needless monies are not thrown away. Problem solved. Common sense is beyond you repubs, dems and rule makers, your eyes only have sight for the money not the issue or resolution.
Divide,
Just to understand your post, your saying that a hospital should be able to order what ever drugs they want in what ever quantity they choose with no incentive to anticipate their usage. Than, when the hospital uses the drug, at that point they pay for only the drug they use. If they over order and the drug goes bad, the hospital owes the supplier nothing for the drugs they over ordered. All this going on in every hospital in the country which would be doing the same thing.
Maybe you would consider going to work every day and having your employer not paying you until the product you are making is shipped, sold and paid for? If the porduct you made never gets sold, you just don't get paid.
Right you are jrl, if you think the drug lobbists are bad now just wait till this policy goes into effect! Sharks!
if all the hospitals/pharmacists got together and kept a collective inventory and the drug packaging was redesigned, perhaps they could manage it beter and save billions.
so this is not an obamacare issue, it's more of a profit margin issue.
because you make more money by sustaining demand for drugs, than you do by actually "curing" the ailments of the patients.
is there ANYTHING that government doesnt f#@k up. At some point people our government has to lose its power and we have to take life back over. I'm sick of reading every day how governement is always in the way.
So that there can be complete chaos and we can revert back to mideval times with lords and serfs. I don't think so. Give me government any day just revamp current regulation and remove some of it.
MGates73
When has government EVER done that in any meaningful way?
Ahhhh...the intrusion of business in medicine yet again! It is unthinkable the amount of hospital waste because a package is "opened". Some items are worth several thousand dollars and into the trash it goes...I've seen it and as a materials management worker I have DONE it...cringing all the way! Some organizations are able to accept the donation of out-of-date items and drugs. We need more middlemen who will do this and make this stuff useable! Waste...waste and more waste..................
I witnessed something related at my local pharmacy recently. A prescription was ordered for a patient but the pharmacist would not even open the package to fill it until he had talked to the insurance carrier and the customer because the order was for a drug that cost almost $2000 and once the package was opened to dispense the ordered doses the storage time was incredibly short. (I don't know who the patient or doctor were or what the drug was.) I don't know how this all turned out, but it highlighted a huge problem for dispensing pharmacies.
There are many reasons for this "once it's opened" rule. Contamination, whether intentional or unintentional, being one of them. Trust me, this happens very very frequently and it's so easy you wouldn't even know you've done it. This is why many medications can't be removed in small quantities and placed in another container. The risk of contamination is far too great.
Another reason is the shelf life problem. Like a bottle of soda or a jar of mayo, once the medication has been opened there are certain requirements for its storage and even if it is stored properly it will never be the same as before you opened it, losing its properties every moment.
I smell a Capitalistic Pig and its Piglets.
If the companies don't run extensive testing and validate the expiration dates, they put a "default" expiration date on. This goes for all the over the counter drugs- most aren't tested because of the cost, that they would pass on to the consumer. Don't be such a douche and always think the drug companies are trying to screw everyone. But you can count on the govt to do that.
I just love the government, don't you? They always have our best interest in mind. And they are always so efficient, much better than the private sector. What we need is more government, more regulations, more red tape, more bureaucracy and more paper work if we want to get anything done. Vote Democrat.
we got more goverment these are all operating room drugs and the goverment is buying the supplies up for the war in Iran creating the shortage. AH HA!