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Some hospitals have had to discard cyatarabine, a cancer drug in such short supply that it has been rationed.
Amid ongoing shortages of critical drugs, 60 percent of hospital pharmacists surveyed said they’ve been forced to trash life-saving or expensive medications because of misguided government rules, a new poll shows.
Discarded have been more than 100 different drugs, including 80 percent that are now or have been in short supply, and costly medications such as Velcade, a cancer treatment that can go for between $1,500 and $2,500 per 3.5-milligram vial.
That’s according to a just-published survey of 715 hospital pharmacy directors, managers and clinicians nationwide who responded to queries by the Institute for Safe Medication Practices.
“We wanted to do some research and see how big of a problem it is,” said Mike Cohen, president of ISMP, a drug safety advocacy organization. “It’s really a major issue.”
Cohen said the results weren't surprising to him, given the concerns he'd previously heard. But he said they should spark new discussion.
About 61 percent of pharmacists and managers who responded said they “feel compelled” to discard injectable drugs, the survey found. Most fear facing industry or government sanctions if they don't.
Some hospitals have been cited by officials at the Centers for Medicare & Medicaid Services or by the Joint Commission, an accrediting agency, for not following explicit directions in drugmakers’ package inserts.
In the new survey, the drugs tossed include cancer medications such as cytarabine and bleomycin, which have been so scarce that some hospitals have turned patients away or resorted to rationing.
Nearly 80 percent of the pharmacists said that existing rules “often” or “always” lead to unnecessary waste, contributing to the crisis that saw a record shortage of 267 drugs last year, the survey found.
At issue are rules imposed by regulators, including CMS, which require hospital pharmacists to follow drug manufacturers’ written instructions for storage, stability and by-use-dates for injectable drugs -- even when that information is outdated or incomplete.
The most current evidence-based data about how long a drug can be used or stored is often available not from the manufacturers, but from widely used compendia, or summaries, such as the American Hospital Formulary Services drug information database.
That information is available in the package inserts that are approved by the federal Food and Drug Administration when a new drug is cleared. But it can be costly and time-consuming to seek new FDA label approval, so updated information often isn’t added to the directions.
Many times, having the latest information can mean the difference between being able to store a diluted drug for a week rather than a day, as in the case of an IV blood pressure medication, nicardipine, which has been in shortage.
The crucial neuro-muscular blocker succinylcholine can be stored for a week, according to manufacturers’ directions. But it can be used for up to a month according to updated data in Trissel’s Handbook, a widely used compendium.
Often, drugs are packaged in sizes that don't lead to easy dosing, forcing pharmacists to discard unused portions.
About 40 percent of pharmacists buck the rules and decline to discard injectable drugs based solely on manufacturers’ guidelines, the survey found. Only about half of the pharmacists said they “always” follow package instructions, when they exist.
Nearly all of the pharmacists, 97 percent, felt that CMS rules contribute to the crisis, the survey found.
"That's an alarming response," said Dr. Ana McKee, the chief medical officer for the Joint Commission.
McKee says her agency is in frequent conversations with CMS and either has or will soon consider the issue of using package instructions only to determine drug storage and stability parameters.
CMS officials did not immediately respond to requests for comment about the survey findings. Previously, Dr. Patrick Conway, CMS chief medical officer, said the agency would work with the ISMP to resolve the issue.
The survey results should help with discussions already underway, said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages.
“Overall, I am very hopeful that the CMS rule regarding package inserts will be reversed,” she said in an email to msnbc.com.
In the meantime, she noted that stepped-up federal attention seems to be slowing reported drug shortages.
“We are at 34 new shortages for this year. Half the rate of last year!” Fox said. “I think the FDA’s efforts are paying off."
Related stories:
Amid shortages, rules force hospitals to trash scarce drugs
Bugs in sterile drugs? Behind the shortage of critical meds
Lingering shortage of ADHD drugs unravels lives
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Just the tip of the iceberg. When socialized medicine (Obamacare) takes hold in a nation that is too wealthy, too large, too diverse, and built on the free-market and capitalism model, you aint seen nothing yet compared to the limitations, restrictions, policies, red tape that we'll see under a fully implemented Obamacare that will have successfully uprooted private insurance and the ability to make personal decisions, in favor of 'government healthcare, government rules, or nothing'.
When you're told what doctor you can see and when and that you'll have to make your appointments 2 weeks in advance and be seen by one who got their medical degree by answering an ad in the back of Rolling Stones Magazine. And when you have to get approval from the state's medical review board, operating under "federal guidelines" to use the most advanced testing/diagnostics equipment (provided you're not too old or too young) then perhaps you'll reconsider the "benefits" of Obamacare
As usual, complete BS.
All this "red tape" started long before the Affordable Healthcare Act. You are just someone who is hell bent on keeping everyone from having healthcare, thinking you are paying for someone else.....blah blah blah, I am so sick of hearing all this. Lack of profits and production issues are the main causes for drug shortages. If they can't make enough profit....they won't make the drug. If there are major production problems at any stage, drugs become scarce.
The ACA is not socialized medicine. Perhaps if you read the act you would understand it better.
On the contrary, the ACA will likely REDUCE this problem immensely. The entire root of the problem relates to a pharmaceutical industry that is insufficiently regulated and allowed to make decisions concerning labelling, packaging, and manufacturer's recommendations that are designed to maximize their profits, and not the most efficient use of the drugs in question.
WAAAA, its Obama's fault! WAAAA, its the Republicans fault!
Insurance companies and big pharma is not nearly as short-sighted as John Q Public. They bought off both parties.
But go on with the cry cry that one of these political parties is better than the other...
Instead of throwing the drugs away, I'm sure theres people that would take them. I know a couple of friends that would take them, as long as they come in a perscription bottle there good. Its a shame, waste not, want not.
Nobody would be stupid enough to sell drugs that are expired based on label data. Prescription drugs are still prescribed based on probabilities and risk assessment. People in the US don't understand that and think if you get ill, you go to a doctor, get a drug, and wham! you are automatically and completely cured. If it doesn't work out, you sue the heck out of everyone involved: doctors, nurses, pharmacists, and even manufacturers. That being the case, a pharmacist or hospital that actually sells out of date medicine is opening themselves up for a major lawsuit.
Amphiax, so you didn't read the actual article?
How about all updated labels are immediately approved by the FDA instead of going through a lengthy re-approval process. Or a note stating "If date agrees with X compendium, changes can be made".
Derek-381,
Insurance and pharmaceutical companies?!!!!!! Oh NO!! They couldn't be involved in it! Could they?
Brisaber, the article says:
"That information is available in the package inserts that are approved by the federal Food and Drug Administration when a new drug is cleared. But it can be costly and time-c'onsuming to seek new FDA label approval, so updated information often isn’t added to the directions.
The drug companies aren't willing to spend the money to seek FDA approval when it's found that the medicines have more shelf-life than thought when they were first manufactured. Pharmacists state that other sources are more accurate than the drug's label, and drugs are wasted because of FDA regs that require using only labels.
Seems to me that the solution is to make it easier to get FDA approval to update a label's shelf-life information. I don't see a connection to people in the US supposedly not understanding and thinking that drugs are a cure-all.
You already have to wait two weeks for an appointment. whats the difference. at least you can get regular check up s from a physician and keep healthier as opposed to heading to the ER for everything
And it takes YEARS to get the freaking label approved.
Actually, this is is only the tip of the iceberg if "free markets" are allowed to run if the "follow the constitution" people get their way. Fewer drug companies would find it economical to make certain drugs without some form of federal intervention being it a tax break or subsidy for life saving drugs. This has nothing to do with "Obamacare." Some of the most effective drugs used to treat cancers are among the cheapest drugs around and have a wide range of uses. However with these shortages, the prices of these drugs has skyrocketed more than 10 times while opening a "black market" for these life saving drugs. If fewer companies find it affordable to produce these drugs, there will be shorter supplies and supply lines overall. If a production line falters, it ripples through the distribution system and if a drug like methotrexate is unavailable, it sets off a panic for healthcare providers and parents of children who have childhood leukemia as witnessed over the past few months. This is not an area where we would want "free market capitalism" to run free because if it did, the drugs would not be affordable at all...it needs government intervention to assure the health and survival of all people who need it.
Hey umm you do know that there is now no free market in this country right? I mean it most definitely ceased to exist when the government used our money to bail out the very companies that knowingly ruined our economy, that the market tried to take down itself but was stopped from doing so by the government bailout.
I'm guessing that drug complanies like short lifespan rules. They can sell more drug when unused doses are destroyed. In addition, the law of supply and demand would allow them to make more money when drugs are scarce. Drug companies don't have an incentive to change the labels...who do you think pushed for the rule in the first place?
By the way, I need to wait 2 weeks (or 4 months) to see a doctor now. I also need to hope that my insurance carrier will approve my care...and my doctor is likely to spend time addressing the insurance group's red tape to have it paid for. Maybe my doctor could see more patient if she didn't fill out different forms and bicker with private companies to pay for what they've agreed to.
Regardless of what the many "sources" say, the FDA is the only body that gives the official stamp of approval for expiration dates, package insert information and drug stability, etc. Sure, it takes research and other organizations' information into consideration, but the FDA makes the final decision. Yes, there is a lot of waste, but given the choice between wasting drug and getting caught up in a lawsuit, I'd rather waste the drug. Why don't people try instead to limit tort liabilities against healthcare providers if they want to see real change.
sosad, the article states the problem to be that drug companies don't want to pay for new FDA label approval when it becomes apparent through new research that the shelf-life is longer than first thought. Instead of updating their labels with more accurate information, they stick with the old label because it's cheaper for them. Maybe if the drug companies were looking for the best interest of the consumer, instead of strictly for their bottom line, tort reform would be unecessary.
The issue is not quite as simple as just using the drugs after their expiration dates.
For many drugs there is a very good reason not to use them past their expiration date. Usually it's because they have likely begun to loose potency, often at a highly unpredictable rate, so it's difficult or impossible to dose them properly. In a few cases they metabolize into something harmful.
But there's also another side to the story. Because of simple testing limitations NO drugs can have an expiration date beyond 5 years from date of manufacture. Because many are unstable, and for reasons I have stated above, many are less than 5 years. But there are also drugs which, if stored properly, would be stable for years or even decades beyond the 5 year limit. And it's virtually impossible to find out, even for a doctor or a pharmacist, which drugs these are.
Changing that would help. A little.
Where the biggest problem arrises is with some injectable drugs.
Many of these come it what is called "unit" packaging and they are designed for a single use. But sometimes because doses can vary they may contain enough drug for several patients who require less than the maximum dose. But because of manufacturer recommendations/FDA regulations/hospital or clinic policy these are discarded because of fears of contamination. There are circumstances where this should not be necessary and ways to minimize the risk of contamination but it's complicated and would involve leaving it up to the pharmacist to make some judgement calls which is where it becomes very tricky. If you follow the rules and throw it away and someone does not get the drug and dies, legally you are entirely blameless. But if you don't and something goes wrong and someone dies, you will certainly lose your job, probably lose your license and maybe lose everything you have. Not a great spot to be in.
There are also other types of waste but they're mostly sort of similar to what I've outlined above.
Believe it or not, the situation has actually improved a little and seems to be getting better. So there's cause for hope.
good thing brain washing is provided free by the Tea Party
nikkinala...obviously it will cost a drug company more money to get the FDA to approve a longer shelf life among other handling parameters for a drug. An article suggesting more drug stability does not provide proof that a drug can last longer on the shelf any more than a scientific research paper that does not have citations and peer review has credibility. What interest does a company have to want to spend its own money to research a longer shelf life...regardless of the motive, who should have to cover the cost of doing that research and submitting an application? Find me one drug company that has the interest of the consumer above its own profit motive? There is not a single one and that is why we have laws that try to protect consumers against drugs which can be harmful if not used properly. Look at our own history and you will see a series of very hard learned lessons on unregulated drug safety. People who are in scientific fields do not rely on anecdotal information to make decisions, however when you have an official source of information, what information do you hang your license and livelihood on? This is the essence of CYA in healthcare. Hartvig is right and the issue is a lot more complex than that just expiration dates.
CRCToday well said, ACH goes some way in reducing the insurance company and drug manufacturer's malpractices. They are having a field day, by first artifically creating drug shortages and then inflating the cost and making huge profits at the expense of the dying and sick. A single payer system would create a level playing field. The single payer system doesn't have to mean socialized medicine, it still could be paying insurance companies but at the same time allowing people to choose which company they go with thus creating a competitive marketplace. Everyone will be insured, Insurance companies will have more people insured thus keeping them solvent, at the same time without losing our free market principles.
As an RN working in an inner city ER, I can say that it has been very difficult on us as healthcare providers and our patients that we are in such short supply of so many common drugs. It is even more upsetting to find out that politics has a big hand in this. Like the article stated, many of these drugs do not come in single dose vials and thus we try to hold on and pull multiple doses from each vial. However it is extremely difficult to do that when outdated rules from the FDA and manufacturers tell us that we must discard these vials filled with expensive, and often times, life saving medication. It is unfortunate that these rules cannot be updated swiftly as other governing bodies ( ie Medicaid, medicare) have their hands in the pot and are for imposing more regulations and rules. I believe it is time for a revamp of the governing agencies in health care, as well as quick attention to the seriousness of the current medication situation. Listen to the people on the front line of health care who are forced to refuse certain drugs to patients in need or use substitutes that don't get the job done!
We have to use Medco for long-term anti-seizure meds for our daughter. We had just received a three month supply of her anti-seizure meds, when her meds were switched. Medco did waive our $40 charge that time, because the prescription had been ordered from the neurologist's office, not by us. Medco would not take the drugs back, even if the shipping package was unopened. We took three months' worth of perfectly good medicine over to our local police station during their drug collection day. It seemed like such a waste. At least the disposal of these powerful meds was done properly.
Too bad you tossed these meds because there are places that will take them so long as the packaging is still sealed. Medco will not take them back because they do not want to give any refunds, not because of any rules.
A big problem is with things like vial sizes in which injectables are distributed. The hospital or doctor can not use a vial from one patient to give meds to another patient, even if there is still plenty in the vial. Any unused amount in the vial is normally just discarded, which ends up wasting a lot of medication.
JS, unless it is in a glass vial, multi-dose vials can and are used for multiple patients. That's the point of them being multi-dose vials. The biggest issue with the vials is when the company only offers large dose vials for drugs when the normal dose is a fraction of the vial and the drug is not a common one.
Not true! I take an VERY expensive set of drugs and due to changes in insurance companies and overlaps in autoships, i have built up a year supply of the medicine (over about 10 years). I actually got to a point of 15 months supply and decided to give 3 months to the poor. I called half a dozen free clinics and the like and none would take my $9k worth of UNOPENED, fully documented medication.
I finally found a group that sends them to Africa. So now when i get to 15 months worth again...some guy in Africa will get them(3 months worth) instead of someone here in the US
I guess the poor in the US are to good for second hand medication
toldin-While it is generous to offer, the liablity of using drugs from another person are too great in the US. Were they heated/frozen or tampered with in another way?
JS in SD
"Medco will not take them back because they do not want to give any refunds, not because of any rules"
It's actually illegal in the U.S. for any pharmacy to re-dispense any prescription drug, no matter what the packaging, once it has left the pharmacies control. They could have refunded the money and taken it back, but they would have had to destroy the product and suffer the loss. In a retail box-store pharmacy, if your doctor calls in a prescription and they fill it but you don't come in to pick it up with in a certain time frame (usually a week or 2) they can put it back on the shelf and re-dispense it because it never left their control.
To toldin-2366624:
There are programs in the U.S. that will take unused, unopened drugs...I know the state of ND has a prescription drug repository program; if you check out the ND Board of Pharmacy's website, there's a link describing how you can donate your unused prescriptions. I would venture to guess there's a few other states that have similar programs. Most likely the issue is they are not very well advertised, so not many people know about them.
JS in Sd claims to be an expert on everything.
State laws vary on some medications, but the Class IV Drug Law is the same in every state.
My husband needed a lot of very expensive antibiotics after a lung transplant, some of which I gave him through an IV. After he passed away, I gave the left-over syringes to a collection for Katrina victims and I sent some of the antibiotics to Aids for Africa. They did say they would not accept expired drugs, but I think there are other agencies that will take them.
Quit yapping about the problem and fix the problem. In case you haven't noticed, the healthcare system and affordability of pharmaceuticals in this country is in crisis and drug manufacturers are clearly part of the problem with their designed product obsolescence, structured drug expiration, and short shelf life.
Really? Well then, next time you need a prescription drug then why don't you fork over the billions of dollars it takes to research a molecule, study it over years of trials, get it approved for use by regulatory agencies, bring it to the market, and pay the liability premiums in case anyone who uses it decides to sue you? I am willing to bet you can't make your own and even if you could you wouldn't end up giving it away after investing all you have in producing it. As far as shelf life is concerned Einstein, chemical molecules have this thing calle a "half life" Like your brain but in a molecular form. Some molecules degrade or erode faster than others. You can't make a magical concoction that can sit on the shelf for years on end. Even when stored properly some drugs just cannot retain potency and efficacy for a long time. Did you not learn that when you took your advanced pharmacology classes? Did you even complete high school? You people amaze me. They don't just dip this stuff out of some magical creek somewhere. You want everything for free? Go live near the magical creek. In Realityville, everything costs money because companies exist to market and sell their products. Good grief. Did someone give you a house? A car? An iPad? May as well bitch about all that too. I don't see GM giving their idiot Volts away. Why should a drug manufacturer do the same? Do you have ANY idea how expensive it is to bring a drug to market? ANY???!! How about asking your doctor to examine and treat you for free? How about asking your dentist to do the same? Why not tell the ER staff next time you are there that they are just being greedy and really don't care about treating you so you are not going to pay for their services. Schmutz.
Right on, Bubba! Let me add that almost all (if not all) "Big Pharma" companies are publicly traded (they sell stock). That means that they have a feduciary responsibility to make a profit for the stockholders (they are required by law to try to make money!). Further, just because the products they make save lives, doesn't change the fact the they are in business to make MONEY - nothing else - just like Apple, Exxon-Mobil, Ford and Walmart.
The cost to bring a drug onto the market is $1B to $1.5B (Billion !) and the drug companies usually have only four or five years to recoup the development costs because of arcane patent laws. Do some math and figure out why drug prices are so high - and don't forget the middle men who do nothing but distribute the drugs but get away with doubling the price.
Finally, just for yucks, I'm going to ask: Have you ever taken a drug that saved your life? I'll bet most of us have. Did anyone send "Big Pharma" a thank you note? Didn't think so! ! !
That's great. But since medical science is the only thing on earth that everyone demands perfection from, this idea is impossible. All it will take is one time someone doesn't listen to the instructions and another dies. The pharmacist will get sued, the pharmaceutical company will get sued and that will end that idea. They should protect their butts from a thankless population who can't understand that putting complex compounds into your system can hurt just as much as it helps.
Play it safe, deal with shortages.
You think no one dies from drugs now, then?
Not following instructions has always been a risk, and a problem.
However, many drugs lose their stability and ultimum efficiency with age, while many illnesses and diseases require precision doses for regulated results, especially injected drugs.
According to the internet, the compendium they referred to, Trissel's Handbook on Injectable Drugs, has only sold 10,000 copies. And the article said 715 hospital pharmacy directors, managers, clinicians took the survey, and also states 61% of pharmacists & managers 'feel compelled' to discard the drugs by the manufacturer's recommended date. The article does not say how many pharmacists participated in the survey.
There are about 11,000 registered and community hospitals in the US, and that does not count federal, militery, prision, psychiatric, or long-term care hospitals. There are 269,900 pharmacists according to DOL, so the number of professionals taking the survey may not accurately reflect the problem described. Also, based on those numbers, the compendium that references the longer storage time by not using the manufacturers recommendations for the drug storage does not seem to be a universal reference.
So, let's follow the money... who pays for the drug? How many times is it paid for from the time it leaves the manufacturer to when the end-user patient pays? Does the hospital purchase it from the manufacturer and then add on their costs of handling, perscribing, and distributing, and add that cost to the patient? In other words, is the hospital wanting to store a drug longer because of 'stock on hand' that they've already purchased and don't want to toss because of lost revenue? There are gaping holes in this article's information.
With that all being said, you are probably right... folks can die, and do already. And yeah, there will be lawsuits, and are already. Anyone who takes a drug on a regular basis knows about risk and side effects, but then perhaps taking an old drug is better than no drug... only the person who needs the drug would know the amount of risk they are willing to take.
So, if the risk of lawsuits should not be on the hospitals or the manufacturer, at least the patient should be aware they are receiving a drug that does not follow the manufacturer recommendation. If there is no risk at all however, let the drug manufacturers get the newly approved updated inserts. It's their product, after all.
Trissels is also included in a lot of drug information databases that hospital pharmacies subscribe to. It isn't the only reference out there of IV drug information though.
Part of the problem is that there are a number of agencies with conflicting rules and guidelines. Many of these agencies are not part of the government. The two big ones are The Joint Commision and the USP.
Still there are a good number of reasons to discard drug products when their safety can't be guaranteed. Over time a lot of inject-able formulations of drugs can break down, normally much faster than oral drugs would. Then there's the issue where introducing a drug IV bypasses a lot of the body's defenses.
I see nothing wrong with disposing drugs according to how the developers meant for them to be disposed. If what the article says is true, and it is difficult to change the labeling on the medications leading to unnecessary disposal, then that is a problem and needs to be fixed.
Could you IMAGINE what would happen if a doctor gave a patient a medication that was outdated but was still "good," according to them, and the patient died because the medication wasn't as potent as it was originally, and the dosage didn't work as designed? That doctor would be sued so much and their name would be slandered so much that no one would ever want to go to them. Not only would it give the doctor a bad name, but it would also give the manufacturers of the specific medicine a bad name, despite the medication being outdated.
Expiration dates are there for a REASON. Just because something is good beyond it doesn't mean it will ALWAYS be good beyond that date. Think of food. One week your milk would be fine a week past it's "best by" date, then the next time you buy milk it could go bad a day after its "best by" date.
Would you take that chance?
Its too bad you can't buy your drugs from Mexico without some cop knocking at your door. I think thats the cheapest way to go. Place an order and get the Master Card out, now why wouldn't that work? I think it would work just fine myself. You have a perscription for it at home from your doctor and when they have to come check on you, show them the perscription and who give a good iota of a good hoot where you bought them. So what if you buy a few extras. I guess that would just depend on how you feel and maybe a little clause in the healthcare program called self medication. You can also try out different drugs to see which ones give you the best results. Sounds like it would work real good to me.
Unless laws have been changed again, you can legally if the drugs are for a catastrophic illness.
Joe, I have had to get many of my meds overseas because of the cost here. My one main med that I take 2 different dosages of has been around for a good 30+ years. I can take the generic, which normally saves you money. But even the generic costs me about $450 and $550, respectively. Another issue is that it is used mainly to treat nausea caused by chemo, so many insurance companies won't approve it, or approve a very limited amount, unless you're on chemo.
You have to look at the root of the issue. The FDA now requires every product to have a "Use By" Date. BUT, they don't regulate what that date is or how it is determined. The pharma are going to be conservative, for more sales, and to assure they are not held liable if the medication looses its potency.
I am in charge of getting rid of expired products and items. You would not believe what we throw out just because it has an expiration date on it. Examples?
Isopropyl Alcohol. What expires in an unopend bottle of alcohol?
Hydrogen Peroxide, comes in a dark plastic bottle. What is there to expire?
Band Aids. Yep, even your good ol band aid now has an expiration date on it.
If you think I am kidding, go look in your medicine cabinet. Oh and how many of us have expired creams, salves, ointments etc. in our cupboards?.
Oh and I even tried donating the outdated alcohol and peroxide to our local animal shelter. I was told they could not use expired products on the animals they get in.
The list goes on and on. The government started this but as usual, they fail to correctly monitor or develop the regulations on how to implement it.
I see what you are saying. I think mostly the use by dates, like you said, are there for liability reasons. Which, with today's sue happy society, is perfectly fine.
But, to play devil's advocate, I can see how all three things you mentioned can go bad. IPA can oxidize and form other things, hydrogen peroxide comes in a dark bottle for a reason. It reacts with light to form water and oxygen. The bottles don't block 100% of light. Bandaids often come with antibiotics on them now-a-day, so I'm assuming that's what actually goes bad on them. Or maybe the sterile packaging goes bad after a while so the sterility of the bandaid can't be guaranteed.
So yes, I can see how all of those things could "go bad" and why they have a use by date. However, whether that date is set to promote new sales is still yet to be determined.
The amount of medication waste in hospitals is spectacular. Hospitals are only following the rules. They are not to blame. Current guidelines and how meds are packaged by bigpharm needs a major overhaul.
It's the same in Nursing Homes. Billions of dollars in medication is thrown out each year. Not because it's bad or outdated. If medication is ordered for patient 1 and for some reason it's stopped (change of direction,reaction to that particular drug) it's tossed out. Even though the patent in the next room needs that same medication but can't afford it. So out it goes. Such a waste.
There was once a time when people care about people..Now it is only money and the people are guinea pigs for the drugs there taking..The drug they advertise is worst than the disease you have...Makes you wonder if it is even worth it..
Indeed, I was going say something along the lines of "What difference does this make when in 10 years the FDA will announce this drug is proven to do more harm than good to the user anyway."
I don't think a lot of people realize how often this happens with medicines here.
What idiots some of these folks are.
The key is right in the article. The drug companies seldom, if ever, seek new labeling when their studies show efficacy may not change based on storage or length of time. The bottom line is PROFIT, not any perceived enemies such as 'Obamacare' or 'socialized medicine.' The drug companies are simply out to make a buck and they don't care a bit about the pharmacies they screw over.
STexan, your screen name explicitly implies that you are a fool. Spinless puppet like the shrub. You know NOTHING of the curent medical foolishness that is consuming upwards of 20% of the national and state budgets, that means money fool. Governments do a better job managing the existing scale of needed benefits and pharmacitucal development and distribution.
The good thing about "socialized" anything is that it excludes pets and vermen like you. You and the other airheads use socialism instead of describing the program you support, fascism. Put Obama back into your mouth now STexan.
Championsaints...do you have an opinion? You sound kind of timid about expressing your feelings. Stop sugar coating it and tell us how you really feel. C'mon, you'll feel better. Let'er rip.
There's a reason for following instructions or guidelines established by the manufacturer. Thru their research they established certain proceedures necessary, such as storage, temperature, expiration date, and if not followed by the hospitals and pharmacies it could result in more illness or death. Using regulations as an excuse for drug shortages is a cop out by the hospitals. They obviously have a problem managing their inventories or its consumption. If a vial of medicine is opened and only 1 mcg is used, the remaining 99 mcg's must be used within a time frame as per the manufacturer for a reason. For the same reason if you change your oil and it hasn't reached 7500 miles yet, you don't reuse it in another vehicle. There's a reason for that as established by the refiner.
Then there are those health care providers that let medicines expire on purpose to create shortages and drive prices higher. Just like big oil, big medicine makes money as the price of drugs go up.
It's not necessarily that they can't manage inventory. Many of the drug companies only offer medications in certain packaging, say 10 ml vials for example, knowing that the standard dose is a FRACTION of that vial. And if it's a med that is not commonly used, but necessary for that patient once or twice, that rest of that bottle goes to waste because another patient won't need it before the expiration date after being opened comes.
I worked in the hazardous waste industry in the 80's and 90's and into the 2000's. WE had many hospitals as clients and the amount of drugs and chemicals they got rid of every month was unbelievable. The shelf life of many of these drugs was years, yet because of government regulation they had to dispose of them almost every month. But, because the government is made up of a bunch of A-holes, they had to cover their asses with STUPID laws and time frames. Pharmaceutical companies and cosmetic companies had to do them same thing. So, you can thank the fed's for shortages and HIGH prices. The F***ing government runs everything we do. This should be no surprise for shortages and high prices.
I'm completely on the opposite side of the fence here. I believe that these guidelines were put into place because quite honestly most people's judgement can't be trusted. And I couldn't emphasize that enough. Granted they are medical professionals but even the pros get it wrong sometimes too. I almost prefer knowing I'm getting a good dose of medication having to wait a while for it and not some spoiled stuff in a vial because someone left it out too long, or thought it would hold up for another week.
These types of regulations are in place for two reasons. Firstly, to protect the public and secondly to make money for the pharmaceuticals. It just so happens that the interests of two frequently clashing parties seem to coincide somewhat. The one thing I have yet to see discussed in these articles is exactly how much in quantity of these drugs is being thrown out for precautionary reasons. If we're talking 1 vile a week that's hardly a reason to get our panties into a twist especially if it's to ensure that a spoiled batch doesn't make it into some poor patient's arms. Now if it were hundreds and thousands then certainly this is worth investigating.
Which cost more? High supply with low demand, or high demand with low supply? Anyone with a basic economics class can figure that. Anyone who know a pharmacist or someone who sells pharma knows this better.
While it's good to see that the shortage number has gotten lower, it's still scary for someone like me who, when I'm in the hospital due to my medical condition, can only take one anti-nausea med for it. And by the time I go into the ER, I can only tolerate it in IV form. One of the main producers of the IV form of several anti-nausea meds has closed down, making all of these options scarce for many with my same condition. The pill form is also scarce due to production problems.
Duh!!!!!!!!!!!!!!!!! Of course, the more you toss, the more you buy. The more scarce the product, the higher the prices will go.
Let's face it - The rich get to live & the poor get to die. What's New?
CMS your worse than the insurance executives making millions in salaries while we die from a fake shortage of cancer drugs.
They trash these drugs because they know there is no real shortage. They know that these shortages have been manufactured by the drug companies to drive up prices. They always say shortages due to companies not making enough, they never say anything about the raw resources required to make the drugs being exhausted. Since the raw resources have not been exhausted there is no shortage. Its like saying there is a shortage of plastic bags because companies are not making plastic bags, even though there is plenty of oil.
The drug companies have to have the appropriate facilities to use all of the resources. Since they make multiple drugs, they have to limit what space is used for each drug.
In a nutshell this comes down to throw it out if it is past the "use by" date. How do they come up with that I wonder? Is it a rectally extracted wild guess or do they actually test for it? Kudos to the hospitals that are taking care of their patients.
Why is it that many Americans go either to Canada or Mexico to get the same FDA approved drugs for 50 % of the current price chaged by American phamacys ?
Our government is fully bought by corporations and we the people get what the corporations pay for.......... err wait thats not right, we the people dont get any of it.
'Morlack - Just don't get caught bringing these drugs back into America - that's illegal even with a perscription. We pay more but don't get more.
Sorry folks for the " Bostonian " accent.....JFK would be rolling over in his grave over this !
You cant type with an accent!? Incredible!:P
Yep, you sur kin pardner. Actually it's called a colloquial hyperdialectic affect.
I just hope this is STILL the case when one of THEIR family members needs one of these drugs!! Oh, but I guess THEY don't have to worry about that, do they?
"At issue are rules imposed by regulators, including CMS, which require hospital pharmacists to follow drug manufacturers’ written instructions for storage, stability and by-use-dates for injectable drugs -- even when that information is outdated or incomplete."
If the information is outdated or incomplete I would blame the manufacturer, no one else. I would also follow their directions, it seems to be logical to me, the ones that CREATE the medication might know a bit more about it than others. After all they not only made it, they CREATED it. Again, if ANYONE is at fault, it is the manufacturers.. regulators are just following their directions. And of course we all know these rich pharmaceutical companies wouldn't put a sooner use by date to make more money now would they.....
When I read this JCAHO stands out like a miserable excuse for a stepparent. They stop by and inspect your institution and grades the institution. What people fail to realise is that the storage of outdated pharmaceuticals is a major penalty. When the institution has penalty problems the per-centage of reimbursement from various insurance providers goes down in accordance to their whim. If any one wants to know how hard the system is try being involved with a beach eroding and your job is to constantly run over the hill and bring back more sand.