States Face Huge Task In Tracking Meningitis-Tainted Drugs 99
An anonymous reader writes "Confronted with a growing meningitis scare, states are coming under enormous pressure to meet federal requests that they contact more than 1,000 hospitals and clinics that received any injectable drugs from the company at the center of the deadly outbreak."
Get rid of the FDA (Score:5, Funny)
Re:Get rid of the FDA (Score:4, Funny)
While we're at it, let's bulldoze those damn hippie free clinics and replace them with good-paying private hospitals.
Then we'll have what it takes to Create Jobs(tm)!
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Or at the very least, eliminate the unemployed.
Re:Get rid of the FDA (Score:4, Interesting)
Probably modded down by a republitard who didn't realize that the pharmacy wasn't regulated by the FDA because they were just a mom&pop pharmacy that wasn't supposed to be manufacturing drugs for resale interstate.
Re:Get rid of the FDA (Score:5)
The first stop for blame IS the pharmacy. They exceeded their license and used sloppy procedure resulting in many serious illnesses and several deaths. That's probably why the pharmacy was singled out, they caused this.
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No, it must be China's fault for making such shit products.
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You're joking, but I'm always amazed when conservatives want to deregulate the government and leave us at the hands of big business. They believe that government is bad, and that the free market should be allowed to work without interference. Look at how that's working out for China. Massive water pollution, schools collapsing during earthquakes due to lax building codes, air that is not breathable, kids working ridiculous hours for puny wages, ubiquitous counterfeiting of foods and medications, and lots of
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Who pays for corruption?
The "Peoples' Republic of China" has free markets? (Score:4, Insightful)
Only if your meaning of free is "free of independent trade unions", "free of civil tort damages", and "free of not-completely corrupted regulatory agencies"
The conservative agenda in the US is freedom only in the sense that you have the freedom to do as you wish with your slaves
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comment to undo bad mod. fucking slashcrap.
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You're joking, but I'm always amazed when conservatives want to deregulate the government and leave us at the hands of big business. They believe that government is bad, and that the free market should be allowed to work without interference. Look at how that's working out for China. Massive water pollution, schools collapsing during earthquakes due to lax building codes, air that is not breathable, kids working ridiculous hours for puny wages, ubiquitous counterfeiting of foods and medications, and lots of other bizarre shit that just make you wonder if the free market without government regulation wouldn't simply be anarchy.
You're only listing how it affects the people, and ignoring the fact that conservatives are working for corporations. I'm sure corporations in China are prospering.
The first rule in optimization is knowing which variable you're optimizing.
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I would have said "even nominally philanthropic corporations". With that slight change I agree with you.
But I've heard too many stories of deals where "gifts" from the Bill and Melinda Gates foundation were closely associated in time with contracts with Microsoft to actually consider them very philanthropic. This isn't to deny that they've done some good things, but when someone does good things for pay you don't normally call it philanthropic. (In this case I think I'd call it a tax avoidance scheme.)
clearly (Score:2)
if you have an injection that murders you, the next time you get an injection you will choose a different supplier
and even if you just get very sick, you will be sure to be an informed consumer and do your research on murky supply chains for medical injections, before it happens again
these damn liberals and their regulations just want to destroy the market with their nanny state ideology
the consumer can take care of himself
in fact: you should be doing your own injections, like a self-sufficient captain of i
Scope of the outbreak (Score:5, Interesting)
First, I have a relative who received an injection at one of the clinics, and I can speak firsthand to what's going on right now.
This article talks about the tracking problem. Well, it's a problem because nobody knows which batches were infected; The lead time on these things can be weeks or months before there's confirmation of a pathogen. By that time, there's potentially hundreds of infected batches out there. We still don't know (and likely won't for up to a year) which batches tested positive. It could be just a one off -- someone missed a sterilization step in a single batch, and the rest are fine. What's happening right now is an abundance of caution approach. They're recalling everything and testing everyone because we don't know exactly where the problem started and ended.
Also, a lot of patients potentially infected haven't been contacted yet and may never be because of out of date or incorrect contact information. Here, the health department has been tasked with contacting patients -- the clinic hasn't reached out at all. When I heard about this on the news, I called her and we went down to ER and got things sorted (tested negative), but the "Contact the patient" step isn't happening for a lot of people.
And lastly, even when they are contacted, and are tested, some of these patients may have already had the infection cleared due to unrelated treatment. My relative, for example, was put on antibiotics for an unrelated condition not long after the injection, and indicated to the doctors symptoms similar to what they were looking for but they cleared up prior to testing. So that data point is lost: They don't know whether the batch used on that patient was a positive now. And given the low rates of patient return and contacting, that one data point could represent hundreds of patients that need to be put on the priority list for contacting.
By far the biggest problem here is a lack of resources and accurate information. It's not that they're incompetent, or that procedures weren't followed (though both could be true)... but the response has been botched because there just aren't enough people to do the leg work. And don't forget: Whether it's their fault or not, you're still the one being billed. A lot of people don't want to eat their deductible or pay for a hospital visit or testing out of pocket (or copay), unless they know there's a problem. Wouldn't be a problem with nationalized healthcare, but with privatized healthcare "preventative medicine" is practically a swear word.
Re:Scope of the outbreak (Score:5, Interesting)
Your post sounded plausible until the last paragraph. Nobody would be billed for getting checked if they received one of these injections. Plus if your relative was given antibiotics the doctor must have had a reason for doing so, a reason as in a lab test that showed that he/she had some kind of an infection. So their record would show what caused the infection.
Lulz. First, my relative got a bill. I've seen it, it's real. Hell, I got a bill for a rape kit once... I didn't pay. A family who's kid was run over by a police car (officer was 100% at fault) was billed for the repair of the dent to the car. That's an argument you just aren't going to win, man. Second, labs don't always test for the bacteria. Take a bladder infection -- if they see red blood cells, that's confirmation of a bladder infection and they prescribe a generic antibiotic. They may or may not send the urine off for a more detailed analysis, depending on severity of symptoms etc. Not every sample is checked for every thing -- this isn't CSI: Your Healthcare Plan.
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There's no such thing as a "generic antibiotic"
Sure there is. For instance, the UTI drug Methenamine -- it operates via a very non-specific mechanism of action, and thus is equally in-effective against everything :P
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Uh, the last time I got an antibiotic it was prescribe first and wait for the test results to come in later. The alternative is to just let the infection grow until they figure out what works.
Usually they take their best guess, and if in a few days it turns out they're wrong they change approach.
At least, that has been my experience with every doctor I've worked with.
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Hell, I got a bill for a rape kit once... I didn't pay.
Not sure I understand this correctly, if you were billed for something you didn't use, or billed for something you feel you shouldn't have to pay for. Anyway though, if you're getting medical bills for random items out of the blue that you didn't receive, it is possible some uninsured person is using your SSI or contact information to obtain care. Better check to make sure weird things aren't going into your medical/credit record.
Take a bladder infection -- if they see red blood cells, that's confirmation of a bladder infection and they prescribe a generic antibiotic.
Suggestive of a bladder infection, but RBC contamination is frequent in mens
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They never said they didn't use it. They said they didn't pay for it. Your second thought mirrors the rest of their examples, that it's something you shouldn't need to pay for when something is done to you out of your control, like the kid getting hit by a cop car and the mother being billed for the car damages.
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First, my relative got a bill. I've seen it, it's real. Hell, I got a bill for a rape kit once... I didn't pay. A family who's kid was run over by a police car (officer was 100% at fault) was billed for the repair of the dent to the car.
My suspension of disbelief is broken. Please pay $100.
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When I heard about this on the news, I called her and we went down to ER and got things sorted (tested negative), but the "Contact the patient" step isn't happening for a lot of people.
First, my relative got a bill. I've seen it, it's real.
Many health insurance plans will not pay for emergency room visits if the patient is not admitted. Without further details, I'd say your relative was billed for the unnecessary ER visit.
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And don't forget: Whether it's their fault or not, you're still the one being billed. A lot of people don't want to eat their deductible or pay for a hospital visit or testing out of pocket (or copay), unless they know there's a problem. Wouldn't be a problem with nationalized healthcare, but with privatized healthcare "preventative medicine" is practically a swear word.
There's one other alternative: make medicine work like any other for-profit service. If I get meningitis from a hospital stay, the HOSPITAL eats the cost like any other business.
You know, come to think of it just because I have circumcision on the brain lately, that would be perfect. Make hospitals eat the costs when something goes wrong. I'll bet you'd see a whole lot more effort go into making sure things don't go wrong. The way it works in our system is the American Academy of Pediatrics says "hey
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If I get meningitis from a hospital stay, the HOSPITAL eats the cost like any other business.
That's called an Accountable Care Organization and outcomes based reimbursement. The US is already going there.
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Maybe. It's not at all clear in my mind that this is actually what's happening.
Yes, I've heard that hospitals must eat the expense if the patient is readmitted quickly, but what that seems to be doing is causing lots of patients who should be admitted, to be classified as "under observation" for a short while and then kicked out. So it doesn't risk the hospital being charged for an admittance that *THE INSURER* deems unwise. This is not good at all.
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What in gods name made you think they saw the report, panicked, he rushed over there in his car, grabbed their relative and dragged them to the ER based on that post? They could have done exactly what you said and deemed it important enough to make a trip out there.
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You're obviously missing that calling the hospital could have been easily implied here, like that they put pants on before they left the house. He was making a summary about the ordeal. You don't expect his story to say "I called the hospital, pressed 1 to get passed the main menu, then 0 for the operator. Waited on hold then talked to someone who told us we might as well come in," do you?
We also don't even know what the "story" on the news said. It might have said if you or someone you know might have been
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The latest outbreak is of fungal meningitis, which is not contagious but also cannot be treated by regular antibiotics. Luckily, your relative was very likely not a victim of the outbreak because the course of antibiotics she was on would have done nothing to stop the fungus from running wild in her system.
Compounding Pharmacy system to blame (Score:4, Interesting)
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My mother frequently uses a compounding pharmacy. The reason is twofold. First, she had an ongoing condition involving healing after surgery, that turned out to be heavily dependent on getting her blood thinned enough that it transported antibiotics properly into bony tissue with poor veinous access. It took a while to get a proper diagnosis on this, but by the time she did, she had found some good doctors, who very regularly monitored her blood viscosity while the treatments that finally cured the conditio
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There's a need for good compounding pharmacies, and it's a pity that there doesn't seem to be national resolve to regulate them in precisely the same way as other pharmacies or businesses that manufacture stock drugs.
The reason that they're not regulated in the same way is that they probably wouldn't exist if they were. The testing quality controls required for the manufacture of even generic drugs are fairly expensive, and they're recouped because of the economies of scale. If the money was there to be made, you wouldn't need a compounding pharmacy in the first place.
The problem isn't from the existence of compounding pharmacies, but rather that a practice designed to regulate small regional companies making botique
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Since the drug companies won't create "children's doses" or other preparations of their profitable drugs
One of the most profitable drugs would be viagra. I see no need for childrens doses.
FDA (Score:4, Interesting)
Such "offlabel" use is necessary, because many drugs are approved for narrow populations, but are useful in wider areas. Some 70% of adult oncology prescriptions are off-label, and virtual all childhood prescriptions in cancer treatment. The same is true of formulation, which is supposed the mixture of pharmacological compounds by standard means.
However, because of cuts to regulation, focus on easier approval soaking up the remaining budget, and fee based payment introduced through the most recent FDA reform, basic enforcement of the mandate of the FDA has decayed drammatical, raising risks as we have seen. Similar problems at the USDA, which has an overlapping mandate in food safety, have seen outbreaks of tainted food.
In this case there were two violations, one of state medical practice, and one of the Food, Drug and Cosmetics Act as amended. The first is that a formulation should be for a particular patient, with a particular script. The second is that introduction of the formulation into interstate commerce is a violation of the FD&C. Both of these practices have been widely winked at, because of the prevalence of off-label formulation, and because there was too much money being made. Formulators would often corner the market on a particular compound, more or less requiring that it be bought through them, at a mark up.
The solution here is for Congress to close the formulation loophole, and for the Agency and the states to work together to create a unified standard of rules. My co-author and I have proposed also a private right of action by indication holders which would allow the to bring qui tam suits against off-label marketers in overlapping indications, thus giving companies an incentive, namely triple damages, to police companies that use their compounds, or who offer off-label competition.
Babies and bathwater? (Score:5, Insightful)
The solution here is for Congress to close the formulation loophole, and for the Agency and the states to work together to create a unified standard of rules.
I always look to people with "the solution" with a bit of skepticism. In this case, I think you're confusing the possibility of a problem with its likelihood.
If Bruce Schneier is to be believed, risk is always a tradeoff. Let's compare the risk of meningitis with the practice of formulation.
Formulation for offlabel purposes and children's doses meets a need, and I would expect that the population benefits are enormous. This meningitis problem is the first one I've heard about in... ever. And the problem is limited to a small number of people because, as people have pointed out, the issue isn't as much the meningitis, it's not knowing how many people may be at risk.
It would seem to me that the risk of problems with formulation is vanishingly low.
If we "close the formulation loophole" as you suggest, that will put all offlabel and children's doses in the hands of the noble and reputable Big Pharma companies. Won't they choose to skip formulations for which there is no substantial market (children's doses, for instance)? Will they not raise prices mercilessly on a captive market?
I dunno... your solution seems formulaic and reflexive. Shouldn't we think through the ramifications first?
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I dunno, you don't seem to know the first thing about what you are talking about. Perhaps you know the different risk rates between specific formulation adverse drug events and general formulation adverse drug events?
You raise a good point. How do we sort through techno-babble and hand-waving by experts?
Experts frequently get caught up in their own world and view everything as through blinders. I'm sure your view makes perfect sense to you and you don't see any problems locally.
Here's a question for you: Another poster pointed out that formulation is the only way to get child-sized doses of certain drugs - the drug companies simply don't want to produce child-sized portions because the market is too small.
Your solution
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But as anyone with a modicum of honesty can tell, which is not you – you, not I, are shilling for an industry – this isn't wha
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Ask yourself the simple question: would you want something injected into your nervous system directly that had been left out over night with an open container?
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I doubt that he works for a drug company. This doesn't mean he's well informed, but you don't seem to be either (nor am I).
One thing that I do know is that children of different ages metabolize drugs significantly differently. So adjusting the dose of a drug proportional to the weight of a child, when it's figured for an adult, and result in EITHER overdosing or underdosing. Depending on the age of the child. This may not be true for all drugs, but it certainly is for many. As I understand it, doctors
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If we "close the formulation loophole" as you suggest, that will put all offlabel and children's doses in the hands of the noble and reputable Big Pharma companies. Won't they choose to skip formulations for which there is no substantial market (children's doses, for instance)? Will they not raise prices mercilessly on a captive market?
Well, if you're going to make a special formulation for three patients per year, SOMEBODY has to pay for it.
Right now it is cheap because somebody just goes into a lab, mixes some stuff up, and mails it off with a note saying that they were careful.
If that were done under the process used for large scale drug manufacture, then what would happen is:
1. Somebody figures out how to mix it all up (not much harder than what was done here), but would document the living daylights out of the process.
2. Somebody f
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Good reply (Score:2)
Good reply. Elegantly puts the risk in perspective.
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Seriously? There have been what, 23 deaths so far? Out of a population of over 300 million people that is nothing.
Here's a helpful statistical hint for you. Only a very small subset of that 300 million got the injections.
If all 300 million people got injections and only 23 died, then you would have a point. But they didn't, so STFU, you're talking out your ass.
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It's like national news reporting a child who has been kidnapped. It is terrible an
Rarity of infection (Score:5, Interesting)
Fungal meningitis is rare, largely unstudied, because rare, and of varying severity. One reason for the danger of this outbreak, is that there is no generally accepted course of treatment. As such, we are about to learn things we did not want to know, and under pressure of several thousand potentially exposed patients.
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I had assumed he was making a euphemism for STD's. Whoops.
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coxsackie
named after coxsackie, ny, where a correctional facility provided the medical sample that the virus was first identified in
http://en.wikipedia.org/wiki/Coxsackie,_New_York [wikipedia.org]
it's actually a nice little hudson river town. but i don't think the virus does much for their tourism rates
then again, lyme, connecticut is a delightful town on the connecticut river
maybe quaint northeastern us river towns are doomed to have diseases named after them
The FDA blew it, among others (Score:4, Interesting)
Re:The FDA blew it, among others (Score:5, Informative)
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Amphotericin B liposomal (Score:3)
Ambisome is a brand of Amphotericin B, which has been around as a generic since the 1960's, and, like Fungisome, is in a liposomal formulation to improve its IV tolerability. Most doctors know the generics well, and generally do not keep track of old generics by their current brand names.
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Amphotericin B (Score:2)
Ambisome is a commercial name.
Recalls aren't that complicated... (Score:3, Informative)
So, I work in a hospital pharmacy in England. If we were in this situation:
1. The drug company would be required by law to notify the Medicines and Healthcare Regulatory Agency (MHRA) upon realising there is a problem. This can be done out of office hours if it is a serious problem (we have class 4 recalls for things like typos in leaflets, which tend not to qualify for urgent action).
2. The MHRA would fax out a drug recall notification to all hospital pharmacies, private hospital pharmacies and Primary Care Trusts in the country, who would be responsible for forwarding it to any community pharmacies, doctors and dentists in their area (assuming this was a drug those groups would be likely to have - this won't happen if the drug is hospital-only). Many pharmacists are also signed up for instant email notifications of drug recalls. The MHRA doesn't waste time working out which hospitals have been affected - it's the hospital's responsibility to determine whether they stock(ed) that drug using the brand names, manufacturers and batch numbers given.
3. In the case of direct harm to patients, this would be a Class 1 Recall ("potentially serious or life-threatening") requiring removal of the product from hospitals/pharmacies/doctors etc immediately. If you are the on-call pharmacist for a hospital and it's 6pm on a Sunday, tough, you'd need to go in and sort it out there and then - quarantine the drugs, take them out of ward stock, etc.
3a. In this case, the original recall has been expanded to include things that only might be problematic, so those could be done as a class 2 recall (action within 48h, not immediate) or even class 3, so hospitals can concentrate on the stuff that's actually killing people.
4. The hospital is also required to contact all potentially affected patients (we don't usually record batch numbers for which drugs have been given to patients except in certain specific cases, so we would usually need to contact all patients who received Drug X within an appropriate timescale).
So that sounds quite simple to me. At which stage does the US system differ? The recall list is very long here, but on the other hand, chances are your hospital doesn't use everything on the list and you can completely ignore the ones you haven't stocked.
(Don't just say "it's because the US has 300m people and you have 60m"; that just means your regulatory agency needs to send out more faxes initially and I'm sure the faxes are done via some sort of batch method.)
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I like that you guys seem to have a sound plan for dealing with this, though I wonder why they use a hierarchy for disseminating information to smaller and small scale pharmacies. Wouldn't it make more sense that all pharmacies should be notified by one central body both for expediency and for reducing the margin of error that one of the links in the chain might goof?
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I like that you guys seem to have a sound plan for dealing with this, though I wonder why they use a hierarchy for disseminating information to smaller and small scale pharmacies. Wouldn't it make more sense that all pharmacies should be notified by one central body both for expediency and for reducing the margin of error that one of the links in the chain might goof?
I suspect the reason is actually fairly simple. In the case of a major recall, speed of confirmed communication is paramount. Hierarchy means that one organization isn't simply trying to contact everybody for personal handoff, but is instead multiplying its capacity by creating a cascade effect. If every pharmacy in the country was centrally registered with emergency contact details, this procedure could probably be done away with, but protocols take a long time to change, even when they're no longer valuab
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Yep, it's a bit of both. There are two registers of pharmacies:
- a national one, run by our regulatory body, which includes both hospitals and community pharmacies
- more local ones, held by the PCTs
You could get the national listing involved but it adds a layer of bureaucracy (the organisation that holds all that data has many other functions which might interfere with speed of recall). So you talk to the PCTs instead, who know exactly whom they're paying locally and don't have as many people to contact. Ad
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I think it's because the hospital system and the community pharmacy system are very separate, and while both are regulated by a central body (the General Pharmaceutical Council) that body has no involvement in drug recall cases, because it doesn't regulate drug standards, only pharmacists and pharmacy premises. So you can either: be the MHRA and directly contact all hospitals plus all PCTs (who will do the legwork of then contacting primary care doctors/dentists/community pharmacists), or be the MHRA and co
Re:Recalls aren't that complicated... (Score:4, Interesting)
So that sounds quite simple to me. At which stage does the US system differ? The recall list is very long here, but on the other hand, chances are your hospital doesn't use everything on the list and you can completely ignore the ones you haven't stocked.
I can't speak to every clinic or hospital involved in the recall, but the pain clinic here in the midwest only recorded the batch numbers in their inventory control system. They did not record which patients received doses from which batch. So all they can say is "batch N was used from date X to date Y." Several batches may have been released from inventory at the same time. As well, we have no national recall framework; It is being run at the state level with varying levels of responsiveness and oversight. In fact, it was the compounding pharmacy that initiated the recall, not the government. The federal government did not issue a recall order until almost a week later -- and that recall order then went to the state health departments, who then decided (based on their own policy) how to go about handling the recall.
In some states, the hospital is responsible for notifying patients. In others, it's the state. While (thankfully) every state has a law or policy to contact the patient, it's actually not required by federal law. If you happened to live in a state that decided recalls weren't important... it would be totally legal for it to simply not happen. :( This is one of the major problems of the United States' "marble cake" government -- each level above pre-empts the level below, but each level below can then interpret the law or impliment it in their own way. And what's worse, funding levels vary by state -- while federal tax dollars are sometimes set aside for enforcement, very often it's left entirely up to the state to fund it. A cash-strapped state may only have 1 guy handling the recall on behalf of the state, and nuts if he's out of town that weekend. Not that this actually happens, but it's an example of what could happen thanks to our marble cake love-in.
Adding even more confusion to an already hopelessly dysfunctional system... we live with privatized health care right now, and even with ObamaCare, the problem will persist. It's not the manufacturers, clinics, or government's responsibility to pay for the testing and/or treatment resulting from a recall. It's you, the individual, who are responsible. You might well guess what some poor bastard without insurance is gonna do when he hears "Danger! Life-threatening illness. It could be you!" ... Like so many other poor people, poor bastard here is going to ignore it until he's obviously sick. And by law, it was his own damn fault for not coming in, going bankrupt, and living in financial ruin for the rest of his life... our culture and our laws pretty much put the individual in the frying pan as early and often as possible. So if you croak, you deserved it... but only if you live here. In any other part of the world, such thinking would be considered barbaric. Here, we call it Tuesday.
"At which stage does the US system differ?" (Score:3)
at the stage where an evil socialist liberal dares suggest that the public health is more important than profit making
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Well, we don't have something called compounding pharmacies here as such, so I think they'd be considered a "specials manufacturer" - premises licensed for the production of unlicensed medications, usually things like syrup versions of tablets or unusual mixtures. But specials manufacturers are still required to notify the MHRA and get a recall cascade going, just like a "proper" manufacturer.
More Drugs tainted!!! (Score:1)
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In case you missed the other Score 5 posts...the FDA has no jurisdiction over compounding pharmacies like the one in Massachusetts. Such pharmacies are under state regulation, not federal.
Also, while we're on the topic of the FDA...don't forget the House Republicans' budget cut FDA funding by $285 million. Kinda hard to have "agents standing in every lab" when you don't have enough money to pay said agents...
List of clinics? (Score:2)
Has anyone put up a list of potential suspect clinics anywhere?
My mother received an epidural steroid injection shot, methylprednisolone, about a year ago. While I'm reasonably certain there are no complications (certainly they would have shown up by now), I would feel much more comfortable if I could verify that the clinic which treated my mother was not one that received any drugs from this compounding pharmacy.
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No idea where the list can be found, but I'd think that something like a prednisone shot would be available from traditional manufacturers.
Not that this necessarily means anything. Several trade magazines have blasted the practice of doctors obtaining things from compounding pharmacies that are otherwise available from conventional manufacturers. I can completely understand the need for alternate sources for unusual medications that otherwise would never be made, but there is really no excuse for using th