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Sterilization is a procedure everyone takes for granted because we expect it to be the standard set in medicine. Patients do not realize that even one microbe can multiply, and when they're left to harvest, devastating events like this are expected to happen. This pharmacy not only didn't adhere to sterilization protocols, but they left the vials unmarked with patient identification!
Now since it lacked patient ID, the receivers of the shipments should have been aware when the medication administrators were utilizing these vials. The place where I work at, if any medicine came to me unmarked with only the drug name and it was supposed to have patient ID on it, I wouldn't do anything unless I contacted the pharmacy first.
The pharmacy is at fault no doubt, but there could have been a secondary method for protection for these people.
Yes, but that probably would have cost a buck or two, so it was decided to just inject it and hope...
Actually we have had expired medication come in, we just send it back and they foot the bill. But quite often, the receiving pharmacist, nurse, or doctor may be too much in a hurry; there should be just enough time allotted to check the expiration date as well would-be patient ID.
Sterilization is not hard and not very costly once you buy the equipment. Performing the tests to test the equipment is only slightly more work than sterilizing anything else. There is no excuse for this to have happened.
See, this is the problem with the wrist-slaps most companies get for violations. No one ever follows up to make sure they're followed.
This is also a big reason these companies don't want to have to deal with the feds.
Wonder which Red state they'll reapply for licensing in? You never can keep a good "Job Creator" down.
Well if this isn't "closing the barn door after the horses have gotten out", I don't know what is. This is what happens when you let business regulate government rather than the other way 'round. The FDA seems to be little more than a lobbying organization for the pharma industry. Every time you hear the republicans saying we need less government regulation you can think of this tragedy.
Bluelake - There are already regulations that are in place to prevent this. NECC wasn't following them. It sounds like they had a pattern of playing fast and loose, but never held accountable. Not always about adding more regs, but enforcing the ones that exist, and making the actions of consequence.
Thunder-I fully agree with your post and rather than more regulations I believe, as do you, that we need to enforce the regulations that are in place. However, I have repeatedly seen the political party influenced by conservative business interests simply refuse to enforce regulations that they cannot eliminate. The perfect example is mine safety regulations. The Bush administration simply appointed representatives of the mine owners to head up the agency in charge of enforcing those mine safety regulations. How do you think that worked out? It's the same story with OSHA and the EPA. As a "cost cutting" provision they simply refuse to properly fund those agencies that they realize they can't eliminate. Polluting industries running the EPA. Airlines running the FAA. Lobbyists for Pharma running the FDA. Etc., etc. And the uncorrupted regulating agencies simply must function with drastic reductions in funding. You're right Thunder, we don't need more regulations, we need to enforce the ones in place and properly fund the enforcing agencies.
Yeah, can't let little things like the health of patients get in the way of makin' that dough, you betcha...
The blinding speed of this government response leaves me breathless....
Cue the teabagger shrieks of "job killer! Commie! SOSHULIST!" in 3...2...1...
Romney has called the FDA an “attack on free enterprise” and the Ryan budget considers the agency “discretionary.” Ryan has voted against a stronger FDA six times and given the chance, he would slash its budget drastically.
And yet no one in that "mainstream liberal media" has bothered to mention that...
Why is it the mainstream media's job? Why can't the internet or the politicians or the state report this to the nation? Why don't you go out and tell people the truth?
Because the FDA had NO AUTHORITY over compounding pharmacies - since 2003.
That's when the Supreme Court threw out part of the federal law regulating them, and the REPUBLICAN Congress in charge (both houses of Congress & Presidency) REFUSED to pass legislation restoring the FDA's power.
Somebody paid off? You betcha.
Puhlease - since 2003, there have been periods when both parties have had control of Congress. During the first 2 years of Obama's term, the Democrats had the majority power to pass the bill to overhaul the healthcare industry. Why didn't they increase funding and authority for FDA then?
I was just wondering if Ryan & Romney were connected to this catastrophe in any manner.
To those members of the Massachusetts board who let this company continue to function.....all should resign. You did not do you job in the inspection of the company or it's product.
When state budgets get tight, there's HUGE pressure on regulatory agencies to back off the "job creators".
That's why corporations lobby so hard for state vs. federal regulation of their industries. They're bigger than a lot of states' budgets and have nothing to fear from state "regulation" once they buy a few high-placed politicians (or a governor).
Looks like the state is really good at closing the barn door after the fungal stock has escaped.
The regulators knew for years that the compounders were acting as manufacturers - I'll bet every compounder in the state has been doing the same thing. It would be a simple thing for them to require a prescription in-hand before shipping each and every dose. They could also require that each shipment can contain medicine for only one patient.
It's all about MONEY. The owners were more concerned about their bottom line and not enough about the end consumer. A a pharmacist, I have seen this both with independent pharmacies, as well as some chains who sacrifice staffing in the name of the bottom line!
I am sorry, annual reports are not good enough. How about weekly, monthly? Food service gets inspected more than that.
Sounds like a very serious crime to me, possibly even negligent homicide. Needs more than license revocation. But they'll probably get an SBA loan to start up somewhere else under a different name.
These people shot craps with people lives for the Bottom Line. Money was more important than safety and the patients were the ones that lost. Hang these greedy bastards from a tree in the town square and leave them to rot!
WEll, one should learn to think twice before allowing any product injected into our bodies if it is not necessary or can be avoided.
Pig framers have more regulation than this industry does.
Annual inspections of their paper work? This state is a joke, all pharma products from this state should be rejected by all those concerned. Maybe when this begins to hurt their pocketbooks things will change, but, I doubt it!
The OWNERS of this business deserve JAIL time...
Any Politicians that knew of this and did nothing deserve JAIL time...
This was and will be a criminal act.
Ok my Question is What about the hospitals, doctors offices and other places who bought the medicines in bulk from a compounding company instead of a manufacturer? Shouldn't they be just as responsible? I mean obviously they got them cheaper because of less or no fed reg. How many more and other medications have they purchased from these non or under regulated companies, I know I'm being general but there are more than just this one compounding company and wheras this one was caught by obvious problems (death) what else is being put into our drug supply?
I remember not too long ago we were told that we couldn't buy from Canada or Mexico because they might not be good enough, hmf OK? Good job protecting us!
Huey - a good portion of these products are being used to fill voids left by the manufacturing shortages of the drug companies. The compounded products are considerably more expensive, and have less shelf life.
These events should strike fear into everyone's heart. There has been an ongoing decline in quality, across many products and services, for some time now. Is it the 'ship it now, we will fix it in the next update syndrome' in which sub-standard products are shipped, with known issues, to be fixed later? This was, and still is, common in the computer industry, where lives usually are not at stake. Is it the influence of owners, or managers, from certain countries where quality, safety, and integrity are concepts not as highly respected as they are in America? We are concerned that this lack of quality is spreading to other industries, with potentially deadly consequences. America has been 'all about the money' for some time now, and we need to get back to creating good, solid, reliable businesses based on long-term goals, not just short-term profits.
Interesting who was governor then in 2006. And he was supposed to correct the problem and didn't. Must have been all those regulations he was for. Mitt weren't you governor then. Should have expected it. W hat else didyou overlook? Or did you just hope for something to come along to kick the can down the road like you said in your 47% tape? You are consistent with that. Too bad before they vote, republcans aren't required to watch that tape in its entirety. That after all is what they are trying to inflict on America.
Pulling their license seems minimal. The people responsible for the decisions which resulted in the distribution of contaminated meds should be prosecuted for negligent homicide at the very least. And the corporation/partnership/whatever utterly disbanded and its assets siezed.
If organizations suffered meaningful consequences of their carelessness and greed, there would be fewer instances of this sort of thing.
(Maybe they can get jobs in China.)