I'm sorry, but we can't get your meds. Federal policy you know.

[Hayabusa Rider]

We've noticed a disturbing trend in health care. Medications that have been commonly available are now not. In one day I found that 5 commonly prescribed drugs could not be ordered. I did a little research and found out a few things well summed up here.

http://healthaffairs.org/blog/2011/06/08/rx-drug-shortages-regulation-can-be-deadly/

Now we've had an effective system which has served us well for quite some time. The Feds know best however, and now they are instituting regulations which work for them, but leaving patients in peril. One is the "zero tolerance" policy, which means that variances which could be corrected (and we're not talking dangerous problems, that's already accounted for in the process) results in the shutdown and redo of production lines. That's costly (read expect medication costs to escalate) and unnecessary. Problems that have to be fixed already are. Worse is that now there are caps on production and if they are exceeded because the crystal ball missed an increase in demand, then the Feds need to do another audit and you can't make any more until that's done.

So the result of this as I've seen it- Three people no longer can get their high blood pressure meds, and there are no substitutes. One who gets anti-seizure meds, same thing. Steroid creams, medications for OCD, a whole bunch of things are effectively off the market and the problem grows daily.

The government? Hey, that's the regs and that's what matters most.

Look for a lot more of this to come.

 

[Schadenfroh]

My best friend interned at a drug company, he said that even if an ingredient for a drug was safe, if it had a slight discoloration or slight problem, even if the problem / discoloration was harmless, they had to destroy the entire batch and start over. They also could not reuse certain chemicals during the production process, even if it was safe to do so. Not sure how much was corporate policy or FDA guidelines, but I could see where the expenses would begin to add up.

 

[Genx87]

Need more regulation obviously!

 

[ProfJohn]

When is the last time you could pick up a bottle of motrin? Or Benadryl?

 

[GoPackGo]

So the "Death Panels" are already in place...

 

[Macamus Prime]

When is the last time you could pick up a bottle of motrin? Or Benadryl?

Yesterday at 4:30ish. Unless, one of the ingrediants was altered and it was the "watered down" Benadryl - but, it still made me drowzy.

 

[Macamus Prime]

So the "Death Panels" are already in place...

Ah, when an HMO does it, the patient shouldn't have abused X which led to sickness Y. Or, HMOs are out to make profits, they need to make sure people don't abuse their services.

When the gubnament does it, it's evil, gawd dammit!!

I am not accusing you directly on this. But, most corporate cock sucking mindless drones are quick to defend a company that does something evil.

 

[Hayabusa Rider]

Ah, when an HMO does it, the patient shouldn't have abused X which led to sickness Y. Or, HMOs are out to make profits, they need to make sure people don't abuse their services.

When the gubnament does it, it's evil, gawd dammit!!

I am not accusing you directly on this. But, most corporate cock sucking mindless drones are quick to defend a company that does something evil.

Insurance companies do not order shutdowns in drug production. There is no "like this".

 

[thraashman]

Regulation in and of itself is a good thing. But regulation like anything else must be done intelligently. The reason regulation like this that we find stupid are in place usually is because someone, somewhere abused there being a lack of this regulation. If there was no regulation, then drug companies would do anything they felt like and likely release unsafe or untested drugs. If they remove these regulations, then someone gets sick or dies because of a lack of inspection, then the same people bitching about excessive regulation will want more.

Unfortunately the main issue here is that things are written in stone. The rules aren't written in a way that a human can use their judgement. Granted, that's to protect the government employees from having to take direct blame for a problem. Really, there's no good way to fix this.

 

[Munky]

Too much regulation in one area. Not enough regulation in another. Leave it to the inefficient bureaucracy to mess things up.

 

[ProfJohn]

Yesterday at 4:30ish. Unless, one of the ingrediants was altered and it was the "watered down" Benadryl - but, it still made me drowzy.

Was it the brand name of the generic?

 

[Hayabusa Rider]

Ah, when an HMO does it, the patient shouldn't have abused X which led to sickness Y. Or, HMOs are out to make profits, they need to make sure people don't abuse their services.

When the gubnament does it, it's evil, gawd dammit!!

I am not accusing you directly on this. But, most corporate cock sucking mindless drones are quick to defend a company that does something evil.

Regulation in and of itself is a good thing. But regulation like anything else must be done intelligently. The reason regulation like this that we find stupid are in place usually is because someone, somewhere abused there being a lack of this regulation. If there was no regulation, then drug companies would do anything they felt like and likely release unsafe or untested drugs. If they remove these regulations, then someone gets sick or dies because of a lack of inspection, then the same people bitching about excessive regulation will want more.

Unfortunately the main issue here is that things are written in stone. The rules aren't written in a way that a human can use their judgement. Granted, that's to protect the government employees from having to take direct blame for a problem. Really, there's no good way to fix this.

Congress is effectivly immune to any consequences of it's actions. When it orders something contrary to our interests there is no fix but to wait and hope that few are harmed until it gets around to it. BTW the system worked well. They just knew better.

 

[Vette73]

Really so if there was a problem you be ok with people dieing/gettig sick and then blame the FDA?

I use to make drugs and know the machines are set to run in batch numbers and then cleaned and reset. If the company did not forsee they would make enough its the Feds fault for holding them to THEIR numbers?
The numbers of materials made on each machine is set by the company/maker and then the FDA approves or declines it. The FDA does not tell them what to do, the compnay tells them what it will do and then has to prove it.

More Hybu faux outrage.

 

[Vette73]

My best friend interned at a drug company, he said that even if an ingredient for a drug was safe, if it had a slight discoloration or slight problem, even if the problem / discoloration was harmless, they had to destroy the entire batch and start over. They also could not reuse certain chemicals during the production process, even if it was safe to do so. Not sure how much was corporate policy or FDA guidelines, but I could see where the expenses would begin to add up.

Your friend is an idiot and did not learn much.

That "safe" ingredient could cause a reaction to someone esp if they have been on that Med and now it has some new thing that they are not aware of.
How does he know it was harmless if it only happened once? Or its harmless to reuse something that has been open? He does not and that is why the batchs get tosed out.

I have seen million dollar batchs tosed out. It was the right thing to do and only the Exe's/bean counters were upset by it.

 

[Hayabusa Rider]

Really so if there was a problem you be ok with people dieing/gettig sick and then blame the FDA?

I use to make drugs and know the machines are set to run in batch numbers and then cleaned and reset. If the company did not forsee they would make enough its the Feds fault for holding them to THEIR numbers?
The numbers of materials made on each machine is set by the company/maker and then the FDA approves or declines it. The FDA does not tell them what to do, the compnay tells them what it will do and then has to prove it.

More Hybu faux outrage.

Bullshit. These are relatively new standards and they are causing more problems then they were intended to resolve. Tell the guy who has epilepsy that it's for his own good. You know you would.

 

[Vette73]

Bullshit. These are relatively new standards and they are causing more problems then they were intended to resolve. Tell the guy who has epilepsy that it's for his own good. You know you would.

AGAIN I worked in the places to make drugs. WE, the drug makers, told the FDA what we could do. The FDA approves that and thats it. If we want to push them more WE have to prove it. The FDA is doing their job.

Want to blame someone, blame the makers. But let me guess we should go back to the old days of serving ethylene glycol as cough med's to kids right?

 

[Slew Foot]

I've noticed a surprisingly large number of anesthesia drug shortages this year. Propofol, succinylcholine, rocuronium, thiopental. All of them have been in short supply this year.

 

[GoPackGo]

AGAIN I worked in the places to make drugs. WE, the drug makers, told the FDA what we could do. The FDA approves that and thats it. If we want to push them more WE have to prove it. The FDA is doing their job.

Want to blame someone, blame the makers. But let me guess we should go back to the old days of serving ethylene glycol as cough med's to kids right?

So why are you creating shortages? Is it so you can continue to rape Patients for drugs that have been around for years and years?

 

[GoPackGo]

Ah, when an HMO does it, the patient shouldn't have abused X which led to sickness Y. Or, HMOs are out to make profits, they need to make sure people don't abuse their services.

When the gubnament does it, it's evil, gawd dammit!!

I am not accusing you directly on this. But, most corporate cock sucking mindless drones are quick to defend a company that does something evil.

I am against drug shortages and price gouging no matter who is doing it.

 

[Hayabusa Rider]

AGAIN I worked in the places to make drugs. WE, the drug makers, told the FDA what we could do. The FDA approves that and thats it. If we want to push them more WE have to prove it. The FDA is doing their job.

Want to blame someone, blame the makers. But let me guess we should go back to the old days of serving ethylene glycol as cough med's to kids right?

You still can't read. The standards aren't the same. Oh, I suspect you've been drinking the antifreeze. Where did I say all regs we're bad? No where. You noted that your company tossed out millions instead of using it. Somehow that worked didn't it?

Arguing against harmful requirements is arguing for none. No. Only an idiot would think those are the only options.

Now why are you defending stupid? Why do you think people upset because changes in policy now prevent them from getting their safe and effective medications is faux outrage? Because you have to.

 

[theeedude]

As early as 2005, hospitals and clinics complained to Health and Human Services Secretary Michael Leavitt that drug manufacturers and distributors were often out of certain drugs.

Bush. Figures.

 

[Vette73]

You still can't read. The standards aren't the same. Oh, I suspect you've been drinking the antifreeze. Where did I say all regs we're bad? No where. You noted that your company tossed out millions instead of using it. Somehow that worked didn't it?

Arguing against harmful requirements is arguing for none. No. Only an idiot would think those are the only options.

Now why are you defending stupid? Why do you think people upset because changes in policy now prevent them from getting their safe and effective medications is faux outrage? Because you have to.

No where in your link does it say they are bringing new regulations. In fact all it says is they are enforcing current regulations.

"The Federal Food and Drug Administration (FDA) has been stepping up its quality enforcement efforts"

Stepping up does not = new, it means they are doing their job.

 

[ShawnD1]

So the result of this as I've seen it- Three people no longer can get their high blood pressure meds, and there are no substitutes. One who gets anti-seizure meds, same thing. Steroid creams, medications for OCD, a whole bunch of things are effectively off the market and the problem grows daily.

The government? Hey, that's the regs and that's what matters most.

Look for a lot more of this to come.

Sounds like Canada. In the name of protecting us, they end up fucking a lot of people over. Doctors are afraid to give out opioid pain killers because they don't want too much government attention. My friend broke his collar bone about a month ago and his doctor told him to take Advil for the pain. It took a bit of convincing before the doctor would give him Tylenol 3s. God damn government.

When is the last time you could pick up a bottle of motrin? Or Benadryl?

Are they trying to make diphenhydramine a prescription drug in the US? I guess that would make sense. It knocks people out as hard as morphine does. I always give benedryl to people for minor problems because I like watching how fucked up they get. They had a little itchy skin or something from some minor allergy but now they can't even walk in a straight line!

 

[her209]

A quick Google search for "cytarabine production" turns up:

http://www.hematology.org/News/2011/6634.aspx

The United States is currently experiencing drug shortages, particularly for generic drugs. Shortages of drugs used to treat patients with hematologic malignancies, including leukemia and lymphoma, have become critical and life-threatening. An increasing number of physicians have been forced to take their patients off therapies mid-treatment, delay treatment, choose alternative therapies that are less effective, and ration their remaining supplies of these therapies. ASH members have reported severe shortages of BiCNU (Carmustine), Cytarabine (ARA-C), and Thiotepa. The Society has recently learned that one manufacturer of Cytarabine has begun to distribute small amounts. Other manufacturers report they have been able to increase production and estimate additional supplies will become available in the next month. Regarding Thiotepa, the FDA has announced it will import the drug from suppliers overseas.

http://community.wegohealth.com/group/bloodcancers/forum/topics/cytarabine-shortage-impacting

Over the past few days, I've heard quite a bit about a shortage of the chemotherapy drug Cytarabine. Cytarabine is used primarily to treat acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In some cases, it's used to treat some lymphomas. Unfortunately, this shortage started last fall and continues to get worse. This is a eye-opening case on how medications are made and distributed across the US.

The three drug companies that make Cytarabine are:

* Bedford Laboratories
* Hospira, Inc.
* APP Pharmaceuticals

Each company has faced challenges meeting production goals for Cytarabine. Hospira had a hard time finding one of the key ingredients that makes up Cytarabine. APP Pharamaceuticals had issues with production quality when crystals formed in the vials holding the Cytarabine. Bedford Laboratories has struggled with production capacity. What bothered me the most? I checked all three corporate sites and not one had any mention of the Cytarabine shortage. Not a single statement. That's not very reassuring for a consumer.

 

[Throckmorton]

Bush. Figures.

No. Obama, Pelosi, and Reid built a time machine and went back to 2005 to kill old people by destroying bad drugs.