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(Boston.com)   There's a 90% chance the pharmacy that made your sterile compound medicine is trying to kill you   (boston.com) divider line 52
    More: PSA, Department of Public Health, Massachusetts, pharmacy, intravenous therapy, Michael Cohen, vehicle inspection, Framingham  
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7120 clicks; posted to Main » on 06 Feb 2013 at 3:14 PM (1 year ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2013-02-06 03:17:25 PM
And you're trying to kill me with a registration wall
 
2013-02-06 03:17:27 PM
But what ever you do DON'T by off brand meds from nasty ole Canada!

Hah!
 
2013-02-06 03:18:33 PM

MLWS: But what ever you do DON'T by off brand meds from nasty ole Canada!

Hah!


Or Mexico in Juarez.
 
2013-02-06 03:21:18 PM
And we pay this industry so much why?
 
2013-02-06 03:21:30 PM
They're not trying to kill you, they just don't care if they do and they're too incompetent to avoid it.
 
2013-02-06 03:22:23 PM

MLWS: But what ever you do DON'T by off brand meds from nasty ole Canada!

Hah!


You do know that those "pills" are just our candy versions of Smarties - right?
 
2013-02-06 03:22:58 PM
That's why I only take meth.
 
2013-02-06 03:23:04 PM

Reverend Monkeypants: And we pay this industry so much why?


Suzanne Sommers told us to. She used big fancy words that sounded real scientificlike.
 
2013-02-06 03:24:03 PM
So Mass has a problem.  That doesn't mean that the pharmacies everywhere else do.
 
2013-02-06 03:25:15 PM
I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.
 
2013-02-06 03:26:53 PM

offmymeds: I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.


Are you still on that stuff
 
2013-02-06 03:28:04 PM
A little of this, a little of that... what's the difference?

www.gonemovies.com
 
2013-02-06 03:29:06 PM

Fark Rye For Many Whores: offmymeds: I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.

Are you still on that stuff


Good Lord, NO! I may be crazy, but I'm not stupid.
 
2013-02-06 03:29:17 PM

offmymeds: I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.


Special K. WOOOOOOT
/never done it.
 
2013-02-06 03:30:09 PM
I'm guessing that the range of infractions is  HUGE....

You've probably got facilities shut down because the business interests said "Fark that rule!  It's too expensive to have a sterile clean room with positive air pressure at all times - we'll use lots of Clorox wipes in the employee break room and call it a day"

all the way down to:

"You're lab notebooks are the wrong color, the regulation clearly states "taupe" covers and yours are more of a dark beige and OMFG do I see BLUE ink on one of these pages?!?"
 
2013-02-06 03:31:14 PM

ChipNASA: offmymeds: I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.

Special K. WOOOOOOT
/never done it.


Hint: Don't.
 
gja [TotalFark]
2013-02-06 03:33:12 PM
Ketamine? Niiiiice. Say 'buh-bye' kidneys.
 
2013-02-06 03:33:21 PM
I'm not saying that the pharmacies mentioned in the article didn't have problems.

I will, though, assert that there is a certain sector of the economy that would benefit from banning in-pharmacy compounding.

I'll also point out that I've noticed a fairly concentrated attack on compounding in the press over the past few months.

/just something to think about
 
2013-02-06 03:33:26 PM

ChipNASA: MLWS: But what ever you do DON'T by off brand meds from nasty ole Canada!

Hah!

Or Mexico in Juarez.


Mine come from the South Pacific paradise/tax haven of Vanuatu.  Eight days, +/- 1.  Only lost one shipment to Customs in 10 years and it was replaced free of charge.
 
2013-02-06 03:34:37 PM
There is a 100% chance this is big pharma using their jack booted thugs to squeeze little compounding pharmacies.
 
2013-02-06 03:36:04 PM
While I don't have a degree, I'm pretty sure I'd have better lab hygiene than most of these assholes.

For god's sake, the rules are not draconian. I'm curious to know which ones they couldn't follow. Don't eat in the lab? Wear gloves?
 
2013-02-06 03:37:01 PM

offmymeds: Fark Rye For Many Whores: offmymeds: I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.

Are you still on that stuff

Good Lord, NO! I may be crazy, but I'm not stupid.


So you're off your meds, then?
 
2013-02-06 03:40:12 PM
If you are taking medication that makes you sterile, do you really want to live?
 
2013-02-06 03:42:18 PM

max_pooper: If you are taking medication that makes you sterile, do you really want to live?


Um, yeah. I have no interest in making more people.
 
2013-02-06 03:43:53 PM

Fizpez: I'm guessing that the range of infractions is  HUGE....

You've probably got facilities shut down because the business interests said "Fark that rule!  It's too expensive to have a sterile clean room with positive air pressure at all times - we'll use lots of Clorox wipes in the employee break room and call it a day"

all the way down to:

"You're lab notebooks are the wrong color, the regulation clearly states "taupe" covers and yours are more of a dark beige and OMFG do I see BLUE ink on one of these pages?!?"


Yup, figured that's why only 11 were "serious infractions" - the rest are (probably) minor stuff.  Better headline to say 90% failed than 30% failed.
 
2013-02-06 03:46:15 PM

potterydove: So Mass has a problem.  That doesn't mean that the pharmacies everywhere else do.


Yyyyyeah right
 
2013-02-06 03:47:07 PM
If you can't get an erection for four hours, she's ugly.
 
2013-02-06 03:47:43 PM

Chinchillazilla: offmymeds: Fark Rye For Many Whores: offmymeds: I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.

Are you still on that stuff

Good Lord, NO! I may be crazy, but I'm not stupid.

So you're off your meds, then?


i1136.photobucket.com
 
2013-02-06 03:51:11 PM
They probably would have passed the regulations (such as they were) 100 years ago when compounding pharmacies were the thing.  Now they should all just go away.
 
2013-02-06 03:52:03 PM

Yes please: Reverend Monkeypants: And we pay this industry so much why?

Suzanne Sommers told us to. She used big fancy words that sounded real scientificlike.


The word you're looking for is "sciency".
 
2013-02-06 03:53:17 PM

Fizpez: I'm guessing that the range of infractions is  HUGE....

You've probably got facilities shut down because the business interests said "Fark that rule!  It's too expensive to have a sterile clean room with positive air pressure at all times - we'll use lots of Clorox wipes in the employee break room and call it a day"

all the way down to:

"You're lab notebooks are the wrong color, the regulation clearly states "taupe" covers and yours are more of a dark beige and OMFG do I see BLUE ink on one of these pages?!?"


Well, yes.

And the reasons for the infractions likewise range from:

We have 14 inspectors with a caseload of 450 facilities each and they can only inspect between the hours of 9:30-11:30 a.m. and 1:30-4:30 p.m. otherwise it's too hard on the plants;

all the way down to

"I was up partying all weekend and I didn't feel like going through the whole facility Monday, so I did a write-up for the dirt in the lobby and called it a day".
 
2013-02-06 03:53:27 PM

Just another Heartland Weirdass: There is a 100% chance this is big pharma using their jack booted thugs to squeeze little compounding pharmacies.


Didn't you learn anything from Zero Dark Thirty, people don't trust absolutes, there is a 95% chance.
 
2013-02-06 03:55:11 PM

potterydove: So Mass has a problem.  That doesn't mean that the pharmacies everywhere else do.


All those people across the nation with fungal meningitis would probably disagree.

Many, if not all, of these pharmacies provide services nationwide.
 
2013-02-06 04:01:48 PM

offmymeds: I can believe that. Prior to my back surgery last December, I was prescribed a compounded medication by a physician's assistant. It was supposed to help relieve some of the pain. It had ketamine in it. After rubbing it on the affected area, I soon felt like I'd just ingested something weird. I didn't know if I was coming or going.


While interesting, does this actually contribute to the conversation?  Did the compounding pharmacy screw up the order or did the PA write for something you had a bad reaction to?  If the former, then you've contributed.  If the latter, I'm not sure why you felt compelled to tell us.
 
2013-02-06 04:04:34 PM

Vegan Meat Popsicle: potterydove: So Mass has a problem.  That doesn't mean that the pharmacies everywhere else do.

All those people across the nation with fungal meningitis would probably disagree.

Many, if not all, of these pharmacies provide services nationwide.


Lots of pharmacies compound.  Many don't ship outside of their states due to differing state laws.  Also, the 11 being shut down is bad. The 21 with minor violations aren't too concerning.  Could be as simple as not having a sign hung where it should be or something of similar importance.
 
2013-02-06 04:08:42 PM
Clearly, this is a case of BIG GOVERNMENT stomping on the rights of private enterprise to turn a profit.
 
2013-02-06 04:16:27 PM

Chinchillazilla: So you're off your meds, then?


Atleast someone got it.
 
2013-02-06 04:16:36 PM
Why are you doing this to me CVS? Am I using too many ExtraBucks Reward coupons?
 
2013-02-06 04:18:16 PM

ronaprhys: Lots of pharmacies compound. Many don't ship outside of their states due to differing state laws. Also, the 11 being shut down is bad. The 21 with minor violations aren't too concerning. Could be as simple as not having a sign hung where it should be or something of similar importance.


That has nothing to do with the thread of discussion you're responding to. Many of these pharmacies do compounding for other pharmacies in other states. If one of the gross pharmacies sends a bad batch of something to a pharmacy in another state, that other pharmacy certainly has a problem.

That's what started all this scrutiny in the first place.
 
2013-02-06 04:24:43 PM

Vegan Meat Popsicle: ronaprhys: Lots of pharmacies compound. Many don't ship outside of their states due to differing state laws. Also, the 11 being shut down is bad. The 21 with minor violations aren't too concerning. Could be as simple as not having a sign hung where it should be or something of similar importance.

That has nothing to do with the thread of discussion you're responding to. Many of these pharmacies do compounding for other pharmacies in other states. If one of the gross pharmacies sends a bad batch of something to a pharmacy in another state, that other pharmacy certainly has a problem.

That's what started all this scrutiny in the first place.


Yeah - just re-read your post and I did have an off response.

However, the shut down pharmacies need to be shut down.  I'm okay with that.  I work in the industry and have seen shady things occur, but the vast majority of folks I've dealt with (nationwide, mind you) are completely on the up and up.  Oddly enough, the shadiest pharmacy I ever saw was in Boston.
 
2013-02-06 05:16:52 PM
Come on.  They're not trying to kill you.  They're just trying to make obscene profits.  They could care less whether you actually live or die.
 
2013-02-06 05:29:54 PM

lilbjorn: Come on.  They're not trying to kill you.  They're just trying to make obscene profits.  They could care less whether you actually live or die.


http://grammar.quickanddirtytips.com/could-couldnt-care-less.aspx
To say you could care less means you have a bit of caring left.
 
2013-02-06 07:16:53 PM

lilbjorn: Come on.  They're not trying to kill you.  They're just trying to make obscene profits.  They could care less whether you actually live or die.

Really, you are just a means to an end and if your end is sooner than later, well there's always someone else . . .

but But but I thought corporations were people . . . Nice rosy cheeked little old ladies not GLIF's in torn stockings with a broken spike heel drunk on profit
 
2013-02-06 07:47:31 PM
You can read the 483's for these right off of the FDA website.  Some crazy awful shiat going on there.

Leaky boilers right next to your sterile processing?  Inch gap in your air barriers?  Basically no environmental monitoring whatsoever?  Holy shiatsnacks.

FDA don't fark around.  If they're up in your business, they're there for a reason.

/works for a pharma in remediation
//thank goodness we have the FDA.
 
2013-02-06 08:14:29 PM

Xaneidolon: I'm not saying that the pharmacies mentioned in the article didn't have problems.

I will, though, assert that there is a certain sector of the economy that would benefit from banning in-pharmacy compounding.

I'll also point out that I've noticed a fairly concentrated attack on compounding in the press over the past few months.

/just something to think about


You're right.

Compounding pharmacies are really just supposed to be making custom medications on a per-patient basis depending on individual needs. They realized they could make a lot of money producing some products in bulk and selling them to hospitals, and I'm sure the hospitals benefited from that as well. And I'm really not against this practice per se, I used to be in the industry and I once asked a compounding pharmacist if he could produce a particular medication for us in bulk, because there was a national shortage. That pharmacist told me he unfortunately could not, as that would be against regulation; he could only make it for a particular patient who has a prescription.

Maybe the regulations vary where some states can and some states cannot, maybe some do it even though they're not supposed to, or maybe it's legal everywhere and that pharmacists was just being cautious, I'm not sure. But when you start producing medication in bulk, you at that point go from being a pharmacist to becoming a manufacturer. And I wouldn't be surprised if being a pharmaceutical manufacturer has a whole different set of regulations and guidelines to be followed, that differ from just you're neighborhood compounding pharmacist.

I personally think that some of the pharmacies might not be adequately equipped to operate on such a large scale while still adhering to proper procedure. It's a really small business, sole proprietor, probably a really relaxed environment, where rules are looked at as optional guidelines.

Having said that, I agree with you, the pharmaceutical manufacturers no doubt view these compounding pharmacies as competitors. The compounding pharmacies are making their products that they have patents on, undercutting their prices and selling to their customers. The pharma companies will probably do everything they can to paint the pharmacies as incompetent.
 
2013-02-06 08:16:08 PM

justoneznot: I personally think that some of the pharmacies might not be adequately equipped to operate on such a large scale while still adhering to proper procedure. It's a really small business, sole proprietor, probably a really relaxed environment, where rules are looked at as optional guidelines.


From what I understand from my colleagues, they appear to have looked at compounding as a chemistry problem while completely ignoring the biological aspect.
 
2013-02-06 08:20:44 PM

Vegan Meat Popsicle: ronaprhys: Lots of pharmacies compound. Many don't ship outside of their states due to differing state laws. Also, the 11 being shut down is bad. The 21 with minor violations aren't too concerning. Could be as simple as not having a sign hung where it should be or something of similar importance.

That has nothing to do with the thread of discussion you're responding to. Many of these pharmacies do compounding for other pharmacies in other states. If one of the gross pharmacies sends a bad batch of something to a pharmacy in another state, that other pharmacy certainly has a problem.

That's what started all this scrutiny in the first place



The difference is- compounding is making something for a specific patient to a specific prescription.  What some of these places are doing is manufacturing- making batches of drugs to sell to 3rd parties, which resell them to someone else.  Nothing wrong with that, but it is a whole different kettle of fish, with different requirements ( like sterility batch testing). Some of these places are manufacturing while only holding a pharmacy compounding license.  I don't think anyone wants compounding stopped, but it should be done properly, and if you are manufacturing you need to be license and inspected based on that.
 
2013-02-06 08:36:43 PM
Related incident from 2011: Deaths of 9 Alabama Patients Tied to Intravenous Supplement created in the compounding pharmacy "Meds IV" in Alabama. Letter from the FDA to Meds IV.
 
2013-02-06 11:10:46 PM

Reverend Monkeypants: And we pay this industry so much why?


The actual pharmaceutical manufacturers themselves are one of the most tightly regulated industries in this country and for good reason. However, once their supply hits store shelves we've got something called "Human Factor" which in itself is a big industry problem. Compound drugs themselves are prescribed at such a customized basis that it's almost impossible to regulate and the FDA often has little control over such businesses. Even if an inspector goes in and finds violations they technically don't have the jurisdiction to shut them down like they could a whole factory. Sometimes, even depending on the state that they're operating in, the FDA can do little else than just mail them a sternly written letter saying "Hey! Knock it off! Or clean your counter space. Please?"

However I believe the problem in Massachusetts was a combination of the above scenarios plus the FDA, somewhat, waiting for a bomb like this to go off anyway because 1) sometimes it's just easier to throw your hands up and say "Hey, not our job!" and 2) some in the industry are hoping to crack down on these companies and bring them under the regulations of the rest of the industry.

Oh, and the f*cktards that infected all those people were also dealing in the illicit kinds of substances as well so they weren't exactly on the up and up anyway.
 
2013-02-07 01:30:26 AM
pot/kettle black


i heard a conservative say it i don't know what it means.  or what pot and black people have to do with each other
 
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