60 minutes: New England Compounding Center

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Thirty sales reps for a compounding pharmacy? 😱 More than a few people are going to go to prison over this...

If the reports from the disguised sales rep are credible, what was news to me was how the hospitals who ordered this stuff seemed to know that NECC was manufacturing and not compounding. These hospitals' liability in this fiasco is significant- EACH lawsuit / settlements is going to run into the millions - if not tens of millions - of dollars. That money has to come from somewhere, and NECC has already declared bankruptcy...
 
I would be ok with no more pharmacy compounding and anyone wanting to compound be registered with the FDA as a manufacturer. It seems like everyday compounding is more and more the route of a sheister. Either NECC selling contaminated steroids or some upscale pharmacy selling bioidentical HRT to rich housewives
 
297point1 said:
Thirty sales reps for a compounding pharmacy? 😱 More than a few people are going to go to prison over this...

If the reports from the disguised sales rep are credible, what was news to me was how the hospitals who ordered this stuff seemed to know that NECC was manufacturing and not compounding. These hospitals' liability in this fiasco is significant- EACH lawsuit / settlements is going to run into the millions - if not tens of millions - of dollars. That money has to come from somewhere, and NECC has already declared bankruptcy...
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The compounding pharmacies I know of are little holes-in-the-wall with a pharmacist and maybe a couple of techs and that's it. I just couldn't imagine any of them having ONE sales rep, let alone 30.
 
npage148 said:
I would be ok with no more pharmacy compounding and anyone wanting to compound be registered with the FDA as a manufacturer. It seems like everyday compounding is more and more the route of a sheister. Either NECC selling contaminated steroids or some upscale pharmacy selling bioidentical HRT to rich housewives
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So in order for me to mix up some omeprazole suspension, I need a manufacturing license?

I could see it for sterile products, though.
 
npage148 said:
I would be ok with no more pharmacy compounding and anyone wanting to compound be registered with the FDA as a manufacturer. It seems like everyday compounding is more and more the route of a sheister. Either NECC selling contaminated steroids or some upscale pharmacy selling bioidentical HRT to rich housewives
Click to expand...
Problem with being a manufacturer is that you have to register all your products with the FDA. So you get an rx for metronidazole and hydrocortisone cream, only need to make 60g of it, but nope, you gotta register with the FDA and do stability studies on it first. Just like if Pfizer wanted to come out with a new product, you would have to do that too. Doesn't matter if it's a new chemical entity or not, like how Mylan, Teva, Actavis, et al have to register when they make any generic product.
 
Logistically there would be some sort compromise but the fact any pharmacist can sloppily throw together some HRT PLO gel or some preservative free intrathecial Fentanyl with near zero oversight is too laissez faire for my liking especially when the patient may not even be the person purchasing the drug or have an understanding of the process and the inharent problems associated with compounding
 
npage148 said:
Logistically there would be some sort compromise but the fact any pharmacist can sloppily throw together some HRT PLO gel or some preservative free intrathecial Fentanyl with near zero oversight is too laissez faire for my liking especially when the patient may not even be the person purchasing the drug or have an understanding of the process and the inharent problems associated with compounding
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Professor Reiman would be ashamed of you. I am ashamed of you. You are a UB grad? How much compounding did you do in lab? NECC broke every rule there was. Once you compromise patient care for profits, it is over. There was no sterile environment. NECC broke the rules, they will pay as they should, but it does not mean every one of us is corrupt. Im surprised at your disregard for independent pharmacy as you come from a university that embraced independents. I think Dennis Galluzzo, Karl and Al would all be surprised at your comments. But i would expect nothing less i guess.
 
The fact that necc could compound "sterile" products in such an environment and only get caught after they managed to kill a bunch of people highlights the blatant lack of oversight

I'm also not sure what my alma mater has anything to do with my opinion. I was taught to be an independent thinker able to formulate my own opinion and not to just parrot the thoughts of some faculty members. I got exposed to enough compounding to understand how easily it is to kill someone especially with the lack of oversight and the urge to maximize profits. One moment Espeically stuck with me, a Karl and Al approved speaker (owner of some compounding phamrmacy) told us point blank that the typically pharmacist shouldn't be compounding and it should be left to the experts like him. Aside from being a pompous jack wagon he had a point. We talk about the quality of grads from the new schools being poor, let's just allow them to make sterile products without any QC mandated
 
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npage148 said:
The fact that necc could compound "sterile" products in such an environment and only get caught after they managed to kill a bunch of people highlights the blatant lack of oversight

I'm also not sure what my alma mater has anything to do with my opinion. I was taught to be an independent thinker able to formulate my own opinion and not to just parrot the thoughts of some faculty members. I got exposed to enough compounding to understand how easily it is to kill someone especially with the lack of oversight and the urge to maximize profits
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You generalized all shysters i guess. You read about a few bad apples and all of all sudden most of us are shysters. With corrupt independents and greedy compounders we should all be shut down. My point of your alma mater is that im sure Al showed you enough compounding for you to understand what real compounding is. Al's classes weren't thoughts, they were published facts and teachings so we don't kill anyone. Obviously these compounders broke every rule in pharmaceutical compounding but doesnt make the rest of us shysters. Formulate your own opinion, but be careful in generalizing the rest of us.
 
npage148 said:
The fact that necc could compound "sterile" products in such an environment and only get caught after they managed to kill a bunch of people highlights the blatant lack of oversight

I'm also not sure what my alma mater has anything to do with my opinion. I was taught to be an independent thinker able to formulate my own opinion and not to just parrot the thoughts of some faculty members. I got exposed to enough compounding to understand how easily it is to kill someone especially with the lack of oversight and the urge to maximize profits. One moment Espeically stuck with me, a Karl and Al approved speaker (owner of some compounding phamrmacy) told us point blank that the typically pharmacist shouldn't be compounding and it should be left to the experts like him. Aside from being a pompous jack wagon he had a point. We talk about the quality of grads from the new schools being poor, let's just allow them to make sterile products without any QC mandated
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Sorry, but making a cream with hydrocortisone does not need an "expert". sterile compounding should be left to an experienced compounder, yes. I do not do sterile compounds. We hire an experienced compounder. And all4mydaughter is correct, most normal pharmacists do not sterile compound. making a pain cream in a PLO gel does not require an expert to make. You argument is all over the place. NECC broke the law, plain and simple. That does not make my pharmacy or the pompous jack wagon shysters.
 
There's plenty of "oversight" in sterile compounding.

Those people broke every guideline/rule/regulation/law possible.
 
iFarm said:
There's plenty of "oversight" in sterile compounding.

Those people broke every guideline/rule/regulation/law possible.
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Agreed. Their entire work environment was unsanitary with sterile hoods not having been cleaned for a long time, mold growing in the clean room, residues (biofilms?) on sterilization equipment, etc. They shut down their air conditioner nightly, which most likely contributed to fungal growth because the proper humidity and temperature could not be maintained. That's how bad it was when it came to violating regulations.
 
stoichiometrist said:
Agreed. Their entire work environment was unsanitary with sterile hoods not having been cleaned for a long time, mold growing in the clean room, residues (biofilms?) on sterilization equipment, etc. They shut down their air conditioner nightly, which most likely contributed to fungal growth because the proper humidity and temperature could not be maintained. That's how bad it was when it came to violating regulations.
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They broke the law and flouted regulations and best practices. They were negligent, and the Massachusetts Board of Pharmacy is at fault for not adequately enforcing the law and being vigilant with inspections. I do wonder if the various state BOPs are the right agency to be inspecting sterile compounding facilities. Most board inspectors aren't trained compounders and might not have the expertise to evaluate the safety of a specialized facility like one that is needed for sterile compounding.

This doesn't mean that compounding is bad overall. Most compounding is not sterile and can be done safely in any pharmacy. Most compounding is Mary's Magic Mouthwash, Magic Butt Cream, grinding up tablets to make suspensions of drugs that don't come in liquid form, and other simple stuff that we all learned in pharmacy school.
 
npage148 said:
Logistically there would be some sort compromise but the fact any pharmacist can sloppily throw together some HRT PLO gel or some preservative free intrathecial Fentanyl with near zero oversight is too laissez faire for my liking especially when the patient may not even be the person purchasing the drug or have an understanding of the process and the inharent problems associated with compounding
Click to expand...

As others have pointed out, there were laws & regulations in place....the broke them. More laws & regulations won't help, when the existing laws & regulations aren't enforced. Some blogs have hypothesized that it was the companies large campaign donations to certain politicians that kept the regulators from following up with them.....when they had already been cited for problems. Whatever the case, the fact is, they were an extremely unsterile compounding center, the FDA knew that & had cited them, but never once in 10 years bothered to follow up to see if anything had improved.
 
I'm pretty sure that I remember reading that one of the executive / managerial pharmacists from NECC's sister company Ameridose was on the MA BOP.
 
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