What do you all think of pharmaceutical quality?

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birchswing

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When I buy a bottle of water, it has a lot number on it. Say it tastes funny. I can call the company that makes it. Speak to someone in the US. They'll take down the lot number and do an investigation.

In 2015, there are no lot numbers on pharmacy prescription bottles.

I recently perceived a quality issue with Teva Seroquel. My pharmacy special orders Teva for me because, at least at the time, it was made in Canada or the US (I think they had a plant in each and said it could be either).

Teva is a huge corporation. I called them yesterday all day all long and only got a voicemail box. How can that be for such a large corporation? Finally got in touch with a man in India (not just based on his barely intelligible English--I asked if he was in Pennsylvania because I called a PA number, and he said he was in India). He took down all my information. I asked if the medication was still made in Canada or the US, and he said that production had moved to Czechoslovakia. I wasn't entirely sure of myself but I was pretty sure Czechoslovakia was no longer a country. I didn't want to say that, though, and appear misinformed.

Anyhow, they wanted to collect a sample of the product. I asked if there had been other complaints and he hinted that there had been without confirming it. I asked where it would be tested and he said it would be tested at the manufacturing site in Czechoslovakia.

Of course I was thinking to myself (before having confirmed that Czechoslovakia is in fact not a country): why would I want it tested at the site that is potentially putting out a crap product?

He told me that FedEx would come today with a mailing label. I asked if it was really being mailed to Czechoslovakia, and he assured me it was. I was pretty sure it wasn't a country, but I didn't want to make a fool of myself.

I hung up and immediately Googled Czechoslovakia and found out I was right--that it has not existed since 1993.

I tried calling them back to get a different representative (hopefully in the US) and got their voicemail again, so I sent an e-mail saying that I did not trust the information I was getting and wanted to know where it's actually made.

The next day (today), FedEx comes and is there for a pickup but was given no mailing label--they had no idea what to do with the bottle of pills. So, I call back and I finally get through to the same guy in India (is he the only person working for Teva's customer service?). He tells me that HE saw my e-mail (the one I sent to Teva's generic e-mail address) about him saying the medication was made in Czechoslovakia (he MUST be the only guy working for Teva customer service). He said that Czechoslovakia is now called the Czech Republic and that it was a name change--he made it sound as if I was confused (it's not just that the name changed--but I didn't get into that).

Anyhow, he went on to tell me that the medication cannot be tested because some of it is made in the Czech Republic and some is still made in the US and that because my pharmacy bottle does not include the Lot Number there is no way to know which manufacturing site produced it. He had already called my pharmacy which receives 100 tablets at a time and then throws them out and they have know way of knowing what lot number I received because they only have 1 100 count bottle on the shelf at a time, and that one is certainly not the one I would have received my pills from over a month ago.

The guy at TEVA almost sounded like he was blaming me for there not being a way to trace the product from the manufacturing site to the consumer, as if I had come up with this convoluted system.

How can the FDA ever do a recall if a pharmacy doesn't know what lot numbers they've distributed?

I just find it all so screwy. This is an Israeli company that had been making meds in the US and Canada, then claimed to have moved production to a country that hasn't existed since 1993, and says that they can't test their own tablets because they don't know where they made them, and all of their support is in India, even though it's a Pennsylvania phone number. I asked if I could speak to someone in Pennsylvania and was told that I couldn't.

If I bought a bottle of Dasani that tasted bad, I would call Coke and have zero of these issues. Guaran-damn-tee it. The pharmaceutical industry is uniquely commodities based. It would be like if end customers had a quality problem with their bacon and had to call the investment companies that buy and sell pork belly futures. It's not a system set up for consumers. It's a really screwy system. I've been affected by Class II recalls a couple of times that I was never informed of so I check the FDA enforcement page each month, and there are a LOT of recalls--and the FDA only has *plans* to itself start testing generic medications. So that means that the recalls to this point have been based on consumers getting a product, going through a byzantine system of filing a complaint, and then *trusting* these companies to follow through.

What about you all as practitioners? Do you trust pills coming from India or "Czechoslovakia"? If you do, you should look into the history of Ranbaxy.

I just don't get why the public doesn't demand something better. People want not just made in the US for their food--they want organic, locally grown. But when it comes to prescriptions they'll put up with companies that don't even have consumer-facing web-sites. Every drug company web-site you go to has a ticker tape of the stock price and says, "We just bought Company X. Our new name is Excelsior. Profits up 50%." It's some sort of weird commodities market. And the FDA literally has not been checking any of these pills. The FDA does some plant inspections and checks quality reports that the companies themselves make--but there is no independent verification.

Honestly, I wish Coke would get into the generic drug business. They have local bottlers all over the US. Every product has a bar code on it. Am I crazy or is that a great idea for some company to take on? The missing ingredient is consumer demand for US made generics with bar codes, but good advertising can create that demand.

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