The Alabama Department of Public Health said it first learned of the problem on March 16, when two hospitals in the state notified officials of patients with bloodstream infections.This event will no doubt raise questions about quality control at compounding pharmacies. Unlike most pharmacies, compounding pharmacies make most of the solutions they dispense themselves. This provides a value for patients that require custom made ointments, oral solutions, and IVs. But it does make it more difficult to ensure the dosage and quality. Instead of mass producing thousands of the same pill on a daily basis as a pharmaceutical manufacturer might do which could be more easily monitored and controlled, compounding pharmacies produce their medications only when a particular patient has a need for it. They're made to order. So one minute a pharmacist is making an oral solution, the next minute the same pharmacist could be producing a completely different inhalant powder.
The cases of bacteremia were caused by Serratia marcescens, a germ that produces bright bright red colonies. The bacterium was identified and named in Italy in the early 1800s, after it was found to be turning polenta blood-red.
We tried visiting the website of "Meds IV" but it appears they've recently taken the site down in light of the allegations. We were able to view a cached version before it was removed (click on image to view full size):
Their most important asset is their reputation...well, I guess that's all gone to shit. If customer satisfaction is guaranteed, what does that mean if they kill you? Do they bring you back to life?
We're trying to find more information about Meds IV, they don't appear to be that well known with much of a presence. They don't even list an address on their website and a search for their phone number 205-837-0899 turns up nothing.
We have found the president of Meds IV, Tim Rogers.
click on image to view full size.
There is next to nothing to be found about Meds IV, besides the latest articles. We're guessing this was a very small operation that was fairly new with not a lot of customers. Perhaps he offered the hospitals a steep discount to get his foot in the door. It could be that there are some legal issues with compounding pharmacies selling to hospitals. It is standard practice for a compounding pharmacy to make medications for a particular patient. But when they start producing it in bulk to resell to hospitals and aren't seeing any patients at all, that could be a problem. Instead of being a pharmacy they're getting into manufacturer territory and need to be treated and regulated as such.
Update 2: Was the Parenteral Nutrition I.V. a hard to find item (HTF)?
If you look at the list of products that were displayed on Meds IV's website, you may or may not notice that many of them are items that are in short supply. Heparin and Promethazine for example have had supply issues for quite some time now. It appears that indeed there were supply issues with the parenteral nutrition I.V., from nutritioncare.org:
Compounding & The Hard-To-Find Market
Parenteral Nutrition Product Shortages
There is a growing and critical shortage of electrolyte and mineral injections needed for parenteral nutrition. We have heard from many consumer groups, healthcare systems, and clinicians regarding their short supplies or inability to obtain these products. The seriousness of this shortage has the potential to be similar to that of intravenous (IV) multivitamins, which resulted in significant complications and some deaths.
People Liking People actually have a little experience in the little known hard to find market of hospital pharmaceuticals/I.V.s. Different medications go in short supply all the time. There's only so much supply to go around, and sometimes there's not enough to meet the demand, whether it's a raw material shortage, a legal issue, or manufacturing problem. Well some medications are absolutely vital and when you have a patient dying on a hospital bed, the hospital will try to do whatever they can to find the medication that they need. And they're also willing to pay a lot more for that medication. This sets the stage for the hard to find market.
The hard to find market consists of many distributors that make their money off these shortage problems. They get wind that a product is going to go short, so they stock up as many as they can at the low price from a variety of suppliers and manufacturers. They may either flip them to another distributor for a quick profit, or wait for the market price to quadruple and sell them to hospitals for much higher. It doesn't always go as planned, so there's a lot of guessing and risk/reward calculating going on.
Well for some medications there simply isn't any product left, even the hard to find distributors don't have any. Hospital pharmacists are calling all the suppliers they can think of and no one is able to get their hands on it. This sets the stage for the compounding pharmacy to enter the hard to find market. When the hospitals have run out, their primary wholesaler has run out, the manufacturer isn't able to produce much more, and the hard to find distributors can't get their hands on any, the compounding pharmacist is the only other option in creating availability, and they then take advantage of this situation and sell their compounded product at ridiculously high profit margins. Something that might cost $4 to make could be sold for $1,000.
It appears to us now that this isn't just your average compounding pharmacy that's just helping out and serving hospitals from time to time. It may be that their whole business revolves around these shortages. Not that that's necessarily an evil business model, but like I said before when you start compounding on a massive scale you go from compounder to manufacturer. And I'm willing to bet that Tim Rogers and whoever else ran Meds IV just wasn't up to the task. Every week they're probably making something new that the week before hadn't even heard of. It's short? Ok let's make it. They don't specialize in a group of particular meds, they switch between what's selling and what's not at the blink of an eye. So if that's truly the model it's no wonder that their quality control wasn't exactly up to par.