For Want of a Nail?

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This problem has been coming and going for a while. For want of a small item, hospitals and clinics are brought to their knees.

This two pound item, costing about $ 1.50, forms the underpinning of many patient treatments. From antibiotic administration to cardiac care, from chemotherapy to painkillers, some 300 to 400 different drugs can’t be administered without it.

What is it? Intravenous saline bags. The US gets its supply from one of three entities- B. Braun Medical, Baxter International, and/or ICU Medical. And, therein lies the problem.

Braun seems to have been producing its saline bags with an unwanted component.  Mold. As if that were not bad enough, some of the bags have been leaking. (It’s not necessarily the loss of saline that is the problem- any leak means microbial contamination is a concern, since microbes have a patent path into the bags via the leaky area.  Hence, the appearance of mold. )  Braun has notified customers that they should seek alternatives due to “unplanned production interruptions” at its IV bag facilities. Perhaps that was also related to the FDA warning letter about “repeat violations” at the Irvine (CA) facility.

Baxter produces its saline bags in Puerto Rico. And, since Hurricanes Irma, Jose, and then Maria have devastated the island (and the US government has been stingy- at best- in providing help), the world’s longest and most wide-ranging blackout has prevented Baxter from maintaining full production at the plant. (Right now, it’s relying on generators to supply power to some of its production lines at the facility. It hopes to have full power in a month or two.)

(An aside: 10% of all pharmaceuticals consumed in the US emanate from Puerto Rico. It’s not just Baxter that is stumbling in the dark; there are about 80 such firms in Puerto Rico. This is why there are shortages for about 175 drugs right now.)

And, ICU Medical is the smaller company.  It actually was part of  Hospira Infusion (a unit of the drug behemoth Pfizer).   ICU has been “content” to be a third supplier of the critical component, and it’s not able to pick up production to make up for the lack of products from the other two, much larger competitors.

As if this were not a calamity in and of itself, the US Department of Justice has cause to believe that these manufacturers are guilty of price fixing and collusion. Which is why there is a criminal investigation revolving about said issues. (In 2015, the US Senate had the industry in its cross-hairs and asked the FTC [Federal Trade Commission] to investigate.)

The real problem is the price of the product. At the $ 1.50 price point, there’s not much profit in the drug. So, even with widespread use, there is not a boatload of bucks available to support new factories, update production, or develop a new method of production.

(Just so you know, the price of dialysate is in the same ball-park, so the chance for new production facilities or systems are just as compressed.)

Roy A. Ackerman, Ph.D., E.A.

 

 

Tick-Tock! Adding Medicare Advantage and/or Medicare Part D (for those over 65)will not be possible next week (7 December is the deadline) . And, if you need health coverage,  PPACA (Obamacare) choices expire in two weeks  (15 December).

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