About That Year-Long “Critical” Saline Shortage

In addition to its previously discussed farcical seasonal adjustment that made a slumping unadjusted Employment index appear as if it was the highest in adjusted series history, which brought a smile to many faces, today’s Non-manufacturing PMI report had a far more curious datapoint that slipped largely under the radar: the ISM’s disclosure of the “commodities in short supply.”

Two of these were also quite comical.

One was labor, which would be a required condition to complete the spin of surging seasonally-adjusted labor conditions, however which would promptly dissolve into a puff of propaganda upon a quick glance at the other set of data, the one showing real hourly wages, and the fact that these have declined in 6 of the past 7 months (and since the data comes from the BLS using an incorrect estimation of inflation, the real wage situation is far more dire). So sadly, judging by the lack of rising wages, a labor shortage is the last thing the ISM’s goalseeked respondents have to worry about.

 

The second commodity in short supply makes far more sense: ammunition. Because one can only assume that for the second month in a row, all those 100+ million Americans that are out of the labor force or unemployed have to spend their time doing something. Shooting is as good a hobby as any.

But it was the third commodity that has been in short supply that caught our attention: a shortage that has lasted for 10 months now, or throughout all of 2014: medical IV solutions, aka saline.

A shortage of saline? And not just a shortage, but according to the FDA, a “critical shortage, which poses a serious threat to patients.” For some perspective on this quite peculiar shortage we go to the source: the US Food and Drug Administration, where we read in reverse chronological order.

[10/16/2014] In response to the ongoing shortage of 0.9% sodium chloride injection (normal saline), B. Braun Medical Inc. of Bethlehem, Pa., will temporarily distribute normal saline in the United States from its manufacturing facility in Germany. FDA is temporarily exercising its discretion regarding the distribution of B. Braun’s saline product from Germany, in addition to Baxter’s saline product from Spain and Fresenius Kabi’s saline product from Norway, to help address this critical shortage, which poses a serious threat to patients.

 

FDA inspected B. Braun’s facility in Melsungen, Germany where its normal saline product is made to ensure the facility currently meets FDA standards. FDA asks that health care professionals contact B. Braun directly to obtain the product. 

 

In addition to this source of normal saline as well as B.Braun’s normal saline that is manufactured in the U.S. , FDA will continue working with Baxter Healthcare Corp., Fresenius Kabi USA, LLC., and Hospira Inc. while they continue distributing their respective saline products and  seek to restore their supply of normal saline for U.S. hospitals and health clinics.

 

While the shipments described above continue to help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection.  Preventing drug shortages is a top priority for the FDA, and we are doing everything within our authority to alleviate this and other drug shortages.

 

[04/28/2014] In response to the ongoing shortage of 0.9% sodium chloride injection (normal saline), Baxter Healthcare Corp. of Deerfield, Ill., will temporarily distribute normal saline in the United States from its Spain manufacturing facility. FDA is temporarily exercising its discretion regarding the distribution of Baxter’s saline product from Spain and Fresenius Kabi’s saline product from Norway as needed to address this critical shortage, which poses a serious threat to patients.

 

FDA inspected Baxter’s Spain facility where its normal saline product is made to ensure the facility meets FDA standards. FDA asks that health care professionals contact the Baxter directly to obtain the product.

 

In addition to these sources of normal saline, U.S.-based manufacturers – Baxter Healthcare Corp. , B.Braun Medical Inc., and Hospira Inc., – are currently producing and releasing normal saline. Baxter’s saline product from Spain will be distributed temporarily in addition to Baxter’s FDA-approved version that is currently manufactured and distributed in the United States.

 

While the shipments described above will help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection. Preventing drug shortages is a top priority for the FDA, and we are doing everything within our authority to improve access and alleviate this shortage.

 

[03/28/2014] Due to the shortage of 0.9% sodium chloride injection (normal saline) Fresenius Kabi USA, LLC of Lake Zurich, Ill., will temporarily distribute normal saline in the United States from its Norway manufacturing facility. FDA is temporarily exercising enforcement discretion for the distribution of Fresenius Kabi USA’s normal saline product while it is needed to address this critical shortage that directly impacts patients.

 

FDA inspected Fresenius Kabi’s Norway facility where its normal saline product is made to ensure the facility meets FDA standards. FDA asks that health care professionals contact the Fresenius Kabi USA directly to obtain the product.

 

Hospitals and health clinics nationwide rely on normal saline to treat patients with hydration and other medical needs.

 

While these initial shipments will help, they will not resolve the shortage. However, FDA is working closely with manufacturers to meet the needs for normal saline across the U.S. in the coming weeks.

 

FDA will continue working with Baxter Healthcare Corp., B.Braun Medical Inc., and Hospira Inc. as they seek to restore their supply of normal saline for U.S. hospitals and health clinics. In addition, FDA is working with Fresenius Medical Care, which supplies normal saline to dialysis centers.

 

FDA remains committed to doing everything it can to address this shortage. While FDA cannot require a manufacturer to produce a product, the agency will continue to use all the tools at its disposal to mitigate this and other drug shortages.

And the very first FDA notice, together with the supposed reason for this saline shortage:

[01/17/2014] FDA is aware of the shortage situation for intravenous (IV) solutions, particularly 0.9% sodium chloride injection (i.e., saline) used to provide patients with the necessary fluids for hydration and other conditions. The shortage has been triggered by a range of factors including a reported increased demand by hospitals, potentially related to the flu season.

 

We are working with the three manufacturers of these products, Baxter Healthcare Corp., B.Braun Medical Inc., and Hospira Inc., to help preserve the supply of these necessary products. Addressing this shortage will depend on the increased demand and the manufacturing production of the current suppliers. Millions of these I.V. solutions are used each week by health care professionals.

Bottom line: a saline shortage that is “Potentially related to the flu season.” A shortage, which according to the ISM is now in its 10th month. That must have been some flu season.

Then again, counting back from October, the first month when there was a saline shortage was in January of this year (as confirmed here), when incidentally there wasn’t much if any major flu outbreak as most people were staying home and away from the infamous Polar Vortex.

Yet one key event did take place just around January of 2014. The WHO reminds us what:

On 26 December 2013, a 2-year-old boy in the remote Guinean village of Meliandou fell ill with a mysterious illness characterized by fever, black stools, and vomiting. He died 2 days later. Retrospective case-finding by WHO would later identify that child as West Africa’s first case of Ebola virus disease. The circumstances surrounding his illness were ominous.

Purely a coincidence, surely.

Then again, with flu season once again just around the corner, only this time with the added fear and threat of Ebola potentially on US soil, where the tiniest sneeze is likely to result in an ER visit, one can’t help but wonder: what happens if indeed there is a major flu outbreak this winter (or worse). Just as one can’t help but wonder: why and how can it be so difficult to restock on what is essentially plastic containers filled with water and 0.9% of salt thrown in?




via Zero Hedge http://ift.tt/1si26af Tyler Durden

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