Shortage of in-home dialysis solution has patients worried

[okarol]

Shortage of in-home dialysis solution has patients worried
Patients face a shortage of home dialysis solution

Giraldo Garcia left, is helped by technician Leodegario Ventura at DaVita Dialysis Center in Inglewood. Patients like Garcia who are treated at dialysis centers are not affected by a shortage of home dialysis solution. (Irfan Khan / Los Angeles Times)

By STUART PFEIFER, CHAD TERHUNE contact the reporters BusinessDrug ResearchMedical ResearchFood and Drug AdministrationMedicare

Higher demand for in-home peritoneal dialysis leads to rationing of solution
Baxter says a shortage of its in-home peritoneal dialysis solution could last until early next year

Unlike the hundreds of thousands of Americans who drive several times a week to a dialysis center, Joanna Galeas relies on an increasingly popular at-home alternative to treat her kidney failure.

Galeas, a 30-year-old Los Angeles resident, is among tens of thousands of U.S. residents who use peritoneal dialysis at home. She fills her abdomen with a sterile solution that helps remove toxins from her blood, a function ordinarily performed by healthy kidneys.

Now, Baxter International Inc., the nation's leading supplier of the home dialysis solution, says it can't keep up with demand and has started rationing the product, directing physicians to limit the number of new patients to whom they prescribe the treatment and reducing the size of shipments sent to existing customers.

We definitely consider this a critical situation. The FDA is doing everything we can to address the problem.
- Valerie Jensen, associate director of the Food and Drug Administration's drug shortage program

Last week, Galeas' shipment of the lifesaving solution didn't arrive, she said. When she was down to her final dose, Baxter made an emergency shipment to her home.

"I was freaking out all weekend until Monday when it arrived," she said.

Baxter, based in Deerfield, Ill., blamed the shortage on an unexpected increase in demand, which it said has outpaced its ability to produce the solution. The company said that the number of U.S. patients using dialysis solution increased 15% in the second quarter compared with a year earlier and that demand for the product "has never been stronger."

The shortage comes as a record number of people in the United States rely on dialysis because their kidneys failed; the U.S. dialysis population has more than doubled since 1995 to more than 400,000.

The number of patients opting to treat themselves at home with peritoneal dialysis jumped 24% from 2008 to 2011, according to the U.S. Renal Data System.

The treatment is not only more convenient for patients but also less expensive for Medicare, which typically pays for it. Medicare spent an average of $87,945 on each dialysis center patient in 2011, compared with $71,630 for those who treated themselves at home with peritoneal dialysis, data show.

This is the latest in a string of drug shortages that have forced many hospitals, doctors and patients to scramble for drugs and crucial supplies, such as saline solution. The shortages are often caused by manufacturers experiencing product quality problems, with a lack of other companies to pick up the slack, according to a report this year by the U.S. Government Accountability Office.

Baxter said the dialysis solution shortage could last until early next year.

 Patients face a shortage of home dialysis solution
Joanna Galeas is among tens of thousands of U.S. residents who use peritoneal dialysis at home. (Luis Sinco, Los Angeles Times)

"We definitely consider this a critical situation," said Valerie Jensen, associate director of the Food and Drug Administration's drug shortage program. "The FDA is doing everything we can to address the problem."

Without access to the dialysis solution, people with kidney disease can use the more traditional hemodialysis treatment, which is most often administered at outpatient clinics. In that treatment, a dialysis machine filters toxins from a patient's blood.

Many patients prefer the convenience of peritoneal dialysis because it can be done at home or in the workplace and on their schedule, said Lori Hartwell, founder of Renal Support Network, a nonprofit that advocates for people with chronic kidney disease.

Jerry Adams, a 75-year-old retiree from Springfield, Ohio, lost a kidney during a childhood bout with scarlet fever. The health of his remaining kidney has been declining because of high blood pressure. After much research, he opted for the at-home therapy, only to be declined in August because of the Baxter shortage.

"I'm down in the dumps," Adams said. "I just think about it a lot."

Adams said he's not comfortable visiting a clinic because he lives far from the city and would not want to drive after receiving the dialysis treatment.

"I don't know how it affects you as far as your energy, and my wife doesn't drive too good anymore," he said.

Baxter intends to open a new manufacturing line in early 2015, which the company says will increase its production capabilities and "enable supply to return to a more predictable state." In the meantime, Baxter has reached an agreement with the country's only other manufacturer of the dialysis solution, Fresenius, to provide solution to Baxter clients.

The FDA is also reaching out to foreign suppliers in an effort to temporarily import the dialysis solution, the FDA's Jensen said.

Tim Logan, Stuart Pfeifer

"We have taken multiple steps to ensure uninterrupted care for existing patients," Baxter spokeswoman Christy Noland said in a statement. "The guidance to customers is to ensure current patients have uninterrupted access to therapy and that new patients should be started based on medical need."

At the same time Baxter was struggling to keep up with increasing orders, the company announced Aug. 13 that it was voluntarily recalling two lots of the solution because they contained stainless steel, garment fiber and PVC particulate matter.

The company said the number of recalled units represented less than 1% of its annual global production and was not a contributing factor to the shortage. But Jensen said the recall "definitely worsened the situation."

Nearly 400,000 people in the U.S. received hemodialysis at clinics in 2011, and about 30,000 people treated themselves at home with peritoneal dialysis, according to the U.S. Renal Data System.

Hartwell, who runs the patient support group, said she's surprised that the modest increase has created supply problems for Baxter.

"Maybe they just had poor planning and underestimated it," she said. "Whatever it is, it's unfortunate."

Galeas was growing concerned even before her shipment failed to arrive last week.

Shipments to her home were smaller, meaning her safety net was thinner. And the shipments were sometimes dropped off by commercial carriers, who did not bring them inside her home, the way Baxter's delivery team does.

The shortage has been unnerving for Galeas because she cannot live without the treatments.

"This puts an extra level of stress in my life."

stuart.pfeifer@latimes.com

Twitter: @spfeifer22

chad.terhune@latimes.com

Twitter: @chadterhune

http://www.latimes.com/business/la-fi-dialysis-shortage-20140913-story.html

[slipkid]

What an utter jerk this Lori Hartwell is.  The inadequate supply of Baxter dialyisate is merely unfortunate?  When does it become serious?  After 10 patients die, 50, 100, 1000?
She claims to be a patient advocate.  I wonder if her web site, organization, and income are from bottom feeding on the misery of nearly 300,000 CKD patients.

[Rerun]

Oh boy.... 

                 

[Charlie B53]

I was sure that there have been other threads on PD Fluid shortages.  Maybe I just don't know how to use the 'Search' function very well.

Today's Baxter delivery had NO Ico, all 5 cases are back-ordered.  Last year sometime this happened, UPS delivered them next to my garage door THEN rang the bell.  Truck was half a block away before I could open the door.   I'm such a weakling any more, I only got those boxes IN TO the garage, and I was pooped.  Called Son.  He came over and carried them in the house for me.   He can be a good kid, sometimes.


I have three bags left, maybe I should call Baxter tomorrow just to stir them up.   Should I admit to the two cases of manual bags I have stashed?

After letting them sweat for a couple of minutes, I will.  I would hate to get some and someone else NOT get any.  I can get by using the manuals, they work fine on the Cycler.  Just clamp off the un-used drain bag.  No problem.

[kickingandscreaming]

Besides being a life-threatening emergency to many people, this is just such a total embarrassment in a capitalist mecca such as the U.S..  This is just basic business and is inexcusable for a "giant" in the medical supply field to fail so miserably in the basics of production.  How hard can it be to make bags of solution? They don't have to invent the wheel.  It's already been invented.  They just needed to manage their production and they failed miserably.

I have been doing manual PD since January and have been waiting patiently for my " allocation" of a  PD cycler-- a rare commodity these days for new PD people due to the continued shortage of fluids for the cycler.  That this whole nightmare started 2 years ago!!!! and still continues to this day is totally unbelievable.  I am finally in line to get a cycler by the end of this month.  But I must say I have some trepidation because of this continuing shortage situation. Shocking.

[Charlie B53]

I thought it was about this time LAST year that Baxter had a problem at one of their pllants in the U.S. with sterilization of product.  And these shortages began.  By mid to late Summer Baxter had sent letters to most PD users advising us of Baxter importing product from across the Atlantic and included pictures of the differences in markings of the product so we would not be alarmed and thinking we had the wrong product to use.

I had a number of 'short' deliveries that were usually delivered anywhere from a day to a week late.  I was never in any real danger of running out, but have been down as low as only a few days supply.

I was under the impression that the U.S. plant had been corrected and back into full production, that all those shortages were no more.

I am finding out differently.   Who really knows what is going on?   Baxter is not keeping me informed.

I find it hard to believe that the number of people starting PD is greater than the production of Cycler units.   The same with Cycler bags.   Manual bags work just fine on the Cycler.  It is just a waste of the drain bag.   Either hang the drain bag with the full bag, or clamp it off unused.  Either will flow just fine.   I have used up several cases of manual of all solutions rather than let them expiration date pass and have to throw them away.   I don't know the cost, but whatever it is I would just hate to waste any solution if I didn't absolutely have to.