With no immediate resolution in sight, Baxter Healthcare is relying on help from competitor Fresenius Medical Care to meet a shortage of exchange fluid for new patients on peritoneal dialysis, while scrambling to meet the needs of existing patients. In a letter to health care professionals last week, Baxter indicated that resolving its problems with under capacity could take four to six months.
Meanwhile, in an Aug. 29 letter to the U.S. Food and Drug Administration, the North American Chapter of the International Society for Peritoneal Dialysis (ISPD-NAC), expressed their “strong concerns” that the ongoing shortage of PD fluid was limiting patients’ option to choose PD.
“To our great dismay, PD growth will effectively stop as a result of the PD solution shortage. As of today, Baxter (who provides dialysis supplies for about 90% of U.S. PD patients) instituted a process to temporarily limit the number of new peritoneal dialysis patient referrals across their entire base of customers, effectively stopping the gains we have made in providing home dialysis to more patients in this country,” wrote North American Chapter president Peter Blake, vice president Rajnish Mehrotra, MD, and three others on behalf of the chapter.
Baxter did institute a process to temporarily limit the number of new peritoneal dialysis patient referrals across their base of customers. "This process will be aimed at ensuring access to PD therapy on an equitable basis," the company told NN&I. The company said they recommend that health care professionals prioritize new PD patient starts based on medical necessity where other therapy options may be contraindicated.
Peritoneal dialysis (PD) is used by nearly 40,000 Americans and has seen steady growth as a modality option since the Centers for Medicare & Medicaid Services put financial incentives in place in 2011 to encourage more home dialysis. In letters to patients and professionals last month about the shortage, Baxter acknowledged that “changing PD prescribing patterns” was one of the causes of the supply constraints for PD fluids.
“ISPD-NAC believes that each and every single kidney failure patient in the United States deserves the right to have the best dialysis treatment for his individual case, whether it is at home or in-center. That decision must be made based upon patient choice and medical concerns, not upon supply inventories. Patients and doctors must have all dialysis options available; choice is vital in an era of both patient centered care and cost constraints. If manufacturers in the United States. cannot supply life-sustaining dialysis solution, it is not an option to deny PD to patients. The repercussions of making patients start in-center hemodialysis (instead of PD) with a hemodialysis catheter are significant and include an increased risk for life-threatening infections.”
Blake and the other ISPD-NAC members suggested the FDA allow the importation of PD fluid from other countries to make up the shortfall, “specifically via an accelerated process for evaluating and licensing well-established PD solution manufacturing plants that have capacity, but are outside the United States. We understand there may be plants in Western Europe capable of assisting in this challenging situation,” they wrote.
Quality control issues
The fluid shortage began with citations by the FDA about quality improvement problems at Baxter’s Marion, North Carolina and Puerto Rico manufacturing plants in June 2013. Baxter had been cited repeatedly about unsanitary conditions at the North Carolina plant and current Good Manufacturing Practices violations at the Puerto Rico plant.
The North Carolina facility manufactures IV solutions and peritoneal dialysis solutions, as well as containers and component parts for other Baxter facilities. The Puerto Rico plant manufactures large and small volume IV solutions, IV drug reconstitution systems and parenteral nutrition products.
Baxter also announced on Aug. 13 it was voluntarily initiating a recall in the US of two lots of its Dianeal Low Calcium (2.5mEq/L) PD solution with 2.5% Dextrose due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process.
With a focus on providing additional CAPD options to a greater number of new patients, Baxter said in an Aug. 28 letter to physicians that it had signed a short-term supply agreement with Fresenius Medical Care that will allow its Stay Safe PD solutions and related ancillaries to be distributed from selected Baxter warehouses, utilizing Baxter drivers and trucks to deliver to home patients.
"As a company with global resources, we are working diligently to explore alternatives to increase the supply of products available for the U.S. market and are working with the U.S. Food & Drug Administration," a Baxter spokesperson told NN&I. "Baxter remains committed to serving patients’ needs, and we are doing everything we can to address the situation." -by Mark Neumann
Download the ISPD-NAC letter.
Download the Baxter letter to patients.
Download the Baxter letter to health care professionals.