ASPN Clinical Alert

Re: Supply of peritoneal dialysis solutions

Dear ASPN membership,

As many of you are aware, there have been recent supply issues with peritoneal dialysis solutions in the US that has impacted some of our patients and families. Baxter Healthcare Corporation has contacted U.S. regulatory authorities to communicate that they are experiencing an increasing number of peritoneal dialysis (PD) solutions backorders in the U.S. which is due to several factors including limited manufacturing capacity along with increased overall demand for sterile solutions and changing PD prescribing patterns. Baxter is working to expand its capacity but service levels may temporarily be impacted until the end of 2014.

Due to supply constraints, Baxter has put a temporary allocation process in place to help respond to the shortage. Specifically, they are now implementing a process to temporarily limit the number of new PD patient referrals until the end of the year, at which time plans are in place to further expand manufacturing capacity dedicated to PD solutions. The goal of this process is to allow current PD patients to continue to receive the PD solutions they need, while limiting new PD patient starts to only those instances where PD is medically necessary.

Baxter has established a list of medial exceptions wherein PD may be initiated. Importantly, pediatric patients under the age of 18 years have been included in the exceptions as a population that may continue with PD as their first modality of choice, when appropriate.

If you have reached your allocation target and have a new pediatric patient needing to start PD, providers need to complete a “Pediatric and Medical Necessity Form”. This form requires the signature and NPI of a physician. To request a form, please contact Baxter Home Care Services at 1-800-284-4060 and follow the prompts to set up a new patient. The completed form should be returned via email to renal_allocation_requests@baxter.com or fax at 1-800-763-9302.
Baxter has sent out letters to patients, doctors, facilities, and developed a FAQs document. All of these are linked below for your information.

If you have any questions or if are having any difficulty with supply access or patient PD initiation, we encourage you to contact your Baxter representative. Please also contact us at ASPN (by emailing Lisa Thompson lthompson@aspneph.com with “PD supply” in the subject line) to report any problems and unresolved issues so we can track the situation and try help to overcome any obstacles.

Letter to Customers
Letter to Doctors
Letter to Facilities
Letter to Patient Homes
FAQ’s