Baxter Healthcare Corporation is experiencing supply constraints for peritoneal dialysis solutions and is exploring alternative options to increase supply, according to a notification sent to Baxter customers this month.
"Several factors, including limited manufacturing capacity along with increased overall demand for sterile solutions and changing PD prescribing patterns, have resulted in the current supply constraints," a spokesperson from Baxter told NN&I.
The company said they are instituting a process to temporarily limit the number of new peritoneal dialysis patient referrals across their entire base of customers. "This process will be aimed at ensuring access to PD therapy on an equitable basis," the company's notice said.
According to the FDA's drug shortage database, this issue was first reported on Aug. 8, 2014. Baxter said they have been communicating with customers and patients regarding changes in delivery of PD solutions since May.
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. The company said they would review and update the specific allocation on a monthly basis as the supply situation improves.
Baxter told NN&I that they have taken the following actions:
- Continued to produce PD solutions at maximum capacity,
- Expedited the delivery of solutions to patients including using commercial carriers to allow for overnight delivery,
- Coordinated more frequent but partial shipments,
- Added drivers to their own delivery team to expand the reach.
Baxter said they are also in the process of adding a manufacturing line dedicated to PD solutions to expand capacity.
"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."
Baxter said that by Aug. 20, an account representative will provide health care providers who use the Baxter PD solutions with a detailed allocation report that will include specific allocation targets of new patient starts by month to the end of the year, according to the notice to customers.