'Incredible, Depressing' Shortage of Peritoneal Dialysate
'Incredible, Depressing' Shortage of Peritoneal Dialysate
Hello. This is Jeffrey Berns, editor-in-chief of Medscape Nephrology.
I've heard from some of my colleagues recently and from others around the country about the difficulty they have had in getting some of their patients started on peritoneal dialysis (PD) because of the ongoing shortage of peritoneal dialysate. This was a problem that started about a year ago, when Baxter was unable to meet the production demands for dialysate to meet the needs of patients throughout the country.
So, there's been a shortage over the past year, despite the fact that Fresenius Medical Care (FMC) has apparently made an arrangement with Baxter, and Baxter has been able to work out an arrangement with the US Food and Drug Administration (FDA) to import some PD solution. There is still an ongoing shortage, which has limited the number and type of patients that can get started on PD.
Dialysis providers have gotten into the pharmaceutical business... Perhaps they need to get more involved in the supply of peritoneal dialysis solution.
I find this absolutely incredible and depressing. I recently saw some statistics about the number of new starts for PD. If we compare the year ending in May 2014 with the year ending in May 2015, there was a 68% reduction in the number of new starts for PD among the 10 largest dialysis providers in the United States.
Overall, about 10% of dialysis patients around the country are on PD. This varies tremendously from one provider to another. Whereas many providers have around 10% of their patients on PD, there are some with as many as 20% of their total dialysis population on PD, and for others, none of their patients are on PD.
Again, this issue about PD solution dates back to about 1 year ago. I am finding it hard to understand how this hasn't been fixed, and why production capacity hasn't increased over the past year to meet the needs of our patients. The dialysis providers have gotten into the pharmaceutical business, with phosphate binders and iron preparations; perhaps they need to get more involved in the production, sale, and supply of PD solution.
I went on a Baxter website, and they make it sound like everything's being fixed. They talk about "we are putting our patients first," that they are "managing inventory to make peritoneal dialysis solution available," with "all hands on deck to improve this situation." Unfortunately, as far as I can tell, this was all put out about a year ago, because they talk about having a more predictable supply of PD solution by early 2015—which clearly hasn't happened.
I trained as a fellow with a large PD population. I have been very supportive of home dialysis, and in particular PD, ever since I was a fellow. I encourage many of my patients to start PD, and I am very frustrated that we are still at a point where patients cannot be started on the dialysis modality of choice because of a failure to meet the manufacturing expectations for PD solution.
I think it's time that the PD solution manufacturers think about ways of stepping up their activity in this area. Baxter needs to make the efforts and commit resources to meeting the demands of our patients.
If necessary, I think the government needs to step in and ensure that the patients for whom they are paying for the cost of dialysis are getting the modality they want and are not being forced to do in-center hemodialysis three times a week simply because there is not enough PD solution available.
Thank you for listening. This is Jeffrey Berns, editor-in-chief of Medscape Nephrology, from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
Hello. This is Jeffrey Berns, editor-in-chief of Medscape Nephrology.
I've heard from some of my colleagues recently and from others around the country about the difficulty they have had in getting some of their patients started on peritoneal dialysis (PD) because of the ongoing shortage of peritoneal dialysate. This was a problem that started about a year ago, when Baxter was unable to meet the production demands for dialysate to meet the needs of patients throughout the country.
So, there's been a shortage over the past year, despite the fact that Fresenius Medical Care (FMC) has apparently made an arrangement with Baxter, and Baxter has been able to work out an arrangement with the US Food and Drug Administration (FDA) to import some PD solution. There is still an ongoing shortage, which has limited the number and type of patients that can get started on PD.
Dialysis providers have gotten into the pharmaceutical business... Perhaps they need to get more involved in the supply of peritoneal dialysis solution.
I find this absolutely incredible and depressing. I recently saw some statistics about the number of new starts for PD. If we compare the year ending in May 2014 with the year ending in May 2015, there was a 68% reduction in the number of new starts for PD among the 10 largest dialysis providers in the United States.
Overall, about 10% of dialysis patients around the country are on PD. This varies tremendously from one provider to another. Whereas many providers have around 10% of their patients on PD, there are some with as many as 20% of their total dialysis population on PD, and for others, none of their patients are on PD.
Again, this issue about PD solution dates back to about 1 year ago. I am finding it hard to understand how this hasn't been fixed, and why production capacity hasn't increased over the past year to meet the needs of our patients. The dialysis providers have gotten into the pharmaceutical business, with phosphate binders and iron preparations; perhaps they need to get more involved in the production, sale, and supply of PD solution.
I went on a Baxter website, and they make it sound like everything's being fixed. They talk about "we are putting our patients first," that they are "managing inventory to make peritoneal dialysis solution available," with "all hands on deck to improve this situation." Unfortunately, as far as I can tell, this was all put out about a year ago, because they talk about having a more predictable supply of PD solution by early 2015—which clearly hasn't happened.
I trained as a fellow with a large PD population. I have been very supportive of home dialysis, and in particular PD, ever since I was a fellow. I encourage many of my patients to start PD, and I am very frustrated that we are still at a point where patients cannot be started on the dialysis modality of choice because of a failure to meet the manufacturing expectations for PD solution.
I think it's time that the PD solution manufacturers think about ways of stepping up their activity in this area. Baxter needs to make the efforts and commit resources to meeting the demands of our patients.
If necessary, I think the government needs to step in and ensure that the patients for whom they are paying for the cost of dialysis are getting the modality they want and are not being forced to do in-center hemodialysis three times a week simply because there is not enough PD solution available.
Thank you for listening. This is Jeffrey Berns, editor-in-chief of Medscape Nephrology, from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
Source...