A critical shortage of solution threatens to hold back unprecedented growth in peritoneal dialysis

The last 12 months have been quite dramatic for peritoneal dialysis (PD) and its advocates in the United States. In late 2013, the first reliable data on the effect of the new ‘bundled’ prospective payment system for end-stage renal disease on home therapies was published in Peritoneal Dialysis International. ¹ This published work confirmed the widespread impression that PD use had dramatically increased since the introduction of the dialysis payment bundle in 2011. Five of the 10 largest dialysis providers in the U.S. reported increases in PD patients, varying from 15–68% between 2009 and 2013. The two largest providers were up 31% and 27%, respectively.

It is now estimated that the prevalent PD population in the U.S. has jumped from 30,000 to 40,000 patients in less than four years. This has demonstrated that the leveling of the financial playing field brought about by the payment bundle has truly increased the opportunity for U.S. ESRD patients to choose PD.

Fluid shortage emerges

This past summer, the news about expanding PD has been less encouraging. Baxter Healthcare, by far the largest provider of PD solutions in the U.S., announced that its sole U.S. manufacturing plant in North Cove, North Carolina that makes the solutions for both CAPD and Cycler PD could not keep up with the unprecedented demand for product. As a result, the company said in August that it would have to ration available production by substantially limiting the number of new patients that it could provide with PD solution.

This has been upsetting for dialysis units that have invested money in building home dialysis training centers and hired personnel as part of plans to expand their PD programs; for physicians who want to promote the benefits of PD to new patients but can’t, and especially for advocates of PD who have waited years for wider acceptance of the home therapy. It is undoubtedly upsetting for those individuals with kidney disease who want to pick PD for their therapy and who will now at least temporarily lose this option.

How did this happen?

It is clear that Baxter did not correctly forecast or anticipate the need to build and bring on line new manufacturing capacity to meet the demands of PD solution as a result of the benefits to home therapy seen in the ESRD payment bundle.

It can be argued that while increased use of PD was predictable, the extent of it was not. A demand for 30% more PD solution between 2011 and 2014 translates into almost 10,000 new prevalent patients.

And there are other factors that may have led to the strained supply. A global market shortage last year of intravenous solutions left Baxter with less reserve capacity for PD solutions Adverse weather conditions at North Cove last winter and new quality requirements for sterile solutions have also impacted manufacturing capacity.

Notwithstanding all this, many physicians have been frustrated and critical of Baxter for not foreseeing this problem. There is a fear that the recent impressive momentum towards increased PD utilization may be partly lost.

What is being done to mitigate the problem?

Unfortunately, Fresenius Medical Care (Waltham, Mass. USA), the only other U.S. PD solution manufacturer, has little reserve supply on hand to help with the Baxter deficit. However, the companies have signed a short-term agreement that allows Baxter to distribute whatever reserve CAPD solutions Fresenius has, primarily to new patients.

Suppliers apparently do have manufacturing capacity in Europe and other parts of the world but the plants have not been approved by the Food and Drug Administration (FDA) to manufacture for the U.S. market.

With this in mind, ISPD NAC has asked the FDA to consider expediting the approval process for the sake of patients who will otherwise not be able to do PD and may have to face the risks associated with temporary hemodialysis access. The Renal Physicians Association and the National Renal Administrators Association has also taken this approach. The FDA has responded constructively but has pointed out that safety concerns require a full evaluation.

While patient safety is crucial, it is hoped that a positive outcome is imminent.

Meanwhile, a Kidney Community Emergency Response (KCER) team has been established and includes a wide variety of stakeholders, including key PD physician leaders, solution manufacturers, dialysis chains, ESRD Networks, the FDA, Medicare and government. ISPD–NAC has been in regular communication with both Baxter and Fresenius, with the aim of representing the point of view of potential PD patients as well as of PD physicians and providers. Baxter is also saying that substantially increased manufacturing capacity will be in place by the first quarter of 2015 and there is hope that the shortage will be over by March or April.

Can we make PD more efficient to reduce fluid needs?

The ISPD NAC has other suggestions.

This may be the time for clinics to more widely embrace the strategy of “incremental PD” to reduce fluid needs. This is the approach whereby PD patients receive a low dose prescription as long as they have sufficient residual renal function to enable them to achieve the widely accepted target Kt/V of 1.7 per week. Examples of such prescriptions would be CAPD with 3 dwells daily rather than the usual 4 or APD without a day dwell. It should be emphasized that these prescriptions are only appropriate if total Kt/V is measured regularly and kept above 1.7 weekly. See page 28 in this issue for more details on incremental PD.

Practitioners should consider this option. This crisis may also be an opportunity for manufacturers and PD programs to improve their management of individual patients’ solution inventories, as there is sometimes inappropriate ordering and consequent substantial wastage.

What about the future?

Even if the PD solution crisis is resolved by March or April of next year, there needs to be a plan to avoid repeat of such an event. It seems risky to have so little reserve capacity in PD solution manufacturing, especially with a growing market. Strategies need to be prepared in advance for potential sudden loss of manufacturing capacity in the future––or an increased in demand.

Could the PD community cope at all if either the sole Baxter or the sole Fresenius manufacturing plant in the U.S. were put out of action for a period of time by an unforeseen event? It seems unlikely given the recent experience, and this does not seem either appropriate or wise. It is hard to conceive of a similar shortage of hemodialyzers occurring, for example.

Perhaps, action could be taken to ensure that plants in adjacent countries such as the U.S., Canada and Mexico should have regular mutual approvals done by regulatory agencies from their countries so that the other two can provide back up in the event of a critical shortage in any one country.

Conclusions

Peritoneal dialysis as a modality option will recover from this setback and continue to grow in the U.S. ESRD patients will again have the opportunity to be treated with whichever dialysis modality they prefer. It is hoped however that lessons are learned from this crisis. The PD community needs to encourage providers to take precautions to ensure that this never happens again. -by G. Blake, MB; Thomas A. Golper, MD, FACP, FASN; Anjali B. Saxena, MD

References

1. Golper TA. The possible impact of the US prospective payment system (bundle) on the growth of peritoneal dialysis. Perit Dial Int 33:596-599, 2013)