December 16, 1998: Bruce Mueller and Meri Kay Scott, Purdue University

Response to AHRQ on CERTs

Responses received to a call for ideas and study topics for implementation of AHRQ's new demonstration program for grants to establish Centers for Education and Research on Therapeutics (CERTs).

This letter is in response to the AHPCR request for potential topics for the 1999 Centers for Education on Therapeutics (CERTs) Program. A therapeutic area that "falls through the cracks" in terms of governmental research and oversight is the area of new technology for the treatment of patients receiving dialysis. Dialysis technology has changed dramatically over past ten years. New hemodialyzers have been developed that remove substances differently than earlier dialyzers. Hemodialyzers are now "re-used" in a cost saving effort. New peritoneal dialysis techniques and machines now provide clearances unheard of in the 1980s. New machines are being developed for the use in the home to do nightly home hemodialysis with new dialysate generators. However, the practice of dialysis nephrology has not kept pace with these advances. Drug dosing, nutritional considerations, patient outcomes, including quality of life are affected by these changes, but little has been published as to how these technology advances influence patient welfare.

The ~300.000 dialysis patients affected by these advances consumed $14.55 Billion in 1996. Minorities, elderly and the poor are overrepresented in this number (36 percent African American, 33 percent >65 years old, 93.5 percent paid by Medicare). These numbers are rapidly growing as diabetes mellitus and hypertension are the primary causes of end stage renal disease. (USRDS 1996 data) Despite all the advances in dialysis technology used in the United States, our dialysis patient mortality is among the highest in the world. (CANUSA, USRDS)

A specific example of how dialysis technology has changed at a faster rate than our practice is the area of hemodialyzer reuse. In a cost saving effort, ~76 percent of all American dialysis centers (encompassing 82 percent of all Americans receiving hemodialysis) reuse hemodialyzers in the same patient over and over again. It is estimated that as much as $500 million can be saved annually by dialyzer reuse. Despite its prevalence, the dialyzer reuse process is not officially recognized by the Food and Drug Administration (FDA). All hemodialyzers marketed in the US specifically state that they are for "single use only." Consequently, dialyzer manufacturers are not mandated to investigate the effects of reuse on the performance of their dialyzers.

Many types of reuse are in place nationally including the use of steam and/or chemicals such as household bleach, formaldehyde, hydrogen peroxide, and glutaraldehyde. All of these reuse processes change the performance of the dialyzer membrane, as they were only designed to be used once. This results in alterations in how efficiently dialyzers can clear waste products from the blood. Preliminary reports have documented increased patient mortality with certain reuse processes. Additionally, nutritional studies have indicated that bleach-based reprocessed dialyzers (currently 40 percent of the reuse market) changes the pores in hemodialyzers such that vital serum proteins are removed from the patient during hemodialysis. Peracetic acid-based reprocessing methods may "plug" the hemodialyzer pores such that biologic waste products normally removed during the first use of a dialyzer are no longer cleared. Obviously, when hemodialyzer membranes are fundamentally altered via steam or chemicals, the dialectic removal of drugs also is changed. Currently no new drug dosing guidelines have been proposed to account for all of the possible membrane changes that occur with reuse. Because of all of the questions inherent in dialyzer reuse, most countries have banned this practice.

Using the above illustration of dialyzer reuse issue as an example, it is clear that 'dialysis technology advances' as a topic would be an excellent candidate for the CERTs program. The essential elements called for in the CERTs request for topics include the following:

1A. Increase awareness of; improve effective use of; and increase awareness of the risks of new uses of drugs and devices. Nephrology practitioners are aware of most of the technology advances, but not of the implications of their use on overall therapy (including drug therapy, nutrition, solute clearance alteration effect on patient welfare, etc.)

1B. Provide clinical information to health care practitioners, PBS, managed care organizations, insurers, governmental agencies, and consumers (patients). The dialysis technology changes have changed the nutritional and pharmacotherapy needs of patients, but these have not been investigated and consequently are unknown to physicians, pharmacists, dietitians, and nurses. Dialysis patients consent to receive these therapies, but are unaware that they may be receiving sub-optimal care.

1C. Improve quality of health care while reducing costs by the appropriate use of drugs and devices and the prevention of adverse effects and their consequences. Dialyzer reuse, new peritoneal dialysis technologies, etc. all have the potential to influence costs and patient morbidity and mortality. For example, if the optimal reuse regimen could be identified, millions of dollars would be saved directly by Medicare, and if done correctly, without incurring the additional costs of adverse patient outcomes.

2. Conduct research on comparative effectiveness and safety. All the existing reuse procedures need to be tested on the dozens of hemodialyzers approved for use in this country to determine which are safe and which are hazardous. Similarly, new hemodialysis and peritoneal dialysis techniques fundamentally alter waste product, drug, and serum protein clearances. How this effects patient outcome and quality of life is largely unknown.

Thank you for considering this topic for the CERTs program.

Bruce A. Mueller, Pharm.D., FCCP
Associate Professor of Clinical Pharmacy

Meri Kay Scott, Ph.D.
Assistant Professor of Pharmacy Practice

Purdue University
School of Pharmacy and Pharmacal Sciences
Department Of Pharmacy Practice

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Current as of October 2012
Internet Citation: December 16, 1998: Bruce Mueller and Meri Kay Scott, Purdue University: Response to AHRQ on CERTs. October 2012. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/policy/foia/certs/cert26.html