Expert Panel Recommendations Chronic Kidney Failure and Commercial Motor Vehicle Driver Safety Medical Expert Panel Members Stephen Fadem, MD Lynda Szczech, MD Mark Unruh, MD Presented to The Federal Motor Carrier Safety Administration March 14, 2008 Table of Contents Introduction ..................................................................................................................................... 1 Scope of Recommendations Document .......................................................................................... 1 Definition and Staging of Chronic Kidney Disease ........................................................................ 1 Composition of Medical Expert Panel ............................................................................................ 2 Methodology ................................................................................................................................... 3 Brief Overview of Evidence Report Methodology ..................................................................... 3 The Medical Expert Panel Meeting and Recommendation Formulation .................................... 3 Medical Expert Panel Commentary on Findings of Evidence Report ............................................ 3 Recommendations to the FMCSA from the Medical Expert Panel ................................................ 4 Recommendation 1: Identification of Individuals with Chronic Kidney Disease ...................... 4 Recommendation 2: Certification of Individuals with Stage 1, 2, or 3 CKD ............................. 7 Recommendation 3: Certification of Individuals with Stage 4 CKD .......................................... 8 Recommendation 4: Certification of Individuals with Stage 5 CKD .......................................... 9 Recommendation 5: Specific Guidance—Individuals with Renal Transplants ........................ 10 Recommendation 6: Recommendations for Further Research ................................................ 11 APPENDIX A: Findings of Evidence Report ............................................................................... 12 APPENDIX B: Current Standards and Guidelines for Renal Disease ......................................... 17 i Introduction The primary mission of the U.S. Department of Transportation’s (DOT’s) Federal Motor Carrier Safety Administration (FMCSA) is to reduce crashes, injuries and fatalities involving commercial motor vehicles, or CMV’s, (including large trucks and buses) in the United States of America. One mechanism by which the FMCSA aims to meet this commitment is to ensure that individuals who drive commercial motor vehicle are physically qualified to do so. While physical qualification standards do exist and all commercial motor vehicle drivers must be certified by a qualified medical examiner as meeting these standards on a biennial basis, the standards have been criticized as being outdated. In addition, a number of disorders exist that are not addressed by the current standards. As a consequence, the FMCSA has embarked on a program whereby it will review all of its current physical qualification standards and begin the process of updating them as necessary by 2009. At the present time there are no physical qualification standards pertaining directly to individuals with chronic kidney disease (CKD). The FMCSA determined that it was necessary to establish whether renal disorders were likely to have a deleterious impact on driver safety and, if it does, to determine how this might best be mitigated. Consequently, the FMCSA requested that Manila Consulting and its research team summarize the best available evidence on the impact that CKD may have on driver safety. In addition, the agency asked Manila Consulting to convene an expert panel to provide recommendations to the agency as to whether and, under what conditions, individuals with kidney disease may be considered physically qualified to drive a commercial motor vehicle. This report serves the purpose of summarizing the considerations and recommendations of a panel of three experts from the field of nephrology (henceforth termed the Medical Expert Panel, or MEP) who examined the FMCSA’s current guidelines for medical examiners pertaining to obstructive renal disease. Scope of Recommendations Document The MEP considered the impact of CKD on CMV driver safety. The impact of acute kidney disease is beyond the scope of the present recommendations document. Definition and Staging of CKD Throughout this recommendations document we have used the classification and classification systems proposed by the National Kidney Foundation (Table 1 and Table 2 respectively). Table 1. Definition of CKD Criteria Definition 1 Kidney damage ≥3 months as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either: • Pathological abnormalities; • Markers of kidney damage including abnormalities in the composition of the blood or urine, or abnormalities in imaging tests. 2 GFR <60 mL/min/1.73 m2 for ≥3 months with or without kidney damage 1 Table 2. Stages of CKD Stage Description Glomerular Filtration Prevalence in US Rate (GFR) Population 1 Renal damage (protein in urine) and normal GFR. Involves mildly ≥90 mL/min/1.73 m2 5.9 million (3.3%) diminished renal function, with few overt symptoms 2 Renal damage and mild decrease in GFR. Kidney damage is defined 60-89 mL/min/1.73 m2 5.3 million (3.0%) as pathologic abnormalities or markers of damage, including abnormalities in blood or urine test or imaging studies 3 Renal damage and moderate decease in GFR 30-59 mL/min/1.73 m2 7.6 million (4.3%) 4 Renal damage and severe decrease in GFR 15-29 mL/min/1.73 m2 400,000 (0.2%) 5 Renal Failure (also known as ESRD). Involves severe illness and ≤15 mL/min/1.73 m2 300,000 (0.2%) requires some form of renal replacement therapy (dialysis or renal transplant). Stage 5 CKD is also called end-stage renal disease (ESRD). Source: The National Kidney Foundation Disease Outcomes Quality Initiative (NKF-K/DOQI) Clinical Practice Guidelines for Chronic Kidney Disease Composition of MEP Members of the MEP charged with making recommendations on whether the current guidelines for renal disease need to be updated are listed in Table 1. Table 1. Members of the MEP Name Current Position Dr. Stephen Z. Stephen Z. Fadem, MD, FACP, FASN (Texas) is Clinical Professor of Medicine at Baylor College of Medicine. He is also Fadem Vice-President of the Board of Directors for Chronic Kidney Disease and on the Medical Advisory Board of the American Association of Kidney Patients. He is a graduate of the University of Oklahoma College of Medicine and completed his internal medicine residency at The University of Texas. He lectures frequently on dialysis management, preventive nephrology, vascular calcification, anemia, patient education, chronic kidney disease education, computer technology and computer security. Dr. Fadem founded the Houston Kidney Center (HKC). The HKC Integrated Service Network, now a part of DaVita, is comprised of six dialysis facilities. The DaVita Medical Center Facility is now one of the largest dialysis units in the United States. Dr. Fadem has been nationally recognized by receiving the American Association of Kidney Patient's Peter Lundin Award and the National Kidney Foundation's Distinguished Service Award. Dr. Mark Unruh Mark Unruh, MD, MSc (Pennsylvania) is Assistant Professor of Medicine at the University of Pittsburgh and also serves as the University’s Sub-Specialty Education coordinator for the Renal-Electrolyte Division. He received his medical degree from the University of Chicago and served his residencies at the University of Pennsylvania and at Tufts-New England Medical Center in Massachusetts. Dr. Unruh’s research interests include the care and treatment of individuals with chronic kidney disease, focusing on the link between sleep disorders and daytime functioning among individuals with chronic illness. In addition, his research group is examining the interaction of nighttime medical therapies such as dialysis on sleep quality. He has written over 30 articles and book chapters and received grant support from the National Institutes of Health, National Kidney Foundation and American Society of Nephrology. Dr. Linda A. Lynda A. Szczech, MD, MSCE (North Carolina) is Associate Professor of Medicine at Duke University Medical Center. Szczech She is also the Director of nephrology research at Duke Clinical Research Institute. Dr. Szczech has extensive experience in nephrological research and clinical epidemiology. She holds a medical degree from Jefferson Medical College in Philadelphia and earned a Master’s degree in Clinical Epidemiology from the University of Pennsylvania School of Medicine. She is the author of numerous peer-reviewed publications on renal disease, especially its effects on HIV+ patients. Dr. Szczech is the recipient of the 1996 Kidney Fund Clinical Scientist in Nephrology Award and the National Research Service Fellowship Award. Dr. Szczech’s clinical and research interests include the epidemiology of chronic kidney disease, the interaction between cardiac and renal disease, and HIV-related renal diseases. 2 Methodology Brief Overview of Evidence Report Methodology The recommendations of the MEP presented in this report were informed in part on the interpretation and assimilation of information presented in a comprehensive evidence report summarizing the best evidence that is currently available in the literature. This