Evidence Report: Licit Schedule II Drug Use and Commercial Motor Vehicle Driver Safety (Comprehensive Review) Presented to Federal Motor Carrier Safety Administration October 21, 2006 Prepared for Prepared by MANILA Consulting Group, Inc. ECRI 1420 Beverly Road, Suite 220 5200 Butler Pike McLean, VA 22101 Plymouth Meeting, PA 19462 This report is comprised of research conducted to analyze the impact of Licit Schedule II Drug Use on Commercial Motor Vehicle Driver Safety. Federal Motor Carrier Safety Administration considers evidence, expert recommendations, and other data, however, all proposed changes to current standards and guidance (guidelines) will be subject to public-notice-and-comment and regulatory processes. FMCSA Evidence Report: Schedule II Drugs and Commercial Motor Vehicle Driver Safety 10/21/2006 Policy Statement ECRI prepared this report under subcontract to MANILA Consulting Group, Inc., which holds prime Contract No. GS-10F-0177N/DTMC75-05-F-00062 with the Department of Transportation’s Federal Motor Carrier Safety Administration. ECRI is an independent, nonprofit health services research agency and a Collaborating Center for Health Technology Assessment of the World Health Organization. ECRI has been designated an Evidence-based Practice Center (EPC) by the United States Agency for Healthcare Research and Quality. ECRI’s mission is to provide information and technical assistance to the healthcare community worldwide to support safe and cost-effective patient care. The results of ECRI’s research and experience are available through its publications, information systems, databases, technical assistance programs, laboratory services, seminars, and fellowships. The purpose of this evidence report is to provide information on the current state of knowledge on this topic. It is not intended as instruction for medical practice or for making decisions regarding individual patients. Page i FMCSA Evidence Report: Schedule II Drugs and Commercial Motor Vehicle Driver Safety 10/21/2006 Table of Contents Executive Summary.........................................................................................................................1 Purpose of Evidence Report ........................................................................................................1 Identification of Evidence Bases .................................................................................................1 Grading the Strength of Evidence................................................................................................2 Analytic Methods.........................................................................................................................2 Presentation of Findings ..............................................................................................................2 Findings .......................................................................................................................................2 Conclusions................................................................................................................................11 Preface............................................................................................................................................12 Organization of Report ..............................................................................................................12 Scope..........................................................................................................................................12 Background....................................................................................................................................14 Schedule II Drugs ......................................................................................................................14 Stimulants–Amphetamines and Methylphenidate ................................................................ 15 Depressants–Barbiturates and Glutethimide......................................................................... 15 Opioids–Opioids and Synthetic Narcotic Analgesics ........................................................... 16 Prevalence and Incidence of Licit Schedule II Drug Use..........................................................16 Federal Regulatory and Medical Advisory Criteria for CMV Operators Pertaining to Controlled Substances ...........................................................................................................17 Current Federal Regulatory Criteria for CMV Operators..................................................... 17 Subpart E: Physical Qualifications and Examinations.......................................................... 18 Subpart B: Prohibitions......................................................................................................... 19 Brief History of CMV Driver and Drug Policy .........................................................................20 Current Drug Testing Policy......................................................................................................20 Subpart B: Prohibitions......................................................................................................... 21 Methods..........................................................................................................................................23 Key Questions............................................................................................................................23 Identification of Evidence Bases ...............................................................................................25 Searches ................................................................................................................................ 26 Retrieval Criteria................................................................................................................... 27 Inclusion and Exclusion Criteria........................................................................................... 27 Page ii FMCSA Evidence Report: Schedule II Drugs and Commercial Motor Vehicle Driver Safety 10/21/2006 Evaluation of Quality of Evidence.............................................................................................28 Statistical Methods.....................................................................................................................29 Synthesis of Results .......................................................................................................................30 Key Question 1: Does the licit use of a prescribed Schedule II drug increase the risk for a motor vehicle crash?...................................................................................................30 Identification of Evidence Base ............................................................................................ 30 Section Summary .................................................................................................................. 31 Key Question 2: Does the licit use of a prescribed Schedule II drug negatively impact indirect measures of driving ability?..............................................................................32 Identification of Evidence Base ............................................................................................ 32 Evidence Base....................................................................................................................... 33 Findings................................................................................................................................. 46 Section Summary .................................................................................................................. 72 Key Question 3: What is the correlation between the serum level of a Schedule II drug and the risk for a motor vehicle crash?..............................................................................78 Identification of Evidence Base ............................................................................................ 78 Section Summary .................................................................................................................. 78 Key Question 4: What is the correlation between the serum level of a Schedule II drug and indirect measures of driving ability? ..........................................................................79 Identification of Evidence Base ............................................................................................ 79 Evidence Base....................................................................................................................... 80 Findings................................................................................................................................. 83 Section Summary .................................................................................................................. 87 Key Question 5: Is there a relationship between the pharmacokinetics of a Schedule II drug and the risk for a motor vehicle crash? ..........................................................87 Identification of Evidence Base ............................................................................................ 88 Section Summary .................................................................................................................. 89 Key Question 6: Is there a relationship between the pharmacokinetics of a Schedule II drug and indirect measures