Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces

Committee to Study the Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces

Robert G. Petersdorf, William F. Page, and Susan Thaul, Editors

Medical Follow-up Agency

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C. 1996



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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces Committee to Study the Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces Robert G. Petersdorf, William F. Page, and Susan Thaul, Editors Medical Follow-up Agency INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1996

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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces NATIONAL ACADEMY PRESS • 2101 Constitution Avenue, N.W. • Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the Department of the Army (contract no. DAMD17-95-5028). The views, opinions, and/or findings contained in this report are those of the Committee to Study the Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. International Standard Book No. 0-309-05593-8 Additional copies of this report are available from: National Academy Press Box 285 2101 Constitution Avenue, N.W. Washington, DC 20055 Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area) Copyright 1996 by the National Academy of Sciences . All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.

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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces COMMITTEE TO STUDY THE INTERACTIONS OF DRUGS, BIOLOGICS, AND CHEMICALS IN U.S. MILITARY FORCES ROBERT G. PETERSDORF, Chair, Distinguished Professor of Medicine, University of Washington, Puget Sound Health Care System, Seattle DONNA DAY BAIRD, Epidemiologist, Epidemiology Branch, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina WALTER H. CARTER, Chair, Department of Biostatistics, Virginia Commonwealth University/Medical College of Virginia JOY A. CAVAGNARO, Senior Pharmacologist, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland JOHN DOULL, Professor, Department of Pharmacology, Toxicology and Therapeutics, University of Kansas Medical Center, Kansas City MARY CAROLYN HARDEGREE, Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland DAVID KORN, Professor of Pathology, Stanford University School of Medicine and Distinguished Scholar in Residence, Association of American Medical Colleges, Washington, D.C. GENEVIEVE M. MATANOSKI, Professor of Epidemiology, School of Hygiene and Public Health, Johns Hopkins University PHILIP K. RUSSELL, Professor of International Health, School of Hygiene and Public Health, Johns Hopkins University JAY P. SANFORD, Professor of Internal Medicine, University of Texas Southwestern Medical Center, and Dean Emeritus, Uniformed Services University of the Health Sciences, Bethesda, Maryland ANDY STERGACHIS, Chair, Department of Pharmacy, School of Pharmacy, University of Washington STEPHEN I. WASSERMAN, Chair, Department of Medicine, University of California at San Diego Medical Center RAYMOND S. H. YANG, Director, Center for Environmental Toxicology and Technology, Colorado State University Study Staff RICHARD N. MILLER, Director, Medical Follow-up Agency WILLIAM F. PAGE, Study Director CAROL A. MACZKA, Senior Program Officer ERIN M. BELL, Research Associate PAMELA C. RAMEY-McCRAY, Project Assistant

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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces Preface At the request of the Department of the Army, the Medical Follow-up Agency of the Institute of Medicine established a committee to review the available medical and scientific information on the interactions of drugs, biologics, and chemicals. The committee was asked to consider this topic further, specifically regarding U.S. military personnel, who are exposed to numerous drugs, biologics, and vaccines throughout their basic training and prior to and during deployment. The committee met in Washington, D.C., on four separate occasions: September 5–6, 1995, and March 5–6, May 1–2, and June 18, 1996. During the first two meetings the committee heard testimony from officials of the U.S. Army, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the British Ministry of Defence. This report sets forth the results of the committee's deliberations. The committee is deeply appreciative of the testimony and written material submitted by the various agencies and of the work of the Medical Follow-up Agency. In particular, the committee thanks Richard Miller, William Page, Carol Maczka, Erin Bell, Pamela Ramey-McCray, and Nancy Diener for staff support. The committee also thanks Michael Hayes and Michael Edington for editorial review. Robert G. Petersdorf, Chair

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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces Contents     EXECUTIVE SUMMARY   1      Background,   1      The Committee's Charge,   2      Scope of the Problem,   2      Categorical Approach,   3      Available Literature,   4      Uses of Automated Multipurpose Databases for Epidemiologic Surveillance,   4      Study and Management of Interactions,   5      Findings and Recommendations,   6  1   INTRODUCTION   9      Background,   9      The Committee's Charge,   10      Scope of the Problem,   10      Report Focus,   12  2   CURRENT PROPHYLACTIC AGENTS   14      Basic Preventive Series,   15      Agents Used During Deployments,   15  3   SURVEILLANCE TOOLS CURRENTLY AVAILABLE TO THE MILITARY   19      Current Military Surveillance Systems,   20      U.S. Department of Veterans Affairs Automated Databases,   27

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Interactions of Drugs, Biologics, and Chemicals in U.S. Military Forces      Current Civilian Surveillance Systems,   29      Summary of Strengths and Limitations of Current Surveillance Tools,   32  4   STRATEGY FOR IDENTIFYING AND DEALING WITH INTERACTIONS   34      Known Interactions,   35      Potential Interactions,   36      Unknown Interactions,   37  5   THE STUDY AND MANAGEMENT OF INTERACTIONS   52      Known Interactions,   52      Potential Interactions,   53      Unknown Interactions,   55      Conclusion,   68  6   FINDINGS AND RECOMMENDATIONS   69      Findings,   69      Recommendations,   70     REFERENCES   73     APPENDIX   77     GLOSSARY   79