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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

Developing and Strengthening
the Global Supply Chain
for Second-Line Drugs for
Multidrug-Resistant Tuberculosis

WORKSHOP SUMMARY

Anna Nicholson, Rebecca A. English, Rita S. Guenther, and
Anne B. Claiborne, Rapporteurs

Forum on Drug Discovery, Development, and Translation

Board on Health Sciences Policy

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

NOTICE: The workshop that is the subject of this workshop summary 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.

This activity was supported by contracts between the National Academy of Sciences and Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and HHSF223001003T), Abbott Pharmaceuticals, American Diabetes Association, American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly and Company, Eli Lilly & Co. Foundation, FasterCures, Foundation for the NIH, Friends of Cancer Research, GlaxoSmithKline, Janssen Research & Development, LLC, March of Dimes Foundation, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer Inc. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.

International Standard Book Number-13: 978-0-309-26595-9

International Standard Book Number-10: 0-309-26595-9

Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2013 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 Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.

—Goethe

image

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

PLANNING COMMITTEE FOR THE WORKSHOP ON GLOBAL DRUG SUPPLY CHAIN FOR SECOND-LINE ANTI-TUBERCULOSIS DRUGS1

BARRY R. BLOOM (Co-Chair), Harvard School of Public Health, Boston, MA

GAIL H. CASSELL (Co-Chair), Harvard Medical School (Visiting), Carmel, IN

RIFAT ATUN, Imperial College Business School, Imperial College London, England

PETER CEGIELSKI, U.S. Centers for Disease Control and Prevention, Atlanta, GA

LUCICA DITIU, Stop TB Partnership, World Health Organization, Geneva, Switzerland

GARY L. FILERMAN, Atlas Health Foundation, McLean, VA

HELLEN GELBAND, Center for Disease Dynamics, Economics & Policy, Inc., Washington, DC

MARK J. GOLDBERGER, Abbott Pharmaceuticals, Rockville, MD

DOUGLAS L. KEENE, Management Sciences for Health, Arlington, VA

SALMAAN KESHAVJEE, Harvard Medical School, Boston, MA

MONTSERRAT MEIRO-LORENZO, World Bank, Washington, DC

ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY

PAUL P. NUNN,2 World Health Organization, Geneva, Switzerland

ARIEL PABLOS-MéNDEZ, United States Agency for International Development, Washington, DC

TRACY J. SIMS, Eli Lilly & Co. Foundation, Indianapolis, IN

BRENDA WANING, UNITAID, World Health Organization, Geneva, Switzerland

PRASHANT YADAV, University of Michigan, Ann Arbor

IOM Staff

ANNE B. CLAIBORNE, Forum Director

RITA S. GUENTHER, Program Officer

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

ANDREW M. POPE, Director, Board on Health Sciences Policy

ROBIN GUYSE, Senior Program Assistant

___________________

1 Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

2 Paul Nunn was with the World Health Organization during the planning of the workshop.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

JEFFREY M. DRAZEN (Co-Chair), New England Journal of Medicine, Boston, MA

STEVEN K. GALSON (Co-Chair), Amgen Inc., Thousand Oaks, CA

MARGARET ANDERSON, FasterCures, Washington, DC

HUGH AUCHINCLOSS, National Institute of Allergy and Infectious Diseases, Bethesda, MD

CHRISTOPHER AUSTIN, National Center for Advancing Translational Sciences, Bethesda, MD

LESLIE Z. BENET, University of California, San Francisco

ANN BONHAM, Association of American Medical Colleges, Washington, DC

LINDA BRADY, National Institute of Mental Health, Bethesda, MD

ROBERT CALIFF, Duke University Medical Center, Durham, NC

C. THOMAS CASKEY, Baylor College of Medicine, Houston, TX

GAIL H. CASSELL, Harvard Medical School (Visiting), Carmel, IN

PETER B. CORR, Celtic Therapeutics, LLLP, New York, NY

ANDREW M. DAHLEM, Eli Lilly and Company, Indianapolis, IN

TAMARA DARSOW, American Diabetes Association, Alexandria, VA

JAMES H. DOROSHOW, National Cancer Institute, Bethesda, MD

GARY L. FILERMAN, Atlas Health Foundation, McLean, VA

GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia

MARK J. GOLDBERGER, Abbott Pharmaceuticals, Rockville, MD

HARRY B. GREENBERG, Stanford University School of Medicine, CA

STEPHEN GROFT, National Center for Advancing Translational Sciences, Bethesda, MD

LYNN HUDSON, Critical Path Institute, Tucson, AZ

MICHAEL KATZ, March of Dimes Foundation, White Plains, NY

PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD

JACK D. KEENE, Duke University Medical Center, Durham, NC

RONALD L. KRALL, University of Pennsylvania Center for Bioethics, Steamboat Springs, CO

FREDA LEWIS-HALL, Pfizer Inc., New York, NY

MARK B. MCCLELLAN, The Brookings Institution, Washington, DC

CAROL MIMURA, University of California, Berkeley

___________________

1 Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY

JOHN ORLOFF, Novartis Pharmaceuticals Corporation, East Hanover, NJ

AMY PATTERSON, National Institutes of Health, Bethesda, MD

MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ

JANET SHOEMAKER, American Society for Microbiology, Washington, DC

ELLEN SIGAL, Friends of Cancer Research, Washington, DC

ELLIOTT SIGAL, Bristol-Myers Squibb, Princeton, NJ

ELLEN R. STRAHLMAN, GlaxoSmithKline, Research Triangle Park, NC

NANCY SUNG, Burroughs Wellcome Fund, Research Triangle Park, NC

JANET TOBIAS, Ikana Media and Mount Sinai School of Medicine, New York, NY

JOANNE WALDSTREICHER, Janssen Research & Development, LLC, Raritan, NJ

JANET WOODCOCK, Food and Drug Administration, White Oak, MD

IOM Staff

ANNE B. CLAIBORNE, Forum Director

RITA S. GUENTHER, Program Officer

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

ANDREW M. POPE, Director, Board on Health Sciences Policy

ROBIN GUYSE, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

Reviewers

This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:

Colin Boyle, University of California, San Francisco, Global Health Sciences

Jennifer Furin, Case Western Reserve University School of Medicine

Robert Matiru, UNITAID

Owen Robinson, Partners In Health

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by Enriqueta C. Bond, QE Philanthropic Advisors. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×

Acronyms

ACT artemisinin-combination therapy
AIDS acquired immune deficiency syndrome
AMC advance market commitment
AMFm Affordable Medicines Facility-malaria
AMRH African Medicines Regulatory Harmonization
APC advance purchase commitment
API active pharmaceutical ingredient
ARV antiretroviral
   
BMGF Bill & Melinda Gates Foundation
BRICS Brazil, Russia, India, China, and South Africa
   
CDC U.S. Centers for Disease Control and Prevention
CHAI Clinton Health Access Initiative
   
DOT directly observed treatment
DOTS Directly Observed Treatment-Short course
DR TB drug-resistant tuberculosis
DST drug susceptibility testing
   
EMA European Medicines Agency
EMR electronic medical record
   
FDA U.S. Food and Drug Administration
FLD first-line anti-TB drug
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
×
FPP finished pharmaceutical product
   
GDF Global Drug Facility
GHC Global Health Committee
GLC Green Light Committee
   
HCP health care professional
HIV human immunodeficiency virus
   
ICH

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

IFFIm International Finance Facility for Immunization
IOM Institute of Medicine
IQA internationally quality-assured
   
MDR TB multidrug-resistant tuberculosis
MSF Médecins Sans Frontières
MSH Management Sciences for Health
M.tb. Mycobacterium tuberculosis
   
NGO nongovernmental organization
NRA national regulatory authority
NTP national TB control programme
   
OpenMRS Open Medical Record System
PAS 4-aminosalicylic acid
PEPFAR U.S. President’s Emergency Plan for AIDS Relief
PMDT programmatic management of drug-resistant tuberculosis
PQ prequalified (by WHO)
PRI Program-Related Investment
   
QA quality-assured/quality assurance
QC quality control
   
SCM supply chain management
SCMS Supply Chain Management System (PEPFAR/USAID)
SLD second-line anti-TB drug
SLDAII Second-Line Drug Access Improvement Initiative
SMS short message service
SRA stringent regulatory authority
   
Page xvii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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TB tuberculosis
   
UNICEF United Nations Children’s Fund
USAID United States Agency for International Development
USP U.S. Pharmacopeial Convention
   
WHO World Health Organization
WHO PQ WHO prequalification
WHO PQP WHO Prequalification of Medicines Programme
   
XDR TB extensively drug-resistant tuberculosis
Page xviii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Page xvii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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Page xviii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13524.
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To effectively treat patients diagnosed with drug-resistant (DR) tuberculosis (TB) and protect the population from further transmission of this infectious disease, an uninterrupted supply of quality-assured (QA), second-line anti-TB drugs (SLDs) is necessary. Patients diagnosed with multidrug-resistant tuberculosis (MDR TB)—a disease caused by strains of Mycobacterium tuberculosis (M.tb.) resistant to two primary TB drugs (isoniazid and rifampicin)—face lengthy treatment regimens of 2 years or more with daily, directly observed treatment (DOT) with SLDs that are less potent, more toxic, and more expensive than those used to treat drug-susceptible TB. From 2000 to 2009, only 0.2-0.5 percent of the estimated 5 million MDR TB cases globally were treated with drugs of known quality and in programs capable of delivering appropriate care (Keshavjee, 2012). The vast majority of MDR TB patients either died from lack of treatment or contributed to the spread of MDR TB in their communities. A strengthened global supply chain for SLDs could save lives by consistently delivering high quality medicines to more of the people who need them.

This public workshop explored innovative solutions to the problem of how to get the right SLDs for MDR TB to people who critically need them. More specifically, the workshop examined current problems and potential opportunities for coordinated international efforts to ensure that a reliable and affordable supply of high-quality SLDs is available. Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis: Workshop Summary covers the objectives of the workshop, which were to review:

-To what extent and in what ways current mechanisms are or are not effectively accomplishing what is needed, including consideration of bottlenecks.

-The advantages and disadvantages of centralization in the management of the global drug supply chain, and potential decentralized approaches to improve operations of the supply chain.

-What can be learned from case studies and examples from other diseases (e.g., the Affordable Medicines Facility-malaria (AMFm) and the U.S. President's Emergency Plan for AIDS Relief [PEPFAR])

- The current allocation of responsibilities and roles of the private (including industry and nonprofit public health organizations) and public sectors, and examination of opportunities for enhancing and optimizing collaboration

-Identification of potential innovative solutions to the problem

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