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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

Countering the Problem of
Falsified and Substandard Drugs

Committee on Understanding the Global Public Health Implications of
Substandard, Falsified, and Counterfeit Medical Products

Board on Global Health

Gillian J. Buckley and Lawrence O. Gostin, Editors

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. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
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THE NATIONAL ACADEMIES PRESS    500 Fifth Street, NW    Washington, DC 20001

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 competences and with regard for appropriate balance.

This study was supported by Contract No. HHSF22301024T, TO #25 between the National Academy of Sciences and the U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

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International Standard Book Number-10: 0-309-26939-3

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Suggested citation: IOM (Institute of Medicine). 2013. Countering the problem of falsified and substandard drugs. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

—Goethe

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INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
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COMMITTEE ON UNDERSTANDING THE GLOBAL
PUBLIC HEALTH IMPLICATIONS OF SUBSTANDARD,
FALSIFIED, AND COUNTERFEIT MEDICAL PRODUCTS

LAWRENCE O. GOSTIN (Chair), the Linda and Timothy O’Neill Professor of Global Health Law; Director, WHO Collaborating Center on Public Health Law and Human Rights, Georgetown University Law Center, Washington, DC

DANIEL CARPENTER, Allie S. Freed Professor of Government, Harvard University, Cambridge, MA

HANS HOGERZEIL, Professor of Global Health, Groningen University, The Netherlands; Former Director, Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland

THOMAS P. LAYLOFF, Senior Quality Assurance Director, Supply Chain Management System, Arlington, VA

ANN MARIE KIMBALL, Senior Program Officer of Epidemiology and Surveillance, Bill & Melinda Gates Foundation, Seattle, WA

PATRICK LUKULAY, Director, Promoting the Quality of Medicines Program, U.S. Pharmacopeia, Rockville, MD

MARGARETH NDOMONDO-SIGONDA, Pharmaceutical Coordinator, New Partnership for Africa’s Development, Pretoria, South Africa

ARTI K. RAI, Elvin R. Latty Professor, Duke University School of Law, Durham, NC

MARCO ANTONIO STEPHANO, Professor, University of São Paulo, School of Pharmaceutical Sciences, Brazil

JOHN THERIAULT, Former Vice President of Security, Apple Inc., Cupertino, CA; Former Vice President of Security, Pfizer, Inc., New York, NY

MARY E. WILSON, Adjunct Associate Professor of Global Health and Population, Harvard University School of Public Health, Boston, MA

PRASHANT YADAV, Director, Healthcare Research, William Davidson Institute, University of Michigan, Ann Arbor

IOM Staff

GILLIAN BUCKLEY, Program Officer, Study Director

KENISHA PETERS, Research Associate

MEGAN GINIVAN, Research Assistant

KATHLEEN BURNS, Intern

JULIE WILTSHIRE, Financial Associate

PATRICK W. KELLEY, Director, Boards on Global Health and African Science Academy Development

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Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
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Reviewers

This report 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 report as sound as possible and to ensure that the report 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 deliberative process. We wish to thank the following individuals for their review of this report:

Georges Benjamin, American Public Health Association

Martha Brumfield, Martha A. Brumfield, LLC

Stephen Byrn, Purdue University

Philip Chen, formerly of Georgetown University Law Center

Charles Clift, Chatham House

Michael Greene, Centers for Disease Control and Prevention

William Greene, St. Jude Children’s Research Hospital

Noel Greis, University of North Carolina at Chapel Hill

Harparkash Kaur, London School of Hygiene and Tropical Medicine

Thomas Kubic, Pharmaceutical Security Institute

Joshua Sharfstein, Maryland Department of Health & Mental Hygiene

Marv Shepherd, University of Texas at Austin

Andy Stergachis, University of Washington

Chen Yang, Sidley Austin, LLP

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Harold Fallon, Medical University of South Carolina, and Elaine Larson, School of Nursing and Mailman School of Public Health, Columbia University. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

Acknowledgments

This report is a product of the cooperation and contributions of many people. The committee and staff are especially grateful to Danielle Turnipseed and Livia Navon for their work on the manuscript, and to Deepali Patel and Susan McCutchen for their fast and accurate reference review. The project ran smoothly because of the contributions of Jim Banihashemi, Sarah Ziegenhorn, Laura Harbold DeStefano, Anne Claiborne, and Vilija Teel of the Institute of Medicine. Janice Mehler of the Report Review Committee oversaw a careful peer review of the manuscript.

Many experts outside of the Academies helped the committee and staff with this project. Bryan Liang of the University of California, San Diego, was not able to serve on the committee but contributed to the first meeting. Michael Deats, Jitka Sabartova, and Sabine Kopp of the WHO shared their technical expertise; Tom Kubic of PSI, Inc. shared and explained his organization’s unpublished data; Vincent Ahonkai of the Bill & Melinda Gates Foundation, Kelly Catlin of CHAI, and James Droop and Saul Walker of DFID shared information about medicine procurement and quality assurance; Mark Paxton of the FDA explained RFID technology; Ashifi Gogo of Sproxil explained mobile verification; Mariam Khan of BMI shared pharmaceutical sales data; and Lynda Scammell of the MHRA shared her technical expertise.

Members of the committee and staff traveled to Brasília, Delhi, Geneva, Hyderabad, London, and São Paulo, during this project. Their meetings abroad were made easier because of the help and hospitality of Teija Katajainen of the WHO; Maria Alves of the EMA; Arthy Santhakumar of Chatham House; A. Srinivasa Chakravarthy, K.V. Surendra Nath,

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

and Syed Mohammed Arifullah of the U.S. Pharmacopeia–India; Carlos Morel of FIOCRUZ; and Laura Oliveira of the University of São Paulo. Charles Nwasor of the Altarum Institute, Kelley Badiane of USAID, Monica Eimunjeze of NAFDAC, Henrietta Williams of the Catholic Medical Association of Nigeria, and Isaac Umunna also helped the staff and committee prepare for their meetings.

The committee is grateful to the following participants who spoke at meetings and helped staff plan agendas:

Martin Harvey Allchurch

P.V. Appaji

Amir Attaran

Martin Auton

Sunil Bahl

Roger Bate

Ilisa Bernstein

Katherine Bond

Regina Brown

Gian Luca Burci

Claudio Henrique Cabral

Nicholas Cappuccino

Ranjan Chakrabarti

Ranjit Chaudhury

Lim Chin Chin

John Clark

Charles Clift

David Cockburn

Emer Cooke

Ediná Alves Costa

Alan Coukell

Elize Massard da Fonseca

Filipe Soares Quirino da Silva

Ashok Dang

Joelle Daviaud

Leandro Teixeira de Morais

Jenifer Devine

Pritu Dhalaria

Albinus D’Sa

Douglas Duarte

Paul Ellis

Frederico Benite Filho

Michele Forzley

Odile Frank

Laurie Garrett

David R. Gaugh

Debora Germano

Raj Shankar Ghosh

Ashifi Gogo

Antony Raj Gomes

Subhash Gouda

L.C. Goyal

Wendy Greenall

Jeffery Gren

Catherine Hill-Herndon

Meghana Inamdar

Mariaou Tala Jallow

Kees de Joncheere

Connie Jung

Mohga Kamal-Yanni

Harparkash Kaur

Sabine Kopp

Alan Leather

Jamie Love

Rohit Malpani

Paola Manchisini

Linda Marks

Sylvia Meek

Mayira Milano

Bejon Misra

Archna Mudgal

Koduru Surendra Nath

Paul Newton

Fernando Nogueira

Doroteia Koparanova Ollivier

Arun Panda

Sharon Peacock

Patrícia Oliveira Pereira

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

Rebeca Mancini Pereira

Greg Perry

Terezinha de Jesus Andreoli Pinto

Aline Plancon

Flávia Poppe

Tiago Lanius Rauber

Subbi Reddy

Christophe Rérat

Judit Rius

Nicolina Romano-Lieber

Francis Roodt

Luciano Gonçalves Rosado

Bruce Ross

Percy Alberto Ocampo Rujel

Niall Sargent

Philippa Saunders

Lynda Scammell

Aluísio Segurado

Nirupa Sen

Dilip Shah

Sangeeta Shashikant

Janice Soreth

Sadu Srivinas

Fergus Sweeny

Nirmalya Syam

Paulo Teixeira

Mary Lou Valdez

German Velasquez

Tarun Vij

Simeon Wilson

Mark Witkowski

Shunmay Yeung

Regina Zamith

Anthony Zook

Howard Zucker

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Acronyms and Abbreviations

ACTA

Anti-Counterfeiting Trade Agreement

ADDO

Accredited Drug Dispensing Outlet

AIDS

acquired immune deficiency syndrome

AMRH

African Medicines Regulatory Harmonization

Anvisa

National Health Surveillance Agency of Brazil

API

active pharmaceutical ingredient

BMI

Business Monitor International

CDC

Centers for Disease Control and Prevention

CHAI

Clinton Health Access Initiative

DFID

Department for International Development

DOTS

Directly Observed Treatment–Short Course

EMA

European Medicines Agency

ESI

electrospray ionization

EU

European Union

FDA

U.S. Food and Drug Administration

FIP

International Pharmaceutical Federation

GC-MS

gas chromatography and mass spectrometer

Global Fund

Global Fund to Fight AIDS, Tuberculosis, and Malaria

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
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HIV

human immunodeficiency virus

HPLC

high-performance liquid chromatography

ICH

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

IFC

International Finance Corporation

IMPACT

International Medical Products Anti-Counterfeiting Taskforce

Medicrime Convention

Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health

MSF

Médecins Sans Frontières (Doctors Without Borders)

MSH

Management Sciences for Health

NABP

National Association of Boards of Pharmacy

NGO

nongovernmental organization

NIST

National Institute of Standards and Technology

NSF

National Science Foundation

OECD

Organisation for Economic Co-operation and Development

OPIC

Overseas Private Investment Corporation

PhRMA

Pharmaceutical Research and Manufacturers of America

PQM

Promoting the Quality of Medicines

PSI

Pharmaceutical Security Institute

PSM

Partnership for Safe Medicines

RFID

radio frequency identification

SBIR

Small Business Innovation Research

SSFFC

substandard, spurious, falsely-labeled, falsified, counterfeit

TLC

thin layer chromatography

TRIPS

Trade-Related Aspects of Intellectual Property Rights

Unicef

United Nations Children’s Fund

UNODC

United Nations Office on Drugs and Crime

USAID

United States Agency for International Development

USP

U.S. Pharmacopeia

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
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VIPPS

Verified Internet Pharmacy Practice Sites

WCO

World Customs Organization

WHA

World Health Assembly

WHO

World Health Organization

WIPO

World Intellectual Property Organization

WTO

World Trade Organization

WWARN

WorldWide Antimalarial Resistance Network

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6-3

Chinese Mobile Laboratories

6-4

The Global Pharma Health Fund Minilab

FIGURES

1-1

A two-dimensional description of medicine quality and registration

2-1

Increasing incidence of multidrug-resistant tuberculosis (MDR-TB)

2-2

Percentage of nosocomial Staphylococcus aureus isolates with resistance to meticillin in studies in Latin American countries

2-3

The increasing costs of drug development

2-4

Comparative values of trafficking flows in West Africa

3-1

Results of packaging and product analysis, 2011

3-2

Geographic distribution of pharmaceutical sales in $U.S. billions, 2011 data

3-3

Geographic distribution of Pharmaceutical Security Institute incident reports, affected countries, 2011 data

3-4

Registration status of antimalarial samples by distribution level

3-5

Quality failures of registered and unregistered antimalarials in 267 samples

3-6

Results of full quality-control analysis in 267 samples

4-1

Schematic block diagram of a pharmaceutical manufacturing process

4-2

Arrests by activity, 2010-2011

4-3

Average of country-level mean percentage availability of medicines by World Bank income group

4-4

Number of sub-Saharan African countries out of 26 surveyed meeting the main functions of a regulatory authority

4-5

An FDA public service announcement that promotes the Verified Internet Pharmacy Practice certification

4-6

The English translation of a Cambodian poster encouraging consumers to buy medicines only from licensed pharmacies and to examine the drug’s color, shape, and taste for abnormalities

5-1

The drug distribution system

5-2

The private, public, and NGO drug distribution systems for essential medicines in developing countries

5-3

Risks in the medicine distribution system

Page xxiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
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5-4

Number of pharmacists per 10,000 people and number of pharmacies per 10,000 people in 50 countries

5-5

The world’s pharmacists, pharmacy technicians, and pharmacy assistants, 2006 data

5-6

Legislation of internet pharmacy operations by WHO region

6-1

More sophisticated fakes require more sophisticated technologies to detect them

6-2

The printing on a fake Cialis blister pack is less crisp at 32× magnification

6-3a

An HPLC chromatogram with distinct peaks for chloroquine, quinine, and mefloquine can be used to identify cheap chloroquine and quinine treatments labeled as the more expensive mefloquine

6-3b

The similar chemical structures of chloroquine, quinine, and mefloquine

6-4

Infrared Spectra for artemisinin (top) and artemether, an artemisinin-derivative (bottom) illustrate differences in their chemical composition

6-5

Use of FT-IR spectroscopy to distinguish between real (left) and falsified (right) packaging in Singapore

6-6

Image (a) is a pain relief tablet, image (b) its near-infrared spectra

6-7

Proton NMR spectrum of aspirin (o-acetoxybenzoic acid)

6-8

Nearly identical analogues of tadalafil (left, 389.40 g/mol), aminotadalafil (right, 390.39 g/mol)

6-9

CODFIN analysis flowchart

6-10

Genuine (left) and falsified (right) holograms on artesunate blister packs found in Southeast Asia

TABLES

1-1

Definitions of Counterfeit Pharmaceuticals

1-2

National Definitions of Counterfeit Pharmaceuticals

1-3

Definitions of Substandard Pharmaceuticals

1-4

National Definitions of Substandard Pharmaceuticals

1-5

Other Terms of Interest

2-1

Medicines Use to Treat the Most Common Causes of Child Death Are Compromised in Developing Countries

3-1

Ranking of Seizures or Detections by Country, 2011

3-2

Ten Countries Most Named in PSI Incident Reports, 2011

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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today.

The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

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