Growing Threat of Substandard and Counterfeit Medicines in Developing
Countries Addressed by New USAID-USP Cooperative Agreement
ROCKVILLE, Md., Oct. 26 /PRNewswire-USNewswire/ -- With substandard and
counterfeit versions of medicines intended to treat life-threatening diseases
such as malaria, HIV/AIDS and tuberculosis posing a growing threat throughout
the developing world, the U.S. Agency for International Development (USAID)
and the U.S. Pharmacopeial (USP) Convention will expand their joint efforts to
combat this menace by launching a new program over the next five years.
The Promoting the Quality of Medicines (PQM) Program, a $35 million
cooperative agreement, will serve as a primary mechanism to help assure the
quality, safety and efficacy of medicines that are essential to USAID's
priority health programs. USAID is a U.S. government agency that provides
economic, development and humanitarian assistance around the world in support
of the foreign policy goals of the United States. USP is a nonprofit
scientific organization that develops globally recognized standards for the
quality of medicines.
Building on a 10-year USAID-USP partnership in this arena that assists health
officials and others in 28 countries around the world, the program will
increase work to address the significant public health challenge posed by
substandard and counterfeit medicines. According to the U.S.-based Center for
Medicines in the Public Interest, counterfeit drug sales alone will reach $75
billion globally in 2010, an increase of more than 90 percent from 2005.
Various factors contribute to the growth of substandard and counterfeit
medicines, including the globalization of trade and weak regulatory capacity
in developing countries.
"Substandard and counterfeit medicines represent a threat to public health
worldwide but pose a particular problem in developing countries, where lack of
financial, technical and other resources make it difficult to protect the drug
supply chains," said Gloria Steele, USAID acting assistant administrator for
Global Health. "Such medicines undermine decades of investments in public
health. Without good quality, safe medicines to treat diseases such as malaria
and tuberculosis, the impact of other health initiatives is severely weakened
if not negated completely. The PQM Program focuses on this critical aspect of
combating these diseases."
"The lives of patients are put in serious jeopardy when they take substandard
or counterfeit drugs," said Roger L. Williams, M.D., chief executive officer
of USP. "Such 'medicines' have health as well as economic implications.
Moreover, substandard medicines contribute to the development of
drug-resistant strains of infectious diseases. Such strains are a leading
challenge in the fight against malaria, HIV/AIDS and tuberculosis."
The program will help ensure the quality, safety and efficacy of medicines by:
working with countries to strengthen their medicines regulatory bodies, which
are responsible for protecting the supply chains; increasing the supply of
good-quality medicines, which often are not available, with shortages giving
health facilities no choice but to use medicines that may not have undergone
rigorous quality control; combating the availability of counterfeit and
substandard medicines through testing programs and other means; and conducting
global advocacy to raise awareness of the dangers of substandard and
counterfeit drugs.
The PQM Program builds on the work of USAID and USP over the past decade
through a predecessor program, the Drug Quality and Information (DQI) Program.
Like DQI, the PQM Program will be managed by Patrick Lukulay, PhD, partnering
with USAID's Office of Health, Infectious Diseases, and Nutrition, under the
direction of Anthony Boni. Highlights of the DQI Program's work include:
-- Establishing the first large-scale continuous monitoring program for
medicines quality in Africa, Asia and Latin America. The DQI Program
developed robust drug quality surveillance programs in 19 nations,
leading to recalls of substandard and counterfeit medicines and
closures
of illicit pharmacies operating in the countries. This had never been
done before in any developing region beyond an ad hoc basis.
Monitoring
is conducted largely through 107 sentinel sites that were established
to
perform quality testing. In July 2009, one such sentinel site in Ghana
detected a counterfeit antimalarial drug that was being sold to
patients
as Novartis' Coartem((R)). The product, which lacked any active
ingredient, was promptly seized from pharmacies in Ghana by the
country's Foods and Drug Board, helping prevent further harm to
patients
who may be using the drug for treatment of their "uncomplicated"
malaria, which is endemic in 108 countries, 45 of which are in Africa.
-- Building capacity in Asia to address gaps in medicines quality
assurance. When tested in the Greater Mekong Subregion in 2003 for
identity and content, medicines failed at a staggering rate, posing a
significant health problem and contributing to the growth of resistant
strains of malaria. DQI built capacity in national medicine regulatory
agencies, assessed quality control systems in five countries, and
provided equipment and training to four national laboratories, among
other activities. Progress continues with work expanding beyond
antimalarials to anti-retroviral, anti-tuberculosis, anti-viral and
some
antibiotic medicines.
-- Assisting the Global Drug Facility in efforts to increase the
availability of good quality second-line anti-tuberculosis (TB)
medicines at affordable prices. A major challenge in combating
tuberculosis is an inadequate number of WHO pre-qualified second-line
TB
medicines manufacturers--leading to an inadequate supply of products
to
treat patients with multi drug-resistant TB. In order to ensure
quality
products, United Nations procurement agencies, the Global Fund, and
many
international organizations mandate that only medicines prequalified
by
WHO (or approved by stringent regulatory agencies) are suitable for
procurement. To expedite the process of pre-qualification with
WHO--thereby expanding the pool of viable manufacturers--DQI provides
technical assistance to companies on the preparation of drug dossiers
they submit to WHO. This effort helps expand the availability of
quality
medicines for patients with TB.
The new PQM Program will expand on these and other activities in Asia, Eastern
Europe, Latin America, and sub-Saharan Africa.
USP--Advancing Public Health Since 1820 is a scientific, nonprofit,
standards-setting organization that advances public health through public
standards and related programs that help ensure the quality, safety, and
benefit of medicines and foods. USP's standards are recognized and used
worldwide. For more information about USP visit http://www.usp.org.
For more information about USAID, please www.usaid.gov.
The American people, through the U.S. Agency for International Development,
have provided economic and humanitarian assistance worldwide for nearly 50
years.
Public Information: 202-712-4810
SOURCE U.S. Agency for International Development
USAID Press Office, +1-202-712-4320
