E-DRUG: Substandard & counterfeit medicines: USAID-USP Agreement
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Francine Pierson
USP
"Francine Pierson" <FP@usp.org>
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301/816-8588; fp@usp.org
Growing Threat of Substandard and Counterfeit Medicines in Developing
Countries Addressed by New USAID-USP Cooperative Agreement
Rockville, Md., October 26, 2009
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 Convention (USP) 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
USAIDâs 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 multi-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 have the
potential to undermine decades of investments in public health. Without
good quality, safe medicines to treat diseases such as HIV/AIDS, malaria
and tuberculosis, the impact of other health initiatives may be
weakened. 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 and 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, Ph.D., 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 other than on 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'. 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 significant rate, posing a
serious 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.
For more information about the program, please contact
mediarelations@usp.org. For more information about USAID, please
visit www.usaid.gov ( http://www.usaid.gov/ ).