[On nous annonce un accord entre USP (la pharmacopée américaine) et USAID
(l'agence de coopération américaine) pour endiguer la menace croissante
représentée par les contrefaçons et les médicaments sous dosés. Il s'agit
d'un programme de 5 ans de 35 millions de dollars US pour la Promotion de
la Qualité des Médicaments intéressant 28 pays. Cet article est à
rapprocher d'un article récent sur le suivi de médicaments de mauvaise
qualité découverts au Ghana. Note du traducteur CR]
FOR IMMEDIATE RELEASE CONTACT: Francine Pierson
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
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 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/ ).