E-DRUG: USP-Sub-Saharan Africa Center for Pharmaceutical Advancement and Training (CePAT)
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The threat of counterfeit and substandard medicines is a problem that not
only affects developing countries, but has repercussions felt around the
world. Expanding upon its long-standing commitment to improving the quality
of all medicines, the United States Pharmacopeial Convention (USP) has
increased its philanthropic outreach with the proposed creation of a
new USP-Sub-Saharan Africa Center for Pharmaceutical Advancement and
Training (CePAT). It is anticipated that CePAT will be located in Accra,
Ghana to serve sub-Sahara Africa as an integrated platform for training,
education, consulting and laboratory capabilities, offering a systematic
approach to the quality control of medicines in sub-Saharan Africa.
The center will aim to address shortfalls in human and laboratory resources
and supply chain control to build the capacity of African professionals in
quality control and quality assurance of medicines. USP is a scientific
nonprofit organization that sets standards for the identity, strength,
quality and purity of medicines, food ingredients and dietary supplements.
USP’s standards are used in more than 145 countries, and its drug standards
are enforceable in the United States by the Food and Drug Administration.
The issues at hand
Sub-Saharan Africa has the lowest life expectancy, the highest infant and
under-five mortality rate, as well as the highest maternal mortality rate
in the world. It also has the highest burden of HIV infections among
adults, malaria mortality rate and tuberculosis prevalence. Moreover,
Africa is facing an increasing burden from non-communicable diseases such
as cancer and diabetes. The countries in sub-Saharan Africa face
fundamental problems that have created an environment where substandard and
counterfeit medicines have flourished. These are tied to the limited
resources of regulatory infrastructures in African nations, with a shortage
of qualified personnel at national laboratories, heavy dependence on
imported medicines with a lack of adequate oversight, and poor compliance
with Good Manufacturing Practices. CePAT is designed to play an important
role in helping to address these challenges.
USP’s work in the region
For decades, USP has worked in specific African countries on specific
diseases (HIV/AIDS, tuberculosis, and malaria) through grants from the U.S.
Agency for International Development (USAID) with the Promoting the Quality
of Medicines program (PQM) and predecessor programs. CePAT will complement
and build upon this work by significantly scaling up independent USP
activity in the region. Activities will cover support for all diseases and
all medicines, and will focus on stimulating systemic changes that can be
sustained locally. CePAT will be the first initiative of the newly created
Global Health Impact Program (GHIP) at USP, which is intended to build upon
USP’s mission of promoting the public health globally, and work done
through the PQM program. USP strives to transform the global health
landscape by addressing the systemic problems that hamper access to
good-quality medicines for patients in need through GHIP.
“The work that USP has been able to do through the PQM program has opened
our eyes to new opportunities to provide assistance in sub-Saharan Africa,”
said Patrick Lukulay, vice president of global health impact programs at
USP. “Our ability to do long-term work in Africa through this center in
Ghana will improve health of patients in the region who are desperate for
medicines they can trust.”
USP’s proven success
The idea for CePAT came as a result of a pilot Technical Assistance Program
(TAP) that USP launched last year in seven countries: Ethiopia, Ghana,
Kenya, Senegal, Sierra Leone, India and Egypt. Under the program, USP
provided training as well as its documentary and reference standards for
free or at reduced pricing. During a regional training session in Ghana
with the national laboratories of five participating African countries, it
became clear that there was a need for a more permanent presence that could
deliver training on-demand, tailored to local needs. CePAT will serve as a
permanent facility to train local experts and foster a knowledge base, thus
creating a lasting and self-sustaining program.
Thanks to TAP, the Sierra Leone Pharmacy Board national laboratory found
that two brands of antibiotics on the market were substandard and were able
to have them immediately removed from the market by the Pharmacy Board of
Sierra Leone.
How to get involved
The USP Board of Trustees has committed $1.5 million of USP funds toward
the cost of CePAT’s construction. USP is seeking additional funds from
outside donors to cover construction costs not covered by USP funds,
instrumentation for the training laboratories, staffing costs and to
subsidize local use of the center for the first three years. The center is
expected to become self-sustaining after three years through the variety of
services it will provide to local manufacturers, regulators and others.
These are envisioned to include training on topics such as quality control
and current good manufacturing practices; quality control testing services
for donor agencies, procurement organizations or local manufacturers; and
consulting services on supply chain integrity and laboratory design, among
other offerings. Using the USP-Africa CePAT as a model, it is anticipated
that the program will grow to include other regions such as Latin America
and Asia.
João L. Carapinha
Pharmaceutical Policy Analyst
www.carapinha.com
joao@carapinha.com
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