E-DRUG: ARV/FDC NGO testimony in Botswana
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Catholic Relief Services Consortium Statement in the FDC Meeting in
Gaborone, Botswana
March 30, 2004
My name is Jacqueline Patterson and I manage the HIV/AIDS Programs
Portfolio for Interchurch Medical Assistance, which is a member of the
Catholic Relief Services Consortium, one of the 4 awardees of the PEPFAR
ART Initiative.
I appreciate you giving me this bit of time to bring some voices from FDC
utilizing facilities into the proceedings. I'd just like to read a brief
statement comprised of comments from our field partners.
The organizations within CRS and I.M.As collective Membership are currently
providing ART treatment to thousands of people throughout Africa and the
Caribbean through hundreds of affiliated Mission hospitals and clinics.
From our initial survey, completed in preparation for the proposal for the
PEPFAR ART award, we learned that the majority of our partners and
affiliated institutions are currently using FDC ARVs in the provision of
treatment.
Under the PEPFAR initiative CRSC was awarded $24.7 million in Year I to
scale up existing services and provide treatment to 14,900 people in 9
countries. As current PEPFAR guidelines dictate that we cannot use FDCs
due to regulatory issues, our partners were interested in logging their
concerns at this forum about ht issue of broadening access to FDCs.
Therefore, I would like to offer comments coming directly from out
affiliated hospitals, clinics and partners including the Christian Health
Associations in our focal countries as well as sharing excepts from
comments by clinician representatives at the February meeting in
Brackenhurst Kenya, of the Christian Medical and Dental Association.
o We are currently using FDCs, following our national
guidelines/protocols in accordance with WHO prequalification standards.
Therefore, Policies restricting the use of FDCs result in changing of our
regimens and will place us out of compliance with our governmental
policies.
o Our patients on Fixed Dose Combination-based protocols at facilities
such as Muheza and Selian Hospitals in Tanzania, CCAP Hospitals in Malawi,
Kijabe Hospital in Kenya are experiencing positive outcomes that have been
well-documented. Our experiences bear out the quality of these products.
o We appreciate any initiative that results in an expedited process for
making FDCs an approved dr4ug for widespread use, including under PEPFAR.
o FDCs must be an option for our hospitals, thought we certainly
acknowledge that need and utility of individual component-based regimens.
o We are concerned that the pill burden that will result from removal
of FDCs from our arsenal will result in our patients having a difficult
time keeping up with their regimens.
o With non-FDC regimens, there is a significant risk of sharing of
pills among family members as per a prevailing cultural sense of community
o Adherence will suffer greatly as a result of pill burden and the
sharing of pills and resistance will result.
o With the onset of resources from the Global Fund, Clinton Foundation,
World Bank, national programs, etc, our already over-taxed institutions
will suffer under the onerous management burden due to multiple programs
with different drug requirements/allowances.
o In addition to the institutional challenges, volunteer community
workers will have to guide already overwhelmed families with different
people using different pills with different instructions.
o Due to the lower pricing of FDCs, we can treat up to 4 times more
people that we would be able to treat with non-FDC/branded drugs.
o What will happen at the end of the 5-year term of the PEPFAR
initiative after we've all changed out protocols and practices to comply
with regulations excluding FDCs and requiring high-priced regimens and the
resources are withdrawn?
In closing, "It is that you as governmental and regulatory agencies ensure
that constraints are removed so that FDC ARVs are an option for our
facilities and patients, as soon as possible".