I. Introduction, Background, and Objectives
I.1 Introduction
The World Health Organization (WHO) passed in 1975 a
resolution (WHO 28.66) which marked the birth of the Essential Drugs Concept
(EDC). The aim was to solve the problem of accessibility to drugs by the
population in developing countries. In most developing countries people lack
access to drugs because they are expensive and the purchase capacity is very
low. The idea behind the EDC is the recognition that only a few drugs are
necessary for the treatment of the majority of the diseases facing the majority
of the population. In 1977 a model list of Essential Drugs was established, the
criteria of including a drug in the list were: established safety and efficacy,
proven quality, constant availability and affordability. The WHO encouraged all
nations to establish their own Essential Drug List based on the above criteria.
The Rwandan government through the Ministry of Health established its first
national essential drug list in 1991. The principe was that all drugs included
should be, if possible, generics which are cheap and the health workers
(governmental as well as private) were recommend to refer to that list when
prescribing and dispensing. The list was reviewed in 1997 and 1999 and the last
revision was this year.
Counterfeiting of pharmaceuticals and the proliferation of
substandard drugs constitute a serious health risk to the consumers around the
world. The WHO records show that problems of substandard and counterfeit drugs
are on the increase as 50% of all reported cases occurred in the period 1993 to
1997. Most of these incidences (70%) were reported in developing countries. The
report identified the cause of the poor quality of drugs: in about 50% of all
cases the formulations did not contain any drug, 20% contained the wrong active
ingredient and 10% the wrong amount of active ingredients. In another 5% of the
reported incidences did the formulation contain the right active ingredient in
the correct amount, but were judged substandard by failing in other quality
tests. The antibiotics were the major pharmacological class of drugs with the
largest incidence (60%) of counterfeiting (WHO, 2000). According the
International Federation of Pharmaceutical Manufacturers Association (IFPMA)
about 7% of all drugs being sold around the world in 1992 were of poor quality:
being counterfeit or substandard.
In Rwanda
there are no facilities for quality control of pharmaceuticals, no systematic
monitoring of the quality of drugs on the market. This gross deficiency
increases the risk that the importers of pharmaceuticals would go for cheap
possibly low quality products because the substandard products would not be
detected.
After the genocide, the Rwandan pharmaceuticals market is
characterized by the presence of many generics from multisource suppliers and
healthcare providers. Consequently clinicians and pharmacists are faced with
selecting a product that gives the same clinical effect than that claimed to do
so. In most of cases this selection is based on economical considerations and
on the assumption that those dosage forms containing the same amount of active
ingredient are the equivalent.
In addition, there are wide price differences between
formulations containing the same amount of active ingredient (even more than
500%); subsequently patients with low purchasing power will go for cheap
brands. With such differences in price it is essential to know if those brands
are really pharmaceutically equivalent, or if there is a relationship between
price and quality.
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