Medical drug falsification mainly concerns those which are in high demand, such as antimalarials in African regions where malaria is endemic. IRD researchers (1) have examined the quality of antimalarial medicines available from informal distribution networks in Cameroon. They also assessed the impact of malaria patients' taking these medicines, obtained on the illicit market, on their health. Self-medication is common but when it relies on supplies of poor-quality drugs it is ineffectual for controlling the disease. Quite the reverse, as it favours proliferation of treatment-resistant parasites leading to treatment failures and to people spending money futilely on health. Government measures for controlling such fraud are clearly necessary if public health is to be protected.
Large-scale diffusion and sale of medicines that do not comply with regulations or are poor in quality, especially in African countries, stems from several factors. These include: the intensification of trade, a growing demand for medical treatments or vaccines, a proliferation of small pharmaceutical industries, and inadequate regulation of manufacture and commerce of such products. Counterfeiting, which affects all classes of medical drugs, concerns mainly antibiotics and anti-parasitic drugs. This is the case of antimalarials, under high demand in African countries where malaria is endemic. This demand sustains the informal trade of false or poor quality antimalarial drugs, which is the final stage for distribution networks of counterfeit medicines that escape any control by health authorities.
To assess the effect this illegal sector has on malaria control, an IRD team investigated the origin and quality of several antimalarial drugs in tablet or capsule form. They were purported to contain chloroquine, quinine or a sulfadoxin-pyrimethamin mixture. These medicines were collected between 2001 and 2002 on the markets, from street vendors or patients who had obtained supplies from outside official networks, in several towns and villages in Cameroon (1).
A total of 284 samples obtained from 132 different points of sale in 16 localities were submitted to colorimetric tests and chromatographic analyses. The team succeeded in determining if the active principle contained in these medicines really corresponded to that for which they were being sold and approximately evaluate its quantity. They showed that 38% of the drugs supposedly containing chloroquine, 74% said to contain quinine and 12% of those purported to have sulfadoxin-pyrimethamin in fact contained either no active principle, one insufficient in quantity, or an active principle of another sort, or even some unknown compounds. Out of all the samples studied, only 118 bore mention of their origin, 61 coming from the European Union, 6 from East Europe, 39 from Asia and 12 from Africa. In most cases it was impossible to determine the names of pharmaceutical companies responsible either for marketing or for their manufacture. Other analyses were conducted on 15 samples sold purportedly containing chloroquine and quinine, samples collected from 15 patients who had acquired them on the informal market, without prior consultation. Only six of these samples proved to be of acceptable quality (2). Eight among the 15 patients gave negative urine tests for the active principle. Such absence of any trace of the latter results from self-medication with false drugs or under-dosed medicines with insufficient antimalarial active principle.
The illegal trade and free use of these non-compliant products can aggravate the clinical state of patients, possibly leading to death from the disease itself owing to the ineffectiveness of these treatments. These practices often induce a prolongation of treatment times which affects health expenditure. Moreover, they favour the selection of pathogens resistant to authentic antimalarial drugs, effectively holding back the actions of research and national malaria control programmes.
However, the practice of self-medication, on condition that it is based on medicines that comply with quality and dosage requirements, could represent a strategy for rapid, early intervention in case of malaria attack. Applied early, it could reduce the risk of patients' deterioration towards the more severe forms of the disease. In Cameroon, as in most African countries, self-medication is common. People suffering from the disease avoid medical consultations because of their cost, often prohibitive for low-income households, and the absence of or distance from health care facilities. Obtaining such drugs on the informal market is cheaper than buying them from dispensaries authorized to issue medicines.
Government measures therefore appear necessary to provide better regulation of import and distribution of good quality generic medicines, fraud control and training (health authority personnel, pharmacists, medicines, etc.), in order to improve access to treatments, medical follow-up of patients and to contribute effectively to malaria control.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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