Abstract
Nowadays, the circulation of poor quality medicines is becoming an alarming worldwide phenomenon with serious public health and socio-economic concerns. The situation is particularly critical in developing countries where drug quality assurance and regulatory systems for drug manufacturing, importation, distribution and sales are weak. A sustained vigilance on poor quality medicines that regroup counterfeit/falsified, substandard and degraded medicines is therefore required to ensure patient safety and genuine medicines integrity. A case situation is illustrated including a strategic approach and analytical tools that were found useful to detect poor quality medicines, identify unknown components, and timely alerts for appropriate measures against the spread of those harmful products. Several suspected medicines randomly sampled in several strategic Rwandan areas were firstly check-controlled by means of visual inspection and then applying several analytical techniques from simple to more complex ones. The following medicines were studied: quinine sulfate tablets, artemisinin-based combination tablets, and artesunate powders for injection. Taking into account the pharmaceutical forms and the chemical characteristics, the following tests were applied: uniformity of mass, friability, disintegration, fluorescence, identification and assay. They were followed by more complex analytical techniques that allowed more comprehension of abnormal findings among which the presence of a wrong active pharmaceutical ingredient in quinine sulfate tablets which is mainly discussed in this paper to illustrate a strategic approach and various analytical tools that can be used in detecting and identifying unknown component in poor quality medicines.
Highlights
Over the past several years, the health of human beings is threatened by the old and new diseases, and by the consumption of medicines that are not well known and mostly of poor quality
According to the WHO guidelines [2], we focused on differences in packaging, labeling, and physical appearance of the dosage forms characterized by specific size, shape and color in order to identify potential counterfeiting or deterioration
Various cases of poor quality medicines were detected such as the presence of discolored film coated quinine tablets, the packaging of artesunate powder for injection in different size boxes, the unlike batch numbers of artesunate powder for injection vials and outer packaging boxes, the fake packaging of artemether-lumefantrine blister tablets labelled COMBIART (Strides Arcolab Ltd) in LUMARTEM boxes (Quality Chemical Industries Ltd.), and infiltrated artemisinine-based combination therapy drug (ACT) from Uganda to Rwanda with a specific marginal note stating “Government of Uganda, For Public Use Only, Not for Sale”
Summary
Over the past several years, the health of human beings is threatened by the old and new diseases, and by the consumption of medicines that are not well known and mostly of poor quality. The extent of damages caused by such drugs requires high collaborative endeavors at national and international levels to securize the public health, and the trade of genuine products which are targeted by counterfeiters and deliberately falsified. A drug that was initially of good quality may lose it for example by decrease of its potency or becoming toxic due to inappropriate storage conditions that lead to the appearance of impurities or degraded products. Newton et al [5] distinguished three categories of poor quality medicines: 1) Counterfeit/falsified medicines which are illicit products maliciously produced and distributed; 2) Substandard called out-of-specification “OOS” products which are genuine products generally produced in poor manufacturing conditions; and 3) Degraded medicines which are products improperly stored, and spoiled
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