Abstract :
[en] Poor (or low) quality medicines remain a crucial problem of public health around the world. They
encompass falsified /counterfeit, substandard or degraded drugs. If proportion of 1% is estimated in developed countries, they are globally about 10 % of counterfeit drugs according to Food and Drug Administration, with 30% in low income countries and astonishing values (80 %) reported in some African countries. The consequences and dangers of such medicines are therapeutic failure, drug poisoning, microbial resistance or even death. For the pharmaceutical industries, there are loss of image, loss of financial income and employment. There is need to combat this scourge, but most of the time, means are very limited and even lacking. In this context, several means or tools are developed by the ULg Pharmacy Department including the simple ones including organoleptic tests, simple analytical tests such as analytical balance, pHmeter, thin layer chromatography (TLC), UV-visible spectrophotometry to the more complex including liquid chromatography (LC) coupled to UV-Vis detector, or to mass spectrometry, nuclear magnetic resonance, Raman imagery (RIM) and near infrared (NIR) spectroscopy associated with the principal component analysis (PCA).
In this way, we have analyzed several suspected samples obtained via the public health authorities of the D.R. Congo, Benin and Rwanda after their seizure or through collaborations. The results are
presented by therapeutic class, namely:
analgesics:
- by using LC and complementary information from victim patients, we were able to discover an
abnormal presence of a benzodiazepine at very high doses in paracetamol tablets which was the
cause of unusual adverse effects (sedative effects, polyuria and hypotension) in patients who have
consumed it;
- by using the NIR-PCA, we were able to elucidate the substitution of an excipient (glycerol) by
diethylene glycol in paracetamol syrup which caused the death of a hundred babies.
antimalarials:
- we faced cases of arthemether-lumefantrine tablets which had no therapeutic effect. By means of
TLC and LC, the absence of these two active ingredients was clearly demonstrated, but the presence of starch was revealed by RIM;
- another case of quinine tablets that had no expected pharmacological effect was faced. The use of
several combined techniques (TLC, LC-MS, NMR and RIM) allowed to detect the presence of a
substance with an imidazole structure (antamoeba).
antibiotics:
- the case of amoxicillin powder which after reconstitution in hospital caused poisoning of the babies
until death for some was investigated. The reconstitution of the suspension in the laboratory had
revealed the misuse of hydrogen peroxide instead of distilled water;
- we participated to a large-scale study (80 samples of amoxicillin powder) that showed 8% of
overdose.
The cases presented indicate that there are effectively poor quality medicines and there is need to
sustain strong collaborations while reinforcing appropriate measures to protect users.
