FALSIFIED MEDICINES IN AFRICA AND PUBLIC HEALTH - NO ACTION-TALK ONLY

PAUL NEWTON; PATRICIA TABERNERO; PRABHA DWIVEDI; MARIA CULZONI; MARIA MONGE; ISABEL SWAMIDOSS; DALLAS MILDENHALL; MICHAEL GREEN; RICHARD JÄHNKE; MIGUEL SANTOS DE OLIVEIRA; JULIA SIMAO; NICHOLAS WHITE; FACUNDO FERNÁNDEZ

Congreso; ASTMH 63rd Annual Meeting; 2014

Poor quality medicines are neglected impediments to improving globalpublic health. In June 2012 suspected falsified medicines labelled as theantimalarial artemether-lumefantrine bearing the Affordable MedicinesFacility-malaria (AMFm) logo and others labelled as the antihelminthicmebendazole were seized in Luanda, Angola. The tablets wereanalysed by an array of analytical platforms including high performanceliquid chromatography, ambient ionization mass spectrometry, Ramanspectroscopy, X-ray powder diffraction analysis, nuclear magneticresonance spectroscopy, isotope-ratio mass spectrometry, botanical assaysand packaging analysis, using the portable counterfeit detection deviceCD-3. No artemether or lumefantrine or other active pharmaceuticalingredients were detected in the artemether-lumefantrine tablets.Brushite and three different yellow dyes and few pollen grains werefound. No mebendazole was detected in the mebendazole formulation,but calcite and levamisole (270mg/tablet) were present. Both productsshowed marked differences in packaging characteristics from genuineproducts. The discovery of falsified artemether-lumefantrine, labelledas an AMFm product and without any detectable antimalarial, is ofconsiderable concern for malaria control. Presence of levamisole in falsifiedmebendazole is also of great concern as it has been banned for humanuse. This seizure illustrates many of the current problems regardingpoor reporting and transparency and inaction. Enhanced collaborationbetween African MRAs/police and the authorities in China to stop criminaltranscontinental trade in falsified essential medicines is urgently needed.Delays in reporting and action must be reduced by mandatory notificationsystems and independent public health risk assessments. Despite multiplereports, public health research has failed to stimulate actions required toimprove the quality of global drug supply.