Rafaella’s Literature Update
The following message is courtesy of Dr. Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium
Ref. Chiumia FK, Nyirongo HM, Kampira E, Muula AS, Khuluza F (2022) Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi. PLoS ONE 17(12): e0279637
Ref. RPQ/REG/ISF/Alert N°1/2023. Substandard (contaminated) liquid dosage medicines identified in WHO European Region
Today, I would like to share an open-access manuscript by Chiumia and colleagues. They report the findings of a medicine quality survey that assessed the prevalence and factors associated with substandard and falsified (SF) medicines among commonly used, orally-administered antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi. Samples collected at 23 public, faith-based and private health facilities, were subjected to visual inspection for any visible defects; and screened for the content of active pharmaceutical ingredients and disintegration of dosage units, with the Global Pharma Health Fund minilab®. Samples that failed screening and at least 10% of those that passed it, were subjected to pharmacopeia assay and dissolution test for confirmation in a Quality Control laboratory.
Of the 293 medicine samples collected, 14.3% were SF medicines. Among them, we find samples of Amlodipine (1/8), Amoxicillin (5/26), Atenolol (8/11), Ciprofloxacin (7/33), Enalapril (1/7), Flucloxacillin (4/9), and sulfadoxine/ pyrimethamine (10/28). Overall, there were fewer cases of SF medicines among antimalarial and antidiabetic medicines than among antibiotics. Local production did not seem to improve quality: the prevalence of SF medicines was 33% (9/27) for medicines stated to be manufactured in China, 26.7% (4/15) for medicines stated to be manufactured in Kenya, 6.6% (8/122) for medicines stated to be manufactured in India, and 30% (15/50) for medicines stated to be manufactured in Malawi. Furthermore, there were fewer SF cases for medicine samples in blisters, compared to those that used bottles for primary packaging. These findings show the importance of keeping on investing in strengthening regulatory supervision, for protecting people from SF medicines.
This need is sadly confirmed by the attached WHO Alert, which reports two substandard (contaminated) products, identified in Uzbekistan. Both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol (this follows two similar alerts from The Gambia and Indonesia, at the end of 2022). Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. These products are unsafe and their use, especially in children, may result in serious injury or death.
Please, feel very free to share these with any interested/concerned colleague.