Substandard and Falsified Antibiotics and Medicines against Noncommunicable Diseases in Western Cameroon and Northeastern Democratic Republic of Congo

• Published in: The American journal of tropical medicine and hygiene Vol. 103; no. 2; pp. 894 - 908
• Main Authors: Schäfermann, Simon, Hauk, Cathrin, Wemakor, Emmanuel, Neci, Richard, Mutombo, Georges, Ngah Ndze, Edward, Cletus, Tambo, Nyaah, Fidelis, Pattinora, Manyi, Wistuba, Dorothee, Helmle, Irina, Häfele-Abah, Christine, Gross, Harald, Heide, Lutz
• Format: Journal Article
• Language: English
• Published: United States Institute of Tropical Medicine 01.08.2020; The American Society of Tropical Medicine and Hygiene
• Subjects: Adrenergic beta-1 Receptor Antagonists - analysis; Adrenergic beta-1 Receptor Antagonists - standards; Adrenergic beta-2 Receptor Agonists - analysis; Adrenergic beta-2 Receptor Agonists - standards; Anti-Bacterial Agents - analysis; Anti-Bacterial Agents - standards; Antibiotics; Antihypertensive Agents - analysis; Antihypertensive Agents - standards; Cameroon; Chromatography, High Pressure Liquid; Counterfeit Drugs; Democratic Republic of the Congo; Diuretics - analysis; Diuretics - standards; Drugs, Essential - analysis; Drugs, Essential - standards; Humans; Hypoglycemic Agents - analysis; Hypoglycemic Agents - standards; Substandard Drugs; Cameroon; Democratic Republic of the Congo
• ISSN: 0002-9637; 1476-1645
• DOI: 10.4269/ajtmh.20-0184

Falsified and substandard medicines may undermine the progress toward the Sustainable Development Goals. The present study investigated the quality of 13 essential medicines in Cameroon and the Democratic Republic of Congo (DR Congo). Five hundred six medicine samples were collected from the government and faith-based health facilities, private pharmacies, and informal vendors (total 60 facilities). Collected samples were analyzed according to the U.S. Pharmacopeia (USP) for identity, content, and dissolution of their active pharmaceutical ingredients (APIs) and for uniformity of dosage units. Three samples (0.6%) were identified as falsified. Overall, 8.5% of the samples failed USP specifications for the content of the API and 11.7% failed dissolution testing. Medicines from informal vendors showed a higher out-of-specification rate (28.2%) than other types of drug outlets (12.3%; < 0.0001). All three falsified medicines had been sold by informal vendors. The failure rate of medicines stated to be produced in Europe (5.1%) was lower than that for medicines from Asia (17.7%; = 0.0049) and Africa (22.2%; = 0.0042). Medicines against noncommunicable diseases showed a higher failure rate than antibiotics (25.3% versus 12.1%; = 0.0004). Four hundred fifty-one of the samples were analyzed in Cameroon and the DR Congo with the Global Pharma Health Fund Minilab (thin-layer chromatography and disintegration testing). The three falsified medicines were readily detected in Minilab analysis. However, substandard samples were detected with low sensitivity. A well-enforced ban of medicine sales by informal vendors and increased attention to supplier qualification in the procurement process may reduce the prevalence of substandard and falsified medicines.