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. 2020 Aug;103(2):894-908.
doi: 10.4269/ajtmh.20-0184. Epub 2020 May 7.

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

Simon Schäfermann  1 , Cathrin Hauk  1 , Emmanuel Wemakor  1 , Richard Neci  2 , Georges Mutombo  2 , Edward Ngah Ndze  3 , Tambo Cletus  3 , Fidelis Nyaah  4 , Manyi Pattinora  4 , Dorothee Wistuba  5 , Irina Helmle  1 , Christine Häfele-Abah  6 , Harald Gross  1 , Lutz Heide  1
Affiliations

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

Simon Schäfermann et al. Am J Trop Med Hyg. 2020 Aug.

Abstract

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%; P < 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%; P = 0.0049) and Africa (22.2%; P = 0.0042). Medicines against noncommunicable diseases showed a higher failure rate than antibiotics (25.3% versus 12.1%; P = 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.

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Conflict of interest statement

Disclaimer: The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Figures

Figure 1.
Figure 1.
Map of the locations from which samples were collected in Cameroon and the Democratic Republic of Congo (DR Congo). This figure appears in color at www.ajtmh.org.
Figure 2.
Figure 2.
Distribution of all collected samples (n = 506) over different categories. In the pie chart in (A), the different active pharmaceutical ingredients (APIs) are arranged in clockwise orientation. This figure appears in color at www.ajtmh.org.
Figure 3.
Figure 3.
Frequency of noncompliance with pharmacopoeial specifications for assay and dissolution in different subgroups of medicines. This figure appears in color at www.ajtmh.org.
Figure 4.
Figure 4.
Pictures of the three samples identified as falsified medicines. (A) Falsified Augmentin (sample no. QMCA241), containing no detectable active pharmaceutical ingredient (API). (B) Falsified penicillin V tablets (sample no. QMCA035), containing 50 mg paracetamol. Note that the API is misspelled on the label. (C) Left: falsified Metronyl (sample no. QMC266); manufactured date: February 2017, batch no: L3028, containing 93 mg metronidazole benzoate. Right: Metronyl (sample no. QMC036); manufactured date: March 2016, batch no: K2343, complying with U.S. Pharmacopeia 41 specifications for metronidazole tablets. This figure appears in color at www.ajtmh.org.
Figure 5.
Figure 5.
Content of the active pharmaceutical ingredient (API) determined for each sample. This figure appears in color at www.ajtmh.org.
Figure 6.
Figure 6.
Dissolution of the active pharmaceutical ingredient (API) determined for each sample. This figure appears in color at www.ajtmh.org.
See this image and copyright information in PMC

References

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