The response to substandard and falsified medical products in francophone sub-Saharan African countries: weaknesses and opportunities.

Assuring the quality of medical products manufactured, imported or distributed in francophone sub-Saharan Africa remains a challenge, despite positive signals like the growing engagement in the benchmarking of regulatory authorities and -particularly- in the establishment of the African Medicines Agency. In this short report, we describe the existing activities to prevent, detect and respond to substandard and falsified products (SF) in this region, either through African multilateral organizations and initiatives led by the World Health Organization, or through the contribution of other stakeholders, such as local universities and procurement agencies. We underline that these emerging local stakeholders may play a pivotal role to guide and inform the national regulatory authorities about the prevalence and patterns of SF medical products, complementing the market surveillance and control, and building awareness of the importance of pharmaceutical quality assurance for public health.

Surveillance for substandard and falsified medicines by local faith-based organizations in 13 low- and middle-income countries using the GPHF Minilab.

This study evaluates the use of the Global Pharma Health Fund (GPHF) Minilab for medicine quality screening by 16 faith-based drug supply organizations located in 13 low- and middle-income countries. The study period included the year before the COVID-19 pandemic (2019) and the first year of the pandemic (2020). In total 1,919 medicine samples were screened using the GPHF Minilab, and samples showing serious quality deficiencies were subjected to compendial analysis in fully equipped laboratories. Thirty-four (1.8%) of the samples were found not to contain the declared active pharmaceutical ingredient (API), or less than 50% of the declared API, or undeclared APIs, and probably represented falsified products. Fifty-four (2.8%) of the samples were reported as substandard, although the true number of substandard medicines may have been higher due to the limited sensitivity of the GPHF Minilab. The number of probably falsified products increased during the COVID-19 pandemic, especially due to falsified preparations of chloroquine; chloroquine had been incorrectly advocated as treatment for COVID-19. The reports from this project resulted in four international WHO Medical Product Alerts and several national alerts. Within this project, the costs for GPHF Minilab analysis resulted as 25.85 € per sample. Medicine quality screening with the GPHF Minilab is a cost-effective way to contribute to the global surveillance for substandard and falsified medical products.

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

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.

Identification of Falsified Chloroquine Tablets in Africa at the Time of the COVID-19 Pandemic.

Reports that chloroquine and hydroxychloroquine may be effective against COVID-19 have received worldwide attention, increasing the risk of the introduction of falsified versions of these medicines. Five different types of falsified chloroquine tablets were discovered between March 31, 2020 and April 4, 2020, in Cameroon and the Democratic Republic of Congo by locally conducted thin layer chromatographic analysis. Subsequent investigation by liquid chromatography and mass spectrometry in Germany proved the absence of detectable amounts of chloroquine and the presence of undeclared active pharmaceutical ingredients, that is, paracetamol and metronidazole, in four of the samples. The fifth sample contained chloroquine, but only 22% of the declared amount. Such products represent a serious risk to patients. Their occurrence exemplifies that once medicines or vaccines against COVID-19 may be developed, falsified products will enter the market immediately, especially in low- and middle-income countries (LMICs). Timely preparations for the detection of such products are required, including the establishment of appropriate screening technologies in LMICs.

Availability, prices and affordability of selected antibiotics and medicines against non-communicable diseases in western Cameroon and northeast DR Congo.

Access to safe, effective and affordable medicines of good quality is included into the Sustainable Development Goals of the United Nations. Furthermore, WHO has developed a Global Action Plan with the aim to raise access to essential medicines against non-communicable diseases (NCDs) to 80%, and to improve their affordability. In order to contribute to the monitoring of progress towards these goals, the present study investigated the availability and affordability of seven antibiotics and six medicines against non-communicable diseases in the northeast of the Democratic Republic of Congo and the west of the Republic of Cameroon. Data on availability and prices of these medicines were collected in 60 different sites (34 in the DR Congo, 26 in Cameroon), including government health facilities, church health facilities, private pharmacies and informal vendors, as part of a study on medicine quality. The data were analyzed using a standardized procedure developed by WHO and Health Action International (HAI). Average availability of the investigated antibiotics ranged from 62% to 98% in the different types of facilities in both countries, including the informal vendors. Average availability for medicines against NCDs in the different types of facilities showed a higher variation in both countries, ranging from 11% up to 87%. The average availability of medicines against NCDs in government health facilities was only 33% in Cameroon, and as low as 11% in the DR Congo. In contrast, availability of medicines against NCDs in church health facilities in Cameroon was 70%, not far from the 80% availability goal set by WHO. Medicine prices were clearly higher in Cameroon than in the DR Congo, with median price ratios to an international reference price of 5.69 and 2.17, respectively (p < 0.001). In relation to the daily minimum wages in both countries, treatment courses with five of the seven investigated antibiotics could be considered as affordable, while in each country only one out of the five investigated medicines against NCDs could be considered as affordable. Especially generic medicines provided by government and church health facilities showed reasonable affordability in most cases, while originator medicines offered by private pharmacies were clearly unaffordable to a major part of the population. Despite some encouraging findings on the availability of antibiotics in both countries, the availability and affordability of medicines against NCDs urgently requires further improvements.