E-DRUG: New Minilab article in Nature Scientific Reports
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E-Druggers,
I have just read an impressive article about the use of the Minilab in 13 LMICs. The article was published in Nature Scientific Reports but I read about it in the EPN e-Pharmalink newsletter.
The URL is
https://www.epnetwork.org/centre-of-excellence/surveillance-for-substandard-and-falsified-medicines-by-local-faith‑based-organizations-in-13-low‑-and-middle‑income-countries-using-the-gphf-minilab/
The reference would be Gnegel, G., Häfele-Abah, C., Neci, R. et al.
Surveillance for substandard and falsified medicines by local faith-based organizations in 13 low- and middle-income countries using the GPHF Minilab. Sci Rep 12, 13095 (2022). https://doi.org/10.1038/s41598-022-17123-0
The abstract reads:
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.
What impresses me about this article is the clear description of both the Minilab system and the Minilab network. There is a very good figure which provides a flow chart of the process that was used in the 13 countries. The key results were that out of 2055 samples submitted, 1919 were suitable for analysis. Only 88 (4.6%) failed testing. 54 were labelled as 'probably substandard' and this related to labelling, failure to disintegrate, visual deficiencies, and insufficient or decomposition of the API.
The 34 samples that were labelled probably falsified (1.8%) included 16 with no API, 9 with the declared API absent or non declared API present or API content less than 25% of stated content. The confirmation of the quality deficiency was by compendial analysis at MEDS QC laboratory or at a University lab, 4 of these discoveries resulted in WHO Alerts, 6 closely similar product were confirmed to be falsified by compendial analysis or by WHO or an NRA alert and only 5 depended on the Minilab TLC results.
So these are impressive results showing that the Faith Based Organizations are generally procuring quality assured products and 4.6% of the time substandard or falsified products are detected. The paper provides details on the national origin of the samples tested and the therapeutic categories of the products.
One paragraph I found particularly telling so I quote it directly from the article.
'Notably, out of the 34 probably falsified medicines, 22 samples (64.7%) were reported to show deficiencies already in visual inspection, such as missing data or mistakes in the labelling, or visible deficiencies of the dosage forms. In contrast, out of the 1885 medicines considered non-falsified, 34 (i.e., only 1.8%) were reported to show visual deficiencies. This difference is statistically significant and emphasizes that careful visual inspection is an important and powerful tool in the screening for falsified medicines.
This means that visual inspection by a trained person receiving the medicine into the facility can detect nearly two thirds of the falsified medicines.
The paper has a section about the costing of project pointing how much lower the cost is using the Minilab system than depending on compendial analysis even using the MEDS lower cost quality testing facility.
All of the authors and everybody who contributed from the 13 countries deserve congratulations and appreciation for the work that led to this publication. Often work like this occurs, but is known to only a few people who appreciate the value of the work but the field workers who collect the samples, the lab technicians or pharmacists who do the testing and the staff at Difam at Tubingen and MEDS in Nairobi who do the compendial testing and putting the results together frequently do not get the recognition they deserve! This paper should ensure that they are all recognized for doing this outstanding work!
My congratulations to all involved!
Richard Laing
Richard Laing
Retired Professor, Department of Global Health
Boston University School of Public Health,
Tel 617 435 7860 (Mobile)
E mail richardl@bu.edu