Substandard and falsified antimicrobials: A potential biohazard in disguise?

Tie, Yaxin; Adams, Erwin; Deconinck, Éric; Vanhee, Céline

doi:10.1002/dta.2740

Cited by 2 publications

(4 citation statements)

References 32 publications

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“…In case of no hits with a sufficient log(score), hits with log(score) values between 1.70 and 2.00 were reported on genus level (in case of Bacillus spp.). The fungi encountered in the samples were also isolated on Sabouraud medium prior to fungal material extraction and subsequent analysis by MALDI-TOF [28]. Also, here, hits with log(score) values equal or higher than 2.00 were considered as a high-confidence identification at the species level.…”

Section: Methodsmentioning

confidence: 99%

“…are known to be opportunistic pathogens [50]. Another study, conducted in 2019 on falsified antimicrobiologicals, demonstrated that 35% of the samples (6/17) were not compliant for the total yeast and mold count (TYMC) and were mainly contaminated with Penicillium rubens, a fungus that is very common in subtropical regions [28]. Although this species has rarely been linked to human mycoses, this mold can produce mycotoxins that can cause liver and kidney intoxication [51].…”

Section: Bioburden Determination and Identification Of The Microorgan...mentioning

confidence: 99%

“…Although this species has rarely been linked to human mycoses, this mold can produce mycotoxins that can cause liver and kidney intoxication [51]. Therefore, we initially set out to check the TAMC and the TYMC as described by Tie et al, 2019 [28]. According to the USP and EP, the acceptance criteria for non-aqueous preparations for oral use are 10 3 colony-forming units (CFU)/g in the TAMC test and 10 2 CFU/g in the TYMC test, corresponding to a maximum acceptable count of, respectively, 2000 CFU/g and 200 CFU/g [26,43,45].…”

Section: Bioburden Determination and Identification Of The Microorgan...mentioning

confidence: 99%

“…Based on the scientific literature, the major health risks associated with the use of these SF medicinal products are supplemented by the fact that they are not produced in accordance with the good manufacturing practices (GMP). This may result in them containing only inactive ingredients, wrong ingredients, an improper amount of an active pharmaceutical ingredient (API) or potentially toxic impurities and might also be contaminated with potentially pathogenic microorganisms [1,[4][5][6][7][8][9][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28]. Nevertheless, rogue online pharmacies still promote the use of unregistered or unlicensed medicinal products by distinguishing their product from "traditional" falsified products and their associated bad reputation.…”

Section: Introductionmentioning

confidence: 99%

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Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

Vanhee,

Jacobs,

Mori

et al. 2023

Forensic Sciences

Self Cite

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Illicit PDE-5 inhibitors are frequently encountered by regulatory agencies. Self-medicating with substandard and falsified (SF) PDE-5 inhibitors could be dangerous as they are likely taken without any medical supervision and might be of poor quality which could result in adverse reactions. In order to provide an overview of the quality deficiencies present in recently seized illicit PDE-5 samples that may pose health risks, we set out to identify the products’ different chemical and/or biological risks. Our results indicate that 38% of the samples harbored a chemical risk including the significant exceedance of the maximum recommended dosage, a large heterogeneity in API content between the different tablets in the same package or blister and the presence of only 40% of the claimed dosage. Moreover, our results also demonstrate that 16 of the 32 samples were not compliant with the internationally set microbiological quality standards. Startlingly, two samples were severely contaminated with potentially pathogenic bacteria, which could result in a gastrointestinal illness upon oral intake.

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Section: Methodsmentioning

confidence: 99%

Section: Bioburden Determination and Identification Of The Microorgan...mentioning

confidence: 99%

Section: Bioburden Determination and Identification Of The Microorgan...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

Vanhee,

Jacobs,

Mori

et al. 2023

Forensic Sciences

Self Cite

View full text Add to dashboard Cite

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Substandard and falsified ivermectin tablets obtained for self‐medication during the COVID‐19 pandemic as a source of potential harm

Vanhee,

Jacobs,

Kamugisha

et al. 2023

Drug Testing and Analysis

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In 2019, a global viral pandemic, due to the SARS‐CoV‐2 virus, broke out. Soon after, the search for a vaccine and/or antiviral medicine began. One of the candidate antiviral medicines tested was ivermectin. Although several health authorities warned the public against the use of this medicine outside clinical trials, the drug was widely used at the end of 2020 and in 2021. Simultaneously, several reports started to emerge demonstrating serious adverse effects after self‐medicating with ivermectin. It stands to reason that the self‐administration of substandard or falsified (SF) medicines bearing harmful quality deficiencies have contributed to this phenomenon. In order to have a better view on the nature of these harmful quality deficiencies, SF ivermectin samples, intercepted in large quantities by the Belgian regulatory agencies during the period 2021–2022, were analyzed in our official medicines control laboratory. None of the samples (n = 19) were compliant to the quality criteria applicable to medicinal products. These SF products either suffered from a systematic underdosing of the active pharmaceutical ingredient or were severely contaminated with bacteria, two of which were contaminated with known pathogens that cause gastrointestinal illness upon oral intake. In addition to the direct risks of self‐medicating with such a product, the improper usage and dosage of ivermectin medication might also facilitate ivermectin tolerance or resistance in parasites. This may have detrimental consequences on a global scale, certainly as the number of newly developed active pharmaceutical ingredients that can safely be used to combat parasites is rather scarce.

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Substandard and falsified antimicrobials: A potential biohazard in disguise?

Cited by 2 publications

References 32 publications

Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

Substandard and falsified ivermectin tablets obtained for self‐medication during the COVID‐19 pandemic as a source of potential harm

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