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

    Gnegel, Gesa / Häfele-Abah, Christine / Neci, Richard / Heide, Lutz

    Scientific reports

    2022  Volume 12, Issue 1, Page(s) 13095

    Abstract: 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 ...

    Abstract 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.
    MeSH term(s) COVID-19/drug therapy ; COVID-19/epidemiology ; Chloroquine ; Counterfeit Drugs/analysis ; Developing Countries ; Faith-Based Organizations ; Financial Management ; Humans ; Pandemics
    Chemical Substances Counterfeit Drugs ; Chloroquine (886U3H6UFF)
    Language English
    Publishing date 2022-07-30
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-022-17123-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Verification of the active pharmaceutical ingredient in tablets using a low-cost near-infrared spectrometer

    Julia Gabel / Gesa Gnegel / Waltraud Kessler / Pierre-Yves Sacré / Lutz Heide

    Talanta Open, Vol 8, Iss , Pp 100270- (2023)

    2023  

    Abstract: The present study investigated the possibilities and limitations of using a low-cost NIR spectrometer for the verification of the presence of the declared active pharmaceutical ingredients (APIs) in tablet formulations, especially for medicine screening ... ...

    Abstract The present study investigated the possibilities and limitations of using a low-cost NIR spectrometer for the verification of the presence of the declared active pharmaceutical ingredients (APIs) in tablet formulations, especially for medicine screening studies in low-resource settings. Spectra from 950 to 1650 nm were recorded for 170 pharmaceutical products representing 41 different APIs, API combinations or placebos. Most of the products, including 20 falsified medicines, had been collected in medicine quality studies in African countries. After exploratory principal component analysis, models were built using data-driven soft independent modelling of class analogy (DD-SIMCA), a one-class classifier algorithm, for tablet products of penicillin V, sulfamethoxazole/trimethoprim, ciprofloxacin, furosemide, metronidazole, metformin, hydrochlorothiazide, and doxycycline. Spectra of amoxicillin and amoxicillin/clavulanic acid tablets were combined into a single model. Models were tested using Procrustes cross-validation and by projection of spectra of tablets containing the same or different APIs. Tablets containing no or different APIs could be identified with 100 % specificity in all models. A separation of the spectra of amoxicillin and amoxicillin/clavulanic acid tablets was achieved by partial least squares discriminant analysis. 15 out of 19 external validation products (79 %) representing different brands of the same APIs were correctly identified as members of the target class; three of the four rejected samples showed an API mass percentage of the total tablet weight that was out of the range covered in the respective calibration set. Therefore, in future investigations larger and more representative spectral libraries are required for model building. Falsified medicines containing no API, incorrect APIs, or grossly incorrect amounts of the declared APIs could be readily identified.Variation between different NIR-S-G1 spectroscopic devices led to a loss of accuracy if spectra recorded with different ...
    Keywords Near-infrared spectroscopy ; Pharmaceuticals ; Medicine quality ; Substandard and falsified medicines ; DD-SIMCA ; Authentication ; Analytical chemistry ; QD71-142
    Subject code 540
    Language English
    Publishing date 2023-12-01T00:00:00Z
    Publisher Elsevier
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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

    Gesa Gnegel / Christine Häfele-Abah / Richard Neci / Difäm-EPN Minilab Network / Lutz Heide

    Scientific Reports, Vol 12, Iss 1, Pp 1-

    2022  Volume 13

    Abstract: Abstract 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 ...

    Abstract Abstract 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.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2022-07-01T00:00:00Z
    Publisher Nature Portfolio
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Quality of oxytocin and misoprostol in health facilities of Rwanda.

    Bizimana, Thomas / Hagen, Nhomsai / Gnegel, Gesa / Kayumba, Pierre Claver / Heide, Lutz

    PloS one

    2021  Volume 16, Issue 1, Page(s) e0245054

    Abstract: Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol ... ...

    Abstract Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol tablets are medicines of first choice for the management of PPH in low- and middle-income countries (LMICs). Unfortunately, both substances are chemically unstable, and previous studies have revealed serious quality problems of these medicines in LMICs. The present study is the first report on their quality in Rwanda. From 40 randomly selected health facilities (hospitals, health centers, retail pharmacies and private clinics) in different parts of Rwanda, as well as from six wholesalers and government stores, oxytocin injections and misoprostol tablets were collected. Oxytocin storage temperatures in the health facilities were monitored for six months using temperature data loggers, and found to correctly follow the storage requirements stated by the manufacturers (2-8°C, or room temperature) with few minor deviations. Oxytocin injections (57 samples, representing seven batches of four brands) were tested for their oxytocin content and pH value according to the United States Pharmacopeia. Twenty-four samples from three European manufacturers passed all tests. However, all nine samples of one batch of a Chinese manufacturer showed an excessive content of oxytocin (range 117.2-121.5% of the declared amount). Another batch of the same manufacturer showed extreme variations of the concentration of the preservative benzyl alcohol. Misoprostol tablets (25 samples, representing ten batches of six brands) were tested for content and dissolution according to the International Pharmacopoeia. Fifteen samples passed, but all 10 samples of two brands from India failed with extreme deviations, containing only 42.5-48.7% of the stated amount of misoprostol. In conclusion, oxytocin quality in Rwanda was better than reported from other African countries. However, two extremely substandard brands of misoprostol tablets were found. The Rwandan authorities reacted quickly and efficiently, and recalled these substandard medicines from the market. For oxytocin and misoprostol, with their well-known problems of quality and stability, procurement should possibly be restricted to medicines which are WHO-prequalified or which have been manufactured in countries with stringent regulatory authorities.
    MeSH term(s) Drug Storage/standards ; Health Facilities/standards ; Humans ; Oxytocics/analysis ; Oxytocics/standards ; Oxytocics/supply & distribution ; Quality Assurance, Health Care/standards ; Quality Control ; Rwanda
    Chemical Substances Oxytocics
    Language English
    Publishing date 2021-01-08
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0245054
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Quality of oxytocin and misoprostol in health facilities of Rwanda.

    Thomas Bizimana / Nhomsai Hagen / Gesa Gnegel / Pierre Claver Kayumba / Lutz Heide

    PLoS ONE, Vol 16, Iss 1, p e

    2021  Volume 0245054

    Abstract: Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol ... ...

    Abstract Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol tablets are medicines of first choice for the management of PPH in low- and middle-income countries (LMICs). Unfortunately, both substances are chemically unstable, and previous studies have revealed serious quality problems of these medicines in LMICs. The present study is the first report on their quality in Rwanda. From 40 randomly selected health facilities (hospitals, health centers, retail pharmacies and private clinics) in different parts of Rwanda, as well as from six wholesalers and government stores, oxytocin injections and misoprostol tablets were collected. Oxytocin storage temperatures in the health facilities were monitored for six months using temperature data loggers, and found to correctly follow the storage requirements stated by the manufacturers (2-8°C, or room temperature) with few minor deviations. Oxytocin injections (57 samples, representing seven batches of four brands) were tested for their oxytocin content and pH value according to the United States Pharmacopeia. Twenty-four samples from three European manufacturers passed all tests. However, all nine samples of one batch of a Chinese manufacturer showed an excessive content of oxytocin (range 117.2-121.5% of the declared amount). Another batch of the same manufacturer showed extreme variations of the concentration of the preservative benzyl alcohol. Misoprostol tablets (25 samples, representing ten batches of six brands) were tested for content and dissolution according to the International Pharmacopoeia. Fifteen samples passed, but all 10 samples of two brands from India failed with extreme deviations, containing only 42.5-48.7% of the stated amount of misoprostol. In conclusion, oxytocin quality in Rwanda was better than reported from other African countries. However, two extremely ...
    Keywords Medicine ; R ; Science ; Q
    Subject code 650
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Identification of Falsified Chloroquine Tablets in Africa at the Time of the COVID-19 Pandemic.

    Gnegel, Gesa / Hauk, Cathrin / Neci, Richard / Mutombo, Georges / Nyaah, Fidelis / Wistuba, Dorothee / Häfele-Abah, Christine / Heide, Lutz

    The American journal of tropical medicine and hygiene

    2020  Volume 103, Issue 1, Page(s) 73–76

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Cameroon ; Chloroquine/analysis ; Chromatography, High Pressure Liquid ; Chromatography, Thin Layer ; Coronavirus Infections/epidemiology ; Counterfeit Drugs/analysis ; Democratic Republic of the Congo ; Humans ; Mass Spectrometry ; Pandemics ; Pneumonia, Viral/epidemiology ; SARS-CoV-2
    Chemical Substances Counterfeit Drugs ; Chloroquine (886U3H6UFF)
    Keywords covid19
    Language English
    Publishing date 2020-05-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2942-7
    ISSN 1476-1645 ; 0002-9637
    ISSN (online) 1476-1645
    ISSN 0002-9637
    DOI 10.4269/ajtmh.20-0363
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Gnegel, Gesa / Hauk, Cathrin / Neci, Richard / Mutombo, Georges / Nyaah, Fidelis / Wistuba, Dorothee / Häfele-Abah, Christine / Heide, Lutz

    Am. j. trop. med. hyg

    Abstract: 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 ... ...

    Abstract 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.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #32400349
    Database COVID19

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