DOI record:
{
"DOI": "10.1002/dta.3618",
"ISSN": [
"1942-7603",
"1942-7611"
],
"URL": "http://dx.doi.org/10.1002/dta.3618",
"abstract": "<jats:title>Abstract</jats:title><jats:p>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 (<jats:italic>n</jats:italic> = 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.</jats:p>",
"alternative-id": [
"10.1002/dta.3618"
],
"assertion": [
{
"group": {
"label": "Publication History",
"name": "publication_history"
},
"label": "Received",
"name": "received",
"order": 0,
"value": "2023-10-11"
},
{
"group": {
"label": "Publication History",
"name": "publication_history"
},
"label": "Accepted",
"name": "accepted",
"order": 1,
"value": "2023-11-10"
},
{
"group": {
"label": "Publication History",
"name": "publication_history"
},
"label": "Published",
"name": "published",
"order": 2,
"value": "2023-12-03"
}
],
"author": [
{
"ORCID": "http://orcid.org/0000-0002-6634-3706",
"affiliation": [
{
"name": "Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks Sciensano Brussels Belgium"
}
],
"authenticated-orcid": false,
"family": "Vanhee",
"given": "Celine",
"sequence": "first"
},
{
"ORCID": "http://orcid.org/0000-0001-7307-9619",
"affiliation": [
{
"name": "Service of Foodborne Pathogen, Scientific Direction of Infectious Diseases in Humans Sciensano Brussels Belgium"
}
],
"authenticated-orcid": false,
"family": "Jacobs",
"given": "Bram",
"sequence": "additional"
},
{
"affiliation": [
{
"name": "Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks Sciensano Brussels Belgium"
}
],
"family": "Kamugisha",
"given": "Angélique",
"sequence": "additional"
},
{
"affiliation": [
{
"name": "Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks Sciensano Brussels Belgium"
}
],
"family": "Canfyn",
"given": "Michael",
"sequence": "additional"
},
{
"affiliation": [
{
"name": "Federal Agency for Medicine and Health Care Products Brussels Belgium"
}
],
"family": "Van Der Meersch",
"given": "Hans",
"sequence": "additional"
},
{
"affiliation": [
{
"name": "Federal Agency for Medicine and Health Care Products Brussels Belgium"
}
],
"family": "Ceyssens",
"given": "Bart",
"sequence": "additional"
},
{
"affiliation": [
{
"name": "Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks Sciensano Brussels Belgium"
}
],
"family": "Deconinck",
"given": "Eric",
"sequence": "additional"
},
{
"affiliation": [
{
"name": "Service of Foodborne Pathogen, Scientific Direction of Infectious Diseases in Humans Sciensano Brussels Belgium"
}
],
"family": "Van Hoorde",
"given": "Koenraad",
"sequence": "additional"
},
{
"affiliation": [
{
"name": "Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks Sciensano Brussels Belgium"
}
],
"family": "Willocx",
"given": "Marie",
"sequence": "additional"
}
],
"container-title": "Drug Testing and Analysis",
"container-title-short": "Drug Testing and Analysis",
"content-domain": {
"crossmark-restriction": true,
"domain": [
"analyticalsciencejournals.onlinelibrary.wiley.com"
]
},
"created": {
"date-parts": [
[
2023,
12,
4
]
],
"date-time": "2023-12-04T02:11:26Z",
"timestamp": 1701655886000
},
"deposited": {
"date-parts": [
[
2023,
12,
4
]
],
"date-time": "2023-12-04T02:11:36Z",
"timestamp": 1701655896000
},
"indexed": {
"date-parts": [
[
2023,
12,
4
]
],
"date-time": "2023-12-04T05:14:44Z",
"timestamp": 1701666884608
},
"is-referenced-by-count": 0,
"issued": {
"date-parts": [
[
2023,
12,
3
]
]
},
"language": "en",
"license": [
{
"URL": "http://onlinelibrary.wiley.com/termsAndConditions#vor",
"content-version": "vor",
"delay-in-days": 0,
"start": {
"date-parts": [
[
2023,
12,
3
]
],
"date-time": "2023-12-03T00:00:00Z",
"timestamp": 1701561600000
}
}
],
"member": "311",
"original-title": [],
"prefix": "10.1002",
"published": {
"date-parts": [
[
2023,
12,
3
]
]
},
"published-online": {
"date-parts": [
[
2023,
12,
3
]
]
},
"publisher": "Wiley",
"reference": [
{
"DOI": "10.46234/ccdcw2020.017",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_2_1"
},
{
"DOI": "10.1056/NEJMoa2001017",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_3_1"
},
{
"key": "e_1_2_5_4_1",
"unstructured": "World Health Organization. Coronavirus disease (COVID‐19) pandemic 2023. Accessed September 19 2023.https://www.who.int/europe/emergencies/situations/covid-19"
},
{
"DOI": "10.1016/j.antiviral.2012.06.008",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_5_1"
},
{
"DOI": "10.1042/BJ20120150",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_6_1"
},
{
"DOI": "10.1016/j.antiviral.2013.10.004",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_7_1"
},
{
"DOI": "10.1038/srep23138",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_8_1"
},
{
"DOI": "10.1016/j.ceb.2019.01.001",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_9_1"
},
{
"DOI": "10.1016/j.pt.2017.02.004",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_10_1"
},
{
"DOI": "10.1016/j.antiviral.2020.104787",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_11_1"
},
{
"DOI": "10.1016/j.antiviral.2020.104805",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_12_1"
},
{
"DOI": "10.1186/s12879‐022‐0",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_13_1"
},
{
"DOI": "10.3390/antibiotics11040445",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_14_1"
},
{
"DOI": "10.1056/NEJMc2114907",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_15_1"
},
{
"key": "e_1_2_5_16_1",
"unstructured": "United States Food and Drug Administration Ivermectin intended for animals: letter to stakeholders—do not use in humans as a treatment for COVID‐19 2020. Accessed September 19 2023.https://www.fda.gov/safety/medical‐product‐safety‐information/ivermectin‐intended‐animals‐letter‐stakeholders‐do‐not‐use‐humans‐treatment‐covid‐19"
},
{
"key": "e_1_2_5_17_1",
"unstructured": "Centers of Disease Control Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID‐19 2021. Accessed September 19 2023.https://emergency.cdc.gov/han/2021/pdf/CDC_HAN_449.pdf"
},
{
"DOI": "10.1016/j.cmi.2022.03.022",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_18_1"
},
{
"DOI": "10.1016/j.therap.2022.03.002",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_19_1"
},
{
"DOI": "10.3390/ijerph18147475",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_20_1"
},
{
"key": "e_1_2_5_21_1",
"unstructured": "Swiss medic Illegal imports 2021: Swissmedic seizes significantly more packages than in 2020.2022. Accessed September 19 2023.https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/medicinal-products-from-the-internet/statistical-data/importe-illegaler-am-2021.html"
},
{
"DOI": "10.1007/s40278‐022‐07672‐3",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_22_1"
},
{
"key": "e_1_2_5_23_1",
"unstructured": "World Health Organization WHO global surveillance and monitoring system for substandard and falsified medical products. World Health Organization.2017. Accessed September 19 2023.https://apps.who.int/iris/handle/10665/326708"
},
{
"DOI": "10.1787/a7c7e054‐en",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_24_1"
},
{
"DOI": "10.4269/ajtmh.14‐0539",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_25_1"
},
{
"DOI": "10.1136/bmjgh‐2017‐000409",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_26_1"
},
{
"DOI": "10.1056/NEJMc0807678",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_27_1"
},
{
"DOI": "10.1111/j.1742‐1241.2009.02328.x",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_28_1"
},
{
"DOI": "10.1016/j.jpba.2013.03.023",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_29_1"
},
{
"DOI": "10.1186/2050‐6511‐15‐34",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_30_1"
},
{
"DOI": "10.1002/dta.2740",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_31_1"
},
{
"DOI": "10.3390/forensicsci3030031",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_32_1"
},
{
"DOI": "10.1016/j.talanta.2018.10.078",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_33_1"
},
{
"key": "e_1_2_5_34_1",
"unstructured": "International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use—validation of analytical procedures. Accessed 30/05/2023. Available online:https://database.ich.org/sites/default/files/Q2(R1)Guideline.pdf"
},
{
"DOI": "10.1016/j.chroma.2007.02.021",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_35_1"
},
{
"DOI": "10.1007/s00769‐005‐0081‐9",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_36_1"
},
{
"key": "e_1_2_5_37_1",
"unstructured": "ISO/IEC 17025.General requirements for the competence of testing and calibration laboratories.2005."
},
{
"DOI": "10.3390/separations10080444",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_38_1"
},
{
"key": "e_1_2_5_39_1",
"volume-title": "United States Pharmacopoeia 42",
"year": "2022"
},
{
"key": "e_1_2_5_40_1",
"volume-title": "European Pharmacopoeia 10.0",
"year": "2022"
},
{
"DOI": "10.1186/1471‐2105‐11‐595",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_41_1"
},
{
"DOI": "10.3389/fmicb.2020.580691",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_42_1"
},
{
"DOI": "10.3389/fmicb.2023.1173594",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_43_1"
},
{
"DOI": "10.1128/AAC.02412‐14",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_44_1"
},
{
"DOI": "10.1002/jps.2600811008",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_45_1"
},
{
"DOI": "10.1111/j.1365‐2125.2009.03394.x",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_46_1"
},
{
"key": "e_1_2_5_47_1",
"unstructured": "International Conference on Harmonisation (ICH) of technical requirements for the registration of pharmaceuticals for human use Q3C (R8): impurities: guidelines for residual solvents Step 42021. Accessed September 19 2023.https://database.ich.org/sites/default/files/ICH_Q3C-R8_Guideline_Step4_2021_0422_1.pdf"
},
{
"DOI": "10.1099/ijsem.0.003775",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_48_1"
},
{
"DOI": "10.1128/microbiolspec.GPP3‐0032‐0018",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_49_1"
},
{
"DOI": "10.1128/JCM.00881‐06",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_50_1"
},
{
"DOI": "10.1186/s12866‐019‐1632‐2",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_51_1"
},
{
"DOI": "10.3389/fmicb.2020.599524",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_52_1"
},
{
"DOI": "10.3390/foods11162480",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_53_1"
},
{
"DOI": "10.14309/01.ajg.0000785384.55403.41",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_54_1"
},
{
"DOI": "10.1046/j.1365‐2958.2000.02147.x",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_55_1"
},
{
"DOI": "10.1128/JCM.43.8.4277‐4279.2005",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_56_1"
},
{
"DOI": "10.1128/JCM.05129‐11",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_57_1"
},
{
"DOI": "10.1136/bcr‐2020‐238716",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_58_1"
},
{
"DOI": "10.4315/0362‐028x‐68.3.636",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_59_1"
},
{
"DOI": "10.3390/toxins12110701",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_60_1"
},
{
"DOI": "10.4315/0362‐028X.JFP‐11‐481",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_61_1"
},
{
"DOI": "10.1128/CMR.00073‐09",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_62_1"
},
{
"DOI": "10.1016/0041‐008x(69)90058‐1",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_63_1"
},
{
"key": "e_1_2_5_64_1",
"unstructured": "United States Food and Drug Administration Leaflet Stromectol® tablets.2009. Accessed September 23 2023.https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050742s026lbl.pdf"
},
{
"DOI": "10.4269/ajtmh.17‐0042",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_65_1"
},
{
"DOI": "10.7759/cureus.42603",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_66_1"
},
{
"key": "e_1_2_5_67_1",
"unstructured": "European commission.The falsified medicines directive 2011/62/EU.2011. Accessed September 19 2023.https://health.ec.europa.eu/system/files/2016-11/dir_2011_62_en_0.pdf"
},
{
"key": "e_1_2_5_68_1",
"unstructured": "European commission.EU logo for online sale of medicines.2017. Accessed September 19 2023.https://health.ec.europa.eu/system/files/2016-11/logosancointernet_charte_v2_0.pdf"
},
{
"DOI": "10.1111/bcp.12298",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_69_1"
},
{
"DOI": "10.1586/14787210.2015.1015990",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_70_1"
},
{
"DOI": "10.1038/ja.2017.11",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_71_1"
},
{
"DOI": "10.1016/j.jpha.2014.03.002",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_72_1"
},
{
"DOI": "10.1002/dta.2690",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_73_1"
},
{
"DOI": "10.1186/s40360‐021‐00478‐x",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_74_1"
},
{
"DOI": "10.1155/2017/5163968",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_75_1"
},
{
"DOI": "10.2147/IDR.S332378",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_76_1"
},
{
"DOI": "10.1016/j.vprsr.2023.100907.223",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_77_1"
},
{
"DOI": "10.1093/bjd/ljad308",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_78_1"
},
{
"DOI": "10.1016/j.pt.2020.09.004",
"doi-asserted-by": "publisher",
"key": "e_1_2_5_79_1"
}
],
"reference-count": 78,
"references-count": 78,
"relation": {},
"resource": {
"primary": {
"URL": "https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/dta.3618"
}
},
"score": 1,
"short-title": [],
"source": "Crossref",
"subject": [
"Spectroscopy",
"Pharmaceutical Science",
"Environmental Chemistry",
"Analytical Chemistry"
],
"subtitle": [],
"title": "Substandard and falsified ivermectin tablets obtained for self‐medication during the COVID‐19 pandemic as a source of potential harm",
"type": "journal-article",
"update-policy": "http://dx.doi.org/10.1002/crossmark_policy"
}