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

{ 'indexed': {'date-parts': [[2023, 12, 4]], 'date-time': '2023-12-04T05:14:44Z', 'timestamp': 1701666884608}, 'reference-count': 78, 'publisher': 'Wiley', 'license': [ { 'start': { 'date-parts': [[2023, 12, 3]], 'date-time': '2023-12-03T00:00:00Z', 'timestamp': 1701561600000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://onlinelibrary.wiley.com/termsAndConditions#vor'}], 'content-domain': { 'domain': ['analyticalsciencejournals.onlinelibrary.wiley.com'], 'crossmark-restriction': True}, '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>\u2009=\u200919) 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>', 'DOI': '10.1002/dta.3618', 'type': 'journal-article', 'created': {'date-parts': [[2023, 12, 4]], 'date-time': '2023-12-04T02:11:26Z', 'timestamp': 1701655886000}, 'update-policy': 'http://dx.doi.org/10.1002/crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Substandard and falsified ivermectin tablets obtained for self‐medication during the COVID‐19 ' 'pandemic as a source of potential harm', 'prefix': '10.1002', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-6634-3706', 'authenticated-orcid': False, 'given': 'Celine', 'family': 'Vanhee', 'sequence': 'first', 'affiliation': [ { 'name': 'Service Medicines and Health Products, Scientific Direction of ' 'Chemical and Physical Health Risks Sciensano Brussels ' 'Belgium'}]}, { 'ORCID': 'http://orcid.org/0000-0001-7307-9619', 'authenticated-orcid': False, 'given': 'Bram', 'family': 'Jacobs', 'sequence': 'additional', 'affiliation': [ { 'name': 'Service of Foodborne Pathogen, Scientific Direction of ' 'Infectious Diseases in Humans Sciensano Brussels Belgium'}]}, { 'given': 'Angélique', 'family': 'Kamugisha', 'sequence': 'additional', 'affiliation': [ { 'name': 'Service Medicines and Health Products, Scientific Direction of ' 'Chemical and Physical Health Risks Sciensano Brussels ' 'Belgium'}]}, { 'given': 'Michael', 'family': 'Canfyn', 'sequence': 'additional', 'affiliation': [ { 'name': 'Service Medicines and Health Products, Scientific Direction of ' 'Chemical and Physical Health Risks Sciensano Brussels ' 'Belgium'}]}, { 'given': 'Hans', 'family': 'Van Der Meersch', 'sequence': 'additional', 'affiliation': [ { 'name': 'Federal Agency for Medicine and Health Care Products Brussels ' 'Belgium'}]}, { 'given': 'Bart', 'family': 'Ceyssens', 'sequence': 'additional', 'affiliation': [ { 'name': 'Federal Agency for Medicine and Health Care Products Brussels ' 'Belgium'}]}, { 'given': 'Eric', 'family': 'Deconinck', 'sequence': 'additional', 'affiliation': [ { 'name': 'Service Medicines and Health Products, Scientific Direction of ' 'Chemical and Physical Health Risks Sciensano Brussels ' 'Belgium'}]}, { 'given': 'Koenraad', 'family': 'Van Hoorde', 'sequence': 'additional', 'affiliation': [ { 'name': 'Service of Foodborne Pathogen, Scientific Direction of ' 'Infectious Diseases in Humans Sciensano Brussels Belgium'}]}, { 'given': 'Marie', 'family': 'Willocx', 'sequence': 'additional', 'affiliation': [ { 'name': 'Service Medicines and Health Products, Scientific Direction of ' 'Chemical and Physical Health Risks Sciensano Brussels ' 'Belgium'}]}], 'member': '311', 'published-online': {'date-parts': [[2023, 12, 3]]}, 'reference': [ {'key': 'e_1_2_5_2_1', 'doi-asserted-by': 'publisher', 'DOI': '10.46234/ccdcw2020.017'}, {'key': 'e_1_2_5_3_1', 'doi-asserted-by': 'publisher', 'DOI': '10.1056/NEJMoa2001017'}, { 'key': 'e_1_2_5_4_1', 'unstructured': 'World Health Organization. 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