[e-drug] Medical Product Quality Report COVID-19 issues from April-May 2021

E-DRUG: Medical Product Quality Report COVID-19 issues from April-May 2021
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Dear colleagues,

The COVID-19 pandemic is accompanied by a multitude of reports of diverted,
substandard and falsified (SF) medical products, ranging from personal
protective equipment to diagnostic tests, medicines, and vaccines. In
response to this, we started in July 2020 issuing reports in which we share
data available in the public domain on quality concerns related to COVID-19
medial products. The Medical Product Quality Reports hold reports from
scientific literature, public alerts/warnings, and lay press:

https://www.iddo.org/mq/research/medical-product-quality-reports

The eleventh issue, covering the months of April and May 2021, is now
available and reports on 135 different incidents of diverted or SF medical
products from different articles from searches in Google News.
It is out at
https://www.tropmedres.ac/research-areas/medicine-quality/covid-19-pandemic

(scroll down to "Medical Product Quality Reports - COVID-19 Medical Products" -->
Issue 11- April to May 2021)

Almost two-thirds of incidents in this issue were reported in India. With
the country experiencing a second wave the demand for COVID-19 supplies
drastically exceeded supply. A high number of incidents of diversion or SF
issues of COVID-19 medicines is described in this issue. The medicines
which were most reported were remdesivir, amphotericin B, and tocilizumab;
88.3% of the incidents relating to COVID-19 medicines were reported for
remdesivir.

This report also highlights a surge of diverted or SF ventilation and oxygenation equipment and consumables, particularly in the month of May. We are very concerned about the reports on substandard oxygen
concentrators and falsified oxygen cylinders, including those made from
fire extinguishers.

We remain very concerned about the global risk of diverted and SF COVID-19
medical products, especially vaccines and medicines. We continue to urge
much more international coordination to mitigate the risks.

Any remarks or additions to content are greatly appreciated
Please write to
medicinequality@iddo.org

We would be delighted if you could disseminate this information within your network.

Very best wishes,

Kerlijn Van Assche, Céline Caillet, Paul N Newton
Medicine Quality Research Group, Infectious Diseases Data Observatory
(IDDO) & Mahidol Oxford Research Unit (MORU), Centre for Tropical Medicine
& Global Health, Nuffield Department of Medicine, University of Oxford,
Oxford, UK
Kerlijn Van Assche <kerlijn.vanassche@iddo.org>

E-DRUG: Medical Product Quality Report COVID-19 Data from June-July
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Dear colleagues,

The COVID-19 pandemic is accompanied by a multitude of reports of diverted,
substandard, and falsified (SF) medical products. Since the beginning of
the pandemic, we have identified 845 relevant articles on quality problems
with COVID-19 medical products in the English language lay press. Please
read about these in the Medical Product Quality Report - COVID-19 Issues

<https://www.iddo.org/mq/research/medical-product-quality-reports&gt;

which hold reports from the scientific literature, public alerts/warnings, and lay press.

The twelfth issue, covering the months of June & July 2021, is now
available and reports on 104 different incidents of quality issues with
COVID-19 medical products from articles from searches in English language
Google News.
It is out at
https://www.iddo.org/document/medical-product-quality-report-covid-19-issues-issue-12-october-2021-data-june-july-main

Because of the increasing amount of work required, we have amalgamated the
reports on COVID-19 medical products and on COVID-19 vaccines into one
report.

COVID-19 VACCINES: In part A, we have issued a further summary of public
domain reports on quality issues with COVID-19 vaccines we are aware of. So
far we have recorded 150 reports of incidents on quality issues with
COVID-19 vaccines linked to 41 different countries. In June and July 2021,
27 new incidents were reported. For the first time quality issues were
reported in Iran, Lebanon, Russia, Thailand, Uganda, and Canada.
Ten incidents involved falsified COVID-19 vaccines including products labelled as made by Pfizer/BioNTech, Covishield, Oxford-AstraZeneca, Moderna, Sinopharm, and Sinovac.

OTHER COVID-19 MEDICAL PRODUCTS: Part B discusses diagnostics, Personal
Protective Equipment, sanitisers & disinfectants, medicines, and
ventilation & oxygenation equipment and consumables. The surge of reported
cases of SF remdesivir in India has slowed down. But Operation Pangea XIV,
led by INTERPOL, reveals that criminals continue to cash in online on the
demand for COVID-19 medical products generated by the pandemic.

We remain very concerned about the global risk of diverted and SF COVID-19
medical products, especially vaccines and medicines. The incidents we
describe risk harm to people receiving SF products. We continue to urge
much more international coordination to mitigate the risks.

Any remarks or additions to content are greatly appreciated (please write
to medicinequality@iddo.org). We would be delighted if you could
disseminate this information within your networks.

Very best wishes,

Kerlijn Van Assche, Celine Caillet, Paul N Newton
Medicine Quality Research Group, Infectious Diseases Data Observatory (IDDO)
& Mahidol Oxford Research Unit (MORU), Centre for Tropical Medicine &
Global Health, Nuffield Department of Medicine, University of Oxford,
Oxford, UK
Kerlijn Van Assche <kerlijn.vanassche@iddo.org>