14 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 P h a r mTe c h . c o m
Drug Safety
establish and maintain effective lines of com-
munication and information sharing with
medical products regulatory authorities."
To address the issue of substandard and falsified
medical products, WHO has used the following
approach since 2012:
• WHO Global Surveillance and Monitor-
ing System (GSMS): Countries report inci-
dents of substandard and falsified medical
products into a database. After which time,
WHO's technical staff provide assistance.
According to WHO, this is the basis for
structuring evidence-based policies and
deploying projects.
• Member State Mechanism on Substan-
dard and Falsified Medical Products: To
facilitate political support for operational
initiatives, members identify major needs
and work with technical experts to fill the
gaps in this intergovernmental process.
"Through the GSMS, we have reports from mul-
tiple countries regarding the distribution for sale
of falsified COVID-19 vaccines," said WHO. "The
hoarding of certain therapeutics is also a concern
for us because constrained access (for example,
due to shortages) is a known driver of SF [sub-
standard and falsified] medical products. We
regularly communicate both to the general public
and specific target audiences (national regulatory
authorities) on confirmed SF medical products,
identified threats, or watch lists."
Substandard and falsified COVID-19 vaccines
may not cause harm immediately. In some cases, it
may simply lead to a false sense of safety. But over
time and with enough incidences, these illicit prod-
ucts could lead to a lack of faith in the vaccine's ef-
fectiveness. The only stop to the pandemic is either
herd immunity or more of the world's population
having access to legitimate vaccines—and taking
it. Therefore, a secure global supply chain is more
important now than ever.
References
1. H. Ritchie, et. al. "Coronavirus (COVID-19) Vaccinations,"
Our World Data, www.ourworldindata.org/covid-
vaccinations?country=USA, accessed August 12, 2021.
2. ResearchAndMarkets, "Coronavirus Disease 2019 (COVID-19)
Vaccines—Opportunity Assessment and Forecast to 2026,"
www.researchandmarkets.com/reports/5360021/coronavirus-
disease-2019-covid-19-vaccines, June 2021.
3. Medicine Quality Research Group, Centre of Tropical Medi-
cine & Global Health, Nuffield Department of Medicine, Uni-
versity of Oxford, Medical Product Quality Report– COVID-19
Vaccine Issues, p. 4, 7, April 16, 2021.
4. J. Hopkins, J. de Córdoba, "Pfizer Identifies Fake Covid-19
Shots Abroad as Criminals Exploit Vaccine Demand," The
Wall Street Journal, April 21, 2021.
5. S. Gupta, J. Yeung, "Thousands Thought They Were Getting
the Covid Vaccine. They Were Injected with Salt Water In-
stead," CNN, July 5, 2021.
6. A. Wexler, "Fake Covid-19 Vaccines Pose New Threat in Af-
rica," The Wall Street Journal, June 6, 2021.
7. FDA, "Counterfeit Medicine," www.fda.gov/drugs/buying-us-
ing-medicine-safely/counterfeit-medicine, accessed 08/12/2021.
8. WHO, "A Study on the Public Health and Socioeconomic Im-
pact of Substandard and Falsified Medical Products," WHO.
int, www.who.int/medicines/regulation/ssffc/publications/SE_
Study_EN.pdf, 2017.
9. WHO, "The WHO Member State Mechanism on Substandard
and Falsified Medical Products," WHO.int, www.who.int/
publications/i/item/WHO-MVP-EMP-SAV-2019.04, June 24,
2020.
PT
While some counterfeit drug products are almost identical visually to the
original drug product, here are some of the World Health Organization's
(WHO's) key considerations (1):
• Look at the condition of the package
• Look for spelling or grammatical mistakes
• Check if the manufacturing and expiration dates on the outer packaging
match the inner packaging
• See if it's discolored, smells unusual, etc.
• Exercise caution when purchasing drug products from unregulated websites.
However, if vaccines are supplied through the standard—and regulated—
supply chains, WHO states there is a low risk of falsified vaccines (2).
References
1. WHO, "Substandard and Falsified Medical Products," WHO.int, www.who.
int/news-room/fact-sheets/detail/substandard-and-falsified-medical-prod-
ucts, January 31, 2018.
2. Gavi, "How Can I Spot A Fake COVID-19 Vaccine?," Gavi.org, www.gavi.org/
vaccineswork/how-can-i-spot-fake-covid-19-vaccine, July 2, 2021.
Spotting counterfeit COVID-19 vaccines
