www.biopharminternational.com October 2021 eBook BioPharm International 9
stakeholders of the supply chain.
• "Traceability of medical products is
an important aspect of supply chain
integrity.
• "Effective and well-resourced national
health regulator y authorities are
essential to secure national and global
regulated supply chains.
• "It is crucial that national authorities
are given appropriate powers to
enforce reg ulations on the good
distribution practice of medica l
products.
• "Customs authorities must also be
trained and made aware of the issue
of SF [substandard and falsif ied]
m e d ic a l p r o d u c t s a n d s h o u l d
establish and maintain effective lines
of communication and information
sha r ing w it h med ica l produc ts
regulatory authorities."
To address the issue of substan-
dard and falsif ied medical products,
WHO has used the following approach
since 2012:
• W HO Globa l Sur veil lance and
M o n it o r i n g S y s t e m (G S M S) :
C ou nt r ie s re p or t i nc ident s of
substandard and falsif ied 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.
• Memb er St ate Me c h a n ism on
Substandard 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.
" T hrough the GSMS, we have
reports from multiple countries regard-
ing the distribution for sale of falsi-
fied COVID-19 vaccines," said WHO.
"The hoarding of certain therapeutics
is also a concern for us because con-
strained access (for example, due to
shortages) is a known driver of SF [sub-
standard and falsified] medical prod-
ucts. We regularly communicate both
to the general public and specific target
audiences (national regulatory authori-
ties) on confirmed SF medical products,
identified threats, or watch lists."
Substandard and falsified COVID-
19 vaccines may not cause harm imme-
diately. In some cases, it may simply lead
to a false sense of safety. But over time
and with enough incidences, these illicit
products could lead to a lack of faith in
the vaccine's effectiveness. The only stop
to the pandemic is either herd immunity
or more of the world's population having
access to legitimate vaccines—and tak-
ing 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 Medicine & Global
Health, Nuffield Department of
Medicine, University 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
Instead," CNN, July 5, 2021.
6. A. Wexler, "Fake Covid-19 Vaccines Pose
New Threat in Africa," The Wall Street
Journal, June 6, 2021.
7. FDA, "Counterfeit Medicine," www.fda.
gov/drugs/buying-using-medicine-safely/
counterfeit-medicine, accessed 08/12/2021.
8. WHO, "A Study on the Public
Health and Socioeconomic Impact 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.BP
Regulatory Sourcebook Drug Safety
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 reg-
ulated—supply chains, WHO states there is a low risk of falsif ied
vaccines (2).
References
1. W H O, " Su b s t a n d a r d a n d Fa ls i f i e d M e d i c a l Pr o d u c t s ," W H O. i nt ,
www.who.int/news-room/fact-sheets/detail/substandard-and-falsi-
fied-medical-products, Januar y 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
According to
statistics released
by WHO in 2017,
there is a 10.5%
failure rate of
medicines in low-
and middle-income
countries.
