Counterfeit Drugs

M a h m o u d H . B a s s i o u n y, P h r D r.
Anti Counterfeit Drugs Awareness Campaign
SIFE Egypt.
 Mahmoud H. Bassiouny,
Sife-Egypt.

Counterfeit Drugs
“Counterfeit drugs Market Value: US$40 Billion”
Detroit free press.

“25% of all drugs in developing Countries are

Fake” World Health Organization.

“50% of drugs sold on the Internet believed to

be fake” Reuters, MSNBC.

“30% of Drugs sold in Africa are Fake” VOA news.

“CFDs will reach US$ 75 billion of sales globally in 2010,

an increase of more than 90% from 2005” Centre for Medicines in the
Public Interest, USA.
 Mahmoud H. Bassiouny,
Sife-Egypt.

“Estimated DEATH from

Counterfeit drugs vary
from tens of thousands to more
than 200,000” International Herald tribute.
 Mahmoud H. Bassiouny,
Sife-Egypt.

‘’The Asian and African

regions seem to be the
most affected by
counterfeit medicines‘’
United Nations Inter-regional Crime and Justice Research Institute
 Mahmoud H. Bassiouny,
Sife-Egypt.

Counterfeit Drugs
Ø Consequences CFDs could have happened during the
meningitis epidemic in Niger in 1995 (41, 000 cases reported)
Ø Nigeria sent a 88, 000 donation of Pasteur Mérieux and
SmithKline Beecham vaccines .
Ø A Médecins Sans Frontières (MSF) team noticed that the
vaccines from Nigeria had an unusual appearance and
examination were made.
Ø Pasteur Mérieux labs confirmed that the batch numbers and
the expiration dates did not correspond to their
manufacturer records. Tests carried out found NO traces of
active product which confirmed that they were false. Tests carried
out found NO traces of active product which confirmed that they were false.
Ø Bottles and labels were how ever copied to perfection.
According to estimates, around
Ø 60, 000 persons were inoculated with false vaccines
 Mahmoud H. Bassiouny,
Sife-Egypt.

Most Targeted Pharmaceutical product…

• Most commonly counterfeited drugs include
on the top of the list Anti Malarial, Antibiotics,
Vitamins, Pain killers, Hormones and
Steroids.

• They are usually products that are either

popular or where the genuine product is
too expensive for the poor.
 Mahmoud H. Bassiouny,
Sife-Egypt.

As a Health Care Professional What

should I do, and what information
should I advice the Public…
 Mahmoud H. Bassiouny,
Sife-Egypt.

As a HCP you must be able to notice the

General Features of CFD…
• Have a strange smell, color.
• Break apart very easily.
• Be in poor-quality packaging or packages with
misspelled labels.

• Cost very little, especially compared with the normal

price of that particular drug.
• Stay in contact with your patients to determine if
there is any unusual event during their treatment.
• Keep record of any suspected cases and report it to the
legal authorities.
Mahmoud H. Bassiouny,
Sife-Egypt.
 Mahmoud H. Bassiouny,

As Public, how to protect yourself from

Sife-Egypt.

CFDs?
• Do not buy medicines from open markets.
• Buy medicines only from licensed
pharmacies and get a receipt.
• Keep a copy of your prescriptions, including
the brand or generic name and
manufacturer of any medicine that you take
regularly or that prescribed for your for a
trip.
 Mahmoud H. Bassiouny,
Sife-Egypt.

As Public, how to protect yourself from

CFDs?
• Check with the pharmacist whether the
drug has the same active ingredient as
the one that you were taking
• Make sure that the medicine is in its
original packaging & pay attention to
the packaging of the drug for any
damage or differences in design.
• Be attentive in monitoring the medicines
that you take for anything unusual or
different.
• Try NOT to buy any Pharmaceutical
 Mahmoud H. Bassiouny,

As Public, how to protect yourself from

Sife-Egypt.

CFDs?
During a course of treatment,
▫ Be familiar with the shape, size
and color.
▫ When you take the medicine, try
to take note of its feel and taste,
and if any unusual effects that
Chec
you experience after taking it.
k
▫ be sure to observe your
symptoms in case new or
unusual side effects emerge or
the medicine stops being
 Mahmoud H. Bassiouny,
Sife-Egypt.

If you suspect that your medicine

may be counterfeit, keep it
and make sure that you report it
to your pharmacist, doctor, or call
the manufacturer..
 Mahmoud H. Bassiouny,
Sife-Egypt.

What is being done against CFDS…

 Mahmoud H. Bassiouny,
Sife-Egypt.

IMPACT “International Medical Products Anti-Counterfeiting Taskforce”

• A WHO programs that aims to build coordinated

networks across and between countries in 0rder to halt
the production, trading and selling of fake
medicines around the globe.
• It mobilize all relevant sectors of the international
community in support of common strategies against
counterfeiting of medical products
 Mahmoud H. Bassiouny,
Sife-Egypt.

IMPACT stakeholders representatives…

INTERPOL,
Organization for Economic Co-
operation and Development,
World Customs Organization,
World Intellectual Property
Organization,
World Trade Organization,
European Commission,
Council of Europe,
United States Pharmacopoeia,
International Council of Nurses,
Commonwealth Secretariat,
International Federation of
Pharmaceutical Manufacturers
and Associations.
ReMeD and International Alliance
International Generic
Pharmaceuticals Alliance,
World Self-Medication Industry,
International Federation of
harmaceutical Wholesalers,
European Association of
Pharmaceutical Full-line
Wholesalers,
International Pharmaceutical
Federation,
World Medical Association,
the Pharmaceutical Security
Institute,
Pharmaciens sans frontiers,
 Mahmoud H. Bassiouny,
Sife-Egypt.

• FDA along with WHO’s (IMPACT) develop

regulatory, legislative, enforcement,
communication, and technological tools to
combat the problem.
 Mahmoud H. Bassiouny,
Sife-Egypt.

Anti CDFs strategies…

 Mahmoud H. Bassiouny,
Sife-Egypt.

Prescription Drug Marketing Act (PDMA)

• A law passed since 1998.

• pedigree provision.
• It was intended to remove the risk
of stolen or diverted drugs
entering the drug supply and to
create a paper trail for
investigators to follow if they
located questionable drugs.
 Mahmoud H. Bassiouny,
Sife-Egypt.

Prescription Drug Marketing Act (PDMA)

• Nearly two decades since its
passage, the pedigree rule of
PDMA has never been
enforced.
• “E-pedigrees” track-and-trace
technology.
 Mahmoud H. Bassiouny,
Sife-Egypt.

RFID Technology

• Tiny radio transmitters,

when affixed to a package
of drugs, would emit a
unique electronic product
code, which would allow for
each individual package of
drugs to be tracked
through each step of the
supply chain, from
manufacturer to
distributors /
wholesalers and
 Mahmoud H. Bassiouny,
Sife-Egypt.

Validation Technologies
• Technologies include
▫ overt (visible) features such as holograms

▫ Covert (hidden) features such as UV

markers.

Additionally, WHO is currently looking at

proposals from three mobile telephone
companies to apply their technologies to
check the authenticity of medical
products.

IMPACT adopted other approaches DNA-

based technologies, nanotechnology.
 Mahmoud H. Bassiouny,
Sife-Egypt.

Although these verification

technologies can make it
easier to tell real drugs from
counterfeits, the increasing
sophistication of
counterfeit-production rings
means that such anti-
counterfeit features must
constantly be improved and
updated in order to stay one
step ahead of the
 Mahmoud H. Bassiouny,
Sife-Egypt.

• Anti CFDs systems and

technologies are not yet
applied…
High cost.
Lack of the Resources and Authority.
Governments’ unwillingness to
recognize the existence of the
problem.
Ineffective collaboration among
bodies and institutions.
Insufficient international
collaboration and exchange of
information.
Ignorance among the public.
Large number of distribution
channels, many intermediaries.
Manufacturers sometimes do not
report copies of their drugs as it
may affect their sales
 Mahmoud H. Bassiouny,
Sife-Egypt.

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