Combating against Counterfeit medication
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Transcript of Combating against Counterfeit medication
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 Consequences CFDs could have happened during the
meningitis epidemic in Niger in 1995 (41, 000 cases
reported)
Nigeria sent a 88, 000 donation of Pasteur Mérieux and
SmithKline Beecham vaccines .
A Médecins Sans Frontières (MSF) team noticed that the
vaccines from Nigeria had an unusual appearance and
examination were made.
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.
Bottles and labels were how ever copied to perfection. According to estimates, around
60, 000 persons were inoculated with false
vaccines out of a total 5 million vaccinated.
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, Sife-Egypt.
As Public, how to protect yourself from 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
product via Internet.
Mahmoud H. Bassiouny, Sife-Egypt.
C h e ck
As Public, how to protect yourself from 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 you
experience after taking it.
▫ be sure to observe your symptoms in
case new or unusual side effects
emerge or the medicine stops being
effective.
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.
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,
Commonwealth Secretariat, International Federation of Pharmaceutical Manufacturers
and Associations.
International Generic Pharmaceuticals Alliance,
World Self-Medication Industry, International Federation of harmaceutical Wholesalers, European Association of Pharmaceutical Full-line
Wholesalers, International Pharmaceutical
Federation, International Council of Nurses,
World Medical Association, the Pharmaceutical Security
Institute, Pharmaciens sans frontiers, ReMeD and International
Alliance of Patients’ Organizations.
IMPACT stakeholders representatives…
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 l a w p a s s e d s i n c e 1 9 9 8 .
• p e d i g r e e p r o v i s i o n .
• I t w a s i n t e n d e d t o re m o v e t h e
r i s k o f s t o l e n o r d i v e r t e d d r u g s
e n t e r i n g t h e d r u g s u p p l y a n d t o
c re a t e a p a p e r t r a i l f o r
i n v e s t i g a t o r s t o f o l l o w i f t h e y
l o c a t e d q u e s t i o n a b l e d r u g s .
Mahmoud H. Bassiouny, Sife-Egypt.
• Nearly two decades since its
passage, the pedigree rule of
PDMA has never been
enforced.
• “E-pedigrees” track-and-trace
technology.
Prescription Drug Marketing Act (PDMA)
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 finally
to pharmacies.
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
counterfeiters.
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.
Lead the Change . . .
Star t by yourself