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.


“Estimated DEATH from

Counterfeit drugs vary from tens of thousands to

more than 200,000” International Herald

tribute.


‘’The Asian and African regions

seem to be the most affected by counterfeit

medicines‘’ United Nations Inter-regional

Crime and Justice Research Institute


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.


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.


As a Health Care Professional What should I

do, and what information should I advice the Public…


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.


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.



• 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.


C h e ck


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.


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..


What is being done against CFDS…


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


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…


• FDA along with WHO’s (IMPACT) develop regulatory, legislative, enforcement, communication, and technological tools to combat the problem.


Anti CDFs strategies…


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 .


• 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)


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.

http://www.rfidjournal.com/

http://www.rfidjournal.com/


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.


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.


• 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


Lead the Change . . .

Star t by yourself

combating against counterfeit medication

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