Powerpoint presentation on counterfeiting, why it is done, statistics and methods to detect counterfeit products.

1. Nancy J Sperling May 10, 2016
TITLE: Detection of Counterfeit Drugs
and Other Products

2. TITLE: Detection of Counterfeit Drugs
and Other Products
A. Introduction (Statistics)
• The prescription drug market is vast and
lucrative – up to $900 billion worldwide
annually.
• 237 people were arrested worldwide and
10,603 websites that were selling
counterfeit medicines were shut down in
2014.
• An estimated 80% of the counterfeit drugs
that are consumed in the United States
come from overseas (China and India).

3. TITLE: Detection of Counterfeit Drugs
and Other Products
A. Introduction (Statistics) Cont’d
• A recent survey of seven African
countries by WHO found that between
20% and 90% of all anti-malarials failed
quality testing.
• The WHO also estimates that between 1%
and 10% of drugs sold around the world
are counterfeits, but it may be as high as
50% in some countries and that 16% of
counterfeit drugs contain the wrong
ingredients, while 17% contain the wrong
levels of necessarily ingredients.

4. TITLE: Detection of Counterfeit Drugs
and Other Products

5. TITLE: Detection of Counterfeit Drugs
and Other Products
B. What is the Risk? Is it Worth it?
Counterfeit medicines may cause
 Death
 Disease
 Disability
 Discomfort
 Dissatisfaction

6. TITLE: Detection of Counterfeit Drugs
and Other Products
COUNTERFEIT: Dosage Form Drugs
USA
 Naprosyn
 Pergonal
 Eldepryl
 Procrit
 Plavix
 Tamiflu
 Percocet
 Phentermine
 Sertraline
 Humatrope
 Metrodin
 Zyprexa
 Proprecia
 Lipitor
 Singulair
 Reductil
 Serostim
 Neupogen
 Nutropin
 Epogen
 Viagra
 Cialis
 Levitra
 Celebrex
COUNTERFEIT: Veterinary
Dosage Form Drugs USA
 Ivomec
 Baytril
 Nuflor

7. TITLE: Detection of Counterfeit Drugs
and Other Products
C. Why Counterfeit?
 Financial Gain
 Minimal Penalties
 Any Size Operations
 Small garage shops to large plants
 Demand
 Cheap Access to Digital Technology
 Access to Bulk Drug Actives
 Internet from China,Inda

8. TITLE: Detection of Counterfeit Drugs
and Other Products
Counterfeiting can involve pharmaceuticals, dietary
supplements, cosmetics, medical devices.
 Black Market
 Internet
 Legal Distribution
An added dimension since September 11 2001 includes
possible terrorism mainly for financial gain.

9. TITLE: Detection of Counterfeit Drugs
and Other Products
D. How Counterfeit Drug Enter The U.S.
Drug Distribution System
 There can be one or more manufacturer or
even repackager who handles the drug
before it reaches the retailer.
 Counterfeit drugs are associated with the
practice of diversion.
 Diversion is the sale of drugs outside the
distribution channels for which they were
originally intended.

10. TITLE: Detection of Counterfeit Drugs
and Other Products
D. How Counterfeit Drugs Enter The U.S.
Drug Distribution System (Cont’d)
 Diverted drugs can originate domestically-redirection
of prescription drugs from other legitimate sources
(free samples for doctors or lower priced drugs for
non- profit clinics or medicaid programs).
 Diverted drugs can originate from the foreign market
(prescription drugs are donated or a lower-priced
product is diverted to a country where a higher price
product is marketed.

11. TITLE: Detection of Counterfeit Drugs
and Other Products
D. How Counterfeit Drugs Enter The U.S.
Drug Distribution System (Cont’d)
 US regulatory system does not have a
legitimate, regulated channels for such diverted
drugs to re-enter the drug distribution system.
 No way to distinguish between effective
authentic lower-cost drugs form drugs that
simply appear to be, but are not legitimate and
maybe harmful.

12. TITLE: Detection of Counterfeit Drugs
and Other Products
D. How Counterfeit Drugs Enter The U.S.
Drug Distribution System (Cont’d)
 Counterfeit drugs enter the US distribution
system, because they are purchased outside
the normal distribution chain and without the
ususal regulatory safeguards.
 Counterfeit, substandard, adulterated or
misbranded products may become
commingled with authentic drugs in the US
distribution system.

13. TITLE: Detection of Counterfeit Drugs
and Other Products
D. How Counterfeit Drugs Enter The U.S.
Drug Distribution System (Cont’d)
 Consumers order medications over the internet.
 Counterfeiters take advantage of internet sales by
combining small purchases form foreign countries
into one and selling them to the US wholesalers or
other unsuspecting entities.

14. TITLE: Detection of Counterfeit Drugs
and Other Products
E. Analytical Method Used to detect counterfeit
Drugs. Chemical Fingerprinting Counterfeits
A. Formulation, Toolmarks, Trace Evidence
Photo documentation
Stereoscopic Light Microscopy
Polarized Light Microscopy
Scanning Electron Microscopy
Image Analysis
Crime Scope
Comparative Microscope
FT-IR
Raman
NIR Imaging
UV-VIS
Microscopy Vibrational Spectroscopy
B. Chemical, Assay, Impurities
HPLC
Gas Chromatography
Ion Chromatography
Headspace GC
Capillary Electrophresis
Thin Layer Chromatography
GC-MS
LC-MS
Chromatographic Techniques

15. TITLE: Detection of Counterfeit Drugs
and Other Products
E. Analytical Method Used to detect counterfeit
Drugs.(Cont’d). Chemical Fingerprinting Counterfeits
C. Physical
Weights
Measures
Hardness testing
Color

16. TITLE: Detection of Counterfeit Drugs
and Other Products-Not Just
Pharmaceuticals
 1999: Counterfeit artesunate and mefloquine in Cambodia 30 people died.
 2001: study in Southeast Asia (Cambodia, Laos,Myanmar,Thailand,
Vietnam) 38% of 104 samples of artesunate found to contain no active
ingredient.
 Oct 2004: Counterfeit Contact Lenses
 Summer Fall 2005: Counterfeit Lipitor Celebrex (Mail Imports US, UK
Supply Chain).
 December 2005: “Generic” Tamiflu.
 In 2008, several infants died and thousands fell ill because of baby milk
powder tainted by a chemical additive.
 In March 2008, FDA reported that at least 81 deaths and 785 reports of
serious injuries were linked to a raw heparin ingredient imported from the
People's Republic of China.
 July 11, 2013: English Citizen Sentenced for Distributing Adulterated and
Counterfeit Cancer Drugs to physicians in the US.
 January 16, 2014: Two Turkish Nationals Indicted for Smuggling
Counterfeit Cancer Drug.
 January 29, 2014: Seven Ohio Oncologists Provided Patients Drugs Not
Approved By The FDA And Are Ordered To Pay $2.6 Million.

17. TITLE: Detection of Counterfeit Drugs
and Other Products
H. Anti-counterfeiting
 Curb illegal Prescription Drug Marketing on the
Internet.
 FDA updgrading and expanding its monitoring of
internet violative sites (unapproved new drugs, heath
fraud and prescriptive drugs sold without valid
prescription).
 Partner with Federal and State bodies and other
organizations .
 Implement outreach to alert consumers to public
health risks of illegitimate offerings.

18. TITLE: Detection of Counterfeit Drugs
and Other Products
H. Anti-counterfeiting (Cont’d)
 The counterfeiting Drug Force was Launched in 2003 by the
FDA to head off the growing threat of counterfeit drugs.
 FDA’s Office of Criminal Investigations (OCI) aggressively
investigates reports of counterfeit products in order to protect
U.S. citizens.
 In March 2013, FDA formed a new Cyber Crimes Investigation
Unit, a special team within OCI, devoted to combating rogue
Internet pharmacies.
 FDA participates in the annual International Internet Week of
Action (IIWA), or Operation Pangea, a global cooperative to
combat conterfeiting problems.
 In 2013 Operation Pangea took action against more than 13,700
websites illegally selling potentially dangerous, unapproved
prescription medicines to consumers.

19. TITLE: Detection of Counterfeit Drugs
and Other Products
H. Anti-counterfeiting (Cont’d)
 Use of Anti-counterfeiting Technologies
 Authentication Technologies
 Protective measures that are visible (overt) to the eye such a
holograms, color shifting inks and some water markers.
 The anti-counterfeiting role of holograms lies in their ability to
combine authentication with detection. Holograms often provide
overt first-line defense.
 Protective measures which are not visible (covert) to the eye
such as : water markers, certain inks and dyes that fluoresce or
absorb light and invisible bar codes. Covert operations such as
scrambled images, micro text, UV-sensitive or other special
links
Offer second line defense for trained examiners equipped with
the appropriate decoding equipment.

20. TITLE: Detection of Counterfeit Drugs
and Other Products
H. Anti-counterfeiting (Cont’d)
 Use of Anti-counterfeiting Technologies
 Track and Trace Technologies
 Radio-frequency identification (RFID)-elecromagnetic
chips/tags which contains special information onto
cartons, pallets and individual products.
 Bar codes.

21. TITLE: Detection of Counterfeit Drugs
and Other Products
In addition to universal health concerns
regarding misuse of prescription drugs…
 Pfizer, Eli Lilly, Bayer
Their patents are being violated
 Consumers
Potentially dangerous
drug interactions
Most people trust the
label
 FDA
Mislabeled products
Unapproved drugs
Herbals not evaluated as drugs