TITLE: Detection of Counterfeit Dru

and Other Products

Nancy J Sperling May 10, 2016

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).

Introduction (Statistics)
TITLE: Detection of Counterfeit
Contd
A.

Drugs

A recent survey of seven African countries

by WHO found
betweenProducts
20% and
andthat
Other

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

TITLE: Detection of Counterfeit

Drugs
and Other Products

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

TITLE: Detection of Counterfeit

Drugs
and Other Products
COUNTERFEIT: Dosage Form Drugs
USA

Naprosyn

Pergonal

Eldepryl

Procrit

Plavix

Tamiflu

Percocet
Phentermine

Sertraline

Humatrope Serostim Viagra

Cialis
Neupoge
Metrodin
n
Levitra
Zyprexa
Nutropin
Celebrex
Proprecia
Epogen Veterinary
COUNTERFEIT:
Lipitor

Singulair
Reductil

Dosage Form Drugs USA

Steroids

Ivomec
Baytril
Nuflor

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

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.

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.

TITLE: Detection of Counterfeit

Drugs
and Other Products
D. How Counterfeit Drugs Enter The U.S.
Drug Distribution System (Contd)

Diverted drugs can originate domesticallyredirection 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.

TITLE: Detection of Counterfeit

Drugs
and Other Products
D. How Counterfeit Drugs Enter The U.S.
Drug Distribution System (Contd)

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.

TITLE: Detection of Counterfeit

Drugs
and Other Products
D. How Counterfeit Drugs Enter The
U.S.
Drug Distribution System (Contd)

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.

TITLE: Detection of Counterfeit

Drugs
and Other Products
D. How Counterfeit Drugs Enter The U.S.
Drug Distribution System (Contd)

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.

TITLE: Detection of Counterfeit

Drugs
and Other Products
E. Analytical Method Used to detect counterfeit
Drugs. Chemical Fingerprinting Counterfeits
A. Formulation, Toolmarks, Trace Evidence
Microscopy

Vibrational Spectroscopy

Photo documentation
Stereoscopic Light Microscopy
Polarized Light Microscopy
Scanning Electron Microscopy
Image Analysis
Crime Scope
Comparative Microscope

FT-IR
Raman
NIR Imaging
UV-VIS

B. Chemical, Assay, Impuritie

Chromatographic Techniques
HPLC
Gas Chromatography
Ion Chromatography
Headspace GC
Capillary Electrophresis
Thin Layer Chromatography
GC-MS
LC-MS

TITLE: Detection of Counterfeit

Drugs
and Other Products
E. Analytical Method Used to detect counterfeit
Drugs.(Contd). Chemical Fingerprinting
Counterfeits
C. Physical
Weights
Measures
Hardness testing
Color

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 thatat 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.

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.

TITLE: Detection of Counterfeit

Drugs
and Other Products
H. Anti-counterfeiting (Contd)

The counterfeiting Drug Force was Launched in 2003 by

the FDA to head off the growing threat of counterfeit drugs.
FDAs 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.

TITLE: Detection of Counterfeit

Drugs
and Other Products
H. Anti-counterfeiting (Contd)

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, UVsensitive or other special links
Offer second line defense for trained examiners equipped
with the appropriate decoding equipment.

TITLE: Detection of Counterfeit

Drugs
and Other Products
H. Anti-counterfeiting (Contd)

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.

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