detection of counterfeit drugs 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).


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.


6 6

20 22

30

58

32

53

0

10

20

30

40

50

60

1999 2000 2001 2002 2003 2004 2005 2006

Counterfeit drug cases opened by FDA per fiscal year


B. What is the Risk? Is it Worth it?Counterfeit medicines may cause Death Disease Disability Discomfort Dissatisfaction


COUNTERFEIT: Dosage Form Drugs USA

Naprosyn

Pergonal Eldepryl Procrit Plavix Tamiflu Percocet Phentermin

e Sertraline

Humatrope Metrodin Zyprexa Proprecia Lipitor Singulair Reductil

Steroids

Serostim Neupoge

n Nutropin Epogen

Viagra Cialis Levitra Celebrex

COUNTERFEIT: VeterinaryDosage Form Drugs USA

Ivomec Baytril Nuflor


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


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 ProductsD. 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 ProductsD. 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.


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.

TITLE: Detection of Counterfeit Drugs and Other ProductsD. 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.


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.

TITLE: Detection of Counterfeit Drugs and Other ProductsE. 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-IRRamanNIR ImagingUV-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

TITLE: Detection of Counterfeit Drugs and Other ProductsE. Analytical Method Used to detect counterfeit Drugs.(Cont’d). Chemical Fingerprinting

CounterfeitsC. 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 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.

TITLE: Detection of Counterfeit Drugs and Other ProductsH. 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 ProductsH. 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.

TITLE: Detection of Counterfeit Drugs and Other ProductsH. 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.


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.


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

detection of counterfeit drugs and other products

Healthcare