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