Flashcards in Counterfeit Drugs Deck (35)
T/F Counterfeit Drugs have been a problem for years
T/F Purchases from Internet sites that conceal actual physical address are counterfeit in > 50% of cases
_____% of all medicines sold worldwide are fakes
_____ are the most counterfeit drug worldwide
-international week of action coordinated by INTERPOL
-highlighted dangers of buying medicines online
T/F Counterfeiting can be applied to BOTH branded and generic products
Counterfeit products include products: (4)
-with correct or wrong ingredients
-without active ingredients
-insufficient active ingredients
Why are counterfeit drugs made?
-medication is too expensive
-medication is needed by a lot of people
______, _____, and _____ are counterfeited in developing countries
T/F ONLY Manufacturers are allowed to import drugs (Closed system)
T/F There is ONE single solution to counterfeiting
Is drug importation legal by individuals?
NO--> FDA permits "limited" personal drug importation
What are the limitations placed by FDA on personal drug importation? (4)
-drug is for personal use only
-the quantity cannot exceed a 90 day supply
-buyer must be under medical supervision
-drug product cannot be imported for commercial reason
What are the 4 types of security measures being used to prevent counterfeit drugs?
Overt security measures?
what you can see
-obvious and apparent the the general public
What are examples of overt security measures? (5)
-optically variable devices
Convert security measures?
can not be detected visually
-require a specific reader/viewer to identify the presence of the security feature
Forensic security measures?
require specialist equipment or lab analysis to verify their presence
What are taggants?
agents incorporated into products (chemical, biological, physical, spectroscopic)
Intelligent security measures?
provide individual or batch coding of products and ability to track throughout the products life cycle
Radio-frequency identification (silicon chip and antenna)
What does RFID do? (2)
-reads electronic product codes
-its a unique number that identifies a specific item in the supply chain
_________ the device allows investigators in the field to conduct on-the spot tests and get real-time results
How do counterfeit drugs enter legitimate drug supply chain? (7)
-complex global supply chains
-may travel through many trading companies
-one or more in supply chain corrupt
-manufacturer may not be aware that ingredients came from uncertified source
-manufacturer appears legitimate
-counterfeiters develop elaborate plan
-weak border control
Drug Quality and Security Act of 2013 (3)
-enable verification of the legitimacy of the drug
-enhance detection and notification of illegitimate products
-facilitate more efficient recalls of drug product
The Drug Supply Chain Security Act is an amendment to....
Food and Drug Cosmetic Act
Key provisions of Drug Supply Chain Security Act (7)
-detection and response
-third-party logistics provider licensing
Those who provide storage and logistical operations related to drug distribution, will obtain a state or federal license
Third-party logistics provider licensing
Wholesale drug distributors will report their licensing status and contact information to FDA and placed in public database
Manufacturers, wholesaler drug distributors, repackagers, and dispensers (primarily pharmacies) will establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found
Manufacturers, wholesaler drug distributors, repackagers, and dispensers (primarily pharmacies) will quarantine and promptly investigate a drug that has been identified as suspect
Detection and response
Manufacturers, wholesaler drug distributors, repackagers, and dispensers (primarily pharmacies) will establish systems and processes to be able to verify the product identifier on certain prescription drug packages
Manufacturers, wholesaler drug distributors, repackagers, and dispensers (primarily pharmacies) in the drug supply chain will provide information about a drug and who handled it each time it is sold in the U.S. market
Manufacturers and repackagers must put unique product identifier on prescription drug packages