Counterfeit Drugs

Question 1

T/F Counterfeit Drugs have been a problem for years

Answer 1

TRUE

Question 2

T/F Purchases from Internet sites that conceal actual physical address are counterfeit in > 50% of cases

Answer 2

TRUE

Question 3

_____% of all medicines sold worldwide are fakes

Answer 3

8-15%

Question 4

_____ are the most counterfeit drug worldwide

Answer 4

antibiotics

Question 5

• international week of action coordinated by INTERPOL

- highlighted dangers of buying medicines online

Answer 5

Operation Pangea

Question 6

T/F Counterfeiting can be applied to BOTH branded and generic products

Answer 6

TRUE

Question 7

Counterfeit products include products: (4)

Answer 7

• with correct or wrong ingredients
• without active ingredients
• insufficient active ingredients
• fake packaging

Question 8

Why are counterfeit drugs made?

Answer 8

• medication is too expensive

- medication is needed by a lot of people

Question 9

______, _____, and _____ are counterfeited in developing countries

Answer 9

antibiotics
antimalarial
antiparasitic

Question 10

T/F ONLY Manufacturers are allowed to import drugs (Closed system)

Answer 10

TRUE

Question 11

T/F There is ONE single solution to counterfeiting

Answer 11

FALSE

Question 12

Is drug importation legal by individuals?

Answer 12

NO–> FDA permits “limited” personal drug importation

Question 13

What are the limitations placed by FDA on personal drug importation? (4)

Answer 13

• 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

Question 14

What are the 4 types of security measures being used to prevent counterfeit drugs?

Answer 14

• overt
• convert
• forensic
• intelligent

Question 15

Overt security measures?

Answer 15

what you can see

-obvious and apparent the the general public

Question 16

What are examples of overt security measures? (5)

Answer 16

• optically variable devices
• security inks
• security printing
• paper
• security threads

Question 17

Convert security measures?

Answer 17

can not be detected visually

-require a specific reader/viewer to identify the presence of the security feature

Question 18

Forensic security measures?

Answer 18

require specialist equipment or lab analysis to verify their presence

Question 19

What are taggants?

Answer 19

agents incorporated into products (chemical, biological, physical, spectroscopic)

Question 20

Intelligent security measures?

Answer 20

provide individual or batch coding of products and ability to track throughout the products life cycle

Question 21

RFID

Answer 21

Radio-frequency identification (silicon chip and antenna)

Question 22

What does RFID do? (2)

Answer 22

Radio-frequency Identification

• reads electronic product codes
• its a unique number that identifies a specific item in the supply chain

Question 23

_________ the device allows investigators in the field to conduct on-the spot tests and get real-time results

Answer 23

portable spectrometer

Question 24

How do counterfeit drugs enter legitimate drug supply chain? (7)

Answer 24

• 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

Question 25

Drug Quality and Security Act of 2013 (3)

Answer 25

- enable verification of the legitimacy of the drug - enhance detection and notification of illegitimate products - facilitate more efficient recalls of drug product

Question 26

The Drug Supply Chain Security Act is an amendment to....

Answer 26

Food and Drug Cosmetic Act

Question 27

Key provisions of Drug Supply Chain Security Act (7)

Answer 27

- product identification - product tracing - product verification - detection and response - notification - wholesaler licensing - third-party logistics provider licensing

Question 28

Those who provide storage and logistical operations related to drug distribution, will obtain a state or federal license

Answer 28

Third-party logistics provider licensing

Question 29

Wholesale drug distributors will report their licensing status and contact information to FDA and placed in public database

Answer 29

Wholesaler licensing

Question 30

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

Answer 30

Notification

Question 31

Manufacturers, wholesaler drug distributors, repackagers, and dispensers (primarily pharmacies) will quarantine and promptly investigate a drug that has been identified as suspect

Answer 31

Detection and response

Question 32

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

Answer 32

product vertification

Question 33

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

Answer 33

Product tracing

Question 34

Manufacturers and repackagers must put unique product identifier on prescription drug packages

Answer 34

product identification

Question 35

Strategies for pharmacist: (5)

Answer 35

- make purchases from trustworthy, reputable wholesalers and distributors - be suspicious of the "good deal" - look at drug shipments closely - look for slight differences in container bottles - listen to patients