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Pharmaceutics Spring 2016 > Counterfeit Drugs > Flashcards

Counterfeit Drugs Flashcards

1
Q

T/F Counterfeit Drugs have been a problem for years

A

TRUE

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2
Q

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

A

TRUE

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3
Q

_____% of all medicines sold worldwide are fakes

A

8-15%

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4
Q

_____ are the most counterfeit drug worldwide

A

antibiotics

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5
Q
  • international week of action coordinated by INTERPOL

- highlighted dangers of buying medicines online

A

Operation Pangea

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6
Q

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

A

TRUE

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7
Q

Counterfeit products include products: (4)

A
  • with correct or wrong ingredients
  • without active ingredients
  • insufficient active ingredients
  • fake packaging
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8
Q

Why are counterfeit drugs made?

A
  • medication is too expensive

- medication is needed by a lot of people

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9
Q

______, _____, and _____ are counterfeited in developing countries

A

antibiotics
antimalarial
antiparasitic

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10
Q

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

A

TRUE

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11
Q

T/F There is ONE single solution to counterfeiting

A

FALSE

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12
Q

Is drug importation legal by individuals?

A

NO–> FDA permits “limited” personal drug importation

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13
Q

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

A
  • 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
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14
Q

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

A
  • overt
  • convert
  • forensic
  • intelligent
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15
Q

Overt security measures?

A

what you can see

-obvious and apparent the the general public

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16
Q

What are examples of overt security measures? (5)

A
  • optically variable devices
  • security inks
  • security printing
  • paper
  • security threads
17
Q

Convert security measures?

A

can not be detected visually

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

18
Q

Forensic security measures?

A

require specialist equipment or lab analysis to verify their presence

19
Q

What are taggants?

A

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

20
Q

Intelligent security measures?

A

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

21
Q

RFID

A

Radio-frequency identification (silicon chip and antenna)

22
Q

What does RFID do? (2)

A

Radio-frequency Identification

  • reads electronic product codes
  • its a unique number that identifies a specific item in the supply chain
23
Q

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

A

portable spectrometer

24
Q

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

A
  • 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
25
Q

Drug Quality and Security Act of 2013 (3)

A
  • enable verification of the legitimacy of the drug
  • enhance detection and notification of illegitimate products
  • facilitate more efficient recalls of drug product
26
Q

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

A

Food and Drug Cosmetic Act

27
Q

Key provisions of Drug Supply Chain Security Act (7)

A
  • product identification
  • product tracing
  • product verification
  • detection and response
  • notification
  • wholesaler licensing
  • third-party logistics provider licensing
28
Q

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

A

Third-party logistics provider licensing

29
Q

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

A

Wholesaler licensing

30
Q

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

A

Notification

31
Q

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

A

Detection and response

32
Q

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

A

product vertification

33
Q

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

A

Product tracing

34
Q

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

A

product identification

35
Q

Strategies for pharmacist: (5)

A
  • 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

Pharmaceutics Spring 2016 (20 decks)

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