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PHRM 871: Law > Reading 6 > Flashcards

Reading 6 Flashcards

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1
Q

What is the PDMA?

A
  • Helped divert Rx drugs/samples from normal distribution
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2
Q

What are the different area of the PDMA?

A
  • Reimportation
  • Preferentail Pricing
  • Samples and Coupons
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3
Q

What is Reimportation within pharmacy law?

A
  • Prohibits it 8 UNLESS by FDA
  • Bans importation of american made drugs from other countries
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4
Q

What made Reimportation illegal?

A
  • American drugs from other countries cost less; so people would buy from them, bring it to the US, then sell for more
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5
Q

What are the two situation where Reimportation is LEGAL

A
  • Manufacturer move supply to sell in US
  • Drug needed for emergency use
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6
Q

What is Perferential Pricing?

A
  • Bans the sale, purchase or trade of Rx drugs purchased at lower prices [by hopsital…]
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7
Q

What is important to know about Samples and Coupons in the PDMA?

A
  • Prohibits the sale, purchase or trade of Samples or Coupons
  • Practitioners need to ask in writing
  • Since free CANNOT make money off them

Samples: promote the sale of a drug

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8
Q

Who is able to have Samples or Coupons?

A
  • RETAIL cant have them
  • HOSPITAL can
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9
Q

What is the final part of the PDMA?

A
  • Whistleblower: basically awarding people for turning others in
  • Snitch
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10
Q

What is the Federal Anti-Tamper Act?

A
  • ## Act helps to prevent tampering
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11
Q

What are the FIVE crimes that the Federal Anti-Tampering Act created?

A
  • Tampering with LABEL
  • TAINTING Product
  • FALSE INFO that prodcut is tainted
  • THREATENING to tamper
  • CONSPIRING to tamper
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12
Q

What is a Tamper-Evident Packaging?

A
  • Packaging that doesnt stop someone from Tampering, just shows that it has been tampered
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13
Q

What are some of the requirements that shows that it is a Tamper-Evident Package?

A
  • Must have barriers that show if its been tampered
  • Must have a unreplicatable design
  • Possilbly a picture on the barrier

NOT MET = Adulteration or Misbranding or Both

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14
Q

What are some of the design features assoicated with Tamper-Evident Packaging?

A
  • Wrappers, Cartons, Breakable Caps, Mouth Seals, Blister Pack…
  • SEAL CAPSULES if used capsules
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15
Q

What is the DSHEA?

A
  • Dietary Supplement Health and Education Act
  • Alterd FDA authority over dietary supplements

DIET SUPPLEMENTS = FOOD not drugs

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16
Q

What are some of the differences between a dietary supplement and a drug?

A
  • Dietary Supplements cannot claim too cure
  • Baically “Food” the FDA cannot require premarker approval; doesnt show how safe or effective it is

**FDA has too prove; safety, effectiveness or adulteration before remova

17
Q

What is the evidence that a manufacturer or the FDA must show for a dietary supplement to be added to or removed from the market?

A
  • ADD: not really anything since its “food”
  • REMOVE: FDA must show that is unsafe or uneffective or adultered
18
Q

What are the claims that Manufacturers can make about Dietary Supplements?

A
  • Claims benefit to classical deficienies
  • Describes a role of an ingredent that affects humans
  • How the supplement acts
  • What happens when taken
19
Q

What type of labeling is require for a dietary supplement to have?

A
  • ALL MUST SAY: not been evaluated by the FDA. This product is not for cure, treat, prevention
  • IN BOLD
20
Q

What information does HIPAA protect, and who is it that its protecting?

A
  • Transaction and Code sets, National Providers Indentites, Security, Privacy
  • Protecting really anyone; mainly patients
21
Q

What is the main aspects of HIPAA that are most considered?

A
  • Security: preventing breaches
  • Privacy: Patient right and when to use it
22
Q

What and who are Entities within HIPAA?

A
  • Groups that use HIPAA
  • Health Plans, Insurance, Providers, Pharmacy…
23
Q

What is PHI?

A
  • Protected Health Information
  • Health and payments that can identify a patient

Name, Address, Health Plan ID, Medical Record Number

24
Q

What is the PDMA?

A

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PHRM 871: Law (19 decks)

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