Reading 6

Question 1

What is the PDMA?

Answer 1

• Helped divert Rx drugs/samples from normal distribution

Question 2

What are the different area of the PDMA?

Answer 2

• Reimportation
• Preferentail Pricing
• Samples and Coupons

Question 3

What is Reimportation within pharmacy law?

Answer 3

• Prohibits it UNLESS by FDA (i.e.; reimported by manufacturer or emergency use)
• Bans importation of american made drugs from other countries but NOT the importation of foreign made drugs

Question 4

What made Reimportation illegal?

Answer 4

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

Question 5

What are the two situation where Reimportation is LEGAL

Answer 5

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

Question 6

What is Perferential Pricing?

Answer 6

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

Question 7

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

Answer 7

• 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

Question 8

Who is able to have Samples or Coupons?

Answer 8

• RETAIL cant have them
• HOSPITAL can

Question 9

What is the final part of the PDMA?

Answer 9

• Whistleblower: basically awarding people for turning others in
• Recordkeeping: needs to be easily retrievable for about 3 y

Question 10

What is the Federal Anti-Tamper Act?

Answer 10

• ## Act helps to prevent tampering

Question 11

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

Answer 11

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

Question 12

What is a Tamper-Evident Packaging?

Answer 12

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

Question 13

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

Answer 13

• 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

Question 14

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

Answer 14

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

Question 15

What is the DSHEA?

Answer 15

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

DIET SUPPLEMENTS = FOOD not drugs

Question 16

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

Answer 16

• 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

Question 17

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?

Answer 17

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

Question 18

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

Answer 18

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

Question 19

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

Answer 19

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

Question 20

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

Answer 20

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

Question 21

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

Answer 21

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

Question 22

What and who are Entities within HIPAA?

Answer 22

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

Question 23

What is PHI?

Answer 23

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

Name, Address, Health Plan ID, Medical Record Number

Question 24

Practice Question 1

All of the following rare crimes created by the tamper-evident packaging On Consumer Products Act (Anti-Tampering Act) except:

a. Opening a bottle of OTC pain reliever to see what the tablets look like and placing it back on the shelf for sale
b. Placing a tablet you made in a bottle of OTC cough suppressant
c. Removing the shrink wrap from a prscription-only products
d. Calling the police to report that an OTC product has been tampered with when it has not been
e. Planning to switch the liquid in an OTC eye drop to rubbing alcohol as a prank with your two friends

Answer 24

• c. Removing the shrink wrap from a prscription-only products

Question 25

# Practice Question 2 All of the following are accurate statements about the Dietary Supplement Health and Educaiton Act except: ## Footnote a. All dietary supplements must contain a disclamier b. Prodcuts may claim a benefit related to a classical nutrient deficiency without being declared a drug c. Dietary supplement are required to undergo premarket approval through the NDA process before being placed on the market d. Dietary supplement manufacturers do no have to prove their product is safe or effective e. Dietary supplement manufacturers can't make misleading statements

Answer 25

- c. Dietary supplement are required to undergo premarket approval through the NDA process before being placed on the market

Question 26

# Practice Question 3 Select all of the following actions that are prohibited by the Prescription Drug Marketing Act (PDMA)? ## Footnote a. A Doctor selling prescription drug samples to a pharmacy b. A Patient purchasing manufacturer coupons for a drug from a Nurse Practitioner c. A Manufacturer importing their own drug into the US from Canada d. A Patient puchasing drug samples from a prescriber e. A Hospital pharmacy selling drugs they received preferential pricing for to a retail pharmacy

Answer 26

- A, B, D, E