L7 Supply Chain, Advertising, & HIPAA

Question 1

what was the goal of the Prescription Drug Marketing Act (PDMA)

Answer 1

“protect public health, and to protect the public against drug diversion by establishing procedures, requirements, and minimum standards for the distribution of prescription drugs and prescription drug samples”

Question 2

what were the 4 main aspects of PDMA?

Answer 2

1. reimportation
2. preferential pricing
3. samples and coupons
4. wholesale licensure

Question 3

PDMA:
A drug cannot be reimported into the United States unless reimported by the drug manufacturer or for emergency use after FDA review.
A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 3

A

Question 4

PDMA:
Bans importation of American-made drugs from foreign countries, not importation of drugs from a foreign country.
A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 4

A

Question 5

PDMA:
Bans the sale, purchase, or trade of a prescription drug purchased at a reduced price by a hospital or other healthcare facility or donated or supplied to a charity.*
A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 5

B

Question 6

PDMA:
Bans the sale, purchase, or trade or of a drug sample or drug coupon, and bans counterfeiting of drug coupons.
A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 6

C

Question 7

PDMA:
- Practitioners must ask for drug samples in writing
- Community pharmacies cannot have drug samples at anytime
- Established Recordkeeping, storage, and handling requirements for drug samples

A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 7

C

Question 8

PDMA:
States were required to license wholesalers
A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 8

D duh

Question 9

PDMA:
Records related to PDMA must be maintained for at least 3 years
A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 9

D

Question 10

PDMA:
Whistleblower awards up to $125,000 enacted for reporting someone violating PDMA
A. Reimportation
B. Preferential Pricing
C. Samples and Coupons
D. Wholesale Licensure

Answer 10

D

Question 11

what is DSCSA and what did it do?

Answer 11

Drug Supply Chain Security Act. was passed to further increase supply chain security

Question 12

5 things DSCSA required

Answer 12

1. Manufacturers and repackagers to add barcodes or QR codes to prescription packages to allow for better tracing and verifying of the products (some drugs are excluded, including nonprescription drugs)
2. Manufacturers and wholesalers must verify the legitimacy of products in question within 24 hours of inquiry from a pharmacy
3. Any illegitimate products must be brought to the FDA within 24 hours of discovery by the manufacturer, repackager, distributor, or dispenser
4. Pharmacies must track specific lot numbers throughout the filling process
5. Product tracking must be documented for all parts of the supply chain and maintained for 6 years

Question 13

im not wasting my time on an NDC card sorry

Answer 13

fuck you

Question 14

if an NDC is shown as “16729-097-12” where would you put a 0?

Answer 14

in the number that is short (should be 4-4-2)