Exam 1 - supply chain, advertising, & HIPPA Flashcards
(20 cards)
what are the 4 main aspects of PDMA
reimportation
preferential pricing
samples and coupons
wholesale licensure
describe reimportation
drug cannot be reimported into the US unless its by the manufacturer of for emergency use from the FDA
Bans importation of american made drugs from foreign countries
describe preferential pricing
bans the sale, purchase, or trade of a rx drug purchased at a reduced price by a hospital or healthcare facility or donated or supplies to a charity
describe PDMA samples and coupons
bans sale of drug samples or coupons and counterfeiting them
practitioners MUST ask for samples in writing
community pharmacies cannot have samples
established standards for samples
records relating to PDMA must be maintained for how long
at least 3 years
what is the drug supply chain security act (DSCSA)
further increase supply chain security
according to DSCSA, what must manufacturers add to prescription packages for better tracing
QR codes/barcodes
manufacturers must verify legitimacy of products in questions how quickly?
within 24 hours
all illegitimate products must be brought to FDA within how quickly
withing 24 hours of discovery
product tracking must be documented for all parts of the supply chain and maintained for how long
6 years
NDC structure
55555-4444-22
what are the 5 DTC ad standards
presented in consumer friendly language
presented w/ appropriate audio
using audio and text for TV
text must be easily readable
free of audio or visual elements that might interfere with comprehension
off label advertising for journal articles
company must have applied for approval for that indication and submit a copy of info and data at least 60 days before disseminating
what must be included in off label advertising documents
disclosure noting info has not been approved
copy of official labeling
any other products that have been approved for off label use
funding source for the studies
bibliography of publications to the use
what three groups does HIPPA apply to
health care providers
health plans
healthcare clearing houses
what are the 4 key pieces of HIPPA
privacy rule
security rule
breach notification rule
enforcement rule
when MUST PHI be disclosed
individuals requesting access to their own PHI
HHS when its doing an investigation
when MAY PHI be disclosed
-individual
-treatment, payment, and health care operations
-opportunity to agree or object
-incidental use
-public interest
-limited data set
if a HIPPA breach affects fewer than 500 individuals…
report the breach to HHS within 60 days of the end of the calendar year in which breach was discovered
if a HIPPA breach affects 500 or more individuals…
report breach to HHS within 60 days from the discovery of breach
report breach to media outlets of that jurisdiction
