PHCY 722 - Law Exam #2 Questions with Correct Answers
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Module
RN- Nursing
Institution
RN- Nursing
Prescription Drug Marketing Act of 1987
- What 2 things does it regulate? Correct Answer-1) Regulates drug samples - prohibits sale/purchase/trade of samples
2) Bars re-importation of drugs
Drug sample regulations Correct Answer-Samples can never be sold, purchased, nor traded
- Samples may b...
PHCY 722 - Law Exam #2 Questions with Correct
Answers
Prescription Drug Marketing Act of 1987
- What 2 things does it regulate? Correct Answer-1) Regulates drug
samples - prohibits sale/purchase/trade of samples
2) Bars re-importation of drugs
Drug sample regulations Correct Answer-Samples can never be sold,
purchased, nor traded
- Samples may be distributed to practitioners that prescribe or to
pharmacies at hospitals/clinics (on behalf of prescriber), but NOT to
retail pharmacies
- Samples must be stored appropriately and maintain receipt of
requesting prescriber
- Drugs cannot be bought by hospitals and re-sold at a profit
*some institutions refuse to store samples d/t possibility of influencing
prescribing
Selling drug samples would be considered ____________ Correct
Answer-Adulterated and misbranded
- Adulterated: contamination when taken out of sample packaging, may
be improperly stored
- Misbranded: taken out of sample packaging
TRUE/FALSE
,Hospitals can use buy drugs at a cheaper price than at retail pharmacies
(ex: 340b pricing), then re-sell them to local pharmacies Correct
Answer-FALSE --- violation of the PDMA
- Results in misbranding and adulteration
Re-importation of drug may be considered __________ Correct Answer-
Adulteration and misbranded - NOT FDA approved
- Adulterated: outside of US controls, may not have correct API or
amount
- Misbranded: different labeling requirements in different countries
(misbranded if label has something prohibited in US or lacks something
required)
*ex: Canadian Ambien API as Haldol
What may be an exception to the re-importation rule? Correct Answer-
Manufacturers can reimport their own drug only in emergency situations
(shortages)
- Wholesale importation from Canada would be permitted if Secretary of
HHS certifies no public health nor safety risk (has NEVER happened)
- Current Secretary stated that states can also seek FDA approval to
import drugs (also NEVER happened)
*impossible to guarantee/monitor safety if produced outside of the US
Even if the Secretary of HHS certified no risk or a state got FDA
approval to import drugs from Canada, why might such a plan fail?
Correct Answer-Canada would not have sufficient drugs to treat their
own patients if they export large amounts of drugs
,Legal or illegal?
1) Taking personal supply of drug from foreign country into the US
2) Get personal supply of drug shipped in from foreign country
3) Bringing back a drug legally prescribed in foreign country
4) Drug manufacturer imports from own manufacturing facility in
foreign country Correct Answer-Illegal - 1,2
Legal - 3,4 (ex: GSK has manufacturing facility in China that is
registered with FDA, complies with cGMP regulations)
US vs RxDepot
- Court
- Issue
- Outcome
- Significance Correct Answer-District court
- Issue: RxDepot helped pts procure Canadian Rx's by sending Rx
written in US to Canada, have Canadian physician re-write Rx, then ship
drug back to pts; stores in US functioning as storefront for Canadian
pharmacies; FDA issues warning letter but RxDepot simply expands;
admits to shipping non-FDA approved Rx's, argue for implicit exception
for pts unable to afford Rx in US
- Outcome: unlicensed pharmacy (Canadian pharmacy not licensed in
US) + non-FDA approved (adulterated, misbranded) = FDCA violation
under interstate commerce act --> shut them down!
*significance: reimportation and unapproved drugs cannot be shipped
into US; we take gold standard of efficacy/safety very seriously; only
, option would have been to make argument to Congress to pass law
allowing
How might pharmaceutical manufacturers prevent reimportation of
drugs? Correct Answer-Cut off supply to Canadian (or other country)
distributors known to supply "internet" pharmacies in the US
Anti-tampering act Correct Answer-Requires most OTC items be
dispensed in tamper-evident packaging to prevent adulteration
Poison Prevention Packaging Act of 1970 Correct Answer-Requires use
of child-resistant container for OTC and Rx drugs
- Patients must opt out of CR container to get easy-open containers, and
can make blanket request for non-CR
- Providers can state on Rx to dispense in non-CR container, but cannot
make blanker request
- Exceptions: sublingual nitroglycerin, oral contraceptives, powders, etc.
(if it comes in blister packs, ask pt what they prefer)
OBRA 90
- Intended as.....
- Regulates.... Correct Answer-Intended as cost-saving measure, but
effectively regulates practice of pharmacy by conditioning state
Medicaid eligibility on OBRA compliance (opting out of Medicaid
funding isn't financially possible)
- Forces states to elevate standard of care pharmacists owe to pts
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