EXAM 3 Kevin Clauson Drug Donation Act

Question 1

Allow drugs to be donated and re-dispensed

Answer 1

the idea was to “recycle” cancer drugs of patients who died and their drug was wasted

-but the Act doesn’t only apply to cancer drugs but to all Rx drugs

Question 2

What must ensured before re-dispensing drugs?

Answer 2

-pharmacies can elect to participate and act as depository

-the pharmacy that re-dispenses have to make sure the drugs that are re-dispensed are unadulterated, safe, suitable for dispensing

-the donated Rx has to be unopened and in temper-evident packaging (the single unit dose is intact but the main package was opened - is acceptable)

Question 3

What is the prioritizing order of re-dispensing meds?

Answer 3

1. indigent person

indigent means a person with an income that is below six hundred percent (600%) of the federal poverty level

2. no Rx insurance or can’t afford
3. everyone else

Question 4

When does a pharmacy can charge fees when re-dispensing drugs?

Answer 4

-Can’t charge fees to those who receive the drugs (?)

-can charge handling fees

-can charge usual and customary fees to
donors
the eligible patients
PBMs
manufactures

-can distribute to other repositories (pharmacies who re-dispense)

Question 5

What must be done by the pharmacy on the first donation?

Answer 5

-make sure the donor meets the qualifications of a donor (can be a person, facility, pharmacy, or manufacturer)

-record name, address, phone number, license number (if it is a medical facility)

-the donor has to attest that they are making a donation according to the criteria set in the statute (they have to sign a form)

Question 6

Handling drug donations

Answer 6

-Pharmacist inspects (make sure it is not adulterated)

-Donations kept separate from non-donations

-Redact donor information

-Repackage if necessary (label with name,
dose, expiration date)

-Maintain electronic inventory (of all the donated drugs)

Question 7

Handling re-dispensig drug cont’d

Answer 7

-Return or destroy drugs not suitable for dispensing
destroy by incineration

-Maintain transaction history of donations by donor (ex: if a manufacturer donates on a regular basis)

-Expiration date required
-can’t dispense after the expiration date

-Maintain records for 3 years

Question 8

Which drugs cannot be used for re-dispensing?

!!!

Answer 8

-after the expiration date

-no controlled substances
-no drugs requiring REMS

Question 9

How long should the pharmacy keep records of re-dispensed drugs?

!!!

Answer 9

3 years

Question 10

Pharmacists are not liable for things going wrong except for acts of gross negligence, willful misconduct, or bad faith. T/F

Answer 10

True

Question 11

Samples can NOT be donated?

Answer 11

False.