Lect 3 Dispensing

Question 1

Durham-Humphry Amendment of 1951

Answer 1

• established 2 classes of drugs, OTC and RX
• RX: require medical supervision and warnng “Caution, federal law proibits dispensing w/o script”
• OTC: products do not require supervision
• Authorized oral scripts/refills

Question 2

TO move from OTC to Rx, FDA must prove…

Answer 2

1) Toxicity and method of use require supervision

2) Collateral measures necessary to use the drug require supervision

Question 3

Collateral measures

Answer 3

1) seriousness of the harm of delay of care
2) length of delay is detrimental
3) quality of advice contained on the label
4) possibility of drug alleviating symptoms (but not curing)

Question 4

Enacted e-scripts

Answer 4

Medicare Part D (along with state laws)

Question 5

Durham Humphry Labeling reqs

Answer 5

• Name, initials, or license # of pharmacist
• Expiration date
• Drug name/strength
• Address of patient
• Name of manufacturer
• Lot #

Question 6

NC State labeling reqs

Answer 6

• Name (not initials) of dispensing pharmacist
• Discard date
• Name of patient
• Name/address of pharmacy
• script #
• Date or RX or refills remaining
• Name of prescriber
• directions
• generic name if brand

Question 7

Ways a drug can switch from Rx to OTC

Answer 7

1) manufacturer may request the switch by submitting a supplemental NDA
2) manufacturer may petition the FDA
3) FDA may add or amend an OTC monograph

Question 8

Combat methamphetamine epidemic act of 2005

Answer 8

• Retail sales may not exceed 3.6g PSE/day/purchaser
• 9g PSE/30d/purchaser
• Retail must maintain a logbook (electronic in NC) and sell in blister packages

Question 9

FDA 2002 Compliance Policy Guide

Answer 9

• pharmacists can compound reasonable quantities of drugs extemporaneously in anticipation of a script
• not subject to GMP
• FDA notes increase in pharmacists manufacturing

Question 10

Title I of the Drug Quality and Security Act of 2013

Answer 10

Created outsourcing facilities:

1) must comply with CGMP
2) will be inspected by FDA on a risk-based schedule
3) Must meet certain conditions, such as reporting AE and providing FDA wih certain info about the products they compound
- In return these companies can sell products in bulk to hospitals and physicians

Question 11

Orange book substitution

Answer 11

• pharmacists are responsible for ensuring that the substituted generic drug prduct is bioequivalent
• FDA published Orange book

Question 12

A rating (orange book)

Answer 12

-the FDA considers the drug to be the therapeutic equivalent of another product

Question 13

B rated (orange book)

Answer 13

actual or potential bioequivalence differences have been identified; therefore, the drug cannot be considered therapeutically equivalent

Question 14

3 methods for stopping product selection

Answer 14

1) sign on DAW line
2) handwrite DAW on script
3) state DAW if script is oral

Question 15

Substiution is permissible if drug has the same:

Answer 15

• Active ingredient
• strength
• quantity
• dosage form