Federal Regulations of Dispensing: Dispensing Objectives Exam 1

Question 1

What makes a drug a prescription drug?

Answer 1

• Harmful effects or toxicities that makes it safe to be used under supervision of practitioner
• Dispensed upon written or oral rx by licensed professional or a refill

Question 2

What is proper label information for a prescription drug?

Answer 2

• name and address of the dispenser
• serial number and date of the prescription or of its filling
• name of the prescriber
• name of the patient
• directions for use and cautionary statements
• Rx only

Question 3

Supreme court says that FDA must prove what two things for a drug to be a prescription?

Answer 3

• that the toxicity and method of use require practitioner supervision
• that the collateral measures necessary to use the drug require supervision

Question 4

Durham-Humphrey Amendment

Answer 4

• Authorize refills
• Recognize E-sign
• Made labeling requirements

Question 5

Labeling requirements of the Durham-Humphrey Amendment

Answer 5

label must not be false or misleading, drug must not be an imitation drug, drug must not be sold under name of another drug, packaging and labeling must conform of official compendia standards, must be packaged and labeled appropriately to minimize deterioration, contain name / initials / license # of pharmacist, exp date of drug, name & strength, address of pt, name of manufacturer or distributor, lot or control #

Question 6

Identify the issues associated with off-label drug

Answer 6

• promotion of drug products by manufacturers for “off-label” uses generally constitutes misbranding and is subject to significant restrictions
• certain third-party insurance and managed healthcare plans will not compensate providers for drugs prescribed and dispensed for off-label indications
• Pharmacists can provide information about off-label uses but cannot advertise them

Question 7

Orange Book

Answer 7

• rates pharmaceutically equivalent drugs on the basis of therapeutic equivalence using a two-letter coding system
• Approved drug products that are “pharmaceutical equivalents” (defined by the FDA as products that contain the same active ingredients and are identical in strength and are of the same dosage form) are rated in the publication for “therapeutic equivalence.”

Question 8

Prescription Drug Marketing Act (PDMA)

Answer 8

• Require states to license wholesale distributors of prescription drugs
• Ban the reimportation of prescription drugs, except by the manufacturer or for emergency use
• Ban the sale, trade, or purchase of drug samples
• Mandate storage, handling, and recordkeeping requirements for drug samples
• Ban the trafficking in or counterfeiting of drug coupons
• Prohibit the resale of prescription drugs purchased by hospitals or healthcare facilities, with certain exceptions
• PDMA prohibits the sale, purchase, or trade (or offer to do so) of prescription drugs that have been purchased by a hospital, healthcare entity, or charitable organization.

Question 9

Poison Prevention Packaging Act (PPPA)

Answer 9

• requires the use of child-resistant containers for packaging most OTC drugs and nearly all prescription drugs that the pharmacist will dispense directly to the consumer
• 80% of the children less than 5 years of age cannot open them, whereas at least 90% of adults can
• “Package Not Child-Resistant” disclaimer if necessary