Reading 5

Question 1

What is the PPPA and why was it created?

Answer 1

• Made to combat child poisoning - UNDER 5 YO

Question 2

Who enforces the PPPA?

Answer 2

• The Consumer Product Safety Commission [CPSC]`

Question 3

What does the PPPA require to happen?

Answer 3

• ONLY meant to prevent poisoning in kids YOUNGER than 5 years old

Question 4

What is Speacial Packaging?

Answer 4

• A package that is hard for kids under 5 to open BUT easy for adults to open

Known as Child Resistant Packaging

Question 5

How is a package classifed as “Child Resistant”

Answer 5

• 90% of adults should open
• 85% on kids <5yo shouldnt open within 5 mins
• 80% of kids cant open after shown how

Question 6

What are the drugs that require Special Packaging?

Answer 6

• Controlls, Rx, OTC after 2002, Samples
• ALL THAT COME IN ORAL DOSAGE FORM

Question 7

What happens when a pharmacist fails to dispense a medication in a CRC?

Answer 7

• Misbranded

Question 8

What products do not have requirements for Special Packaging?

Answer 8

• Non-Oral [Nasal Spray, Eye Drops, Ointments…]
• Waviers

Question 9

What are waviers and what are the different types?

Answer 9

• Giving up rights on purpose
• Prescription-by-Prescription, & Blanket

Question 10

What is a Prescription-by-Prescription Wavier?

Answer 10

• From Prescribers on Rx-by-Rx basis, for that specfic Rx (they CANNOT do a blanket one)

Question 11

What is a Blanket Wavier?

Answer 11

• From Patients or Patient Representatives for ALL Rx

Question 12

When should the Manufacturer be responsilbe for making sure something is made or dispensed in speacil packging?

Answer 12

• They dont care
• Really when its like a unit-dose medication
• Maybe for when speacial packaging makes it harder to get

Question 13

When the is Pharmacist responsible for dispensing in Speacial Packaging?

Answer 13

• ALWAYS unless told not too

Question 14

What are the different types of labels?

Answer 14

• Package Insert
• Patient Labeling
• Consumer Medication Information
• Patient Package Insert
• Medications Guides
• Proposed Patient Medication Info
• Nonpresription Labeling

Question 15

What is a Package Insert and what are some of the things that the Package Insert must have?

Answer 15

• Drug Monograph
• Provides info to Health Providers about the drug
• NO PI = Misbranded\
• NO Cat A, B, C, D, X anymore

Question 16

What is Patient Labeling and what are some of the things that is important about it?

Answer 16

• Info in patient friendly terms
• NOT required to be given

Question 17

What is Consumer Medication Information and what is important to know about it?

Answer 17

• Drug info NOT FDA regulated
• Written by a third party
• NOT required to be given

Question 18

What are Patient Package Inserts and what is important to know about it?

Answer 18

• FDA approved written in patient friendly terms
• From manufacturer
• MUST be given or Misbranded
• ONLY required for Estrogens and Oral Contraceptives

Question 19

What is a Medication Guide and what is important to know about them/

Answer 19

• FDA approved patient friendly info about the drug/drug class
• Must be given with EVERY refill or new start (misbranded if not)
• Required with… NSAIDs, Amphetamines, PPIs, SSRIs, Opioids…

Question 20

What are Nonprescription Labels and what is importnat to know about them?

Q

Answer 20

• On OTC drugs listed as “Drug Facts”
• Contains: Active Ingredents, Uses, Warnings, Directions, Other Info, Inactive Ingredents, Questions
• MUST have tamper-evident, experation date, overdose info to avoid misbranding

Question 21

What is the United States Pharmacopeial Convention, and what does this organization make/

Answer 21

• USPC: makes standards around areas of drug products
• Makes the USP-NF

Question 22

What information is found within the USP-NF?

Answer 22

• Monographs, Descriptions, Standards for quality, strength, purity, etc for a drug

Question 23

What are some of the most relevent chapters that are used in the USP?

Answer 23

• 795: Nonsterile
• 797: Sterile
• 800: Hazardous
• 825: Radiopharmaceuticals
• 1178: Repackaging

Question 24

What is the difference between Expiration and Beyond Use Date

Answer 24

• Expiration: The last day the product meets the USP standards
• Beyond Use Date: When the products shouldnt be used

Question 25

How long is the BUD and how long is the Expiration?

Answer 25

- BUD: **1 year from dispensed** - Expiration: What manufacturer says

Question 26

What does repackaging mean?

Answer 26

- From manfacturer bottle to new package WITHOUT doing anything to it

Question 27

What are some **repackaging guidance** that pharmacist should follow?

Answer 27

- For a **apporved Rx** OR **Rx on shortage list** - Repackaged **by** OR **under supervision** of a Pharmacist - Distributed **ONLY after the reciept** of a vaild Rx - Assigned a **BUD** ## Footnote BUDs are noted on another slide

Question 28

Based around the **repackaging guidance of BUD**, what are some of the **general notes** about it? | Spectific or WIthout [Sterile]?

Answer 28

- **Specific In-use time**: BUD or Expiration [whichever is 1st] - **Without In-use time**: non-aqueous [6m or Expiration]; Water oral [ 14d or expiration]; Water topical [30d or Expiration] - **Sterile Specific In-use time**: BUD or Expiration - **Sterile Without In-use time**: BUD by 797 or Expiration

Question 29

# Practice Question 1 Medication Guides are part of the required labeling for drugs with serious risks associated with their use? ## Footnote a. True b. False

Answer 29

- a. True

Question 30

# Practice Question 2 Which of the following is true regarding the Poison Preventions Packaging Act ## Footnote a. Child-resistant continare are required for all manufacturer-produced drug products b. The Consumer Product Safety Comminssion provides full exemptions for drugs under the PPPA c. Prescribers can issue blanket waivers for a patient d. There are no set standards for what is or is not special packaging e. All childern should struggle to open child-resistant containers

Answer 30

- b. The Consumer Product Safety Comminssion provides full exemptions for drugs under the PPPA

Question 31

# Practice Questions 3 The information listed in USP chapters 795 and 797 must be followed if adopted as part of the law federally or in your state or practice but is otherwise unnecessary. ## Footnote a. True b. False

Answer 31

- b. False

Question 32

# Practice Question 4 Which of the following is the approprite beyond use date for a repackaged, FDA-approved water-containing oral formation with no specific in-use time? ## Footnote a. 7 days b. 14 days c. 30 days d. 180 days e. 1 year

Answer 32

- b. 14 days