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PHRM 871: Law > Reading 5 > Flashcards

Reading 5 Flashcards

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1
Q

What is the PPPA and why was it created?

A
  • Made to combat child poisoning - UNDER 5 YO
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2
Q

Who enforces the PPPA?

A
  • The Consumer Product Safety Commission [CPSC]`
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3
Q

What does the PPPA require to happen?

A
  • ONLY meant to prevent poisoning in kids YOUNGER than 5 years old
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4
Q

What is Speacial Packaging?

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

Known as Child Resistant Packaging

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5
Q

How is a package classifed as “Child Resistant”

A
  • 90% of adults should open
  • 85% on kids <5yo shouldnt open within 5 mins
  • 80% of kids cant open after shown how
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6
Q

What are the drugs that require Special Packaging?

A
  • Controlls, Rx, OTC after 2002, Samples
  • ALL THAT COME IN ORAL DOSAGE FORM
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7
Q

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

A
  • Misbranded
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8
Q

What products do not have requirements for Special Packaging?

A
  • Non-Oral [Nasal Spray, Eye Drops, Ointments…]
  • Waviers
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9
Q

What are waviers and what are the different types?

A
  • Giving up rights on purpose
  • Prescription-by-Prescription, & Blanket
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10
Q

What is a Prescription-by-Prescription Wavier?

A
  • From Prescribers on Rx-by-Rx basis, for that specfic Rx
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11
Q

What is a Blanket Wavier?

A
  • From Patients or Patient Representatives for ALL Rx
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12
Q

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

A
  • They dont care
  • Really when its like a unit-dose medication
  • Maybe for when speacial packaging makes it harder to get
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13
Q

When the is Pharmacist responsible for dispensing in Speacial Packaging?

A
  • ALWAYS unless told not too
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14
Q

What are the different types of labels?

A
  • Package Insert
  • Patient Labeling
  • Consumer Medication Information
  • Patient Package Insert
  • Medications Guides
  • Proposed Patient Medication Info
  • Nonpresription Labeling
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15
Q

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

A
  • Drug Monograph
  • Provides info to Health Providers about the drug
  • NO PI = Misbranded\
  • NO Cat A, B, C, D, X anymore
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16
Q

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

A
  • Info in patient friendly terms
  • NOT required to be given
17
Q

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

A
  • Drug info NOT FDA regulated
  • Written by a third party
  • NOT required to be given
18
Q

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

A
  • FDA approved written in patient friendly terms
  • From manufacturer
  • MUST be given or Misbranded
  • ONLY required for Estrogens and Oral Contraceptives
19
Q

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

A
  • FDA approved written in patient friendly terms
  • MUST be given because of Med Risks and effectiveness or Misbranded
20
Q

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

A
  • On OTC drugs listed as “Drug Facts”
  • Contains; ingredient, purpose, use, warnings, directions…
  • MUST have tamper-evident, experation date, overdose info to avoid misbranding
21
Q

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

A
  • USPC: makes standards around areas of drug products
  • Makes the USP-NF
22
Q

What information is found within the USP-NF?

A
  • Monographs, Descriptions, Standards for quality, strength, purity, etc for a drug
23
Q

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

A
  • 795: Nonsterile
  • 797: Sterile
  • 800: Hazardous
  • 825: Radiopharmaceuticals
  • 1178: Repackaging
24
Q

What is the difference between Expiration and Beyond Use Date

A
  • Expiration: The last day the product meets the USP standards
  • Beyond Use Date: When the products shouldnt be used
25
Q

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

A
  • BUD: 1 year from dispensed
  • Expiration: What manufacturer says
26
Q

What does repackaging mean?

A
  • From manfacturer bottle to new package WITHOUT doing anything to it
27
Q

What are some of the general BUDs that are nited in the guideance?

Spectific or WIthout [Sterile]?

A
  • 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

PHRM 871: Law (19 decks)

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