Reading 5 Flashcards
What is the PPPA and why was it created?
- Made to combat child poisoning - UNDER 5 YO
Who enforces the PPPA?
- The Consumer Product Safety Commission [CPSC]`
What does the PPPA require to happen?
- ONLY meant to prevent poisoning in kids YOUNGER than 5 years old
What is Speacial Packaging?
- A package that is hard for kids under 5 to open BUT easy for adults to open
Known as Child Resistant Packaging
How is a package classifed as “Child Resistant”
- 90% of adults should open
- 85% on kids <5yo shouldnt open within 5 mins
- 80% of kids cant open after shown how
What are the drugs that require Special Packaging?
- Controlls, Rx, OTC after 2002, Samples
- ALL THAT COME IN ORAL DOSAGE FORM
What happens when a pharmacist fails to dispense a medication in a CRC?
- Misbranded
What products do not have requirements for Special Packaging?
- Non-Oral [Nasal Spray, Eye Drops, Ointments…]
- Waviers
What are waviers and what are the different types?
- Giving up rights on purpose
- Prescription-by-Prescription, & Blanket
What is a Prescription-by-Prescription Wavier?
- From Prescribers on Rx-by-Rx basis, for that specfic Rx
What is a Blanket Wavier?
- From Patients or Patient Representatives for ALL Rx
When should the Manufacturer be responsilbe for making sure something is made or dispensed in speacil packging?
- They dont care
- Really when its like a unit-dose medication
- Maybe for when speacial packaging makes it harder to get
When the is Pharmacist responsible for dispensing in Speacial Packaging?
- ALWAYS unless told not too
What are the different types of labels?
- Package Insert
- Patient Labeling
- Consumer Medication Information
- Patient Package Insert
- Medications Guides
- Proposed Patient Medication Info
- Nonpresription Labeling
What is a Package Insert and what are some of the things that the Package Insert must have?
- Drug Monograph
- Provides info to Health Providers about the drug
- NO PI = Misbranded\
- NO Cat A, B, C, D, X anymore
What is Patient Labeling and what are some of the things that is important about it?
- Info in patient friendly terms
- NOT required to be given
What is Consumer Medication Information and what is important to know about it?
- Drug info NOT FDA regulated
- Written by a third party
- NOT required to be given
What are Patient Package Inserts and what is important to know about it?
- FDA approved written in patient friendly terms
- From manufacturer
- MUST be given or Misbranded
- ONLY required for Estrogens and Oral Contraceptives
What is a Medication Guide and what is important to know about them/
- FDA approved written in patient friendly terms
- MUST be given because of Med Risks and effectiveness or Misbranded
What are Nonprescription Labels and what is importnat to know about them?
- On OTC drugs listed as “Drug Facts”
- Contains; ingredient, purpose, use, warnings, directions…
- MUST have tamper-evident, experation date, overdose info to avoid misbranding
What is the United States Pharmacopeial Convention, and what does this organization make/
- USPC: makes standards around areas of drug products
- Makes the USP-NF
What information is found within the USP-NF?
- Monographs, Descriptions, Standards for quality, strength, purity, etc for a drug
What are some of the most relevent chapters that are used in the USP?
- 795: Nonsterile
- 797: Sterile
- 800: Hazardous
- 825: Radiopharmaceuticals
- 1178: Repackaging
What is the difference between Expiration and Beyond Use Date
- Expiration: The last day the product meets the USP standards
- Beyond Use Date: When the products shouldnt be used
How long is the BUD and how long is the Expiration?
- BUD: 1 year from dispensed
- Expiration: What manufacturer says
What does repackaging mean?
- From manfacturer bottle to new package WITHOUT doing anything to it
What are some of the general BUDs that are nited in the guideance?
Spectific or WIthout [Sterile]?
- 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
