exam 1 - packaging requirements Flashcards
(25 cards)
what is special packaging
targeted at kids under 5
not difficult for normal adults to access
most kids under 5 should struggle to open, and those that can open will be prevented from obtaining a toxic amount in a reasonable time
what does child resistant mean
20% of children or less can open after 10 minutes
at least 90% of adults can open after 10 minutes
what drugs are required to have special packaging
drugs for oral administration
what is not required to be in special packaging
-bulk products
-unit dose containers
-non oral dosage forms
-anything with a waiver
-the 23 products
what are the stipulations with special packaging waivers
prescription-by-prescription wavers
blanket waivers
what are the notable CPSC exemptions
sublingual nitroglycerin
oral contraceptive in paks
steroid dose packs
some oral powder formulations
unit dose potassium
class I recall
drug product may cause serious adverse health consequences including death
class II recall
drug may cause temporary or reversible effects but the probability of serious health consequences is remote
class III recall
drug product is unlikely to cause serious adverse health consequences
what is the difference between a drug recall and a seizure
a drug recall is voluntary, a seizure is not
what does the FDA require tamper-evident packaging for
OTC human drug products
what is a label
any printed, written, or graphic material on the product container
what is labeling
all labels and written, printed, or graphic material on the container, container wrapper, or accompanying the product
if a drug on a shelf does not have a PI…
it is misbranded
what are the 3 sections for pregnancy
pregnancy
lactation
people of reproductive potential
what are the drugs that require PPIs
estrogens and oral contraceptives
when must med guides be provided
with new and refill prescriptions for patients in an outpatient environment
when are medguides required
labeling could prevent serious AEs
serious risk of use exist which patients should be made aware of
patient adherence to directions is crucial to drug effectiveness
what are the 4 REMs types
patient friendly labeling
communication plans
elements to assure safe use
implementation system
what is patient friendly labeling
med guides and PPIs
what is communication plans
info sent directly to practitioners informing them about the drug
what is elements to assure safe use
required activities that must be done before prescribing, dispensing, or receiving a product
what is an implementation system
quality assurance process to ensure risks are being mitigated
