Lec 5 Packaging Flashcards
the Poison Prevention Packaging Act (PPPA) required rx drugs to be packaged in child resistant containers (CRCs), also known as “_______ _______”
“special packaging”
3 criteria for “special packaging”
-targeted at kids under 5
-not difficult for adults to access
-most kids under 5 should struggle to open, and if they do it will prevent them from getting a toxic amount out
-child resistant means ___% of children or less can open after 10 minutes
-at least ___% of adults can open after 10 minutes
20%
90%
which drugs require special packaging?
a. IV
b. IM
c. oral
d. topical
c. oral
which of the following statements is FALSE about child-resistant containers (CRCs)?
a. bulk products and unit dose containers are NOT required to be in CRCs
b. drugs intended to be dispensed in the manufacturer’s packaging must be in CRCs
c. all oral drugs must be in a CRC no matter what
d. non-oral dosage forms do NOT need special packaging
c. all oral drugs must be in a CRC no matter what
(there are 2 exceptions; slide 7)
T or F: drugs for oral administration require special packaging, EXCEPT for samples of oral products
F
if bulk products and unit-dose containers are being dispensed, they must be dispensed in appropriate CRCs, otherwise they may be _______
a. adulterated
b. misbranded
b. misbranded
two waivers for special packaging exemptions
-prescription-by-prescription waivers (can be given by prescribers and pts)
-blanket waivers (pt authorization only)
prescription-by-prescription waivers can be given by:
a. patients
b. prescribers
c. both
d. neither
c. both
blanket waivers for CRCs can be given by:
a. patients
b. prescribers
c. both
d. neither
a. patients
how many products are on the CPSC (consumer product safety commission) exemption list?
23
T or F: as a general rule, packaging should be reused
F (plastics wear down, can make it no longer child-resistant; only one exception to this rule)
what is the one exception to reuse packaging?
packaging is glass, and a new cap is used
Drug product may cause serious adverse health consequences including death (pharmacies notify patients who received recalled drugs)
a. class I recall
b. class II recall
c. class III recall
a. class I recall
Drug may cause temporary or reversible effects, but the probability of serious health consequences is remote
a. class I recall
b. class II recall
c. class III recall
b. class II recall
Drug product is unlikely to cause serious adverse health consequences
a. class I recall
b. class II recall
c. class III recall
c. class III recall
T or F: a drug seizure is voluntary, a recall is not
F (recall is voluntary, seizure is not)
what was the aftermath of the Chicago tylenol murders?
FDA requires tamper-evident packaging for OTC human drug products (look at slide 13 for the rest)
which act made tampering a federal crime in 1983?
federal anti-tampering act
T or F: a label is part of the labeling
T
any printed, written, or graphic material on the product container
a. label
b. labeling
c. package insert (PI)
d. patient package inserts (PPIs)
a. label
all labels and written, printed or graphic material on the container, container wrapper, or accompanying the product.
a. label
b. labeling
c. package insert (PI)
d. patient package inserts (PPIs)
b. labeling
Required as part of the labeling of prescription drugs and biological products, these are sometimes referred to as “prescribing information” or a “drug monograph.”
a. label
b. labeling
c. package insert (PI)
d. patient package inserts (PPIs)
c. package insert (PI)
T or F: if a drug on a shelf does not have a PI, it is adulterated
F (misbranded, not adulterated)
for the OLD pregnancy categories, which category is considered the most safe?
a. A
b. B
c. C
d. D
e. X
a. A
for the OLD pregnancy categories, which category should NOT be used bc the drug is CI for use during pregnancy?
a. A
b. B
c. C
d. D
e. X
e. X
for the NEW pregnancy categories, which is NOT one of the labeling requirements?
a. pregnancy
b. lactation
c. osteoporosis risk
d. females and males of reproductive potential
c. osteoporosis risk
which of the following is FALSE about PPIs (patient package inserts)?
a. must be dispensed with the drug they correspond to whenever that product is dispensed
b. failure to dispense the PPI with the drug product results in adulteration
c. these requirements apply to any person who dispenses medications, including institutions and practitioners
d. currently, the only drugs requiring PPIs are estrogens and oral contraceptives
b. failure to dispense the PPI with the drug product results in adulteration
(misbranding not adulteration)
T or F: MedGuides must be provided with new prescriptions, but not for refills in an outpatient environment
F (must be provided for new rx and for refills)
MedGuides are required when one or more of the following exists: (3 things)
-labeling could help prevent serious AE
-serious risks of use exist which pts should be made aware of
-adherence to directions is crucial to drug effectiveness
failure to dispense a MedGuide with a required drug is _______
a. adulteration
b. misbranding
b. misbranding
used to address serious risks assoc with using a medication or class of medications
a. labeling
b. package inserts
c. MedGuides
d. patient package inserts
e. REMS
e. REMS
T or F: REMS can be required by the FDA as part of a drug’s labeling
T
4 types of REMS
-patient friendly labeling
-communication plans
-elements to assure safe use (ETASU)
-implementation system
REMS: Medication Guides and Patient Package Inserts. Something to provide patients essential information about the drug
a. patient-friendly labeling
b. communication plans
c. elements to assure safe use (ETASU)
d. implementation system
a. patient-friendly labeling
REMS: Information sent directly to healthcare practitioners informing them about the drug and how to mitigate issues for patients
a. patient-friendly labeling
b. communication plans
c. elements to assure safe use (ETASU)
d. implementation system
b. communication plans
REMS: Required activities that must be done before prescribing, dispensing, or receiving a product. Can be required from practitioners, patients, or pharmacies
a. patient-friendly labeling
b. communication plans
c. elements to assure safe use (ETASU)
d. implementation system
c. elements to assure safe use (ETASU)
REMS: A quality assurance process to ensure that risks are being mitigated successfully
a. patient-friendly labeling
b. communication plans
c. elements to assure safe use (ETASU)
d. implementation system
d. implementation system
which of the following is FALSE about consumer medication information?
a. it is patient information provided when medication is dispensed by a pharmacy, but is not classified as PPIs or MedGuides
b. regulated by the FDA, legally required to be dispensed to patients
c. does not take the place of formal counseling provided by pharmacists
b. regulated by the FDA, legally required to be dispensed to patients
(not regulated, not legally required)
all OTC products are required to have a _____ _____ sections, which includes things such as active ingredient and directions
drug facts
the drug facts section on an OTC label includes what 7 things?
-active ingredient
-inactive ingredients
-purpose
-use(s)
-warning(s)
-directions
-other information
if there is no expiration date on an OTC label, the drug should be considered expired _____ _____ after purchase
a. 3 months
b. 6 months
c. 1 year
d. 3 years
e. 5 years
d. 3 years
in addition to the “drug facts” label, an OTC label must also have all of the following EXCEPT:
a. net quantity of contents
b. name and address of manufacturer, packer, or distributer
c. description of the type of tamper-evident packaging utilized
d. description of the manufacturing process utilized
e. lot or batch code
d. description of the manufacturing process utilized
FDA’s voluntary reporting system for adverse events with drug products, biologics, medical devices, nutritional products, cosmetics, and dietary supplements
MedWatch
which MedWatch form allows for Health Professionals to report serious AE associated with drugs or FDA-covered products?
a. FDA Form 3500
b. FDA Form 3500A
c. FDA Form 3500B
a. FDA Form 3500
which MedWatch form allows for Patients to report serious AE associated with drugs or FDA-covered products?
a. FDA Form 3500
b. FDA Form 3500A
c. FDA Form 3500B
c. FDA Form 3500B
T or F: in 2007, a law was passed “mandating that pharmacies provide patients with notification of a toll-free number so they can report adverse events.”
T
