Lec 5 Packaging

Question 1

the Poison Prevention Packaging Act (PPPA) required rx drugs to be packaged in child resistant containers (CRCs), also known as “_______ _______”

Answer 1

“special packaging”

Question 2

3 criteria for “special packaging”

Answer 2

-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

Question 3

-child resistant means ___% of children or less can open after 10 minutes
-at least ___% of adults can open after 10 minutes

Answer 3

20%
90%

Question 4

which drugs require special packaging?

a. IV
b. IM
c. oral
d. topical

Answer 4

c. oral

Question 5

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

Answer 5

c. all oral drugs must be in a CRC no matter what

(there are 2 exceptions; slide 7)

Question 6

T or F: drugs for oral administration require special packaging, EXCEPT for samples of oral products

Answer 6

F

(oral administration, including OTC and Rx drugs, CS, and samples of oral products)

Question 7

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

Answer 7

b. misbranded

Question 8

two waivers for special packaging exemptions

Answer 8

-prescription-by-prescription waivers (can be given by prescribers and pts)
-blanket waivers (pt authorization only)

Question 9

prescription-by-prescription waivers can be given by:

a. patients
b. prescribers
c. both
d. neither

Answer 9

c. both

Question 10

blanket waivers for CRCs can be given by:

a. patients
b. prescribers
c. both
d. neither

Answer 10

a. patients

Question 11

how many products are on the CPSC (consumer product safety commission) exemption list?

Answer 11

23

Question 12

T or F: as a general rule, packaging should be reused

Answer 12

F (plastics wear down, can make it no longer child-resistant; only one exception to this rule)

Question 13

what is the one exception to reuse packaging?

Answer 13

packaging is glass, and a new cap is used

Question 14

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

Answer 14

a. class I recall

Question 15

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

Answer 15

b. class II recall

Question 16

Drug product is unlikely to cause serious adverse health consequences

a. class I recall
b. class II recall
c. class III recall

Answer 16

c. class III recall

Question 17

T or F: a drug seizure is voluntary, a recall is not

Answer 17

F (recall is voluntary, seizure is not)

Question 18

what was the aftermath of the Chicago tylenol murders?

Answer 18

FDA requires tamper-evident packaging for OTC human drug products (look at slide 13 for the rest)

Question 19

which act made tampering a federal crime in 1983?

Answer 19

federal anti-tampering act

Question 20

T or F: a label is part of the labeling

Answer 20

T

Question 21

any printed, written, or graphic material on the product container

a. label
b. labeling
c. package insert (PI)
d. patient package inserts (PPIs)

Answer 21

a. label

Question 22

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)

Answer 22

b. labeling

Question 23

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)

Answer 23

c. package insert (PI)

Question 24

T or F: if a drug on a shelf does not have a PI, it is adulterated

Answer 24

F (misbranded, not adulterated)

Question 25

for the OLD pregnancy categories, which category is considered the most safe? a. A b. B c. C d. D e. X

Answer 25

a. A

Question 26

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

Answer 26

e. X

Question 27

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

Answer 27

c. osteoporosis risk

Question 28

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

Answer 28

b. failure to dispense the PPI with the drug product results in adulteration (misbranding not adulteration)

Question 29

T or F: MedGuides must be provided with new prescriptions, but not for refills in an outpatient environment

Answer 29

F (must be provided for new rx and for refills)

Question 30

MedGuides are required when one or more of the following exists: (3 things)

Answer 30

-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

Question 31

failure to dispense a MedGuide with a required drug is _______ a. adulteration b. misbranding

Answer 31

b. misbranding

Question 32

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

Answer 32

e. REMS

Question 33

T or F: REMS can be required by the FDA as part of a drug's labeling

Answer 33

T

Question 34

4 types of REMS

Answer 34

-patient friendly labeling -communication plans -elements to assure safe use (ETASU) -implementation system

Question 35

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

Answer 35

a. patient-friendly labeling

Question 36

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

Answer 36

b. communication plans

Question 37

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

Answer 37

c. elements to assure safe use (ETASU)

Question 38

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

Answer 38

d. implementation system

Question 39

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

Answer 39

b. regulated by the FDA, legally required to be dispensed to patients (not regulated, not legally required)

Question 40

all OTC products are required to have a _____ _____ sections, which includes things such as active ingredient and directions

Answer 40

drug facts

Question 41

the drug facts section on an OTC label includes what 7 things?

Answer 41

-active ingredient -inactive ingredients -purpose -use(s) -warning(s) -directions -other information

Question 42

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

Answer 42

d. 3 years

Question 43

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

Answer 43

d. description of the manufacturing process utilized

Question 44

FDA’s voluntary reporting system for adverse events with drug products, biologics, medical devices, nutritional products, cosmetics, and dietary supplements

Answer 44

MedWatch

Question 45

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

Answer 45

a. FDA Form 3500 (b. we didn't talk about; c. is for Patients)

Question 46

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

Answer 46

c. FDA Form 3500B (a. is for Health Professionals; b. we didn't talk about)

Question 47

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.”

Answer 47

T

Question 48

special packaging is targeted at kids under ____ years old

Answer 48

5

Question 49

-child resistant means ____% of children or less can open after ____ minutes -at least ____% of adults can open after ____ minutes

Answer 49

20%, 10 90%, 10

Question 50

notable CPSC (consumer product safety commission) exemptions (slide 7; 5 listed)

Answer 50

-SL NTG -oral contraceptives in mnemonic dispenser packages -steroid dose packs -some oral powder formulations -unit-dose potassium (there are 23 total, these are the ones on the slide)