E1 Lecture 4

Question 1

Prior to 1970, what was thought to be the leading cause of injury for children 5 and under?

Answer 1

unintentional poisonings by medicine and household products

Question 2

Poison Prevention Packaging Act (PPPA)

Answer 2

1970

required prescription drugs to be packaged in child resistant containers (CRC) –> special packaging

Question 3

Special Packaging

Answer 3

• targeted at kids under 5 years old
• not difficult for normal adults to access
• most kids under 5 should struggle to open and those that can open it will be preventing from obtaining a toxic amount at reasonable time

Question 4

Child Resistant

Answer 4

• 20% of children or less can open after 10 minutes
• 90% of adults can open after 10 minutes

Question 5

What drugs must be in special packaging?

Answer 5

drugs for ORAL administration
- OTC
- Rx
- controlled substances
- samples of oral products

Question 6

What is one exception to oral drugs within special packaging?

Answer 6

bulk products and unit dose containers are not required to be in special packaging

Question 7

Special Packaging Exemptions

Answer 7

• non oral dosage forms
• waivers
• CPSC exemptions (23 products)

Question 8

Waivers

Answer 8

prescription-by-prescription waivers (prescriber or patient)
- waives for the life of single prescription

blanket waivers (patient only)
- waives for all products

Question 9

Notable CPSC Exemptions

Answer 9

SL NTG

oral contraceptives

steroid dose packs

oral powder formulations

unit-dose potassium

STUDY COMPLETE LIST IN LAW

Question 10

1 Exception to Packaging Reuse

Answer 10

Glass Container
+
New Cap

Question 11

Class 1 Recall

Answer 11

drug product may cause serious adverse health consequences including death
- pharmacies notify patients who received drugs

Question 12

Class 2 Recall

Answer 12

drug may cause temporary or reversible effects but the probability of serious harm is remote

Question 13

Class 3 Recall

Answer 13

drug product is unlikely to cause serious adverse health consequences

Question 14

Seizure

Answer 14

FDA:
- physically isolate a drug that is adulterated or misbranded while civil lawsuit is filed

DEA:
- physically isolate a drug that is illegal to possess or distribute while a criminal lawsuit is filed –> only controlled substances

Recall is voluntary
Seizure is mandatory

Question 15

Federal Anti-Tampering Act of 1983

Answer 15

requires tamper-evident packaging for OTC drug products:
- indicators or barriers to entry to show visible evidence that tampering has occurred
- “distinctive by design” and not able to be duplicated
- two piece hard gelatin capsules must be sealed
- features described on package

Question 16

Label

Answer 16

any printed, written, or graphic material on the stock bottle

Question 17

Labelling

Answer 17

all labels and written, printed, or graphic material on the stock bottle, container wrapper, or accompanying the product

Question 18

Is the label a part of labelling?

Answer 18

Yes

Question 19

Package Inserts

Answer 19

required as part of labeling of prescription drugs and biological products
- intended for HC professionals but can be given to patients

Question 20

If a drug on a shelf does not have a PI….

Answer 20

misbranded

Question 21

3 Sections related to Reproduction

Answer 21

Pregnancy

Lactation

Females & Males of Reproductive Potential

Question 22

Patient Package Inserts (PPI)

Answer 22

FDA-approved labeling written in patient-friendly language which covers:
- drug uses
- risks
- precautions

Question 23

If a PPI is not dispensed with drug they correspond to…

Answer 23

misbranded

Question 24

Which drugs require PPIs?

Answer 24

estrogens

oral contraceptives

Question 25

Medication Guides (MedGuides)

Answer 25

FDA-approved labeling written in patient-friendly language that explains issues related to drug or drug class must be provided with new and refill prescriptions for patients in outpatient environment not under direct supervision of HC professional

Question 26

When are MedGuides required?

Answer 26

- labeling could help prevent serious adverse effects - serious risks of use exist which patients should be made aware of - patient adherence to directions is crucial to drug effectiveness

Question 27

Failure to dispense MedGuide with a required drug ...

Answer 27

misbranded

Question 28

Risk Evaluation and Mitigation Strategy (REMS)

Answer 28

used to address serious risks associated with using a medication or class of medications - may be required by FDA as part of labeling

Question 29

4 Types of REMS

Answer 29

Patient-Friendly Labeling - MedGuides and PPI to provide patients with info Communication Plans - information sent directly to HC practitioner informing them about the drug & how to mitigate issues for patients Elements to Assure Safe Use (ETASU) - required activities that must be done before prescribing, dispensing, or receiving product Implementation System - quality assurance process to ensure that risks are being mitigated successfully

Question 30

Consumer Medication Information

Answer 30

patient information provided when medication is dispensed by a pharmacy but not classed as PPI, MedGuide, nor regulated by FDA does not take the place of formal counseling

Question 31

OTC Drug Facts

Answer 31

Active Ingredient Inactive Ingredient Purpose Use Warning Directions Other Info

Question 32

OTC Label Requirements

Answer 32

Expiration date --> if none, 3 years after purchase Lot/Batch # Name, Address of Manufacturer, packer, or distributor Net quantity of contents Description of type of tamper-evidence packaging

Question 33

MedWatch

Answer 33

FDA voluntary reporting system for adverse events with drug products, biologics, medical devices, nutritional products, cosmetics, and dietary supplements Types: - 3500 --> HC professionals - 3500B --> patients In 2007, mandatory that pharmacies provide patients with notification of toll-free number to report