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MPJE > Reading 4 & 5 - Federal Law > Flashcards

Reading 4 & 5 - Federal Law Flashcards

1
Q

Scope of Practice

A

what a practitioner can do based on their education and professional licensure

*** can ONLY prescribe under their scope of practice

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2
Q

What must ALWAYS be on a prescription label in order to not be misbranded?

A

Name and address of dispenser
Prescription #
Date of prescription or filling
Name of prescriber

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3
Q

What may be added to a label if included on the prescription?

A

Name of patient
Directions for use
Cautions for use

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4
Q

Expiration date for all OTC medication prescriptions

A

After 1 year of WRITTEN date

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5
Q

Agency and its limitations

A

a principal hiring an agent to deal with a third party on their behalf (a nurse calling in prescriptions)

**CANNOT be done for C-II medications

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6
Q

Drug Utilization Review

A

DUR
ongoing process to maintain appropriate and effective use of medications

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7
Q

OBRA ‘90

A

Omnibus Reconciliation Act
- ensures $$ is spent appropriately
-targets DUR
- Medicaid beneficiaries is a focus

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8
Q

The act that requires special packaging to protect from child poisoning:

A

Poison Prevention Packaging Act (PPPA)

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9
Q

The requirements of the PPPA

A

90% of adults can open without significant difficulty
85% of children under 5 who have never seen the package cannot open within 5 minutes
80% of children under 5 who have given instructions still cannot open within 5 minutese

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10
Q

CRC

A

Child Resistant Container

NOT CHILDPROOF!!!

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11
Q

What is required to have CRC according to the PPPA?

A
  • CS for oral adminstration
  • Rx for oral adminstration
  • OTC for oral adminstration
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12
Q

What is NOT required to have CRC?

A

Nasal sprays
eye drops
ointments/creams

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13
Q

What are some drug exceptions for CRC?

A

NTG SL
Isosorbide dinitrate SL
Erythromycin grandules < 8 grams
Erythromycin tablets < 16 grams
Oral contraceptives
Anhydrous Cholestyramine (powder)
Potassium < 50 mEq
Betamethasone tab in manufacturers dispensed packages
Prednisone tab < 105 mg
Medroxyprednisolone < 84 mg
Colestipol poweder </= 5 g
Mebendazole tab </= 600 mg

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14
Q

What products MUST contain PPI?

A

estrogen products or oral contraceptives in both outpatient and inpatient!!!

** if not it is MISBRANDED

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15
Q

Package insert: label or labeling?

A

labeling

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16
Q

What is a FDA approved labeling written in patient friendly language that explains issues related to a specific drug or class?

A

MedGuide

17
Q

What FDA approved labeling is required in both inpatient and outpatient setting?

A

PPI for estrogen and oral contraceptives

**MedGuides are only for outpatient settings

18
Q

What medications are required to have MedGuides?

A
  • drug is where patient labeling could help prevent serious ADR
  • drug has serous risks for patient to be aware of and could affect decision to use
  • drug adherence to directions of use is important for effectiveness

EX: NSAIDs, PPIs, SSRIs, opioids, amphetamines

19
Q

Failure to dispense a required product with a MedGuide is assumed the drug is….

A

Misbranded

20
Q

What must be included on a non-prescription label?

A

“Drug Facts” that include:
active ingredients
purpose
use
warnings
directions
inactive ingredients
EXPIRATION DATE
tamper-evident safety features

21
Q

USP

A

United State Pharmacopeia is an official compendia to develop and piblish standards for drug products, excipients, and dietary supplements

— not technically law!

22
Q

USP 795

A

Nonsterile compounding

23
Q

USP 797

A

Sterile Compounding

24
Q

USP 800

A

Hazardous substances:
- carcinogenicity
- teratogencity
- reproductive toxicity
- organ toxicity at low doses
- genotoxicity
- any new drugs that mimic existing hazardous drugs in structure or toxicity

25
Q

If just a month/year appears as the expiration, we assume:

A

the product is good until the end of that month

EX: 3/24 —– march 31, 2024

26
Q

Repackaging

A

taking a drug from the manufacturer’s bottle and putting it into a new package

27
Q

BUD for non-aqueous formulations

A

no more than 6 months or products expiration date

28
Q

BUD for Water-containing topical/dermal

A

no more than 30 days or product expiration

29
Q

BUD for water-containing oral formulations

A

no more than 14 days or the products expiration date

30
Q

T or F - filling a prescription by taking the stock bottle of tablets and despensing in a new prescription bottle is repackaging

A

NO - it is based on patient-specific prescription

31
Q

FDA voluntary reporting system for ADR

A

MedWatch

MPJE (11 decks)

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