NU553 Unit 2 Exam

Which clinical trial phase tests safety, tolerability pharmacokinetics, and dosing in 20-100 healthy volunteers

phase 1

What phase of clinical trial evaluates effectiveness and side effects in patients with the disease

Phase 2

What clinical trial phase is large-scale studies comparing the drug to standard treatment or placebo

Phase 3 clinical trial

What happens in phase 4 clinical trial

Post-marketing surveillance for long-term safety and rare adverse effects

FDA Approval based on surrogate endpoints for serious diseases while additional studies continue

Accelerated approval

What is the REMS program

Risk Evaluation and Mitigation Strategy

What makes a generic drug equivalent (5 things)

same active ingredient, dosage form, strength, route, and bioequivalence

Bioequivalence requirement

AUC and Cmax within 80-125%

High abuse potential, no accepted medical use

Schedule 1 drugs (Heroin, LSD, Marijuana)

What schedule drugs can cause high abuse potential but accepted medical use

Schedule 2 drugs (Morphine, Oxycodone, Adderall, Methylphenidate)

Which schedule drug has a moderate abuse potential

Schedule 3 drugs (Testosterone)

which medication schedule has lower abuse potential

Schedule 4 drugs (Lorazepam, diazepam)

Lowest abuse potential

Schedule 5 drugs (Codeine cough syrup)

Purpose of PDMP?

Track controlled substance prescriptions

Avoid misuse

When should PDMP be checked?

Before prescribing controlled substances and during ongoing controlled substance treatment

Required components for writing a script? (11 things)

• Patient name

• Date

• Drug name

• Strength

• Dose

• Route

• Frequency

• Quantity

• Refills

• Prescribers signature

• Npi and dea number

What is a black box warning?

FDA's strongest safety warning

Where are serious adverse events reported

FDA MedWatch

Lowest cost generics

Tier 1 drugs

preferred brands

Tier 2 drugs

non-preferred brands

Tier 3 drugs

What tier drugs are specialty medications with highest copays

Tier 4 drugs

Insurer approval required before coverage

Prior authorization

Must fail cheaper therapy first before insurer covers another drug

Step therapy

Switching to a different drug with similar therapeutic effect is…

Therapeutic interchange

What the body does to the drug

Pharmacokinetics

4 steps of Pharmacokinetics

absorption, distribution, metabolism, excretion

Process that occurs from the time a drug enters the body to the time it enters the bloodsteam to be circulated

Absorption

After the drug is absorbed into the bloodstream, it is carried by the blood or tissue fluids to its sites of inteded pharmacologic action

distribution

Method by which drugs are inactivated or biotransformed by the body

metabolism

Elimination of a drug from the body

excretion

Drug is metabolized in liver before reaching circulation

First-pass metabolism

Example of first pass metabolism

nitroglycerin bypassess first-pass metabolism

Drugs cross membranes best when (3 things)

-lipid soluble

-non ionized

Low mollecular weight

Binds many medications in circulation

albumin function

High protein binding + Low Albumin =

(with 2 examples)

More free drug (increased toxicity risks)

Examples: warfarin or phenytoin

Unbound drug that produces therapeutic effect

Free drug

Drugs cross the blood brain bairrer easier if (3 things)

-lipid soluable

• low molecular weight

• Non ionized

Drugs cross placental crossing easier if (3 things)

• lipid soluble

• Low molecular weight

• Protein binding

Best practice to prevent medication errors? (4 things)

Use electronic prescribing

Verify allergies

Review medication list

Use teach-back method

Hypoalbuminemia effect increases…. (two things)

free drug concentration

toxicity risk

Major CYP450 Enzymes (4)

CYP3A4

CYP2D6

CYP2C19

CYP2C9

Increases drug levels and toxicity risk

CYP inhibitor effect

Examples of CYP inhibitors (3)

Fluconazole

Erythromycin

Grapefruit juice

Decreases drug levels and effectiveness

CYP inducer

Examples of CYP inducers (4)

Rifampin

Carbamazepine

Phenytoin

St. John’s wort

risk when adding cyp inhibitor?

toxicity

Risk when adding cyp inducer

treatment failure

Constant percentage eliminated over time

first-order kinetics

Most drugs follow what kinetics?

First order

Constant amount eliminated over time

Zero-order kinetics

Examples of zero-order kinetics medications (3.. PEA)

Phenytoin

Ethanol

Aspirin

Time required for drug concentration to decrease by 50%

Half life

Occurs after approx 4-5 half-lives

steady state

What the drug does to the body

Pharmacodynamics

Activates a receptor

Agonist

Blocks a receptor

antagonist

Partial agonist example

buprenorphine

Small difference between therapeutic and toxic dose

Narrow therapeutic index

Examples of narrow therapeutic index drugs (4)

Warfarin

Lithium

Digoxin

Phenytoin

Choosing the safest, most effective, affordable medication based on patients needs

Rational prescribing

Provider and patient collaborate to select treatment

Shared decision-making

Most effective method to assess understanding

teachback

Health literacy strategy is…

uses plain language and avoiding medical jargon

Most effective way to improve adherence

simple instructions plus teachback

Best response to medication cost barrier

Choose a therapeutically equivalent, generic, or lower cost alternative

Major Age-related PK change in geriatrics

decreased renal function

Primary assessment before renal dosing in geriatrics

creatinine clearance or eGFR

List of potentially inappropriate medications in older adults

Beers criteria

Beers criteria examples (3)

Diphenhydramine

Benzodiazepines

Meperidine

reduced metabolism and reduced renal clearance

Neonate pharmacokinetics

Neonate risk

increased medication toxicity

Infants have increased what percantage?

Total body water

Highest teratogenic risk period

weeks 3-8 (organogenesis)

Best principle for prescribing during pregnancy

balance maternal benefit with fetal risk

drug properties increasing breast milk transfer (3 things)

lipid soluability

Low molecular weight

Low protein binding

Best dosing strategy during breastfeeding

take medication immediately after breastfeeding

Acetaminophen in pregnancy

generally safest analgesic

ACE inhibitors in pregnancy are…

contraindications

Avoid _ in third trimester

NSAIDS

Reduced enzyme activity causing higher drug levels

Poor metabolizer

increased enzyme activity causing altered drug response

ultrarapid metabolizer

increased conversion to active drug and potential toxicity

ultrarapid metabolizer taking prodrug

example of prodrug

codeine

Reduced drug metabolism and increased adverse effects

CYP2C19 poor metabolizer effect

Treatment based on likely pathogens before cultures results

empiric therapy

narrowing therapy after culture results indentify the pathogen

De-escalation

Why complete antibiotic course

reduce recurrence and resistance

Inhibits bacterial cell wall synthesis

penicillin mechanism

Major penicillin side effect

allergic reaction

Fluorquinolone examples (2)

Ciprofloxacin

Levofloxacin

Fluoroquinolone black box warnings (3)

Tendon rupture

Neuropathy

Aortic aneurism risk

Aminoglycoside example

gentamicin

Aminoglycoside toxicities

nephrotoxicity

Ototoxicity

Vancomycin toxicity

Nephrotoxicity

Histamine-mediated flushing associated with vancomycin

Red man syndrome

Increased warfarin effects and INR

TMP-SMX interaction

Major drug interaction with Metronidazole

Alcohol causes disulfiram-like reaction

Time-dependent antibiotic killing examples (3)

Penicillins

Cephalosporins

Vancomycin

Concentration-dependent killing antibiotics examples (2)

Aminoglycosides

Fluoroquinolones