Final Exam Review - Introduction Flashcards

1
Q

Explain the 4 phases of clinical trials.

A

Phase 1

  • Safety
  • Small # (<100)
  • Healthy subjects

Phase 2

  • Efficacy
  • Small # (100s)
  • In patients w/ disease
  • Compare to placebo or current drug

Phase 3

  • Larger and longer
  • Possibly >10000 participants
  • Randomized, double blind

Phase 4
-Post marketing

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2
Q

What is the difference between off-label and off-patent?

A
  • Off-label is using a drug for something originally not approved for.
  • Off patent is when anyone can make the drug without paying the developer
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3
Q

What is controlled substance and what are the classifications?

A

Classifies a drug as being abusable.
Classified into Schedule 1 to 5, with 1 having the most abuse potential with no medical usage. Class 5 has a med usage with low abuse potential

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4
Q

What is the acronym ADME and explain each.

A
  • Absorption- Can be enteral (GI tract) or parenteral (non GI tract)
  • Distribution- Distribution through the body. Measured as Vd, higher Vd means there is more drug in tissue than blood.
  • Metabolism- How a drug is inactivated and prepared for elimination. Involves CYP enzymes.
  • Excretion- How the drug leaves the body.
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5
Q

What is the difference between first order and zero order elimination?

A

Firsts Order:

  • Eliimination is proportional to concentration
  • 10 to 5 to 2.5 to 1.25

Zero Order:

  • Constant elimination rate
  • 10 to 7.5 to 5 to 2.5
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6
Q

How many half lives does it take for a drug to be considered “cleared”?

A

5

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7
Q

What is the difference between specificity and selectivity?

A

Selective is associated with subtypes of a receptor while specificity is just the receptors.
-Selective is more selective than specificity.

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8
Q

What are the subtypes of agonists and antagonists?

A
  • Competitive antagonist
  • Noncompetitive antagonist
  • Partial agonist
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9
Q

What is the difference between the competitive and noncompetitive antagonists?

A

Competitive will compete with the agonists while noncompetitive bind to a separate site, meaning its irreversible.

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10
Q

What is a partial agonist?

A

A partial drug agonist will take up a slot but gives a lower effect than if there were a perfect fit drug.

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11
Q

Is a drug with a lower ED50 more or less potent? Why?

A

Lower, there is a lower dose reuired to get to 50% of expected response

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12
Q

Does a NTI drug have a lower or higher chance of AE and toxicity?
What is the formula for TI?

A
  • Higher

- TD50/ED50

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13
Q

A DDI can result in either a _________ or _________ reaction.

A
  • synergestsic

- antagonistic

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14
Q

What are the other 2 types of drug interactions that may occur?

A
  • drug-food interactions

- drug allergies

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15
Q

What can cause increased risk for ADRs?

A
  • Age
  • Genetic variations
  • Disease states
  • DDI
  • HCP error
  • Nonadherance
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16
Q

pain is an experience based on complex interactions of _________ and ________ processes.

A

physical and psychological

17
Q

What are the three types of pain?

A
  • Nocioceptive
  • Neuropathic
  • Psychogenic
18
Q

Where do opioids act?

A

Act in the substantia gelatinosa to prevent Substance P

and 2nd order neuron transmission of pain.

19
Q

Examples of opioids:

A
  • Codeine
  • Hydrocodone
  • Oxycodone
  • Morphine
  • Fentanyl
  • Tramadol
  • Methadone
20
Q
  • What are opioids used to treat?
  • What is the MOA?
  • Most common AE?
  • PT concerns?
  • Specific problems?
A
  • Mild to moderate pain
  • Bind opioid receptors in CNS to inhibit ascending pain pathways
  • Sedation, Nausea, Constipation
  • Schedule therapy to maximize pain relief; increased fall risk; avoid heat on patches
  • Addiction and psychological dependence; respiratory depression
21
Q

What is used to treat an opioid OD?

A

Naloxone

22
Q
  • What is PCA?

- What are the advantages over oral dosing?

A
  • Patient controlled analgesia

- continuous pain control, lower AE

23
Q

What are the dosing strategies of PCA? Explain them.

A
Loading Dose
-amount to get patient to therapeutic range
Demand Dose
-preset amount
Lockout Interval
-sets time between doses
Background Infusion Rate
-steady stream that can be increased by patient with a demand dose
24
Q

What are the PT concerns for PCA?

A
  • Drowsiness

- Pump malfunctions

25
Q

Examples of NSAIDs:

A
  • Aspirin
  • Ibuprofen
  • Naproxen
  • Diclofenac
  • Meloxicam
26
Q
  • What are some common uses of NSAIDs?
  • What is the MOA?
  • What are the most common AE?
  • What are the PT concerns?
A
  • arthritis, mild to moderate pain
  • blocks COX which lowers PG, which are involved in inflammation
  • GI, increased BP, nephrotoxicity, CV risk
  • GI AE most common, increased risk for bleeding, interaction with cardiac meds, HTN, can inhibit muscle recovery
27
Q
  • What is neuropathic pain?
  • What causes it?
  • Treatment?
A
  • Disease or injury to PNS or CNS
  • diabetes, immune deficiencies, shingles, trauma, MS, ischemic issues
  • Gabapentin often first line (Opioids NOT first line)
28
Q

What is RA?

A

-A chronic, systemic inflammatory disease

29
Q

What are the 2 main drug groups used to treat RA?

What is the gold standard?

A
  • non-biological and biological DMARD

- methotrexate (MTX)

30
Q
  • What is the MOA of MTX?
  • AE?
  • PT concerns?
A
  • unknown in RA
  • GI, lots of boxed warnings
  • immunosupression, infection risk
31
Q
  • What is the second line treatment for RA?

- Are they used long term?

A
  • Corticosteroids

- No, they are used short term for disease flare

32
Q
  • What is SLE?
  • Treatment is based on severity. What 3 drug classes are used mild-moderate SLE?
  • What drug is used for severe SLE?
A
  • Systemin Lupup Erythematosus
  • NSAID, Steroids, Antimalarials
  • Immunosupressives
33
Q

What are the PT concerns with SLE treatment?

A
  • Immunosupression
  • Infection
  • Photosensitivity
34
Q

What are the main drug classes used to treat OA?

A
  • Acetaminophine

- NSAID if acetaminophine contraindicated

35
Q

What is an injectable treatment option for OA?

A

intrarticular hyaluronate

36
Q

What are 3 considerations for selecting antibiotic treatment?

A
  • Bacteria factors
  • Host specific factors
  • Drug specific factors
37
Q

How do we prevent resistance to antibiotics?

A

e