Final Exam Review - Introduction Flashcards
Explain the 4 phases of clinical trials.
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
What is the difference between off-label and off-patent?
- 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
What is controlled substance and what are the classifications?
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
What is the acronym ADME and explain each.
- 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.
What is the difference between first order and zero order elimination?
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
How many half lives does it take for a drug to be considered “cleared”?
5
What is the difference between specificity and selectivity?
Selective is associated with subtypes of a receptor while specificity is just the receptors.
-Selective is more selective than specificity.
What are the subtypes of agonists and antagonists?
- Competitive antagonist
- Noncompetitive antagonist
- Partial agonist
What is the difference between the competitive and noncompetitive antagonists?
Competitive will compete with the agonists while noncompetitive bind to a separate site, meaning its irreversible.
What is a partial agonist?
A partial drug agonist will take up a slot but gives a lower effect than if there were a perfect fit drug.
Is a drug with a lower ED50 more or less potent? Why?
Lower, there is a lower dose reuired to get to 50% of expected response
Does a NTI drug have a lower or higher chance of AE and toxicity?
What is the formula for TI?
- Higher
- TD50/ED50
A DDI can result in either a _________ or _________ reaction.
- synergestsic
- antagonistic
What are the other 2 types of drug interactions that may occur?
- drug-food interactions
- drug allergies
What can cause increased risk for ADRs?
- Age
- Genetic variations
- Disease states
- DDI
- HCP error
- Nonadherance
pain is an experience based on complex interactions of _________ and ________ processes.
physical and psychological
What are the three types of pain?
- Nocioceptive
- Neuropathic
- Psychogenic
Where do opioids act?
Act in the substantia gelatinosa to prevent Substance P
and 2nd order neuron transmission of pain.
Examples of opioids:
- Codeine
- Hydrocodone
- Oxycodone
- Morphine
- Fentanyl
- Tramadol
- Methadone
- What are opioids used to treat?
- What is the MOA?
- Most common AE?
- PT concerns?
- Specific problems?
- 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
What is used to treat an opioid OD?
Naloxone
- What is PCA?
- What are the advantages over oral dosing?
- Patient controlled analgesia
- continuous pain control, lower AE
What are the dosing strategies of PCA? Explain them.
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
What are the PT concerns for PCA?
- Drowsiness
- Pump malfunctions
