NURP 422 - Exam 1 Study Guide
50 QUESTIONS - REVIEW KEY TOPICS
REGULATION & PRESCRIBING
o Pre-Clinical
Animal testing, no human testing, many years
o Once determined they want to start testing on humans, an investigational new drug
application is filed --- once approved different phases will occur
o Phase I
Short phase (only few months), small group of HEALTHY individuals, usually
less than 100 individuals
Looking at identifying side effects, tolerance, determining safe dose range
o Phase II
SAFETY PHASE --- Months to years
Studies are on humans with TARGET disease, small population of100-200 individuals
Identifying side effects, common short-term side effects, best treatment regiment
Highest rate of drug failure in this phase
o Phase III
REGULATORY PHASE --- years to decades
Monitoring safety and efficacy, large population - thousands of individuals in
multiple locations
Specialists in the field
o NEW DRUG APPLICATION- done investigating and want this drug available to the
general population
o Phase IV
AFTERMARKET
Drug is on the market but continues to be monitored, specifically looking at
special populations, safety and adverse events, observational studies
Know your nurse practice act- know what it is and how it influences NPs
o Regulatory bodies
Board of nursing
Determines scope of practice for RN and NP
DEA
o know what it is/role/function/ect
o DEA does NOT determine the scope of practice for NP- only provide number so
NP can prescribe according to scope of practice in home state
Important to know what each category includes
Schedule I
High abuse potential, no current medical use per FDA
, Marijuana: states are passing law, but FDA is not in
agreement Heroin, ecstasy
Schedule II
High abuse potential
Narcotics, amphetamines such as stimulants (ADHD),
There are some regulations on refills, how rx gets to
pharmacy Schedule III
Moderate abuse
potential Schedule IV
Low abuse
Schedule V
Lowest abuse potential
What does it mean to be a conscientious prescriber?
o What we need to ASK before prescribing medications
Allergies?
What happens when they take a medication?
What medications is this individual on?
What is the past medical Hx?
If child bearing age, when was last period?
o What do I need to CONSIDER?
How much is the Rx, can pt afford? Can they fill the rx?
Health literacy: Do they understand what I am saying? Can they read the
information presented?
Has my pt been involved in decision making process? Is pt agreeable to this
Rx/plan of care? If not involved- they may not want to take the medication failure
Have I done everything I can to make sure the pt is
adherent? What can I do to help my pt follow this Tx plan?
Have I selected the most appropriate drug and
dose? Have I considered co-morbidities?
Have I taken into consideration current meds/allergies?
Master at writing correct, appropriate, and complete Rxs-
o full SIG is very important. He says #10 on the practice sheet is a very common test question that
you might see again
o 10. Prescribe 60 year old F Lisinopril for new diagnosis of hypertension.
Lisinopril 10mg-Take 1 tablet by mouth daily for high blood pressure. #30 tabs 0 refills.
Big key is to understand the simple
concepts Side effects vs. Adverse Effects
o What does that mean for us as a provider?
o Side Effect:
If pt has side effect, we may avoid in future to improve adherence
But if ONLY drug that will work for pt, we can still prescribe
Common SE: GI issues (make sure to ask what “allergy” is)
o Adverse effect
You can’t, won’t, don’t want to prescribe
, Something that is not
expected o Example: Lisinopril
Commonly causes a cough in patients --- SIDE EFFECT If
lisinopril causes angioedema --- ADVERSE EFFECT
PHARMACODYNAMICS: Action of the drug
What is pharmacodynamics?
o The study of the biochemical and physiologic effects of drugs and places emphasis on
dose-response relationship (drug concentration and effect). Mechanism of action- How
a drug affects an organism, whereas pharmacokinetics is how the organism affects the
drug, both of these together influence dosing, benefit and adverse effects. What can
affect pharmacodynamics? Route of administration, rate of metabolism, rate of
distribution and excretion. 1. Individual characteristics (age and ethnicity) 2. Disorder. 3.
Concentration of the drug at the receptor site. 4. Drug to drug interaction.
Characteristics of ligand-receptor binding: Lock and Key. Depends on size and shape of the drug and
the receptor. Drug binds to receptor site, transduces the signal across the cell membrane to
produce a biologic/cellular response. Dependent on affinity. Binding with either mimic the
body’s effects (agonist) or block the body’s effect (antagonist)
Receptors (LOCK)
o Proteins that interact with ligand
o Primarily present on plasma membrane
o Have life cycle and can be recycled
Agonist (KEY)
Ligand binds to receptors
o Ligands can be neurotransmitters, hormones, medications
Medication binds to receptor and activates response
o (Key fits into lock, key turns, door opens RESPONSE)
Receptor Types
o Ligand Gated Ion Channel
Ligand binds open channel- Na goes in, K comes out
o Cytokine receptors
Respond to peptides
o G- Protein
Most common
Require 2nd messengers & energy
o What is going on in body to make these drugs work?
Signal Transduction Pathway Triggered by ligand binding, cell recognition, creating a conformation
change in the receptor and then the signal is transmitted across the cell membrane to initiate a response.
o Occurs by 2nd messenger
o Phase I
Signal recognition- Ligand binds
o Phase II
50 QUESTIONS - REVIEW KEY TOPICS
REGULATION & PRESCRIBING
o Pre-Clinical
Animal testing, no human testing, many years
o Once determined they want to start testing on humans, an investigational new drug
application is filed --- once approved different phases will occur
o Phase I
Short phase (only few months), small group of HEALTHY individuals, usually
less than 100 individuals
Looking at identifying side effects, tolerance, determining safe dose range
o Phase II
SAFETY PHASE --- Months to years
Studies are on humans with TARGET disease, small population of100-200 individuals
Identifying side effects, common short-term side effects, best treatment regiment
Highest rate of drug failure in this phase
o Phase III
REGULATORY PHASE --- years to decades
Monitoring safety and efficacy, large population - thousands of individuals in
multiple locations
Specialists in the field
o NEW DRUG APPLICATION- done investigating and want this drug available to the
general population
o Phase IV
AFTERMARKET
Drug is on the market but continues to be monitored, specifically looking at
special populations, safety and adverse events, observational studies
Know your nurse practice act- know what it is and how it influences NPs
o Regulatory bodies
Board of nursing
Determines scope of practice for RN and NP
DEA
o know what it is/role/function/ect
o DEA does NOT determine the scope of practice for NP- only provide number so
NP can prescribe according to scope of practice in home state
Important to know what each category includes
Schedule I
High abuse potential, no current medical use per FDA
, Marijuana: states are passing law, but FDA is not in
agreement Heroin, ecstasy
Schedule II
High abuse potential
Narcotics, amphetamines such as stimulants (ADHD),
There are some regulations on refills, how rx gets to
pharmacy Schedule III
Moderate abuse
potential Schedule IV
Low abuse
Schedule V
Lowest abuse potential
What does it mean to be a conscientious prescriber?
o What we need to ASK before prescribing medications
Allergies?
What happens when they take a medication?
What medications is this individual on?
What is the past medical Hx?
If child bearing age, when was last period?
o What do I need to CONSIDER?
How much is the Rx, can pt afford? Can they fill the rx?
Health literacy: Do they understand what I am saying? Can they read the
information presented?
Has my pt been involved in decision making process? Is pt agreeable to this
Rx/plan of care? If not involved- they may not want to take the medication failure
Have I done everything I can to make sure the pt is
adherent? What can I do to help my pt follow this Tx plan?
Have I selected the most appropriate drug and
dose? Have I considered co-morbidities?
Have I taken into consideration current meds/allergies?
Master at writing correct, appropriate, and complete Rxs-
o full SIG is very important. He says #10 on the practice sheet is a very common test question that
you might see again
o 10. Prescribe 60 year old F Lisinopril for new diagnosis of hypertension.
Lisinopril 10mg-Take 1 tablet by mouth daily for high blood pressure. #30 tabs 0 refills.
Big key is to understand the simple
concepts Side effects vs. Adverse Effects
o What does that mean for us as a provider?
o Side Effect:
If pt has side effect, we may avoid in future to improve adherence
But if ONLY drug that will work for pt, we can still prescribe
Common SE: GI issues (make sure to ask what “allergy” is)
o Adverse effect
You can’t, won’t, don’t want to prescribe
, Something that is not
expected o Example: Lisinopril
Commonly causes a cough in patients --- SIDE EFFECT If
lisinopril causes angioedema --- ADVERSE EFFECT
PHARMACODYNAMICS: Action of the drug
What is pharmacodynamics?
o The study of the biochemical and physiologic effects of drugs and places emphasis on
dose-response relationship (drug concentration and effect). Mechanism of action- How
a drug affects an organism, whereas pharmacokinetics is how the organism affects the
drug, both of these together influence dosing, benefit and adverse effects. What can
affect pharmacodynamics? Route of administration, rate of metabolism, rate of
distribution and excretion. 1. Individual characteristics (age and ethnicity) 2. Disorder. 3.
Concentration of the drug at the receptor site. 4. Drug to drug interaction.
Characteristics of ligand-receptor binding: Lock and Key. Depends on size and shape of the drug and
the receptor. Drug binds to receptor site, transduces the signal across the cell membrane to
produce a biologic/cellular response. Dependent on affinity. Binding with either mimic the
body’s effects (agonist) or block the body’s effect (antagonist)
Receptors (LOCK)
o Proteins that interact with ligand
o Primarily present on plasma membrane
o Have life cycle and can be recycled
Agonist (KEY)
Ligand binds to receptors
o Ligands can be neurotransmitters, hormones, medications
Medication binds to receptor and activates response
o (Key fits into lock, key turns, door opens RESPONSE)
Receptor Types
o Ligand Gated Ion Channel
Ligand binds open channel- Na goes in, K comes out
o Cytokine receptors
Respond to peptides
o G- Protein
Most common
Require 2nd messengers & energy
o What is going on in body to make these drugs work?
Signal Transduction Pathway Triggered by ligand binding, cell recognition, creating a conformation
change in the receptor and then the signal is transmitted across the cell membrane to initiate a response.
o Occurs by 2nd messenger
o Phase I
Signal recognition- Ligand binds
o Phase II
