|QUESTIONS AND 100% CORRECT WELL DETAILED
Regulations - ANSWER ∙all states have title protection for nps
•the board of nursing regulates practice
-5 states have joint oversight with medical board
•scope of practice is determined by NP license
Investigational new drug (IND) - ANSWER •required before an investigational drug or
bio product can be administered to a human
•the IND app is a compilation of all known information about the compound
•it also includes a description of the clinical research plan for the product
•specific protocol for phase I study
Phases of clinical study - ANSWER •phase I clinical eval is the 1st testing of a new
compound in subjects for the purpose of establishing the tolerance of healthy human
subjects
•phase II clinical eval is controlled studies performed on pts having the target disease or
disorder to determine a compound's potential usefulness and short term risks
•phase III trials are controlled and uncontrolled clinical trials of a drug's safety and efficacy in
hospital and outpt settings
•phase III trials verify that the acceptable risk/benefit ratio seen in II persists under
conditions of anticipated usage in groups of pts large enough to identify statistically and
clinically significant responses
Clinical judgment in prescribing - ANSWER •is there clear indication for drug?
•what drugs are effective for the disease?
1
, •what are the goals of therapy?
•monitoring to see if drug is meeting goals
•duplications in med pts is taking
•otc vs prescription
•cost
•sources of info
The process of prescribing - ANSWER •identify the pts problem
•specify the therapeutic objective
•collab with the pt
•choose the treatment
•edu the pt
•mt for effectiveness
•individualize drug choice
Special population: pregnancy - ANSWER •avoid ACEI, consider BB
•bulk laxative
Special population: nursing moms - ANSWER avoid ACEI, consider BB
Special population: pediatric - ANSWER •best pharmaceuticals for children act (BPCA)
•authorizes research to promote efficacy and safety
Special population: older adults - ANSWER •beers criteria
-looks at potential risk
-does not look at effectiveness
2
Regulations - ANSWER ∙all states have title protection for nps
•the board of nursing regulates practice
-5 states have joint oversight with medical board
•scope of practice is determined by NP license
Investigational new drug (IND) - ANSWER •required before an investigational drug or
bio product can be administered to a human
•the IND app is a compilation of all known information about the compound
•it also includes a description of the clinical research plan for the product
•specific protocol for phase I study
Phases of clinical study - ANSWER •phase I clinical eval is the 1st testing of a new
compound in subjects for the purpose of establishing the tolerance of healthy human
subjects
•phase II clinical eval is controlled studies performed on pts having the target disease or
disorder to determine a compound's potential usefulness and short term risks
•phase III trials are controlled and uncontrolled clinical trials of a drug's safety and efficacy in
hospital and outpt settings
•phase III trials verify that the acceptable risk/benefit ratio seen in II persists under
conditions of anticipated usage in groups of pts large enough to identify statistically and
clinically significant responses
Clinical judgment in prescribing - ANSWER •is there clear indication for drug?
•what drugs are effective for the disease?
1
, •what are the goals of therapy?
•monitoring to see if drug is meeting goals
•duplications in med pts is taking
•otc vs prescription
•cost
•sources of info
The process of prescribing - ANSWER •identify the pts problem
•specify the therapeutic objective
•collab with the pt
•choose the treatment
•edu the pt
•mt for effectiveness
•individualize drug choice
Special population: pregnancy - ANSWER •avoid ACEI, consider BB
•bulk laxative
Special population: nursing moms - ANSWER avoid ACEI, consider BB
Special population: pediatric - ANSWER •best pharmaceuticals for children act (BPCA)
•authorizes research to promote efficacy and safety
Special population: older adults - ANSWER •beers criteria
-looks at potential risk
-does not look at effectiveness
2
