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NURS 8024 Pharmacology for APNs Study Guide Exam Questions with Verified Answers,100% CORRECT
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NURS 8024 Pharmacology for APNs Study Guide Exam Questions with Verified Answers
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NURS 8024 Pharmacology for APNs Study Guide ExamQuestions with Verified Answers
Understand the following concepts:
FDA
• Role/functions of the FDA
Sponsor responsibilities. File an investigational new drug application prior
to phase 1 testing. Reporting any serious and unexpected adverse effects
within 10 days. Bioavailability studies. Seek final approval. FDA approval
and official labeling. Approves consumers marketing of legend drugs.
• Understand and explain the phases of research related to an investigational
drug application-
through FDA approval of a new drug
Phase 1- is on healthy volunteers. Want to know if it is safe.
20-100 people Phase 2- does it work? Look at it in people w
the disease 100-200 people Phase 3- bigger study. Does it
work, double blind? Placebo. 1000-6000 people Phase 4-
postmarketing surveillance.
• Understand the role and responsibility of the APN in post-market
surveillance and Medwatch
reporting
-Evaluating effectiveness in patients
Observing for AE- organs that metabolize or
excrete. Reporting AE to FDA – Medwatch
report card.
Monitor literature for AE reports.
- What not to report- vaccine adverse event reporting system. Suspected
unlawful stale of medical products on the Internet and not for veterinary
medicine product adverse event reporting.
• Understand the clinical implications of a Black Box Warning
Drug presents a unique risk/benefit concern compared to other
drugs in the same class. Potential adverse reaction is extremely
significant above the drugs benefits. When such adverse reaction
can be prevented of reduced by limited used or defined cautions.
- require patient medication guides to be given to patient.
Adverse Drug Reactions
,• ADRs- types and categories
Any response that is unfavorable and occurs at usual doses.
Side effect- additional effect, desirable or undesirable that is not the
primary purpose of the drug.
Types:
-Excessive desired effect or unintended side effect- hypoglycemia or
overdose.
-Allergic reaction- immune mediated- with allergic s&sx
-Idiosyncratic effects/intolerances
- augmented effects- hypotension with propranolol
-bizarre effects- angioedema with ACEI
-Chronic effects- tremors from cyclosporine
, delayed effects- cardiomyopathy from adriomycin, moon facies with
steroid use.
End of treatment effect- hypertensive crisis from stopping clonidine,
adrenocortical insuff secondary to abrupt withdraw of steroids.
• Serious drug reaction- as defined by the FDA
• Drug interactions- different
categories/types Drug-drug
interactions
Drug-food
interactions Drug-
disease interactions
• Describe what is an absolute contraindication and relative contraindication
Absolute- pregnancy absolute contraindication in
ACE inhibitors. Relative- smoking relative
contraindication in smokers
• Classic sensitivity reactions- know type 1, IgE mediated
IgE- anaphylaxis- antigen-antibody reaction on mast cells- penicillin.
• Drug interaction possibilities: ETOH related, Drug-Food interactions, OTC
drug interactions w/
Rx drugs, Herbals, supplements, Genetic variations P450 system
ETOH- metaniazide- Flagyl. – can not drink alcohol while on this
medication.
Drug food- grapefruit juice. Iron- give with orange juice and not give with
milk because it wont absorb.
OTC drug interactions with Rx drugs- St johns War herbal and SSI.
ACE inhibitor with Advil/NSAID- increases creatinine.
• Key questions to ask when you suspect ADR
- Has the reaction previously been documented?
- Time course consistent?
- Could reaction be due to another clinical condition?
- Was there improvement with discontinuation?
- Reaction resolve with dose decrease?
- If antidote given, was there improvement?
- Did reaction recur when drug restarted?
- Was dose appropriate for age, organ function?
• Risk factors for ADRs r/t prescriber, Pharmacist, and Patient related risks
, -Prescriber related- duplication of meds, unclear directions, incomplete
drug history, inappropriate dosing, no follow-up.
-Pharmacist related- automatic refills, prescription errors, failure to
review profile, lack of patient education.
Patient related- using OTC drugs, incomplete knowledge of drug history,
ETOH, Multiple pharmacies without coordination, multiple providers,
overuse or underuse.
Pharmacokinetics / Pharmacodynamics- you do NOT have to do any calculations!
• Define and understand the concepts of: pharmacokinetics,
pharmacodynamics, pharmacology, pharmacotherapeutics,
toxicology, legend drug vs OTC drug
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