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N135 Pharmacokinetics, Pharmacodynamics and Drug Legislation
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Pharmacokinetics, Pharmacodynamics &
Drug Legislation
N135 Pharmacology
Shannon Bouchard MS, RNC
Pharmacokinetics & Pharmacodynamics
Pharmacokinetics & Pharmacodynamics
Action
Action
Drug Terminology
Drug Terminology
SE
vs.
ADR
SE
vs.
ADR
Drug Classification
Drug Classification
Drug Development
Drug Development
Legal Regulation
Legal Regulation
FDA Pregnancy Categories
FDA Pregnancy Categories
Legal Regulation
Legal Regulation
Medical Marijuana
Medical Marijuana
Drug Diversion
Drug Diversion
Reflect on your own implicit and explicit bias
What is your language about those suffering with SUD?
Have you used the term 'drug addict' ?
Would you feel safe to tell your peers you have a problem in an environment using this language?
Reflect on your own implicit and explicit bias
Joint Commission Quick Safety PDF: Drug Diversion
https://www.jointcommission.org/assets/1/23/Quick_Safety_Drug_diversion_FINAL2.PDF
SPAN: Statewide Peer Assistance for Nurses
- 10-15% of nurses have SUD
- Employers want to help
http://www.op.nysed.gov/prof/spanbrochure.pdf
https://www.statewidepeerassistance.org/
"That person saved my life".
Statement shared by SPAN representative heard from multiple nurses "turned in" by their coworkers
Self Care
- Mental health debriefing
- boundaries
- self advocate
- Understand mistakes happen (novice to expert)
Practice Questions
Practice Questions
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If a client takes 40 mg of a drug with a half-life of 2 hours, how much of the drug will remain 2 hours after administration?
- 10 mg
- 20 mg
- 30 mg
- 40 mg
A
B: In this case, 20 mg will remain 2 hours after administration. The half-life of a drug is the time it takes for the amount of drug in the body to decrease to one half of the peak level it previously achieved.
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Penicillin causes bacterial cell death without disrupting normal human cell functioning. This is an example of:
- critical concentration.
- selective toxicity.
- first-pass effect.
- enzyme induction.
A
B: affecting only bacterial cells is an example of selective toxicity, the property of a drug that affects only systems found in foreign cells without affecting healthy human cells.
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A nurse is caring for a client who has just been prescribed a loading dose of a drug. The nurse should explain what rationale to the client for administering a loading dose?
- "We want to make sure you get the benefits of the drug as quickly as possible."
- "We want to customize the dose to your body weight."
- "We need to see if your body responds to the drug in the proper way."
- "A loading dose will ensure that subsequent doses remain effective for as long as possible."
A
A: A loading dose is recommended for use with drugs that may take a prolonged period to reach critical concentration so that the effects can be obtained more quickly. While a larger dose may be given due to size, it is not a factor contributing to the option of administering a loading dose. Evaluating the body's response is not an indication for using a loading dose. Duration of action is not an indication for using a loading dose but would be a factor considered when determining how often the drug needs to be given.
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A client’s drug level has reached critical concentration. What action should the nurse perform?
- Assess for evidence of the expected therapeutic effects.
- Assess for indications of impaired metabolism.
- Assess for signs of delayed drug excretion.
- Perform an emergency assessment.
?
A
A: The amount of a drug that is needed to cause a therapeutic effect is called the critical concentration. Critical concentration is a therapeutically desirable state, not grounds for emergency assessment or a sign of impaired pharmacokinetics
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Which agency is responsible for regulating the development and marketing of drugs?
- Centers for Disease Control and Prevention
- American Medical Association
- Food and Drug Administration (FDA)
- National Institutes of Health
?
A
C: The FDA regulates the development and marketing of drugs to ensure safety and efficacy. It regulates the development and sale of drugs.
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A nurse is responsible for maintaining an accurate count and record of the controlled substances on the nursing division. This nursing action is regulated by which law or agency?
- Food, Drug, and Cosmetic Act of 1938
- Public Health Service
- Drug Enforcement Administration
- SPAN
A
C: The Drug Enforcement Administration enforces the Controlled Substances Act. Under this enforcement, nurses are responsible for storing controlled substances in locked containers, administering them only to the people for whom they are prescribed, recording each dose given, and maintaining an accurate inventory. The Food, Drug, and Cosmetic Act of 1938 revised and broadened FDA powers and responsibilities, giving the FDA control over drug safety.
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Which phase of drug development is associated with continual evaluation of the drug?
- phase I study
- phase II study
- phase III study
- phase IV study
A
D: Phase IV study is a phase of continual evaluation in which prescribers are obligated to report to the Food and Drug Administration (FDA) any untoward or unexpected adverse effects associated with the drugs being used. A phase I study uses human volunteers for testing. A phase II study allows investigators to try out the drug in clients who have the disease that the drug is designed to treat. A phase III study involves the use of the drug in a vast clinical market.
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A newly pregnant client has been taking a category A drug for several years. What should the nurse instruct the client about this drug?
- “Your care provider will work with you to see if the risks of taking the drug outweigh the benefits.”
- “Discuss this with your care provider, but you’ll likely be able to keep taking it.”
- “You likely won’t be able to take the drug until you’ve given birth.”
- “Your care provider will likely withhold the drug until you’ve stopped breastfeeding.”
A
B: For drugs in category A, there are adequate studies in pregnant women that have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters. For drugs in categories B, C, and D, the benefits of taking the drug need to be assessed against the potential level of risk. For drugs in category X the risk to the futus outweighs the benefits of the meication.
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In terms of categories of controlled substance, which description reflects schedule IV drugs?
- may lead to severe psychological dependence
- has the highest potential for abuse
- may lead to limited physical dependence
- deemed safe for use in pregnancy
A
C: Schedule IV drugs may lead to limited physical and psychological dependency.
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A nurse notices the smell of alcohol on a nursing colleague upon return from lunch break. The colleague is having difficulty drawing up a dose of insulin, appears uncoordinated, and is unaware that the needle has been contaminated. What is the best action for the nurse to take?
- Take the syringe and insulin vials, draw up the insulin, and instruct the colleague to focus more clearly when giving the injection.
- Take the insulin vials and needle, draw up the insulin, and administer it. Ask a colleague to observe the nurse for the remainder of the shift.
- Reassign the responsibilities, and inform the colleague that the unit manager will be notified if it occurs again.
- Stop the colleague from drawing up the insulin. Notify the supervisor about the incident, and document the observations.
A
D: Acknowledging that there is a problem and protecting the client is a professional responsibility. Calling the supervisor is important so the client can be reassigned and the supervisor can deal with the problem. Taking over the nurse’s responsibilities is not appropriate. The problem then will not be addressed. The incident needs to be reported because client care is in jeopardy.
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The nurse's assessment of a community-dwelling adult suggests that the client may have drug allergies that have not been previously documented. What statement by the client would confirm this?
- “I tend to get sick in the stomach when I take antibiotics.”
- “I've been told that aspirin might have caused my stomach bleed a few years back.”
- “I broke out in hives and got terribly itchy when I started a new prescription last year.”
- “When I fell last year, the health care provider said that it might have been because of my blood pressure pills.”
A
C: True allergic reactions include formation of rash or hives, itching, redness, swelling, difficulty breathing, and anaphylactic shock. Nausea and vomiting, however, are adverse effects of drug therapy. Similarly, an unsafe drop in blood pressure and gastric bleeding from aspirin use are adverse drug effects, not allergic reactions.