Pharm Exam 1 Blueprint

  • Identify the three core ethical principles and how to apply them to nursing practice

    • respect for persons

      • treat patients as independent persons making decisions in their own best interest

      • patients with diminished decision-making capacity are entitled to protection

      • patients should be aware of alternatives, when available, as well as the consequences from taking the alternatives

      • nurses responsibility to be aware when a patient is unable to make a decision in their own best interest

      • autonomy is the right to self determination and is a key component of respect for persons

    • beneficence

      • the duty to protect research subject from harm

        • assessing potential risks and possible benefits and ensuring benefits are greater than the risk

      • risk-benefit ratio

        • most complex problem faced by the researcher

        • all potential consequences of a clinical study must be analyzed and balanced against the inherent risks and the anticipated benefits- physical, psychological, and social

      • DHHS perform institutional review boards (IRB’s) which determine that risks are reasonable related to the benefits

    • justice

      • selection of subjects is fair

        • research subjects reflect all social classes and racial and ethnic groups

  • Describe the objectives of each phase of human clinical experimentation.

    • phase 1

      • small group of healthy volunteers

      • tightly controlled

      • objective is to evaluate safe dosage range, and identify side effects through evaluation of drug metabolism, pharmacokinetics, and biologic effects

    • phase 2

      • drugs are tested in patients who have the disease that the drug is designed to treat

      • performed at various sites across the country (hospitals, clinics, doctors offices)

      • objective is to determine therapeutic effects, safety, and effectiveness

    • phase 3

      • use of the drug in a vast clinical market

      • prescribers observe patients very closely, monitoring them for any adverse effects

    • phase 4 (post-marketing surveillance)

      • drug has been approved for marketing by the FDA

      • continued surveillance once it is released

      • collect info related to drugs effects in various population to assess any side effects associated with long-term use

  • Describe in detail the four processes

    • Absorption

      • How drug is taken into body

      • Orally, subq, vascular, rectally, etc.

      • Breakdown involves two processes

        • disintegration

          • how drug breaks down into small particles

          • usually drugs taken orally

        • dissolution

          • process of combining small particles with a medium

            • water, gastric juices

          • rate of this and disintegration determines rate of absorption

      • absorption occurs through passive diffusion, active transport, and filtration

        • passive does not require energy

        • active transport requires a carrier (energy)

    • Distribution

      • Process by which drug is delivered to tissues and fluids of body, depends on:

        • vascular permeability and permeability of cell membrane

        • regional blood flow and pH

        • drugs lipid solubility

          • can cross placenta and BBB

        • protein binding plasma; albumin most important

    • Metabolism (biotransformation)

      • body’s availability to change a drug into less active/inactive form by enzymes

      • Cytochrome P450 enzyme system

        •  drug metabolizing enzyme in live that are responsible for converting drugs into metabolites

      • mainly in liver

      • those with liver disease alter drug metabolism by inhibiting enzymes in liver

      • factors that affect rate of metabolism:

        • pro drug

          • stimulator to help another drug become more effective

          • medications that turn into active form once they enter the body

        • drug half-life

          • time required for 50% of drug to be used in the body 

          • some drugs are extremely short, others are very long

        • steady state/loading dose

          • time it takes for a drug to reach a steady state

    • Excretion

      • removal of drugs from the body

      • kidneys are primarily responsible

        • can also be excreted by liver, lungs, breast milk

      • renal/kidney dysfunction can lead to increase in duration and intensity in medications response

        • important to monitor duration and intensity

      • two labs to monitor for kidney function are BUN and creatinine

  • Identify the factors that affect absorption

    • first pass

      • refers to most oral drugs because they become metabolized as they pass through body, more specifically the liver, and lose effectiveness

      • some drugs metabolized to inactive form then excreted

      • drug passes from intestinal lumen into liver by portal vein

      • to fix, will have to give higher dose of drug 

      • bioavailability

        • the % of administered drug available for activity

        • drug form (tablet, capsule, liquid, patch, etc.)

        • route of administration (rectal, oral, etc.)

        • gastric mucosa 

        • administering with other drugs/food, etc. 

        • oral drugs bioavailability are never 100%, IV are usually near 100%

  • Describe the influence of protein binding on drug bioavailability

    • drugs can compete for proteins, can lead to

      • toxicity

      • really effective

    • only unbound drugs can leave vascular system, those left bound will decrease effectiveness

  • Differentiate the three types of drug interactions

    • additive

      • double effect of two drugs administered in combination

    • synergistic

      • combined effect is greater than the sum of effects

    • antagonistic

      • one drug reduces or blocks effect of other drug

  • Describe the implications of half-life 

    • used to plan out doses of medications and when to give them 

  • Describe the implications of therapeutic Index

    • ration between therapeutic dose of a drug and the toxic dose of a drug

      • those with a low therapeutic index have a thin fine line between therapeutic and toxic; which means it must be closely monitored with blood labs and drug levels

        • examples: warfarin, digoxin, phenytoin, gentamycin, vancomycin)

    • if a drug isn’t in therapeutic range, the dose of drug increases, vice versa, etc.

  • Discuss the role of pharmacogenetics in drug therapy

    • relatively new; uses a person's genetic makeup to determine appropriate drug therapy

    • some have biological variations that influence their individual response to a specific drug due to genetic makeup

    • those who benefit from pharmacogenetics:

      • take multiple prescription drugs

      • not responding to current therapy

      • having adverse drug reactions

      • taking black box warning drugs

  • Compare and contrast side effects and adverse effects

    • side effects

      • secondary, expected effect of a drug

      • all drugs have a side effect

    • adverse effects

      • unexpected effect of a drug

      • may be severe

      • must be reported to FDA

  • Describe the use of peak and trough levels

    • peak level (absorption)

      • highest plasma concentration of a drug in the body; indicating rate of drug absorption

      • if low, effective concentration has not been reached; drug is not at most effective state

      • measured time we think drug is at peak, shortly after dose

    • trough level (elimination)

      • lowest plasma concentration of a drug in the body; measures rate which the drug is eliminated from the body

      • usually measured by taking blood test before next dose of med

  • Describe the nursing implications of pharmacokinetics and pharmacodynamics

    • nurses are last stop before putting drugs into someone and affecting their life

    • nurses must educate the role drugs play in someone's life

      • compliance

      • lack of education

  • Identify the safety and accountability related to controlled substances.

    • 5 different schedules to classify controlled substances

      • from I-V, I being most dangerous with highest potential to be abused, V with lowest potential to be abused

      • Schedule I

        • “drugs, substances, or chemicals that are defined as drugs with currently not accepted medical use and a high potential for abuse”

        • Examples are: heroin, LSD, marijuana, ecstasy, meth, and peyote

      • Schedule 2

        • “drugs, substances, or chemicals that are defined as drugs with high potential for abuse, with use potentially leading to severe psychological or physical dependence. these drugs are also considered dangerous”

        • examples are: combination products with less than 15 mg of hydrocodone per dosage unit (vicodin), cocaine, methamphetamine methadone, dilaudid, demerol, oxycontin, fentanyl, adderall, etc.

  • Differentiate between chemical, generic, and brand names of drugs.

    • chemical

      • names that reflect the chemical structure of the drug

      • lower case lettering

    • generic

      • the original designation that the drug was given when the drug company applied for the approval process (non-proprietary)

      • universally accepted because it is not owned by any drug company 

      • in lower case lettering

      • generic drugs are usually less expensive than brand drugs but have same ingredients

    • brand

      • also known as trade name, is given to drug by the pharmaceutical company that developed it

      • usually capitalized, have trade “circle” next to name

  • Discuss “over the counter” as it relates to drugs.

    • OTC medication is safe if used as directed

      • is usually abused, and can harm those who abuse them with overdose

      • pt needs to let medical staff know if taken OTC meds as they can interfere with prescription meds

      • taking these drugs can mask signs and symptoms of underlying disease, making diagnosis more difficult

    • need to specify OTC meds as well as herbal remedies when asking a pt what meds they take

  • Explain nursing interventions/actions related to safe administration of drugs

    • six rights of medication administration:

      • right patient

      • right drug

      • right dose

      • right route

      • right time

      • right documentation 

    • why this is important to nurses:

      • maintain safety, assist with right assessment, right teaching, right evaluation, and Autonomy the right to refuse and make decisions independently

    • verify drug 3 time to know if you have the right drug

    • a drug order is complete if it has all 5 rightw

      • if any are missing, drug is incomplete, do not give drug and call health care provider

    • need to pay attention to vital signs and Kidney and Liver labs (BUN and Creatinine)

    • 1.5 million preventable drug errors occur yearly