Module 1: Intro to Pharmacology/ Genetics/ Pharmacogenetics - Dynamics - Kinetics

Clinical Judgment

Observed outcome of critical thinking and decision making

Nursing Proccess

Scientific clinical reasoning approach to client care

What are the steps of the nursing process

Assessment, analysis, planning, implementation, evaluation

What are the steps of CJMM

Recognize cues, analyze cues, prioritize hypothesis, generate solutions, take action, evaluate outcomes

What are common patient problems related to drug therapy

Abdominal pain, confusion, decreased adherence, need for health teaching, cognitive decline, non adherence

What are the core ethical principles?

Respect for persons, beneficence, and justice

What is respect for persons

individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection

What is informed consent?

Right to be informed and that participation is voluntary and without coercion

Who provides informed consent?

The healthcare provider, NOT the nurse

When giving written consent the patient must be

Alert and able to comprehend

What is Beneficience

Duty to protect research subjects from harm

What is the risk-benefit ratio

All possible consequences of a clinical study must be analyzed and balanced against the inherent risks and the anticipated benefits. Physical, physiological, and social risks must be identified and weighed against the benefits.

What is Justice?

Selection of research subjects be fair

What must clinical research follow

Good Clinical Practice Consolidated Guideline

What is the Good Clinical Practice Consolidated Guideline

An international ethical and scientific quality standard for designing, conducting, monitoring, auditing, recording, analyzing, and reporting clinical research. It is the foundation of clinical trials that involve human subjects.

What is achieved during pre-clinical trials

Genotoxicity

What is Genotoxicity

the ability of a compound to damage genetic information in a cell, in addition to drug absorption, distribution, metabolism, and excretion

What is the goal of phase 1 in human clinical experimentation?

Researchers test a new drug or treatment in a small group of people for the risk time to evaluate its safety, determine a safe dosage range, and identify side effects

What is the goal of phase 2 in human clinical experimentation?

The drug or treatment is given to a larger group of people to see wether it is effective and to further evaluate its safety

What is the goal of phase 3 in human clinical experimentation?

The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow the drug to treatment to be used safely

What is the goal of phase 4 in human clinical experimentation?

Studies are done after the drug or treatment has been marketed to gather information on the drug's side effects in various populations and to assess any side effects associated with long term use

What is the purpose of the ANA code of ethics?

*To guide the behavior of the professional nurse*

It's a statement to society outlining the values, concerns, and goals of the profession.

generic name vs trade name

Generic: not owned by a company, written in all lower case letters

Trade: owned by a company, Capitalized with "registered" symbol, registered by the US patent office & approved by FDA

What is pharmokinetics?

Process of drug movement through the body necessary to achieve drug action

What are the 4 processes of pharmokinetics?

absorption, distribution, metabolism, excretion

What is absorption?

movement of the drug into the bloodstream after administration

What are excipients?

Inactive substances used as a carrier for theactive ingredients of a medication

What is disintegration?

the breakdown of a tablet into smaller particles

What affects drug absorption

Blood flow, pain, stress, hunger, fasting, food, and pH

What is the first pass effect?

After oral administration, many drugs are absorbed intact from the small intestine and transported first via the portal system to the liver, where they undergo extensive metabolism, therefore usually decreasing the bioavailability of certain oral medications.

What is bioavailability?

Percentage of administered drugs available for activity

What alters bioavailability?

Drug form, route of administration, gastric mucosa and motility, administration with food and other drugs, changes in liver metabolism caused by liver dysfunction or inadequate hepatic blood flow

What is distribution?

Movement of drug from circulation to body tissues

What influences distribution?

Vascular permeability, permeability of cell membranes, regional blood flow, pH, cardiac output, tissue perfusion, ability of the drug to bind tissue and plasma proteins, and drug's lipid solubility

Highly protein-bound drugs

Drugs that are more than 90% bound to protein

weakly protein-bound drugs

Drugs that are less than 10% bound to protein

What portion of the drug is inactive

Portion bound to protein

What is a free drug?

Unbound; it can leave capillaries when it wants. It is not bound to a protein

What is drug metabolism?

biotransformation or body's ability to change a drug from its dosage form to water soluble that can be excreted

What is a prodrug?

a compound that is metabolized into an active pharmacologic substance

What is drug half-life?

the time required for the amount of drug in the body to decrease by 50%

What is a loading dose?

Dose that is significantly higher than maintenance dose to achieve desired effects rapidly

What is excretion?

elimination of drugs from the body

What are ways of excretion?

Via kidneys, bile, lungs, saliva, sweat, and breast milk

What affects excretion?

Urine pH; prerenal (ex. Dehydration), intrarenal (ex. Chronic kidney disease), and postrenal (ex. Stones)conditions,

What is pharmacodynamics?

Study of the effects of drugs on the body

Primary vs Secondary effect

The primary effect is *desirable*, and the

secondary effect may be *desirable or undesirable*.

Dose-Response relationship

Physiologic response to drug concentration changes at the site of action

Potency

the amount of drug needed to elicit a specific physiologic response to a drug

maximal efficacy

the point at which increasing a drug's dosage no longer increases the desired therapeutic response

Therapeutic Index (TI)

describes the relationship between the therapeutic dose of a drug (ED50) and the toxic dose of a drug (TD50)

What is the therapeutic range?

Range of doses that produce a therapeutic response without causing significant adverse effect in patients

What are the 4 receptor families?

Cell membrane-embedded enzymes

Ligand-gated ion channels

G protein-coupled receptor systems

Transcription factors

Ligand-binding domain

the site on the receptor at which drugs bind

Agonists

drugs that activate receptors and produce a desired response

partial agonist

Drugs that elicit only moderate activity when binding to receptors. Partial agonists also prevent receptor activation from other drugs

Antagonists

Drugs that prevent receptor activation and block a response

Nonspecific drugs

drugs that affect multiple receptor sites

nonselective drugs

drugs that affect multiple receptors

Mechanisms of Drug Action

Stimulation, depression, irritation, replacement, cytotoxic action, antimicrobial action, and modification of immune status

Pharmacogenetics

Study of variability in drug response due to heredity

Polymorphism

Natural variations in a gene, DNA sequence, or chromosome that have no adverse effects, on the individual and occur with high frequency in the general population

What is the role of Pharmacogenetics in drug therapy?

Nurses must integrate knowledge of genetic factors that can either enhance or diminish drug response into their practice, in order to identify patients at an increased risk of adverse drug reactions

What are the 6 rights of medication administration?

Right patient, right drug, right dose, right route, right time, right documentation

How do we determine the right patient?

by verifying at least 2 forms of identical ion (ex. Name, DOB, ID band, MAR)

How do we determine the right drug?

Scan the patient's wristband and then scan the medication label

Before administering the medication what must happen?

The pharmacy and the nurse must validate the accuracy of the patient's prescription order in the EHR

What are the components of a drug order?

PT's name, DOB, date, signature/name of provider, Signature of licensed staff who took T/O or V/O (if applicable), Drug name & strength, drug frequency/dose, route of administration, duration of administration, # of PT refills, # of pills to be dispensed, any special instructions.

What must a nurse do before administering drugs?

Use 2 PT identifiers, become familiar with PT history & complete head to toe assessment including vital signs, review PT's lab work, read the order and get clarification if needed, know PT's allergies, know the reason for for the meds, check drug label, check dosage calculations, know medication order and ending date, and check against original orders

What is the right dose?

Verification that the dose being administered is the amount ordered and that it is safe for the patient for whom it is prescribed

What is the unit dose method

drugs are individually wrapped and labeled for single-dose use for each patient

What is the right time?

Refers to time prescribed dose is ordered for administration

Can every drug be given exactly when ordered?

No, there is specific range of times in which drugs can be administered

What are interventions related to right time?

Administering at specified times, administering drugs affected by food 1 hour before or 2 hours after meals, give drugs that irritate the stomach with food, adjust medication schedule to fit the PT's lifestyle, Check if PT is scheduled for diagnostic procedures that can affect medication administration, check expiration dates, administer antibiotics at even intervals (ex. Every 8 hours),

What is the right route?

Ordered by HCP and indicated the mechanism in which the education enters the body

What are the common routes?

Oral, pill, sublingual, baccalaureate, feeding tube, topical, inhalation, optic, ophthalmic, nasal, suppository, and through parenteral routes (ex. Intradermal, subcutaneous [SQ], IM, or IV)

Interventions related to right route include

PT's ability to swallow, NPO orders, Not altering medications without consulting pharmacy, explaining why a medication may be mixed with another substance, ensuring medication is identifiable until delivery, instruct PT medication must be swallowed with water (unless otherwise specified), using aseptic technique when administering drugs, using sterile technique when using parenteral routes, administer drugs at proper sites, stay with PT until oral drugs have been swallowed

What is right documentation?

Requires the nurse to immediately record the appropriate information about the drug administered

What information is included in right documentation?

Name of the drug, dose given, the route administered , the time and date, and nurse's initials/signature

What else is required to be documented?

PT's response to medications; specifically opioid & non opioid analgesics, sedatives, and antiemetics

Patient's responses to medications are only verbal. True or False

False, patients responses can also be physiologic

When must drugs be charted

When drugs are administered

What is the bill of rights in Nursing?

Supports nurses in workplace situations and includes issues such as unsafe staffing, mandatory overtime, and health and safety issues in the workplace

Medication Error

Any preventable event that may cause or lead to inappropriate medication use or harm to a patient while the medication is in the control of the health care professional

What does "Just Culture" encourage?

Individuals to report drug errors so the system can be repaired and the problems fixed

Are individual practitioners responsible for a failing system?

No, but disregard for patients or gross misconduct are not tolerated

Sentinel event

unanticipated event in a healthcare setting resulting in death or serious injury to a patient unrelated to natural course of illness

Black Box warning

FDA-required warning label on inserts for some prescription drugs indicating that they carry a significant risk of serious or even life-threatening adverse effects

Drug reconciliation

Process of identifying the most accurate list of all medications that the patient is taking at transitions in care

Why was drug reconciliation created

To provide drug continuity during care transitions

CD

controlled delivery

CR

Controlled release

ER

Extended release

IR

Immediate release

LA

Long acting

MR

Modified release

SA

Sustained action OR short acting

SR

Sustained release

TR

Timed release

XR

Extended release