controlled drugs-regulated by the federal, state and local government
recreational drugs-people obtain by illegal means
What are the different names fo drugs?
What are some sources of drug information?
U.S. Pharmacopeia (USP)
National Formulary-Supplement to the USP
Nursing Drug Handbooks
What does the USP provide regarding drug information?
drug must be of high standard to be listed
drugs are reviewed every 5 years
info.: strength, quality, purity, packaging, safety, labeling, dosage form
What does the PDR provide regarding drug information?
list pharmaceutical companies
color pictures of medications
indications for use
What does the Nursing Drug Handbook rpovide with regards to drug information?
generic and trade names
indication for use and recommended doses
action & pharmacokinetics
side effects & nursing implications
first federal law protecting the public from mislabed and dangerous products, developed by the USP
Pure Food and Drug Act of 1906
legislative act that required pharmaceutical companies to test products for safety before selling them
Food, Drug, and Cosmetic Act of 1938
legislative act that defined prescription v. nonprescription drugs
1952: Durham-Humphrey Amendment of the 1938 Act
legislative act resulting from the thalidomide tragedy, required safety and efficacy testing of drugs
1962: Kefauver-Harris Amendment of the 1938 Act
legislative act to fast track drugs anf allow off-label uses of drugs
Food and Drug Administration Modernization Act (1997)
law that allowed the testing of drugs already on the marker
Best Pharmaceuticals for Children (2002)
law that required the testing of all drugs to be used on children
Pediatric Research Equity Act of 2003
What are the regulatory agencies for drugs?
FDA, CDC, DEA, ANA, state board of nursing
What is involved in the pre-clinical testing of new drugs?
extensive animal studies
submit Investigation New Drug (IND) application
application reviewed by FDA & is approved then clinical testing may begin
What is involved in the clinical testing of a new drug?
phase 1-studies the effects of the drug on a small group of healthy volunteers
phase 2-studies the effects of the drug on a small number of individuals with the disease, looks at effectiveness and side effects
phase 3-studies the effects of the drug on a large number of individuals with the disease
submit a new drug application (ND) to FDA, hsa to be apporved in order to marker the drug
phase 4-post market studies, volunteer basis
rights of human subjects to be protected in medical research
What is the purpose of informed consent in research?
describes the study in detail
hazards, risks, and benefits of study
What are the basic tasks for giving informed consent?
decision making capacity
obtain informed consent
What are the nursing responsibilities that are specific to drug therapy?
goals of drug therapy
mechanism of drug action
proper administraiton techniques
What is the purpose of assessment in the nursing process with regards to drug therapy?
gather data: subjective & objective
assess learning needs
verify & cluster
What is the purpose of nursing diagnosis in the nursing process with regards to drug therapy?
formulate nursing diagnosis (NANDA list)-identify health care needs of clients within the realm of nursing practice
nursing diagnosis related to drug therapy-knowledge deficit, noncompliance, or a diagnosis related to side effects
What is the purpose of planning in the nursing process with regards to drug therapy?
establish goals-patient oriented, use action verbs, MEASURABLE, time limited
What is the purpose of interventions in the nursing process with regards to drug therapy?
education-why are you taking it? intended therapeutic response? how often? side effects and which to report?
administration of medications
documentation: date, time, med, dose, route
w/holding medication: pt refuses, side effects. notify physician
What is the window for administering a medication?
What are the 5 rights of medication administration?
What are the components of a drug order?
date & time
patient name & hospital #
drug, dosage, route, frequency, lot #
nurses name & title
What are the types of drug orders?
written orders v. fax orders
phone orders v. verbal orders
What is the purpose of evaluation in the nursing process with regards to drug therapy?
effectiveness of meds for therapeutic & non-therapeutic responses (30 minutes to 1 hour)
determine the extent to which goals of care have been achieved
compare client response to outcome and document responses
analyze reasons for results and conclusions
modify care plan
What are the 3 phases of drug action?
pharmakinetic phase-MUST occur first
the mechanisms by which drugs interact, on a molecular level, with constituents of cells or cellular environments to produce biochemical and/or physiological changes in cells, tissues, organs, and ultimately patients
In order for a drug to have pharmacologic effects, it must be capable of?
influencing some functioning of some cells
The ultimate objective is to select drugs that have a _____ and ______ .
well-defined target or very specific action in the body
The narrower the action of a drug, the ____ widespread damage/adverse effects
What are the 3 theories of drug action?
drug enzyme theory
drug receptor binding
produce dynamic effects by influencing the environment of cells, does not require interaction b/t tje drug & cell
What are the 5 mechanisms of the nonspecific drug theory?
alteration of body chemistry
aborption of toxins, electrolytes, bile salts, and other drugs in the intestinal tract
imposition of a physical barrier
alteration of surface tension
What is the mechanism of the nonspecific theory of drug action that alters body chemistry and an example?
alters gastric or extracellular pH
extracellular osmotic pressure
composition of extracellular electrolytes
example: antacids are used to alter gastric pH
What is the mechanism of the nonspecific theory of drug action that involves the absoprtion of toxins, electrolytes, bile salts, and other drugs in the intestinal tract and an example?
drugs have an irreversible bond in the intestinal tract which prevents absorption
example: activated charcoal binds to (absorbs) other orally ingested drugs & toxins, preventing their absorption
What is the mechanism of the nonspecific theory of drug action that involves the imposition of a physical barrier and an example?
block injury to cells from their exterior
example: sunscreens coat the skin cells blocking UV radiation injury from the sun
What is the mechanism of the nonspecific theory of drug action that involves lubrication and an example?
by decreasing mechanical injury to the cells, they perform a protective function
example: mineral oil decreases friction b/t colonic wall and stool, allowing easier defecation
What is the mechanism of the nonspecific theory of drug action that alters surface tension and an example?
allows solids and liquids to mix, liquid becomes solid
example: stool softeners alter the surface of hard stool allowing water from the colonic lumen to enter the stool, making it softer
What are the 2 forms of drug-enzyme interaction with regards to the drug enzyme theory of drug action? What are examples of each?
drug may bind to the same physical location on the enzyme, preventing the enzyme from functioning normally (digoxin)
drug may interact with an enzyme target changing the physical structure of the enzyme and disrupting its integrity (ACE inhibitors)
mimic actions of the body, can cause a response when they bond to the receptor
What are the 2 types of agonists and example of each?
agonist I-bind to the same receptor site as endogenous biomediator (epinephrine, opiates)
agonist II-bind to a different site on the receptor, but enhances the natural effect of the endogenous biomediator on its own receptor (thyroid hormone, benzodiazepines)
blocks the actions of the body, has no intrinsic activity of their own
What are the 3 types of antagonist and example of each?
antagonist I-bind to the same site and inhibit or block the action of the natural compound (atropine, H2 receptor blockers)
antagonist II-bind to a different molecular extracellular site from the endogenous biomediator and partially inhibit the action of the natural compound (calcium channel blockers)
antagonist III-translocate and inhibit receptor's signal on the inside of the cell, either at the internal part of the receptor or some other secondary messenger mechanims inside the cell (Viagra)
s-shaped curce that demonstrates the dosage rance that produces the desired response for each drug
log-dose drug response curve
the average dose that produces half of the desired response on most patients (recommended dose)
effective dose-ED 50
How is the ED 50 defined?
objective measurements-single patient measurement
subjective symptoms-100's of subjects required
produces death in one half of test animals
lethal dose-LD 50
measurement of a drug's safety/toxicity
TI = LD50/ED50
The wider the curves (further away the LD50 & ED 50 curves) on a graph, the ______
The narrower the curves, ______
safer the drug
more toxic the drug
the measurement of the amount of active ingredient of the drug
the drug with the least amount of active ingrediant producing its ED50 is the most _____
the ability of a drug to produce an effect
What are the different types of drug therapies and examples of each?
acute-new or immediate problem (appendicitis)
maintenance-maintains current functions, does not prevent progression (insulin, BP meds)
supplemental-maintains normal functions (vitamins)
supportive-maintains body function integrity (IV fluids)
prophylatic-preventive care (antibiotics prior to surgery)
palliative-end of life care, comfort measures (pain meds)
What is a Type A adverse drug reaction?
intrinsic adverse drug reaction
direct extension of the known pharmacodynamic actions
most common type of ADR-60-70% of all known ADR's
What is a Type B adverse drug reaction?
idiosyncratic adverse drug reaction
uncommon, unpredictable DR that is not explained by pharmacodynamics
20-30% of ADR's
independent of the size of the dose of drug administered
may be genetically linked
What are the different types of type A intrinsic ADR's?