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any chemical that can affect living processes
the study of drugs and their interactions with living systems
the study of drugs in humans (patient's and healthy volunteers)
the use of drugs to diagnose, prevent, or treat disease or to prevent pregnancy
therapeutics or pharmacotherapeutics
What are the 3 major properties of an ideal drug?
- effectiveness (most important)
What are some additional properties of an ideal drug?
- reversible action
- ease of administration
- low cost
- freedom from drug interaction
- chemical stability
- possession of a simple generic name
What factors determine the intensity of a drug response?
- administration (route, amount of dosage, timing)
- individual variation (physiology-age, gender, weight, genetics, pathphysiology)
What are sources of drugs?
What are the types of drug therapy?
- prescription drugs-healthcare provider must write
- nonprescription drugs-OTC drugs
- controlled drugs-regulated by the federal, state and local government
- recreational drugs-people obtain by illegal means
What are the different names fo drugs?
- chemical name
- generic name
- brand/trade name
What are some sources of drug information?
- U.S. Pharmacopeia (USP)
- National Formulary-Supplement to the USP
- Nursing Drug Handbooks
- Pharmaceutical companies
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
- drug action
- recommended dosage
- indications for use
- side effects
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
- teaching tips
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?
- human studies
- 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
- study termination
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
- expected effects
- proper administraiton techniques
- assess responses
- client education
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?
- medications orders
- 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?
- right patient
- right drug
- right dose
- right route
- right time
What are the components of a drug order?
- date & time
- patient name & hospital #
- drug, dosage, route, frequency, lot #
- MD name
- nurses name & title
What are the types of drug orders?
- written orders v. fax orders
- phone orders v. verbal orders
- standing order
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
- pharmacodynamic phase
- pharmacotherapeutic phase
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 ______ .
- very narrow
- 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?
- nonspecific theory
- 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
- therapeutic index
- 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?
toxic reaciton, tachyphylaxis, tolerance, dependence (physical and psychological), additive/synergist effects, antagonist effects
What are the different typess of type B idiosyncratic ADR's?
- allergic reaction/anaphylaxis
- idiosyncratic or paradoxial response
- carcinogenic effect
- teratogenic effect
- extrapyramidal effect
- serum sickness
- fetal alcohol syndrome
- iatrogenic reaction
drug poisoing or an overdose
tolerance occurs very rapidly to a drug with just a few doses
decrease responsivenesss to a drug as a result of repeated drug administration
physical symptoms from withdrawing from a drug
intense cravings for a drug
combining 2 drugs which increases their effects
blocking the effects of a drug
results from an immune response, must have previously been exposed
an effect that is opposite of what is expected
idiosyncratic or paradoxial response
the ability of certain medications and environment chemicals to cause cancers
a drug-induced birth defect
mimick's Parkinson's disease
a delayed reaction that occurs about a week after the administration of a drug
caused by a mother drinking alcohol during pregnancy which leads to congenital defects in the fetal body
fetal alcohol syndrome
a healthcare induced ADR
sensitivity or an abnormal reaction to light
mixing 2 substances which turns the substances a chalky consistency
taking 8+ drugs, including OTC drugs
therapeutic effects with inactive substances