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NSG 313 Exam 1 (Chapters 1,2,3,4,6) With Complete Solution...
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Food and Drug Administration (FDA) - ANSWER federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies; regulates development and ensures safety and reliability of drugs
Preclinical Trials - ANSWER Who: lab animals; Purposes: determine whether chemicals have presumed effects in living tissues, evaluate for adverse effects
Phase I Study - ANSWER Who: healthy human volunteers who are well informed of the risks & may be financially compensated; Purpose: scientists scrutinize drug's effects in humans as well as observing for adverse effects & toxicity
Phase II Study - ANSWER Who: patients diagnosed with the disease the drug is intended to treat; Purpose: monitor patients very closely to evaluate the effects; Where: various clinical sites across the country
Phase III Studies - ANSWER Who: vast clinical market; Purpose: prescribers observe patient very closely and monitor for any adverse effects, patients usually keep journals and record any symptoms they experience; totally unexpected responses may occur
FDA Approval - ANSWER Who: committees of experts familiar with the specialty area the drug will be used for; if approved, they will enter the market
Phase IV Studies - ANSWER continual evaluation of approved drug; prescribers and HCP are required to report any unwanted or unexpected
adverse effects associated with the drug; phase in which majority of drug recalls occur -> may cause unexpected effects that are not observed until wide distribution occurs
Generic Name - ANSWER original designation the drug is given when the drug company applied for the approval process; lower case
Chemical Name - ANSWER reflect the chemical structure of a drug
Brand (Trade) Name - ANSWER name given to a drug by the pharmaceutical company that developed it; capitalized
Brand Name vs. Generic Drugs - ANSWER same active ingredient, use same dosage form, same route of administration; bioequivalent (work/effect the body in the same way); generic and brand name medications can affect people differently due to margins of error and the inactive ingredients used; generic is usually cheaper
Contraindications - ANSWER factors that prevent the use of a drug or treatment; drug should not be prescribed due to their potential to cause serious or life-threatening adverse reactions
DAW - ANSWER "dispensed as written"; written by prescribers when they specifically want the brand name of a product used; typically used with drugs that have a narrow safety margin
Drug Enforcement Agency (DEA) - ANSWER enforces the control of controlled substances
Controlled Substances Act of 1970 - ANSWER established categories for ranking of the abuse potential of various drugs
Schedule I Drugs - ANSWER high abuse potential, no accepted medical use;
to fetus but there are no adequate studies in pregnant women; animal studies have shown an adverse effect but but adequate studies in pregnant women have not demonstrated a risk to fetus
Pregnancy Category C - ANSWER animal studies show an adverse effect on fetus but no adequate studies in human; benefits from use of drug may be acceptable despite potential risks; no animal studies or adequate studies in humans
Pregnancy Category D - ANSWER evidence of human fetal risk but potential benefits from use of drug in pregnant women may be acceptable despite risks
Pregnancy Category X - ANSWER studies in animals or humans demonstrate fetal abnormalities or adverse reactions; risk of use in pregnant women clearly outweighs any possible benefit
Orphan Drugs - ANSWER drugs that have been approved but are not financially viable and therefore have not been "adopted" by any drug company; may be useful in treating rare diseases
Over the Counter Drugs (OTC) - ANSWER products that are available without prescription for self-treatment of a variety of complaints; many have been "grandfathered" into use because they have been used for so long
Implications of OTC Drugs - ANSWER could mask signs and symptoms of underlying diseases; drug-drug interactions with prescribed medications, not taking as directed could result in overdoses
Pharmacodynamics - ANSWER study of interactions between the chemical components of the living systems and the foreign chemicals that enter those systems
4 Ways Drugs Work - ANSWER 1. to replace or act as substitutes for missing chemicals; 2. to increase or stimulate certain cellular activities; 3. to depress or slow cellular activities; 4. to interfere with the functioning of foreign cells
Agonist Drug - ANSWER interact with the receptor sites to cause the same activity that natural chemicals would cause at that site; can also precipitate a greater than normal response
Competitive Antagonist Drug - ANSWER reacts with the receptor site to block normal stimulation, producing no effect
Noncompetitive Antagonist Drug - ANSWER react with receptor sites on a cell to prevent the reaction of another chemical with a different receptor site on that cell
Selective Toxicity - ANSWER ability of a drug to attack only those systems found in foreign cells
Pharmacokinetics - ANSWER the study of absorption, distribution, metabolism, and excretion of drugs
Critical Concentration (Therapeutic Range) - ANSWER amount of the drug needed to produce a therapeutic effect
Loading Dose - ANSWER a higher dose than that usually used for treatment in order to reach a critical concentration
Absorption - ANSWER refers to what happens to a drug from the time it is introduced to the body until it reaches circulating fluids and tissues; affected by route of administration
Distribution - ANSWER the movement of a drug to the body's tissues; affected by drug's lipid solubility and ionization as well as the tissue's
Factors Affecting Absorption of IV Drugs - ANSWER not affected by anything; absorbed directly into the venous system
Factors Affecting Absorption of IM Drugs - ANSWER perfusion of blood flow to muscle; fat content of muscle; temperature of muscle (vasoconstriction or vasodilation)
Factors Affecting Absorption of SubQ Drugs - ANSWER perfusion of blood flow to the tissue; fat content of tissue; temperature of tissue (vasoconstriction vs. vasodilation)
Factors Affecting Absorption of PO Drugs - ANSWER acidity of stomach; length of time it is in stomach; blood flow to GI tract; presence of interacting food or drugs (food increases stomach acidity & length of stay in stomach)
Time for PO Drugs to be Given on Empty Stomach - ANSWER at least 1 hour before or 2 hours after a meal
Factors Affecting Absorption of Topical Drugs - ANSWER perfusion of blood flow to the area; integrity of skin
Other Factors Affecting the Absorption Process - ANSWER is passive diffusion or active transport needed for the drug to enter its intended cell?; absorption occurs quickest when the drug is lipid-soluble/water-soluable and non-ionized
Protein Binding - ANSWER the more bound to a protein, the more difficult it can be for the medication to be released and able to cross membranes; must be free in order to act; tightly bound drugs are released very slowly & have a long duration of action
Blood-Brain Barrier - ANSWER drugs that are highly lipid-soluble are more likely to pass barrier in order to reach CNS; drugs that are not lipid-soluble are unable to pass through
First-Pass Effect - ANSWER oral drugs are absorbed in the small intestine into the portal venous system that takes them to the liver that immediately transforms them into metabolites by a series of liver enzymes; large percentage of oral drugs is destroyed by process and never reaches tissues
P450 System - ANSWER enzymes found in most cells and are especially abundant in the liver; oxidize, reduce, or hydrolyze drug
Half-Life - ANSWER the time it takes for the amount of a drug in the body to
Drug-Food Interactions - ANSWER certain foods interact with drugs when they come in contact with one another in the stomach; can also increase acid production, speed the breakdown of the drug, and prevent absorption &/or distribution
Drug-Laboratory Interactions - ANSWER drugs may alter results of tests that are done on various chemical levels or reactions as part of a diagnostic study
Narrow Therapeutic Range - ANSWER very little difference between a therapeutic dose and a toxic dose of drug & interference with the drug's pharmacodynamics and pharmacokinets can produce serious problems
Wide Therapeutic Range - ANSWER large variation in dosing is allowed without adverse effects occurring; difficult to overdose on and does not have to be closely monitored by a HCP
5 Rights of Drug Administration (And Additional 3) - ANSWER right 1. person 2.medication 3. amount/dose 4. time 5. route of administration; right 1. storage 2. preparation 3. documentation
Adverse Effects - ANSWER undesired effects that may be unpleasant or dangerous & occur do to: the drug having effects on the body other than therapeutic effect; patient is sensitive to drug; drug's action on body may
cause other reactions that are undesirable or unpleasant; patient could be taking too much or too little of drug
Primary Actions of Drugs - ANSWER patients suffers from effects that are an extension of the desired effect; overdose
Secondary Actions of Drugs - ANSWER production of a wide variety of effects in addition to the desired pharmacological effect of a drug
Hypersensitivity - ANSWER excessive response to primary or secondary effects; can result due to pathology or underlying condition
Drug Allergy - ANSWER body forms antibodies to a particular drug, causing an immune response when the person is reexposed to the drug
Drug Allergy: Anaphylactic - ANSWER involves antibody reacting with a specific site in the body that causes the release of histamine; hives, rash, difficulty breathing, increased BP, dilated pupils, diaphoresis, respiratory arrest
Drug Allergy: Cytotoxic - ANSWER antibodies circulate in the blood and attack antigens (drug) on cell site causing death to the cell; not immediate; damage to blood forming cells (decreased hematocrit, WBC count, and
Blood Dyscrasia - ANSWER bone marrow suppression caused by drug effects; occurs when drugs cause cell death and bone marrow cells respond by multiplying rapidly causing them to be highly susceptible to any agent that disrupts cell function
Toxicity - ANSWER can occur due to liver injury (affected metabolism) or renal injury (affected excretion) or both; these can cause drugs to build in the bloodstream and have a negative impact on the body
Liver Injury - ANSWER symptoms: fever, malaise, nausea, vomiting, jaundice, change in color of urine or stools, abdominal pain or colic, elevated liver enzymes, alterations in bilirubin levels, changes in clotting factors
Renal Injury - ANSWER symptoms: elevated BUN, elevated creatinine concentration, decreased hematocrit, electrolyte imbalance, fatigue, malaise, edema, irritability, skin rash
Creatinine Clearance Test - ANSWER Measures the rate at which creatinine is cleared from the blood by the kidney; involves a 24 hr urine sample as well as a serum draw
Poisoning - ANSWER occurs when an overdose of a drug damages multiple
body systems, leading to the potential for fatal reactions
Assessment in Drug Therapy and Patient Safety - ANSWER systematic, organized collection of data about the patient; data must be holistic; includes history & physical exam
Data to Collect in a Patient's History - ANSWER chronic conditions, drug use (prescription, OTC, street, alcohol, nicotine, alternative therapies, caffeine), allergies, level of education & understanding, social supports, financial supports, pattern of healthcare
Data to Collect in Patient's Physical Exam - ANSWER weight, height, age
Nursing Diagnosis in Drug Therapy and Patient Safety - ANSWER a statement of the patient's status from a nursing perspective; conclusions based on data and will lead to a particular goal and set of interventions
Planning in Drug Therapy and Patient Safety - ANSWER using and prioritizing the information gathered and synthesized in diagnosis to plan patient care; set goals and desired patient outcomes to assure safe and effective drug therapy; SMART goals
Implementation in Drug Therapy and Patient Safety - ANSWER using nursing
influenced by the internet advertising, the media, and the alternative therapy industry; comes in with requests and demands
Federal Guidelines on Drug Advertisement - ANSWER determines what can be said; if the use of the drug is stated, the contraindications, adverse effects, and precautions must also be stated
Grandfathering of OTC Drugs - ANSWER when stringent testing and evaluation systems became law, OTC were not tested or evaluated to the extent drugs are today; FDA is slowly determining effectiveness and safety; partially determined on one's ability for self-care
Alternative Therapies and Herbal Medicine - ANSWER found in ancient records and have often been the basis for the discovery of an active ingredient that is later developed into a regulated drug; not controlled by or tested by the FDA; advertising is not as restricted as classic drugs; not required to go through pre-market testing
Concerns of Alternative Therapies and Herbal Medicine - ANSWER active ingredient has not been tested; other ingredients are unknown, patients do not mention therapies to HCP; several drug interactions can cause complications
Off-Label Use - ANSWER uses of a drug that are not part of the stated therapeutic indications for which the drug was approved by the FDA
Health Maintenance Organizations (HMO) and Regulations - ANSWER maintain a centralized control system to provide patient medical care within a budget; usually a centralized building with participating physicians and services housed in one area; insurance is usually less expensive; tradeoff is loss of choice
Proper Disposal of Medications - ANSWER take drug out of original container, mix drug with undesirable substance and put them in an impermeable nondescript container, throw in trash; flush down toilet only if patient info specifically instructs it is safe to do so; pharmaceutical take back locations
Body Surface Area (BSA) - ANSWER a highly accurate method for calculating medication dosages
Therapeutic Class - ANSWER how drugs are classified; refers to the clinical indication for the drug or therapeutic action; the purpose of the drug
Pharmacologic Class - ANSWER Drugs that share similar characteristics; molecular action of a drug