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An overview of key concepts in pharmacology, including the definition of pharmacology and related terms, the classification and sources of drugs, the drug development and approval process, the routes of drug administration, the distribution and metabolism of drugs, and the factors that can affect drug effects. It covers important topics such as the controlled substances act, the fda modernization act, the blood-brain barrier, enzyme induction, drug interactions, and adverse drug effects. A comprehensive review or study guide for a pharmacology examination, covering a wide range of fundamental pharmacology principles and concepts that are essential for understanding the science of drugs and their effects on living organisms.
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Pharmacology - Correct Answer the study or science of drugs (chemicals) that alter functions of living organisms Pharmacotherapy - Correct Answer use of drugs to prevent disease, diagnose disease, or treat signs & symptoms of disease Local effects - Correct Answer act at the site of application (Ex. sunscreen, Neosporin) Systemic effects - Correct Answer circulate through the bloodstream, reach target tissue, excreted (can potentially have an effect throughout the body) Drug - Correct Answer any chemical that affects the physiological processes of a living organism Sources of drugs - Correct Answer historically-plants, animals, minerals Modern- synthetic chemical compounds-less likely to produce allergic reactions (made in a laboratory) Advantages: reduces the likelihood of developing allergies Classifications - Correct Answer -effects on body systems -therapeutic uses -chemical characteristics Example: Morphine -CNS depressant -An opioid analgesic -Opiate Prototype - Correct Answer -drugs that represent a group/class of drugs (i.e. PCN=antibacterial) -usually the first and the rest of the drugs are similar Chemical name - Correct Answer drug's chemical composition and molecular structure Example: N-acetyl-p-aminophenol
Generic name - Correct Answer related to the chemical or official name and is independent of the manufacturer Example: acetaminophen Trade name - Correct Answer patented by the drug company; drug has a registered trademark; designated and copyrighted by the drug company (manufacturer) Example: Tylenol Federal Drug Legislation - Correct Answer -marks an evolution from minimal to extensive control and resulted in safer and more effective drugs Pure Food and Drug Act 1906 - Correct Answer -drugs should be free from adulterants; required labeling of drug products (didn't have to have any testing on the drugs) Food, Drug, and Cosmetic Act 1938 - Correct Answer -required that all drugs undergo testing; results of these tests were to be reviewed by the Food and Drug Administration (FDA); only drugs deemed safe by the FDA would be approved for marketing (violators could be penalized) Durham-Humphrey Amendment 1952 - Correct Answer -modification of Food, Drug, and Cosmetic Act of 1938; differentiated between over the counter (OTC) and prescription medications; identified medications that could and could not be refilled without a prescription Kefauver-Harris Amendment 1962 - Correct Answer -tightened controls on drug safety; required PROOF OF EFFECTIVENESS before a drug could be marketed. This was the first law to demand that drugs actually be of some benefit; also required that all old drugs (1932-1962) be tested for effectiveness. Comprehensive Drug Abuse Prevention and Control Act; Title II Controlled Substances Act 1970 - Correct Answer -set rules for the manufacture and distribution of drugs considered to have potential for abuse; place controlled substances into categories -DEA is responsible for regulating the distribution of these drugs; physicians are given a DEA #- this # must be on all prescriptions for controlled substances -nurses must keep all controlled substances locked, maintain an accurate inventory, and document all wastes Drug Enforcement Agency (DEA) - Correct Answer -the 1st piece of legislation that included nurses Schedule I drugs - Correct Answer -not approved for medical use; have a high abuse potential
Phase I of Clinical Testing - Correct Answer -healthy volunteers (give drug to healthy people) -safe doses -pharmacokinetics -toxicity Phase II of Clinical Testing - Correct Answer -given to diseased subjects (500 people) -responses compared with subjects in Phase I Phase III of Clinical Testing - Correct Answer -larger groups (5000 people) -studies with control groups (randomized) -determine if benefits outweigh risks Phase IV of Clinical Testing - Correct Answer -FDA evaluates results -drug marketed with manufacturer monitoring -drug is more widely used and more adverse effects become evident during this phase (Just because the doctor prescribes it, doesn't mean it's approved by FDA) Phases of Drug Development extra - Correct Answer -a drug is protected by a patent for 14 years; only the developer can market it during this period Safety in Drug Administration - Correct Answer -approximately 1.5 million preventable adverse drug events annually -Rights of Medication Administration (more in Ch. 3) -Quality and Safety Education for Nurses Project (QSEN) (founded by the Robert Wood Johnson Foundation) -National Patient Safety Goals Related to Medication Safety -The Institute for Safe Medications Practices (ISMP) and High Alert Medications -Beers Criteria -Sources of Drug Information Pharmacokinetics - Correct Answer -the study of the movement of drugs through the body (what the body does to the drug) ADME - Correct Answer absorption, digestion, metabolism, excretion Absorption - Correct Answer -process from site of administration to the time the drug enters the blood stream (and have systemic effect) Factors that affect rate and extent of drug absorption include: - Correct Answer 1. Dosage form
Bioavailability - Correct Answer the portion of a drug that reaches the systemic circulation and is available to act on target body cells
Protein binding - Correct Answer 1. Most drugs bind to protein (albumin) in the blood (REVERSIBLE)
Metabolism - Correct Answer -"bagging up the trash" -drugs are inactivated and prepared to be excreted -Prodrugs: do not have a pharmacologic effect until they are metabolized -kidneys only excrete water soluble substances so the job of metabolism to convert fat- soluble metabolites into water soluble metabolites -most drugs are metabolized by cytochrome P450 (CYP) enzymes in the liver (family of enzymes that metabolize drugs are: CYP1, CYP2, CYP3) -other enzymes that aid in metabolism are in the RBCs, plasma, kidneys, lungs, and GI tract Enzyme induction (stimulates metabolism) - Correct Answer -stimulation of liver cells to produce more drug-metabolizing enzymes, thus drug metabolism is increased and larger doses of a drug must be administered to produce/maintain therapeutic effects (I.e. hyperthyroidism) Enzyme inhibition (inhibits metabolism) - Correct Answer -drug-metabolizing enzymes are inhibited, thus drug metabolism is decreased and smaller doses of a drug must be administered to produce/maintain therapeutic effects (I.e. Tagamet is an enzyme inhibitor, grapefruit juice blocks enzymes that metabolize drugs) Special Consideration in Drug Metabolism - Correct Answer 1. Age
-Agonist -Antagonist -the number of receptor sites available on a cell directly affects the extent of drug action -the number of receptor sites on a cell can change -Up-regulation -Down-regulation Agonist - Correct Answer -a drug that binds to and STIMULATES activity of one or more biochemical receptor types in the body Antagonist - Correct Answer -a drug that binds to and INHIBITS the activity of one or more biochemical receptor types in the body; also called inhibitors (block cellular function) Up-regulation - Correct Answer -prolonged inhibition of cell function with an antagonist drug may increase the number of receptor sites on a cell Down-regulation - Correct Answer -prolonged stimulation of cell function with an agonist may decrease the number of receptor sites on a cell Non receptor Drug Actions - Correct Answer -a few drugs do not act on receptor sites...Examples: -Antacids-chemically neutralize Hal acid to raise the pH of gastric fluids -Osmotic diuretics -Saline laxatives Drug Related Variables - Correct Answer -Dosage -Route of Administration -Drug-Diet Interactions -Drug-Drug Interactions Dosage - Correct Answer -frequency, size, and number of doses -determines if therapeutic effects will be reached -too much may lead to overdose -doses that cause death are called lethal doses -recommended doses are only guidelines for individualizing doses Route of Administration - Correct Answer -IV most rapid -IM large blood supply -PO slower than parenteral Drug-Diet Interactions - Correct Answer -the presence of food in the stomach will slow absorption -foods may contain substances that interact with drugs and alter its response -i.e. avoid tyramine foods with MAO inhibitors -Vitamin K antagonist to Coumadin
-Grapefruit is an enzyme inhibitor Drug-Drug Interactions - Correct Answer -action of a drug may be increased or decreased when it interacts with another drug -drug metabolism is the underlying alteration -drugs that alter one of more of the pharmacokinetic processes -Increased Drug Effects Decreased Drug Effects Increased Drug Effects - Correct Answer 1. Additive effects
-all in advanced disease GI disorders - Correct Answer -altered absorption Thyroid disorders - Correct Answer -altered metabolism Psychological Considerations - Correct Answer -some individuals respond to a placebo although the reason is unclear -attitudes and expectations may play a role Tolerance - Correct Answer -body becomes accustomed to a particular drug over time so that larger doses must be given to produce the same affects (i.e. opioid analgesics) Cross-tolerance - Correct Answer -developing tolerance to drugs in a related classification -Example: person on antidepressants may need larger doses of a sedative; person who drinks a large amount of alcohol may need larger doses of sedative Adverse effects (side effects) - Correct Answer -any undesired response to drug administration -usually predictable -side effects are adverse effects that occur with therapeutic doses -Black Box Warning: strongest warning about a drug issued by FDA to enhance safety Toxic effects - Correct Answer -adverse drug reaction caused by excessive dosing Allergic reaction (hypersensitivity) - Correct Answer -adverse immune response Idiosyncratic effect - Correct Answer -an unexpected adverse reaction usually related to genetic predisposition -occurs upon initial administration Physical dependency - Correct Answer -the body has adapted to prolonged drug exposure in such a way that unpleasant physical symptoms will result if drug use is discontinued; usually associated with narcotics & CNS drugs Carcinogenic effect - Correct Answer -cancer causing drugs Teratogenic effect - Correct Answer -drugs that will harm a fetus if taken by a pregnant woman (during 1st trimester) Pregnancy Categories - Correct Answer -Category A -Category B -Category C -Category D -Category X
Category a pregnancy - Correct Answer -studied in pregnant women; no risk to the fetus Category B pregnancy - Correct Answer -no well-controlled studies in pregnant women; no risk indicated from animal studies Category C pregnancy - Correct Answer -most common -risk to fetus identified with animal studies; no adequate data from human studies; potential benefits may outweigh potential risks Category D pregnancy - Correct Answer -evidence of human fetal risk from research studies or after marketed; potential benefits to the mother may be acceptable despite potential risk to fetus Category X pregnancy - Correct Answer -studies demonstrate fetal abnormalities; the risks outweigh the benefits; unacceptable for use in a pregnant woman Drug Overdose - Correct Answer -the ingestion of an excessive amount of a drug; reversible or irreversible damage may ensue to bodily tissues -many drugs have antidotes that will reverse the effects of the drug if toxic levels are present in the body **See Box 2-5 General Management of Toxicity Rights of Administration - Correct Answer Key Nursing Responsibility -Right drug -Right dose -Right patient -Right route -Right time -Right reason -Right documentation -Right to refuse Principles of Administration - Correct Answer -follow the rights ALL THE TIME -knowledge of the drugs -ensure clear interpretation of the order -verify drug name and concentration -minimize use of abbreviations -use only approved abbreviations -accurate calculation -accurate measures -ALWAYS DOUBLE CHECK INSULIN WITH ANOTHER LICENSED NURSE -correct technique for all routes of administration -know about the patient (i.e. diagnosis, labs, allergies, kidney/liver function) -verify correct patient EACH TIME
Drug Preparation and Dosage Forms - Correct Answer -REVIEW INDEPENDENTLY TABLE 3.3 pg. 44- -pay close attention to types of drugs that cannot be crushed, chewed, broken, and opened -Advantages of controlled release-improvement in steady state, once a day dosing improves compliance (any med that is extended relief should NEVER be crushed, chewed, broken, opened) Assessment - Correct Answer -data collection -age, weight, vital signs, ADLs -alcohol/drug abuse -all medications, including OTC -patient knowledge level -allergies -need for long-term therapy -able to communicate? -functioning of vital organs? -laboratory results -current pathology Nursing Diagnosis - Correct Answer -knowledge deficit related to drug therapy regimen/self-administration -risk for injury related to adverse drug effects -noncompliance related to overuse/under use Planning/Goals - Correct Answer -the patient will: -take medication as prescribed -experience relief of signs and symptoms from disease process -not experience any signs and symptoms adverse effects -administer meds safely and effectively -verbalize knowledge regarding drug regimen -maintain all appointments and scheduled laboratory draw for follow-up -inform health care provider of all additional drugs prescribed/or OTC Interventions - Correct Answer -See Box 3.3 pg. 55 -See Patient Teaching Guidelines pg. 56- -monitor for expected response -teach health promotion (i.e. nutrition, exercise, fluids, rest, sleep) -teach hand washing as applicable -teach regarding vital signs-normal and abnormal values -teach specific aspects of drugs (i.e. daily weights, I/O, lab tests, etc.) Evaluation - Correct Answer -monitor if expected response achieved (i.e. pain relief) -obtain verbal feedback regarding teaching -monitor appropriate lab/diagnostic tests
-"Pill counts" Integrating Evidence-based Practice (EBP) with the Nursing Process - Correct Answer -scientific evidence -provides a rationale for all interventions Herbal and Dietary Supplements - Correct Answer -consists of Legal Regulation, Patient Education, and Common Botanicals Legal regulation - Correct Answer -Dietary Supplement Health and Education Act (DSHEA) 1994 -"a vitamin, a mineral, an herb or other botanical used to supplement the diets" -cannot claim to diagnose, prevent, relieve, or cure specific human diseases unless approved by the FDA Patient education - Correct Answer -patients who use herbal remedies may avoid seeking treatment from their health care provider -these products may interfere with many prescription/OTC medications -patients should always inform health care provider of all herbal/OTC meds -the effects of herbal/dietary supplements are largely unknown; lack research -ingredients may not be standardized or included on product label -purchase herbal/dietary supplements from a reputable company -make sure product label contains ingredients with percentages, amounts, and strengths -just because they are "natural" does not mean safe -do not use appropriately -avoid during pregnancy and lactation -Discontinue any herbal/dietary supplement 2-3 weeks before any surgical procedure -keep out of reach of children Common botanicals - Correct Answer -botanicals will be discussed with each system Drug therapy in Children - Correct Answer -consider age, size, developmental level, and organ function -keep all meds in childproof containers -use oral route when possible -knowledge of site selection Drug therapy in Older Adults - Correct Answer -increased potential for adverse effects due to pathologic changes associated with aging -physiologic age (i.e. organ function) is more important than chronologic age -if new symptoms occur, always consider adverse effects of drug -prevention measures should be implemented (i.e. sleep, weight, and smoking) -smallest dose that is effective should be given -consider visual acuity with labels and self-administration
-decreased liver blood flow -decreased total body water -increased body fat -decreased serum albumin True/False: The trade or brand name is related to the chemical or official name and is independent of the manufacturer. - Correct Answer False True/False: The Harrison Narcotic Act prohibits fraudulent claims of drug effectiveness.
True/False: Hyperthyroidism slows metabolism, which shortens drug action and hastens elimination. - Correct Answer False Activated _____ is considered the "universal" antidote. - Correct Answer charcoal _____ is the process that occurs from the time a drug enters the body to the time it enters the blood stream to be circulated. - Correct Answer Absorption Body weight affects drug action mainly in relation to _____. - Correct Answer dose During pregnancy, drugs cross the ____ and may harm the fetus. - Correct Answer placenta _____ are used in clinical drug trials to compare the medication being tested with a "dummy" medication. - Correct Answer Placebo True/False: The fact that a physician wrote an erroneous order excuses the nurse from legal liability if he or she carries out that order. - Correct Answer False True/False: It is safer and quicker to utilize abbreviations for drug names and routes of administration. - Correct Answer False True/False: Controlled release tablets can be crushed or chewed for slow absorption. - Correct Answer False True/False: An example of a transdermal formulation includes nitroglycerin. - Correct Answer True True/False: The desired or ordered dose and the available or labeled dose must be in the same units of measurement. - Correct Answer True Enteric coated tablets and capsules are coated with a substance that is ___ in stomach acid. - Correct Answer insoluble The most commonly used system of measurement is the ___ system. - Correct Answer metric Mill equivalent’s express the ___ activity of a drug. - Correct Answer ionic True/False: Pediatric drug doses are determined strictly using the child's weight. - Correct Answer True True/False: Total body water, fat stores, and protein amounts have no effect on drugs administered to the pediatric population. - Correct Answer False