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Case study: Pharmacology.

Pharmacology is the study of the biological effects of chemicals Drugs are chemicals that are introduced into the body to cause some sort of change Pharmacotherapeutics a.k.a. Clinical pharmacology
branch of pharmacology that uses drugs to treat, prevent, and diagnose disease Pharmacology addresses two concerns the drug’s effects on the body
the body’s response to the drug What are nursing responsibilities regarding drug therapy? Administering drugs
Assessing drug effects
Intervening to make the drug regimen more tolerable
Providing patient teaching about drugs and the drug regimen
Monitoring the overall patient care plan to prevent medication errors Adverse effects drug effects that are not desired therapeutic effects; may be unpleasant or even dangerous Sources of drugs drugs can come from plants, foods, animals, salts of inorganic compounds, or synthetic sources Provide examples of plant-derived drugs digitalis products used to treat cardiac disorders and various opiates used for sedation Provide example of synthetic version of the active chemical found in a plant Dronabinol (Marinol), which contains the active ingredient delta-9-tetrahydrocannabinol found in marijuana. This drug helps to prevent nausea and vomiting in cancer patients but does not have all of the adverse effects that occur when marijuana leaf is smoked. The synthetic version of the active ingredient allows for an accepted form to achieve the desired therapeutic effect in cancer patients. Provide example of how ingestion of plant-derived foods can sometimes lead to a drug effect the body converts licorice to a false aldosterone-a hormone found in the body- resulting in fluid retention and hypokalemia or low serum potassium levels if large amounts of licorice are eaten Inorganic compounds/ elements used for their therapeutic effects *Aluminum* = (1)antacid to decrease gastric acidity
(2) management of hyperphosphotemia
(3) prevention of the formation of phosphate urinary stones
*Fluorine* = (1) prevention of dental cavities
(2) prevention of osteoporosis
*Gold* = treatment of rheumatoid arthritis
*Iron* = treatment of iron deficiency anemia Genetic engineering process of altering DNA, usually of bacteria to produce a chemical to be used as a drug
e.g. production of human insulin by altering Escherichia coli bacteria, making insulin a better product without some of the impurities that come with animal products.
Thyroid drugs and growth hormone preparations are not created synthetically Food and Drug Administration (FDA) federal agency responsible for the regulation and enforcement of development and sale of drugs. FDA regulated tests are designed to ensure the safety and reliability of any drug approved in this country. Preclinical trials initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not human subjects
PURPOSE:
– to determine whether they have the presumed effects in living tissue
– to evaluate any adverse effects Why are some chemicals discarded at the end of preclinical trials? * the chemical lacks therapeutic activity when used with living animals
* the chemical is *too toxic to living animals* to be worth the risk of developing into a drug
* the chemical is highly teratogenic (causing adverse effects to the fetus)
* the safety margins are so small that the chemical would not be useful in the clinical setting Phase I study a pilot study of a potential drug done with a small number of selected, healthy human male volunteers
– studies are more tightly controlled than preclinical trials
– performed by specially trained clinical investigators
– women are not selected , too much risk is involved in taking a drug that might destroy or alter the ova

DRUGS DRopped at the end of Phase I due to :
1) lack therapeutic activity in humans
2) are too toxic
3) produce unacceptable side effectsPhase II study a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat; patients must provide informed consent

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DRUGS REMOVED due to:
(1) less effective than anticipated
(2) are too toxic
(3) Produce unacceptable side effects
(4) have a low benefit-to-risk ratio
(5) are not as effective as available drugsPhase III study use of a proposed drug on a wide scale in the clinical setting with patients who have the disease the drug is thought to treat

DRUGS are removed if :
(1) produce unacceptable side effects
(2) produce unexpected responsesPhase IV study continual evaluation of a drug after it has been released for marketing Brand name name given to the drug by the pharmaceutical company that developed it, aka trade name
BRAND NAME IS ALWAYS ITALICIZED Generic name the original designation that a drug is given when the drug company that developed it applies for the approval process Generic drugs drugs sold by their generic name; not brand or trade name products Chemical names are names that reflect the chemical structure of a drug what is FDA’s primary concern in drug approval? public safety Bonus Q (D2L): Drug label identifies the brand and generic names for the drug, the drug dosage, the expiration date, and special drug warning. Some labels also indicate the route and dose for administration. All nurses must understand and become familiar with each aspect of the drug label. Orphan drugs drugs that have been discovered but would not be profitable for a drug company to develop; usually drugs that would treat only a small number of people for rare diseases; these orphans can be adopted by drug companies to develop Teratogenic having adverse effect on fetus What are pregnancy categories? FDA established *five categories* to indicate the *potential for a systemically absorbed drug to cause birth defects*. The differentiation rests on the degree (reliability) of documentation and the risk-benefit ratio
CATEGORY A: not demonstrated a risk to the fetus in the first trimester of pregnancy in all study groups. No evidence of risk in later trimester

CATEGORY B: not demonstrated risk to the fetus in animal study group only. Lack of adequate adverse effect study in pregnant women, and animal group. not demonstrated a risk to the fetus in the first trimester of pregnancy in all study groups. No evidence of risk in later trimester

CATEGORY C: animal studies have shown adverse effect on fetus but no adequate studies in humans; the benefits from the use of the drug may be acceptable despite its potential risks

CATEGORY D : evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks

CATEGORY X: all studies have demonstrated fetal abnormalities or adverse reaction; reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit.What are controlled substances? Controlled drugs are divided into five DEA schedules based on their *potential for abuse and psychological dependence*
*SCHEDULE I (C-I)*: high abuse potential and no accepted medical use (heroin, marijuana, LSD)
*SCHEDULE II (C-II)*: high abuse potential with severe dependence liability (narcotics, amphetamines, and barbiturates)
*SCHEDULE III (C-III)*: less abuse potential than schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)
*SCHEDULE IV (C-IV)*: less abuse potential than schedule III and limited dependence liability (some sedatives, antianxiety agents, and nonnarcotic analgesics)
*SCHEDULE V (C-V): limited abuse potential. Primarily small amounts of narcotics (codeine) used as antitussives or antidiarrheals. NCLEX Q: The nurse, reviewing a list of potential candidates for a phase I drug study, anticipates what is the major reason young male volunteers will be chosen?
(a) men as group have more similar body builds and tissue mass
(b) females are less likely to adhere to the study
(c) drugs pose a risk to the woman’s ova
(d) men are less likely to experience any adverse effects of the drug (C) drugs pose a risk to women’s ova
Women are not good for phase I studies because the chemicals may exert unknown and harmful effects on a woman’s ova, involving too much risk. Women do not make new ova after birth so once damaged they will not be replaced, while men make new sperm daily. Women are no less likely to adhere to requirements than men. Men’s bodies are just as varied as women’s bodies. Men are not less likely to experience adverse effects NCLEX Q: the nurse reviews various legislations to drug therapies and understands that it is the enactment of the Kefauver -Harris act resulted from what event?
(a) the identification of abuse potential for various drugs
(b) use of ethylene glycol to deliver elixir of sulfanilamide
(c) the use of false or misleading claims on drug labels
(d) use of thalidomide as a sleeping agent for pregnant women (d) use of thalidomide as a sleeping agent for pregnant women
Thalidomide resulted in the birth of many babies with limb deformities. Public outcry resulted in the Kefeuver-Harris act of 1962. NCLEX Q: the entire drug development process can take 5 to 6 years
True
False True
the development of a new drug can take 5 or 6 years, or even longer, as the drug moves through the various phases. some drugs spend 20 years or more in development before testing even begins. This is done to keep our pharmaceuticals as safe as possible. NCLEX Q: What is the branch of pharmacology that uses drugs to treat, prevent and diagnose diseases?
(a) pharmacodynamics
(b) pharmacology
(c) pharmacotherapeutics
(d) chemistry (c) Pharmacotherapeutics
*is a specific branch of pharmacology specifically focused on the use of drugs as therapy, to treat, prevent and diagnose disease*. Pharmacology is the all encompassing term for the study of the biological effect of chemicals. Pharmacodynamics is one topic discussed in pharmacotherapeutics that addressed what drug does to the body, while pharmacokinetics addresses what the body does to the drug. The drug being used to treat, diagnose and prevent disease are all chemicals, but the study of chemistry includes far more than just therapeutic chemicals. NCLEX Q: A nurse is reading about drug development. The article reports the drug has been tested on laboratory animals and is now ready for the next phase. What does the nurse identify this as?
(a) Phase I study
(b) Phase II study
(c) Phase III study
(d) Phase IV study (B) Phase I
*A phase I study uses human volunteers for testing*. This phase occurs after preclinical trials, which involve animal testing. A phase II study allows the investigators to try out the drug in patients who have the disease that the drug is designed to treat. The phase follows testing on human volunteers. A phase III study involves the use of drug in a vast clinical market. NCLEX Q: After teaching a group of students about the responsibilities of Food and Drug Administration (FDA) related to drugs, the instructor determines that the students need additional teaching when they identify what as a major responsibility?
(a) enforcement of standards for testing drug toxicity
(b) setting of standards for drug efficacy and safety
(c) enforcement of control substances with high drug abuse potential
(d) assignment of a pregnant category for each new drug (C) enforcement of control substances with high drug abuse potential
The Drug Enforcement Agency (DEA) is responsible for enforcing the control of drugs with drug abuse potential. NCLEX Q: a drug has been approved by the FDA. What is the next step in the process?
(a) Phase II study
(b) Phase III study
(c) Phase I study
(d) Phase IV study (D) Phase IV study
Once a drug is approved, phase IV study occurs. This is *a phase of continual evaluation in which prescribers are obligated to report to the FDA any untoward or unexpected adverse effects associated with the drug*. A phase III study involves the use of drug in a vast clinical market. FDA approval occurs with completion of this phase. A phase II study allows investigators to try out the drug in patients who have the disease that the drug is designed to treat. The phase follows testing on human volunteers in phase I. NCLEX Q: drugs that have been shown to cause adverse effects in a fetus are termed carcinogenic
True
False False
They are termed teratogens NCLEX Q: after teaching a group of students about source of drugs, the instructor determines that the students need additional teaching when they identify what as an example of a drug from a plant source?
(A) thyroid hormone
(B) digitalis
(C) morphine
(D) opium (A) thyroid hormone
thyroid hormone is derived from an animal source, but may also be created synthetically. Digitalis, opium, and morphine are all created from plant sources. NCLEX Q: the nurse is reviewing a prescription for a medication with a patient. On the prescription, the nurse notes ‘DAW’ . How does the nurse define this abbreviation?
(A) the brand name of the drug must be dispensed
(B) a generic form of the drug must be used if available
(C) the drug written is considered to be an orphan drug
(D) a drug with similar chemical name can be substituted (A) the brand name of the drug must be dispensed
DAW means dispense as written, that is brand name of the product must be used to fill the prescription. A generic form of the drug cannot be used for substitution. Another drug with a similar chemical name could not be substituted. DAW does not refer to the drug being an orphan drug NCLEX Q: most drugs that have been developed from inorganic compounds were discovered based on strict studies to demonstrate efficacy
True
False False
They were developed accidentally when a cause-effect relationship was observed. NCLEX Q: nurses will not receive orders to receive what classification of controlled substances?
(A) schedule IV
(B) schedule II
(C) schedule I
(D) schedule III (C) schedule I
They have no accepted medical use and are not prescribed. Schedule II drugs are often prescribed and include medications such as morphine, demerol and other narcotic analgesics. Schedule iii drugs are often prescribed and include nonbarbiturate sedatives, nonamphetamines, stimulants, and non-narcotic analgesics. Schedule IV drugs are often prescribed and include sedatives, antianxiety agents, and non-narcotic analgesics. NCLEX Q: the following laws were important legislative efforts affecting the clinical use of drugs. Place the events in their proper sequence from earlier to latest 1. Pure Food and Drug Act – 1930
2. Federal Food, Drug and Cosmetic Act – 1938
3. Durham Humphrey Amendment – 1951
4. Kefauver Harris Act – 1962
5. Controlled Substances Act – 1970
5. Orphan Drug act – 1983 NCLEX Q: The FDA regulates the development and sale of drugs
True
False True NCLEX Q: Clinical pharmacology is only concerned with how the body responds to drugs
True
False False
Clinical pharmacology is concerned with two issues: how a drug affects the body and how the body affects the drug NCLEX Q: What is the process called when drugs are created by altering DNA?
(A) Pharmacotherapeutics
(B) Chemistry
(C) Genetic engineering
(D) Pharmacodynamics (C) genetic engineering NCLEX Q: A drug is involved in phase II study. The nurse understands what would be most likely?
(A) the drug is being given to laboratory animals to test for their effects on living tissues
(B) patients with the disease that the drug is designed to treat are receiving the drug
(C) volunteers receive the drug to test its effect on human
(D) a vast number of patients receive the drug under close observation and monitoring (B) patients with the disease that the drug is designed to treat are receiving the drug NCLEX Q: a nurse is preparing to administer morphine and recognizes morphine as belonging to what schedule of drugs?
(A) schedule III
(B) schedule V
(C) schedule IV
(D) schedule II (D) schedule II
*morphine is a schedule II controlled substance with a severe risk of abuse and dependence*. Schedule III drugs have a lower abuse potential and generally contain nonbarbiturate sedatives, nonamphetamine stimulants, and limited amount of certain narcotics. NCLEX Q: the nurse instructs the patient some drugs are no longer covered under patent and may be less expensive, using what name to refer to this type of drug?
(A) generic
(B) controlled
(C) brand name
(D) orphan (A) generic drugs NCLEX Q: after reviewing class material about the natural sources of drugs, the students demonstrate understanding of the material when they identify what as an example of a drug that is derived from inorganic compounds.
(A) codeine
(B) aluminum hydroxide
(C) castor oil
(D) insulin (B) aluminum hydroxide
aluminum hydroxide is an antacid made from inorganic compound. Codeine is derived from a plant source. Castor oil is derived from a plant source. Insulin is originally derived from animal source, but has been created synthetically via genetic engineering . NCLEX Q: what best describes the focus of pharmacotherapeutics?
(A) how the body processes drug for elimination
(B) proper method for drug administration
(C) the effect of the drug on the body
(D) the biological effect of the drug (C) the effect of the drug on the body
*pharmacotherapeutics addresses the drug’s effect on the body’s effect on the drug*. Body processes used to eliminate a drug are a facet of what happens when a drug is administered. Biological effects reflect pharmacology. The proper method for drug administration is a nursing responsibility NCLEX Q: a nurse is to administer several drugs. What class of drug would the nurse interpret as being safest for a pregnant woman?
(A) category A
(B) category B
(C) category C
(D) category X (A) category A
a drug identified as category A is determined to be the safest because studies of such a drug have not demonstrated a risk to the fetus in the first trimester of pregnancy. Pre-quiz (D2L): Pharmacotherapeutics is the branch of pharmacology that uses drugs to treat, prevent, and diagnose disease.
True
False True Pre-quiz (D2L) The generic name of a drug is the name given to the drug by the manufacturer. False Bonus Q: The nurse is teaching a patient about the brand-name drug Coumadin and observes “dispense as written.” The patient states that generic medications are less expensive and questions why he cannot have the generic drug warfarin instead. Explain the possible reasons for this order. Pre-quiz (D2L): The Food and Drug Administration (FDA) is the agency that regulates the development and sale of drugs in the United States True Pre-quiz (D2L): Phase I clinical studies study the effect of a drug on patients with the disease False Pre-quiz (D2L): Pregnancy categories indicate a drug’s potential or actual teratogenic effects. True Pre-quiz (D2L): ___________ drugs are helpful in treating rare diseases and have not been “adopted” by any drug companies. Orphan Pre-quiz (D2L): Over-the-counter (OTC) medications can be purchased without a ___________. Prescription Pre-quiz (D2L): Controlled drugs are divided into _________ schedules by the Drug Enforcement Agency (DEA) based on their potential for abuse or dependence Five Pre-quiz (D2L): ___________ are used during preclinical trials to test the effects of drugs on live tissue Laboratory animals Pre-quiz (D2L): The Federal Food Drug and Cosmetic Act of 1938 established procedures for ________________ new drugs Introducing

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