Controlled Substances and Pregnancy Categories
52 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What does Category C signify regarding drug usage during pregnancy?

  • No potential risks are associated with the drug.
  • The drug is completely safe for use in pregnant individuals.
  • Adequate studies have shown it is harmful to both humans and animals.
  • Adverse effects on the fetus have been demonstrated in animal studies. (correct)
  • Which schedule of controlled substances has the least abuse potential?

  • Schedule II
  • Schedule I
  • Schedule IV (correct)
  • Schedule III
  • What is a characteristic of Schedule I controlled substances?

  • They are used primarily for antitussive purposes.
  • They have limited dependence liability.
  • They have high abuse potential. (correct)
  • They have accepted medical use.
  • What does Category D indicate about a drug's use during pregnancy?

    <p>There is evidence of human fetal risk but benefits may outweigh the risks.</p> Signup and view all the answers

    What is the main difference between Schedule II and Schedule III drugs?

    <p>Schedule II drugs have a higher potential for abuse and dependence.</p> Signup and view all the answers

    What is a key responsibility of nurses in medication administration?

    <p>Provide patient teaching</p> Signup and view all the answers

    Which of the following best describes a prototype drug?

    <p>The first drug of a class to be developed and used as a standard</p> Signup and view all the answers

    Which classification type is NOT used for drugs?

    <p>Manufacturer origin</p> Signup and view all the answers

    What is the primary difference between generic and brand name drugs?

    <p>Generic names are approved by the FDA and presented in lowercase</p> Signup and view all the answers

    Which of the following statements about drug sources is accurate?

    <p>Natural drugs can come from plants, animals, and inorganic compounds</p> Signup and view all the answers

    What is a significant effect of using morphine as an analgesic?

    <p>It serves as a CNS depressant</p> Signup and view all the answers

    Which statement regarding drug evaluation is incorrect?

    <p>Drug evaluation focuses solely on cost effectiveness</p> Signup and view all the answers

    How are brand name drugs primarily designated?

    <p>With capital letters and patented by manufacturers</p> Signup and view all the answers

    What is the most accurate source of drug information that is continually updated?

    <p>Package inserts</p> Signup and view all the answers

    Which of the following describes how drugs can interfere with the function of foreign cells?

    <p>Interfering with foreign cell functions</p> Signup and view all the answers

    What type of drug interaction occurs when a substance binds to a receptor site and produces an effect?

    <p>Agonist</p> Signup and view all the answers

    What is not considered a reliable source of drug information?

    <p>Internet information from social media</p> Signup and view all the answers

    Which of these options describes the interaction of receptors and chemicals as a 'lock and key' mechanism?

    <p>Receptor sites</p> Signup and view all the answers

    What effect do competitive antagonists have on receptor sites?

    <p>They prevent the binding of natural stimulants</p> Signup and view all the answers

    What is the primary focus of pharmacodynamics?

    <p>The interactions of drugs with living systems</p> Signup and view all the answers

    What is one way that drugs can influence enzyme systems?

    <p>By interfering with enzyme reactions</p> Signup and view all the answers

    What is selective toxicity in pharmacology?

    <p>The ability of a drug to attack systems in foreign cells only</p> Signup and view all the answers

    Which component of pharmacokinetics refers to how medications are processed in the body?

    <p>Metabolism</p> Signup and view all the answers

    What is the significance of knowing the half-life of a drug in clinical practice?

    <p>It indicates how long the drug remains effective in the body</p> Signup and view all the answers

    What factor can influence the absorption rate of intramuscular injections?

    <p>Blood flow to the tissue and muscles</p> Signup and view all the answers

    What is critical concentration in pharmacology?

    <p>The minimum concentration required for a drug to start being effective</p> Signup and view all the answers

    Why might some drugs need to be administered via injection instead of orally?

    <p>They are chemically unstable or poorly absorbed when taken orally</p> Signup and view all the answers

    What does a higher therapeutic index indicate about a drug?

    <p>It is safer and has a wider margin between effective and toxic doses</p> Signup and view all the answers

    What route of administration is considered the fastest for drug absorption?

    <p>Intravenous injection</p> Signup and view all the answers

    What role does protein binding play in drug action?

    <p>It influences the drug's duration of action.</p> Signup and view all the answers

    How does the Blood-brain barrier affect drug distribution?

    <p>Only lipid-soluble drugs can pass through it.</p> Signup and view all the answers

    What is the First-Pass Effect?

    <p>It refers to the metabolism of orally taken drugs in the liver.</p> Signup and view all the answers

    Which organ is primarily responsible for drug excretion?

    <p>Kidneys</p> Signup and view all the answers

    What impact does liver dysfunction have on drug metabolism?

    <p>It can lead to sub-therapeutic drug levels.</p> Signup and view all the answers

    What is the role of the CYP-450 system in drug metabolism?

    <p>It metabolizes drugs and can affect the metabolism of other drugs.</p> Signup and view all the answers

    What factors can influence drug effects?

    <p>A wide range of factors, including age, sex, weight, and genetics.</p> Signup and view all the answers

    What does a shorter half-life indicate about a drug?

    <p>It leaves the body more quickly.</p> Signup and view all the answers

    What can happen if drugs are not properly metabolized in the liver?

    <p>Increased risk of toxicity.</p> Signup and view all the answers

    What are adverse effects of drugs?

    <p>Unwanted effects that can extend therapeutic effects.</p> Signup and view all the answers

    What is a potential consequence of drug exposure due to hypersensitivity?

    <p>Development of antibodies</p> Signup and view all the answers

    Which of the following can indicate hepatotoxicity?

    <p>Elevated liver enzyme levels</p> Signup and view all the answers

    What adverse effect is specifically characterized by inflammation of mucous membranes?

    <p>Stomatitis</p> Signup and view all the answers

    Which factor can lead to hypoglycemia?

    <p>Excessive insulin release</p> Signup and view all the answers

    Which drug effect is associated with the destruction of normal flora?

    <p>Superinfection</p> Signup and view all the answers

    What effect does nephrotoxicity have on renal function?

    <p>Decreased urine output</p> Signup and view all the answers

    Which side effect might result from drug-induced hypokalemia?

    <p>Muscle cramps</p> Signup and view all the answers

    Which of the following can indicate a risk of teratogenicity?

    <p>Exposure to developing fetus</p> Signup and view all the answers

    What is a characteristic of neuroleptic malignant syndrome?

    <p>High fever</p> Signup and view all the answers

    Which of the following is primarily an adverse effect of certain antibiotics?

    <p>Auditory ringing, or tinnitus</p> Signup and view all the answers

    Which alteration occurs due to the first-pass effect in drug metabolism?

    <p>Metabolite irritation</p> Signup and view all the answers

    What is included in patient education regarding drugs?

    <p>Name and action of the drug</p> Signup and view all the answers

    Which medication error occurs if the right dose is not provided?

    <p>Right dose</p> Signup and view all the answers

    Study Notes

    NUR 320 Module 1B: Introductory Topics for Pharmacology

    • This module covers introductory topics in pharmacology for nursing students
    • The instructor is Mary Rose Gaughan, PhD, RN, CNE at D'Youville University.

    Agenda

    • Terminology and guidelines for drug order interpretation and transcription
    • Legal and ethical implications related to drug administration
    • Principles of drug action
    • Developmental and cultural (ethnic) considerations

    Today's Objectives

    • Describe the concepts and principles of drug action
    • Identify developmental and cultural considerations of pharmacology and drug administration
    • Understand terminology and guidelines related to pharmacology

    Pharmacology

    • The study of biological effects of chemicals
    • Drugs are chemicals introduced to the body to cause a change
    • Herbals and non-pharmaceuticals can also cause changes to the body
    • Pharmacotherapeutics uses drugs to prevent, diagnose, or treat disease processes
    • Pharmacotherapy uses drugs to prevent, diagnose, or treat symptoms and disease processes

    What does this mean to nursing practice?

    • Nursing guidelines require safe practice when administering medications
    • Drugs can have many effects - some helpful, some undesirable or harmful
    • Responsibilities include: administration of drugs, assessing drug effects, intervening to make the drug regimen more tolerable, providing patient teaching, monitoring the overall care plan to prevent medication errors

    Sources of Drugs

    • Natural sources: plants, animals, inorganic compounds
    • Synthetic sources: genetic engineering, improving established medications

    Classification of Drugs

    • Classified according to effects on a particular body system, therapeutic use, and chemical characteristics
    • Drugs fit into many groups because of their effects on the human body
    • Example: morphine – CNS depressant and an opioid analgesic

    Prototype

    • Often the first drug of the class to be developed
    • The standard to which newer drugs are compared to
    • Example: Morphine is the prototype analgesic
    • Some groups lack a universally accepted prototype
    • Some prototypes are replaced over time with newer, more commonly utilized drugs

    Generic and Brand Names

    • Generic: related to the chemical or official name, independent of manufacturer, presented in lowercase letters
    • Brand Name: also known as trade name, designated and patented by the manufacturer, presented with a capital letter
    • US Adopted Names Council assigns generic names
    • Generic names are required to be therapeutically equivalent and less expensive than brand names
    • Monitored by FDA

    Drug Evaluation

    • U.S. Food and Drug Administration (FDA) has tight control
    • Regulates development and sale of drugs
    • Ensures safety and reliability of drugs
    • Several stages of development to determine if benefits outweigh the known and potential risks of the medication
    • Pre-clinical trials, phase I, II, and III studies
    • Orphan drugs – discovered but not financially viable, have not been 'adopted' by a drug company
    • May be useful in treating rare diseases or have potentially dangerous adverse effects

    FDA Trials and Studies

    • Pre-clinical trials: do not use humans (use animals) to test drug potential, determine whether the drug has effects in living tissue, evaluates adverse effects
    • Phase I studies: human volunteers to test safety and dosage; healthy volunteers with the condition the medication is designed to help; informed consent
    • Phase II studies: more patients who have the disease the drug is intended to treat; performed across the country; if unacceptable adverse effects are detected, the drug is removed from testing
    • Phase III studies: larger sample of population; determine treatment benefit and monitor side effects; participants keep journals and record symptoms
    • FDA approval (Phase IV): continual evaluation after approval for marketing

    FDA Labels and "Off-Label" Uses

    • Prescribing information from studies is refined and "labelled".
    • Label lists the approved uses, risks, and benefits of medication based on clinical trials
    • "Off-label" uses of a drug are not part of the stated therapeutic indications the drug was approved for
    • FDA regulates development and sale of drugs
    • Local laws further regulate distribution and administration of drugs
    • Vary from state to state, and within a state
    • Federal legislation affects clinical use of drugs

    Safety in Pregnancy

    • Category A: Adequate studies not demonstrated a risk to the fetus in any study
    • Category B: Animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant people
    • Category C: Animal studies have shown an adverse effect on the fetus, but there are no adequate studies in humans
    • Category D: Evidence of human fetal risk, but potential benefits may be acceptable
    • Category X: Studies in animals or humans demonstrate fetal abnormalities or adverse reactions

    Controlled Substances

    • Schedule I: high abuse potential, no accepted medical use (heroin, LSD)
    • Schedule II: high abuse potential, severe dependence liability (narcotics, amphetamines, barbiturates)
    • Schedule III: less abuse potential than Schedule II, moderate dependence liability, certain narcotics
    • Schedule IV: less abuse potential than Schedule III, limited dependence liability, sedatives, antianxiety agents
    • Schedule V: limited abuse potential, small amounts of narcotics (codeine)

    Sources of Drug Information

    • Drug labels: name, dosage, expiration date, warnings
    • Package inserts: by manufacturer, all chemical and study information, most accurate source
    • Reference books: compilation of package inserts
    • Journals: new drugs/classes, specific treatment protocols
    • Internet information: government and association websites

    Pharmacodynamics

    • Study of interactions between chemical components of living systems and foreign chemicals (drugs)
    • Drugs work in one of four ways:
      • Replacing missing chemicals
      • Increasing or stimulating cellular activities
      • Depressing or slowing cellular activities
      • Interfering with foreign cells (e.g., microorganisms or neoplasms)

    Receptor Sites

    • Specific areas on cell membranes that react with certain chemicals
    • "Lock and key" analogy
    • Key = specific chemical
    • Lock = receptor site
    • Interactions: Agonists, competitive antagonists and non-competitive antagonists

    Drug-Enzyme Interactions

    • Drugs can cause effects by interfering with enzyme systems
    • Enzyme systems work in a cascade fashion, with one enzyme activating another one

    Selective Toxicity

    • Ability of a drug to attack only those systems found in foreign cells

    Pharmacokinetics

    • Study of how medications travel through the body
    • Includes absorption, distribution, metabolism (biotransformation), excretion
    • In clinical practice, nurses must consider: onset of drug action, drug half-life, timing of peak effect, duration of drug effects, site of excretion

    Critical Concentration and Therapeutic Index

    • Critical concentration: amount of drug needed for a therapeutic effect
    • Therapeutic index: ratio of blood concentration where a drug becomes toxic to concentration where it is effective
    • Loading dose: higher dose than usual to reach critical concentration sooner

    Absorption

    • Time from drug introduction until it reaches circulating fluids and tissues
    • Sites of absorption, rate and amount absorbed (e.g., IV fastest, bypasses barriers, PO non-invasive)
    • Influencing factors: chemical instability, injection methods, intestinal issues

    Distribution

    • Movement of drug into body tissues
    • Factors: blood circulation, cell membrane permeability, plasma protein binding
    • Bound drug = longer duration of action
    • Unbound drug = quicker action, excretion

    Biotransformation (Metabolism)

    • Liver is the primary site
    • Changes drugs into new chemicals
    • First-pass effect: drugs taken by mouth can be significantly reduced by metabolism in the liver before reaching the circulatory system
    • Factors for metabolism: site, route, prior condition

    Biotransformation (Metabolism)

    • Hepatic Enzyme System (CYP-450): abundant in the liver, metabolizes drugs
    • Drugs can increase or decrease CYP-450 activity, affect metabolism of other drugs
    • Liver disease and other factors affect drug metabolism

    Excretion

    • Kidneys play the most important role in excretion
    • Drugs made water-soluble during metabolism readily excreted by the kidney, others secreted or reabsorbed
    • Kidney dysfunction can lead to toxicity due to the inability to excrete the drug.

    Pharmacokinetics Recap

    • Description of drug movement through the body
    • Drugs dissolved, lost in stomach/intestines, absorbed across intestinal wall
    • Drug in liver, biotransformed → non-effective state (bound to plasma proteins), drug in circulation
    • Broken down in tissues, reaching reactive tissues → excretion

    Half-life

    • Time when drug in the body reduces to half of its peak level
    • Short half-life = more frequent dosing
    • Liver/kidney dysfunction can lengthen half-life

    Factors Influencing Drug Effects

    • Interactions: when two or more drugs taken together can cause adverse effects
    • Factors: weight, age, sex, physiological factors, pathological factors, genetic factors, immunological factors, psychological factors, environmental factors, drug tolerance, drug accumulation, interactions

    Adverse Effects

    • Primary actions: effects that are extensions of desired actions
    • Secondary actions: effects not related to therapeutic effect
    • Drugs cause effects in the body.
    • Drug allergies/hypersensitivity can happen when patient develops antibodies.
    • Adverse effects can include: dermatological reactions, GI irritation, superinfection, blood dyscrasia.

    Drug-Induced Tissue & Organ Damage

    • Adverse effects can include rashes, hives, Stevens-Johnson syndrome, stomatitis, GI irritation, nausea, vomiting, constipation, diarrhea, superinfections, and blood dyscrasia

    Toxicity

    • Hepatotoxicity: liver cell damage
    • Nephrotoxicity: kidney damage
    • Poisoning: overdose damaging multiple body systems

    Alterations in Glucose Metabolism

    • Hypoglycemia: low blood glucose
    • Hyperglycemia: high blood glucose

    Electrolyte Imbalances

    • Hypokalemia: altered renal exchange system causing potassium loss (e.g., loop diuretics)
    • Hyperkalemia: potassium retention and increased serum potassium (e.g., anti-neoplastic drugs)
    • Other imbalances: hypercalcemia, hypocalcemia, hypernatremia, hyponatremia, hypermagnesemia, hypomagnesemia

    Sensory Effects

    • Ocular damage: drug deposits cause inflammation, leading to blindness
    • Auditory damage: tiny vessels/nerves in auditory nerve easily irritated, may lead to ringing in ears

    Neurological Effects

    • General CNS effects: alterations in electrolyte and glucose levels, CNS stimulants/depression
    • Anticholinergic effects: blockage of cholinergic receptors, many cold and anti-histamines cause these
    • Extrapyramidal symptoms: dopamine levels affected, Parkinsonian symptoms, antipsychotic/neuroleptic drugs cause these
    • Neuroleptic Malignant Syndrome: general anesthesia can cause this, high fever, potentially fatal

    Teratogenicity

    • Drugs that reach a developing fetus or embryo can cause death and congenital defects
    • Defects include skeletal abnormalities, CNS alterations, heart defects

    Nursing Process

    • Assessment, nursing conclusions, planning, intervention, evaluation; obtaining medication history
    • Application of the nursing process ensures safe, efficient, scientifically based quality, holistic care

    Comfort Measures

    • Managing adverse effects
    • Lifestyle adjustment (e.g., alterations in activities, diet)
    • Placebo effect (anticipation of drug's helpfulness)

    Patient and Family Education

    • Drug education needs to include: drug name, action, dose, timing, storage precautions, specific OTC drugs, special comfort measures, safety measures, and toxicity warning signs.
    • Medication errors must be reported according to the policy of the healthcare facility.

    Medication Errors

    • Nurse's Role: right patient, right drug, right dose, right route, right time, right preparation, right recording, encouraging patient autonomy, provide health teaching.
    • Patient's Role: keeping an accurate record, knowing what each drug is used for, reading labels, following directions, speaking up when necessary, using safe devices.

    Reporting Medication Errors

    • Errors must be reported at the national and institutional level
    • Compiling reports to prevent recurrence
    • Issuing HCP warnings
    • Suggesting ways to avoid errors in the future

    Studying That Suits You

    Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

    Quiz Team

    Related Documents

    Description

    This quiz explores the classifications of controlled substances and their implications for drug usage during pregnancy. It covers topics such as the significance of different categories and schedules of drugs, focusing on abuse potential and safety for expectant mothers.

    More Like This

    Texas Health and Safety Code - Drugs Quiz
    64 questions
    Drug Classification and Key Terms Quiz
    14 questions
    Controlled Drugs and Their Classifications
    23 questions
    Controlled Substances Classification Quiz
    42 questions
    Use Quizgecko on...
    Browser
    Browser