Drug Approval and Controlled Substances

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Questions and Answers

What is the appropriate intervention to take in the event of liver injury due to medication?

  • Increase the dosage
  • Administer activated charcoal
  • Provide supplemental oxygen
  • Discontinue medication (correct)

Which symptom would most likely indicate renal injury?

  • Severe headache
  • Change in urinary pattern (correct)
  • Confusion and disorientation
  • Skin rash

Which of the following is a sign of hypoglycemia?

  • Drowsiness (correct)
  • Thirst
  • Polyuria
  • Dizziness

What intervention should be taken if hyperkalemia is suspected?

<p>Monitor serum potassium levels (A)</p> Signup and view all the answers

How should ocular damage be assessed when administering potentially harmful medication?

<p>Observe for visual changes (C)</p> Signup and view all the answers

Which treatment option is appropriate for poisoning due to drug overdose?

<p>Activated charcoal or stomach pumping (C)</p> Signup and view all the answers

What is a common assessment for hyperglycemia?

<p>Increased thirst (A)</p> Signup and view all the answers

What is the first step to take when assessing for hypokalemia?

<p>Check serum potassium levels (B)</p> Signup and view all the answers

What is the minimum inhibitory concentration (MIC) in relation to antibiotics?

<p>The minimum effect of antibiotics needed to suppress a microorganism (A)</p> Signup and view all the answers

Which route of administration is considered to be the fastest for drug delivery?

<p>Intravenous (C)</p> Signup and view all the answers

How long is the typical duration of antibiotic therapy for acute infections?

<p>5-10 days (D)</p> Signup and view all the answers

What is a disadvantage of combination drug therapy?

<p>It can lead to increased drug interactions. (D)</p> Signup and view all the answers

Which of the following conditions requires the longest duration of antibiotic treatment?

<p>Tuberculosis (A)</p> Signup and view all the answers

Which of the following could lead to the failure of antimicrobial therapy?

<p>Late treatment initiation (A)</p> Signup and view all the answers

What is a characteristic of mono drug therapy?

<p>It is typically better tolerated by patients. (B)</p> Signup and view all the answers

What type of organisms do antivirals target?

<p>Viruses (A)</p> Signup and view all the answers

Which of the following medications is classified as a high alert medication?

<p>Heparin (B)</p> Signup and view all the answers

What is primarily indicated by the Generic Name of a drug?

<p>It is assigned by the USAN Council. (B)</p> Signup and view all the answers

Which category indicates a drug whose risk to the fetus is demonstrated but may still have acceptable benefits during pregnancy?

<p>Category D (B)</p> Signup and view all the answers

Why must drug therapy be tailored to individual patients?

<p>To ensure maximum benefits while minimizing potential harm. (B)</p> Signup and view all the answers

What is true about the side effects of medications?

<p>Every medication can cause side effects in different individuals. (D)</p> Signup and view all the answers

What characteristic is true for Brand/Trade Names of medications?

<p>They start with a Capital letter and are designed to be memorable. (B)</p> Signup and view all the answers

What is a common risk associated with the use of high alert medications?

<p>They can cause harm due to their narrow therapeutic index. (D)</p> Signup and view all the answers

What does Category C in FDA Pregnancy Risk Category indicate?

<p>Risk shown in animal studies but not confirmed in humans. (D)</p> Signup and view all the answers

What is the primary goal of the regular assessment of the 4 A's in pain management?

<p>To monitor analgesia, activity, adverse effects, and aberrant behavior (D)</p> Signup and view all the answers

Which of the following is NOT a recommended nursing intervention for managing patient pain?

<p>Immediately stop all ineffective pain relief measures (C)</p> Signup and view all the answers

Which restorative therapy is specifically mentioned as being effective for postpartum pain?

<p>Transcutaneous electric nerve stimulation (TENS) (D)</p> Signup and view all the answers

What should the focus be when providing pain relief measures according to the patient's report of pain severity?

<p>Align pain relief measures with the reported pain severity (D)</p> Signup and view all the answers

Which physical intervention is characterized by providing stimulation to the skin to alleviate pain?

<p>Cutaneous stimulation (C)</p> Signup and view all the answers

What is a common adverse effect associated with stimulant medications?

<p>Chest pain (C)</p> Signup and view all the answers

What is a key consideration when using bracing techniques for pain management?

<p>Nonrigid bracing can improve function without causing muscle dysfunction (A)</p> Signup and view all the answers

What nursing consideration is essential when administering theophylline?

<p>Monitor plasma levels regularly (B)</p> Signup and view all the answers

What is a critical component of informed consent in pain management?

<p>Ensuring the patient understands the risks and benefits of treatment (D)</p> Signup and view all the answers

Which of the following methods is considered non-pharmacologic in pain relief?

<p>Massage therapy (D)</p> Signup and view all the answers

Which of the following is NOT a feature of Ipratropium?

<p>Can be used as an emergency rescue drug (B)</p> Signup and view all the answers

What condition prevents the use of Ipratropium?

<p>Glaucoma (A)</p> Signup and view all the answers

In which step of chronic asthma management would low-dose inhaled corticosteroids be used?

<p>Step 2: Mild persistent (D)</p> Signup and view all the answers

What is the primary benefit of using bronchodilators like theophylline?

<p>Enhancing bronchodilation (B)</p> Signup and view all the answers

LABAs should be used concurrently with which type of medication for asthma management?

<p>Inhaled glucocorticoids (A)</p> Signup and view all the answers

Which of the following statements about stimulants is true?

<p>High doses can lead to tachycardia. (C)</p> Signup and view all the answers

What must be monitored when administering penicillin?

<p>PT, INR, and platelet counts (D)</p> Signup and view all the answers

Which of the following should be avoided when taking fluoroquinolones?

<p>Dairy products (A)</p> Signup and view all the answers

What are the potential mild CNS symptoms associated with fluoroquinolones?

<p>Dizziness and headache (C)</p> Signup and view all the answers

Which type of injection site is recommended for IM medication administration?

<p>Vastus lateralis (B)</p> Signup and view all the answers

What is a serious risk when using fluoroquinolones in children and older adults?

<p>Achilles tendon rupture (B)</p> Signup and view all the answers

Why is it important to rotate IM injection sites?

<p>To minimize pain and thrombophlebitis (A)</p> Signup and view all the answers

Which medications can potentially interact with ciprofloxacin?

<p>Iron salts and antacids (A)</p> Signup and view all the answers

What must be checked prior to administering fluoroquinolones?

<p>Renal dysfunction (B)</p> Signup and view all the answers

How should vancomycin be infused to minimize discomfort?

<p>Over 60 minutes (C)</p> Signup and view all the answers

What is a common side effect of cefaclor and related antibiotics?

<p>Diarrhea (D)</p> Signup and view all the answers

Flashcards

Generic name

This type of name is assigned by the USAN Council and is used to identify a drug universally. For example, ibuprofen is the generic name for Advil.

Chemical name

This type of name shows the chemical makeup of a drug.

Trade or Brand name

This name is used to identify a drug during the 17 years a company has exclusive rights to make, sell, and use it.

FDA Pregnancy Risk Category A

This category indicates that there's no known risk to the fetus during any stage of pregnancy.

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FDA Pregnancy Risk Category B

This category indicates that the drug may be safe for use during pregnancy, but more research is needed.

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FDA Pregnancy Risk Category C

This category indicates that there's a risk to the fetus based on animal studies, but the benefits of the drug in pregnant women may outweigh the risks.

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FDA Pregnancy Risk Category D

This category indicates that there's a risk to the fetus based on human studies, but the benefits of the drug in pregnant women may outweigh the risks.

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FDA Pregnancy Risk Category X

This category indicates that the drug has been shown to cause fetal abnormalities and the risks outweigh any possible benefits.

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Liver Injury from Medications

Liver damage caused by a drug. It can happen at both high and normal doses.

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Renal Injury from Medications

Kidney damage from medication. It can occur with high or regular doses.

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Hypoglycemia

A state of dangerously low blood sugar levels.

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Hyperglycemia

A state of dangerously high blood sugar levels.

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Hypokalemia

A condition where the blood has low potassium levels.

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Hyperkalemia

A condition where the blood has high potassium levels.

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Ocular Damage from medications

Damage to vision from medication.

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Auditory Damage from medications

Damage to hearing from medication.

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What is MIC?

Minimum antibiotic concentration needed to stop the growth of microorganisms or achieve a therapeutic effect.

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What is the route of administration?

The route used to deliver medication to the body, like intravenous, intramuscular, oral, etc.

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What is the duration of therapy?

The length of time a treatment is given, ranging from days for acute infections to months for chronic conditions.

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What is mono drug therapy?

Treatment that involves using only one medication.

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What is combination drug therapy?

Treatment that involves using two or more medications together.

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Why is frequent drug therapy change not good?

Frequent changes in medication may be harmful as the body needs time for drugs to be absorbed, reach their target, and produce effects.

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What are the causes of antimicrobial therapy failure?

Failure to treat infections effectively can be due to factors like poor medication choice, wrong dosage, inappropriate route, or too late a start.

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What are the different types of antimicrobial agents?

Different types of microorganisms require specific antimicrobial agents for effective treatment, such as antibacterial for bacterial infections, antiviral for viral infections, etc.

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Cefaclor

A type of antibiotic that is well absorbed in the digestive system.

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Cefotetan

A type of antibiotic that is used to treat bacterial infections, and is given intravenously (IV) or intramuscularly (IM).

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Fluoroquinolones

A class of antibiotics that are used to treat a wide range of bacterial infections, including urinary tract infections (UTIs), respiratory infections, and gastrointestinal infections.

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Ciprofloxacin (Cipro)

A type of fluoroquinolone antibiotic that is available in both oral and IV forms.

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Levaquin (Levofloxacin)

A type of fluoroquinolone antibiotic that is used to treat bacterial infections, and is taken once a day.

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Achilles Tendon Rupture

This can occur with the use of fluoroquinolones, especially in children, the elderly, and patients with previous tendon issues.

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Bactericidal

A type of antibiotic that is very effective against bacteria, meaning it can kill the bacteria directly.

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Broad-spectrum

A type of antibiotic that is effective against a wide variety of different types of bacteria.

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CIN endings

This class of antibiotics has a specific chemical ending that helps to distinguish them from other antibiotics.

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Metabolized

The process of breaking down and removing a substance from the body.

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Pre/post intervention pain and function assessment

The assessment of a patient's pain and function before and after an intervention.

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Cutaneous stimulation

A method of pain management that uses devices to stimulate nerves, such as TENS (Transcutaneous Electrical Nerve Stimulation) and ultrasound.

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Traction

A technique used to reduce spinal pain by applying traction to the spine.

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Therapeutic Ultrasound

A therapeutic exercise modality that uses heat to penetrate deep tissues and improve healing, typically using ultrasound equipment.

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Therapeutic Exercise

A therapeutic approach to pain management that involves exercise, stretching, and other physical activities to improve movement and reduce pain.

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Multimodal pain care

A holistic approach to pain management that includes various treatments, such as medication, physical therapy, and psychological interventions.

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Physical Interventions

A method of pain management that uses various techniques to stimulate the skin to reduce pain, such as massage and TENS.

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Periodic review of pain diagnosis

A review of the patient's pain diagnosis, comorbidities, and overall treatment plan to ensure optimal care.

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What are LABAs and how are they used in treating asthma?

Long-acting beta2-agonists (LABAs) are medications used to treat asthma. They work by relaxing the muscles in the airways, making it easier to breathe. However, LABAs should only be used in combination with inhaled corticosteroids for long-term asthma control.

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What is theophylline and what makes it unique?

Theophylline is a medication used to treat asthma and chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles in the airways, making it easier to breathe. Theophylline has a narrow therapeutic index, meaning that there is a small difference between the dose that is effective and the dose that causes side effects.

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What is ipratropium and how does it work?

Ipratropium is an inhaled anticholinergic medication used to treat asthma and COPD. It works by blocking the action of acetylcholine, a neurotransmitter that causes the muscles in the airways to contract, making it harder to breathe.

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What is asthma?

Asthma is a chronic condition that affects the airways, causing inflammation, swelling, and narrowing. This narrowing makes it harder for air to pass through, leading to symptoms like wheezing, coughing, shortness of breath, and chest tightness.

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What are SABAs and how are they used in treating asthma?

Short-acting inhaled beta2-agonists (SABAs) are medications used to quickly relieve asthma symptoms. They work by relaxing the muscles in the airways, making it easier to breathe.

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What are inhaled corticosteroids and how are they used in treating asthma?

Inhaled corticosteroids are medications used to reduce inflammation in the airways. They can be used long-term to prevent asthma symptoms, or short-term to treat flare-ups.

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What is cromolyn and how does it work?

Cromolyn is a mast cell stabilizer medication used to prevent asthma symptoms. It works by preventing the release of histamine and other inflammatory chemicals from mast cells.

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How is asthma severity classified?

Asthma severity is classified into four categories: intermittent, mild persistent, moderate persistent, and severe persistent. This classification helps healthcare providers decide the best treatment approach for individual patients.

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Study Notes

Drug Approval Process

  • Preclinical trials: Chemicals tested on lab animals
  • Phase I: Chemicals tested on healthy human volunteers, assessing safety
  • Phase II: Drug tested on patients with the disease, evaluating effectiveness
  • Phase III: Drug used in various clinical populations, assessing effectiveness in a larger market
  • FDA approval: If approved, the drug can be marketed.
  • Phase IV: Drug continuously evaluated, monitoring for adverse events

Controlled Substances (DEA Schedules)

  • Schedule I: High potential for abuse, no currently accepted medical use. (e.g., heroin, marijuana, LSD)
  • Schedule II: High potential for abuse but approved for medical use. (e.g., cocaine, methadone, Oxycodone)
  • Schedule III: Moderate-to-low potential for dependency. (e.g., Tylenol w/Codeine)
  • Schedule IV: Low potential for abuse. (e.g., Xanax, Ambien)
  • Schedule V: Lowest potential for abuse, primarily used for anti-diarrheal, antitussive, & analgesics. (e.g., Lomotil)

Nurse Responsibilities

  • Administering drugs (addressing 11 rights of medication administration)
  • Assessing drug effects
  • Intervening to improve drug tolerance
  • Patient education regarding the drug regimen and its proper use
  • Monitoring for adverse events and errors
  • Advocating for patient's well-being and safety

Pharmacokinetics

  • Absorption: How the body absorbs a drug
  • Distribution: How the drug is distributed throughout the body
  • Metabolism (biotransformation): How the body changes (breaks down) a drug
  • Excretion: How the body removes a drug

Pharmacodynamics

  • How the drug acts on the body
  • Drug-drug interactions: How one drug affects the action of another drug
  • Drug-food interactions: How food can affect the action of a drug

Medication Orders

  • Must include patient details, medication name, dosage, route, frequency, date, time, and signature of prescriber.

Key Points

  • No drug is completely safe.
  • All drugs can cause side effects.
  • Drug therapy must be personalized for individual patients.
  • Elderly and children require lower doses to compensate for physiological differences.

FDA Pregnancy Risk Categories

  • Category A: No risk to the fetus
  • Category B: No risk in animal studies, or risk unknown in humans but acceptable in pregnant women,
  • Category C: Animal studies have revealed a risk, but adequate studies in humans haven't shown sufficient data. The benefits might be justifiable, but risk must be carefully considered.
  • Category D: Evidence of fetal risk in humans, but the potential benefits to the pregnant woman might outweigh the risks
  • Category X: Animal and human studies show adverse reactions and the risks clearly outweigh any benefits.

Additional Information

  • Drug names (chemical name, generic / brand name ,etc)
  • Adverse reactions/side effects, clinical effects
  • Drug toxicity/interactions with other drugs/foods

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