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?

Monitor serum potassium levels Signup and view all the answers

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

Observe for visual changes Signup and view all the answers

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

Activated charcoal or stomach pumping Signup and view all the answers

What is a common assessment for hyperglycemia?

Increased thirst Signup and view all the answers

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

Check serum potassium levels Signup and view all the answers

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

The minimum effect of antibiotics needed to suppress a microorganism Signup and view all the answers

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

Intravenous Signup and view all the answers

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

5-10 days Signup and view all the answers

What is a disadvantage of combination drug therapy?

It can lead to increased drug interactions. Signup and view all the answers

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

Tuberculosis Signup and view all the answers

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

Late treatment initiation Signup and view all the answers

What is a characteristic of mono drug therapy?

It is typically better tolerated by patients. Signup and view all the answers

What type of organisms do antivirals target?

Viruses Signup and view all the answers

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

Heparin Signup and view all the answers

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

It is assigned by the USAN Council. 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?

Category D Signup and view all the answers

Why must drug therapy be tailored to individual patients?

To ensure maximum benefits while minimizing potential harm. Signup and view all the answers

What is true about the side effects of medications?

Every medication can cause side effects in different individuals. Signup and view all the answers

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

They start with a Capital letter and are designed to be memorable. Signup and view all the answers

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

They can cause harm due to their narrow therapeutic index. Signup and view all the answers

What does Category C in FDA Pregnancy Risk Category indicate?

Risk shown in animal studies but not confirmed in humans. Signup and view all the answers

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

To monitor analgesia, activity, adverse effects, and aberrant behavior Signup and view all the answers

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

Immediately stop all ineffective pain relief measures Signup and view all the answers

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

Transcutaneous electric nerve stimulation (TENS) 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?

Align pain relief measures with the reported pain severity Signup and view all the answers

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

Cutaneous stimulation Signup and view all the answers

What is a common adverse effect associated with stimulant medications?

Chest pain Signup and view all the answers

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

Nonrigid bracing can improve function without causing muscle dysfunction Signup and view all the answers

What nursing consideration is essential when administering theophylline?

Monitor plasma levels regularly Signup and view all the answers

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

Ensuring the patient understands the risks and benefits of treatment Signup and view all the answers

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

Massage therapy Signup and view all the answers

Which of the following is NOT a feature of Ipratropium?

Can be used as an emergency rescue drug Signup and view all the answers

What condition prevents the use of Ipratropium?

Glaucoma Signup and view all the answers

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

Step 2: Mild persistent Signup and view all the answers

What is the primary benefit of using bronchodilators like theophylline?

Enhancing bronchodilation Signup and view all the answers

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

Inhaled glucocorticoids Signup and view all the answers

Which of the following statements about stimulants is true?

High doses can lead to tachycardia. Signup and view all the answers

What must be monitored when administering penicillin?

PT, INR, and platelet counts Signup and view all the answers

Which of the following should be avoided when taking fluoroquinolones?

Dairy products Signup and view all the answers

What are the potential mild CNS symptoms associated with fluoroquinolones?

Dizziness and headache Signup and view all the answers

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

Vastus lateralis Signup and view all the answers

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

Achilles tendon rupture Signup and view all the answers

Why is it important to rotate IM injection sites?

To minimize pain and thrombophlebitis Signup and view all the answers

Which medications can potentially interact with ciprofloxacin?

Iron salts and antacids Signup and view all the answers

What must be checked prior to administering fluoroquinolones?

Renal dysfunction Signup and view all the answers

How should vancomycin be infused to minimize discomfort?

Over 60 minutes Signup and view all the answers

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

Diarrhea Signup and view all the answers

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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Description

This quiz explores the drug approval process, including the stages of clinical trials and the criteria for FDA approval. It also examines the classification of controlled substances as per DEA schedules, highlighting their potential for abuse and medical use. Test your knowledge on these vital topics in pharmaceutical regulations.