Pharmacovigilance and Clinical Trials Overview

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Questions and Answers

What is the primary focus of pharmacovigilance?

  • Studying the marketing strategies of pharmaceuticals
  • Detecting, assessing, and preventing adverse effects of pharmaceutical products (correct)
  • Evaluating the financial success of pharmaceutical companies
  • Testing the market demand for new drugs

Which phase of clinical trials involves the assessment of effectiveness and side effects?

  • Phase 04
  • Phase 03
  • Phase 02 (correct)
  • Phase 01

What is a significant issue associated with pharmacovigilance?

  • Improper dosage regulations
  • High patient satisfaction rates
  • Increase in drug marketing expenditures
  • Lack of efficiency in ADR reporting (correct)

In which phase of clinical trials are thousands of participants typically involved?

<p>Phase 03 (A)</p> Signup and view all the answers

What is a key responsibility of pharmacists in emergency pharmacy?

<p>Participating in resuscitation efforts (D)</p> Signup and view all the answers

What type of study is conducted in Phase 01 of clinical trials?

<p>Pharmacokinetic study on drug interactions (C)</p> Signup and view all the answers

What does a post-marketing surveillance program aim to address?

<p>Long-term effectiveness and adverse effects of medications (C)</p> Signup and view all the answers

In which clinical trial phase is the drug assessed for long-term use after approval?

<p>Phase 04 (D)</p> Signup and view all the answers

What does a code blue signify in a hospital setting?

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

Which of the following is NOT a typical sign or symptom of coronary artery disease?

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

What is the primary role of a respiratory therapist in a code blue situation?

<p>Provide respiratory support (A)</p> Signup and view all the answers

Which of the following is a modified risk factor for coronary artery disease?

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

Stable angina is typically characterized by which condition?

<p>Plaque formation exceeding 50% artery diameter (D)</p> Signup and view all the answers

What diagnostic method uses high-frequency sound waves to create images of the heart?

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

What effect does low-density lipoprotein (LDL) have on endothelial cells?

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

Which symptom is primarily associated with unstable angina?

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

What is the primary purpose of the triage process in emergency care?

<p>To determine the severity of a patient's condition (B)</p> Signup and view all the answers

During the registration process in emergency care, what two things does staff aim to accomplish?

<p>Gather information for patient records and obtain consent for treatment (D)</p> Signup and view all the answers

What are the correct steps to follow before commencing CPR?

<p>Ensure scene safety, check for patient response, call for help, check pulse (A)</p> Signup and view all the answers

Which of the following is NOT a level in the triage scale?

<p>Level 3 - Critical (B)</p> Signup and view all the answers

What should be included in the home-care instructions given to discharged patients?

<p>Guidelines that ensure their condition is managed post-discharge (C)</p> Signup and view all the answers

Which of the following correctly describes the function of an AED?

<p>To supply electrical impulses to diagnose and maintain heart rhythm (B)</p> Signup and view all the answers

What action should be taken if a pulse is not found during the initial assessment of a patient?

<p>Commence CPR right away (B)</p> Signup and view all the answers

What is the first step in emergency care protocols?

<p>Triage of the patient (D)</p> Signup and view all the answers

Flashcards

Pharmacovigilance Scope

Detecting, assessing, and preventing adverse effects of medications.

Clinical Trial Phase 01

Initial safety and dosage testing (fewer than 100 participants).

Clinical Trial Phase 02

Effectiveness and side effects evaluation (hundreds participants).

Clinical Trial Phase 03

Confirming effectiveness compared to existing treatments (thousands participants).

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Clinical Trial Phase 04

Long-term use evaluation after approval.

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Emergency Pharmacy

Pharmaceutical interventions during emergency treatment.

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Pharmacist Responsibilities (Emergency)

Involve medication selection, dosage, monitoring, and consultation.

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Adverse Drug Reactions (ADRs)

Unwanted effects of medication.

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Code Blue

A medical emergency code indicating a patient requires immediate resuscitation.

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Resuscitation Team

A group of healthcare professionals responding to a Code Blue, including doctors, nurses, respiratory therapists, and pharmacists.

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Coronary Artery Disease (CAD)

A condition where the coronary arteries narrow due to plaque buildup, reducing blood flow to the heart.

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Ischemic Heart Disease (IDH)

A broad term encompassing conditions caused by reduced blood supply to the heart, often due to CAD.

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Angina

Chest pain or discomfort caused by reduced blood flow to the heart.

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Stable Angina

Chest pain that occurs predictably during exertion and resolves with rest.

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Unstable Angina

Chest pain that occurs unpredictably and is more severe, requiring immediate medical attention.

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ECG (Electrocardiogram)

A test that records the electrical activity of the heart, used to diagnose IDH and other heart problems.

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Triage

The process of sorting patients based on the severity of their condition to determine the urgency of care needed.

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Emergency Department (ED) Registration

Collecting patient information and obtaining consent for treatment in an emergency setting.

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ED Treatment Process

Providing immediate care and stabilization for patients in the emergency department, aiming to make them comfortable and informed.

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ED Reevaluation

Assessing a patient's condition after initial treatment to determine if hospitalization is necessary or if they can be discharged.

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Cardiac Arrest

A condition where the heart stops functioning, leading to cessation of blood circulation and breathing.

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CPR (Cardiopulmonary Resuscitation)

A life-saving procedure used to restore circulation and breathing in someone experiencing cardiac arrest.

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AED (Automated External Defibrillator)

A portable device used to deliver an electrical shock to the heart to restore a normal rhythm during cardiac arrest.

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Hospital Codes

Standardized communication systems within hospitals, often using colors, to convey urgent situations and allow for efficient response.

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Study Notes

Pharmacovigilance

  • The science of detecting, assessing, and preventing adverse effects of pharmaceutical products
  • Scope includes: ADRs, drug monitoring, reporting product surveillance, and post-marketing legislation

Issues

  • Medication errors
  • Substandard medication
  • Lack of efficient reporting
  • Unapproved medicine use
  • Case reports of acute and chronic poisoning
  • Studies of drug-related diseases (morbidity)
  • Abuse and misuse of medicine (irrational use)
  • ADRs of medicines with other medicines and food drug interactions

Clinical Trials

  • Research studies testing new medical approaches in people

Phases of Clinical Trials

Phase 01

  • Assaying initial safety and dose

Phase 02

  • Evaluating effectiveness and side effects

Phase 03

  • Confirming efficacy compared to a standard

Phase 04

  • Allowing long-term use after approval

Phase 01 specifics

  • Number of participants is less than 100
  • Participants may be diseased or healthy
  • Focuses on pharmacokinetic study
  • Identifies drug interactions and developing conditions

Phase 02 specifics

  • Involves hundreds of participants
  • Focuses on treatment efficacy
  • Identifies ADRs

Phase 03 specifics

  • Involves thousands of participants
  • Compares experimental treatments with standard treatments

Phase 04 specifics

  • Drug is ready for general use

Emergency Pharmacy

  • Emergency treatment as a medical specialty focusing on emergency situations
  • Pharmacist responsibilities in emergency situations:
    • Participation in resuscitation efforts
    • Providing evidence-based medication selection consultations
    • Consultations on medication dosages and adjustments
    • Providing drug information consultations to emergency medical professionals
    • Monitoring for patient allergies and drug interactions
    • Monitoring patient therapeutic responses
    • Assessing for and managing ADRs continuously
    • Collection or review of patient medication histories and reconciling medications

Types of Emergency Treatment

  • First Aid: Basic skills for the public
  • Basic Life Support (BLS): Care provided by emergency assistants on ambulances
  • Intermediate Life Support (ILS): Limited Advanced Life Support (LALS) – expanded BLS skills
  • Advanced Life Support (ALS): Expanded skill set including IV therapy, cricothyrotomy, and electrocardiogram interpretation
  • Critical Care Transport (CCT): Involves traditional healthcare professionals in intensive care units of hospitals

Emergency Care Protocols

  • Step 1 - Triage: Determining patient condition severity using a five-level scale (1-cardiopulmonary resuscitation, 2-emergency, 3-urgent, 4-semi-urgent, 5-non-urgent)
  • Step 2 - Registration: Gathering patient information for records and obtaining consent
  • Step 3 - Treatment: Ensuring patient comfort and providing appropriate information
  • Step 4 - Reevaluation: Assessing patient condition by a physician or practitioner to determine if hospitalization is necessary or if they can be discharged home
  • Step 5 - Discharge: Providing written home care instructions to discharged patients

Cardiopulmonary Resuscitation (CPR)

  • Procedures for when a person suffers cardiac arrest and breathing stops

  • Parameters before CPR commencement

    • Check for danger for rescuer
    • Check for response (waking the patient)
    • Call emergency services
    • Obtain AED (automated external defibrillator) if available
    • Check carotid pulse (5-10 seconds)
    • If no pulse, start CPR

  • Hospital Codes (e.g., code black, code red, code blue) for emergencies

Ischemia (Heart Disease)

  • Reduced blood supply in an organ or body part (especially the heart)
  • Causes: Atherosclerosis, fatty acid deposits in blood capillaries, blood clots
  • Symptoms: Chest discomfort, chest pain, chest stiffness/tightness/heaviness, dyspnea (shortness of breath), dysrhythmia (irregular heartbeat), tachycardia (rapid heartbeat), bradycardia (slow heartbeat)

Risk Factors for Ischemia (Heart Disease)

  • Modifiable: Increased cholesterol, obesity, lack of estrogen in females, lack of physical activity, lack of exercise
  • Non-Modifiable: Age, gender, race, hereditary

Diagnostic Methods for Ischemia (Heart Disease)

  • ECG, ECHO Cardiogram, CT Scanning, MRI (Magnetic resonance imaging), Angiography

Pathophysiology of Ischemia (Heart Disease)

  • Exact mechanism is unknown
  • Possible causes: hypercholesterolemia (high cholesterol), low density lipoprotein (LDL), triglycerides

Endothelial Cells

  • Lining of capillaries
  • Can be damaged by LDL
  • Plaque formation

Management of Ischemia (Heart Disease)

  • Stable Condition: Managing risk factors (e.g., dietary management, blood pressure control, smoking cessation)
  • Unstable Condition: Often requires immediate hospitalization
  • Treatments: Aspirin, Clopidogrel, beta-blockers, nitrates, lipid-lowering drugs, ACE inhibitors

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