Pharmacovigilance and Clinical Trials Overview
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Questions and Answers

What is the primary purpose of triage in emergency care?

  • To gather patient records
  • To determine the severity of a patient's condition (correct)
  • To administer immediate medication
  • To obtain consent for treatment
  • Which level of triage indicates the need for immediate life-saving intervention?

  • Level 5
  • Level 3
  • Level 2
  • Level 1 (correct)
  • What should be done first when commencing CPR on a person in cardiac arrest?

  • Call for emergency assistance
  • Administer rescue breaths
  • Ensure no further danger for the rescuer (correct)
  • Check the carotid pulse
  • Why is the registration process important in emergency care?

    <p>To gather information for patient records and obtain consent</p> Signup and view all the answers

    What does an AED do?

    <p>It supplies electrical impulses to maintain heart rhythm</p> Signup and view all the answers

    What is the function of discharge instructions given to patients?

    <p>To provide detailed home-care guidelines</p> Signup and view all the answers

    During which step in the emergency care protocol are patients evaluated for admission or discharge?

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

    Which of the following is NOT involved in the initial assessment before CPR?

    <p>Administer medication immediately</p> Signup and view all the answers

    What does code blue signify in a hospital setting?

    <p>A medical emergency</p> Signup and view all the answers

    What is the primary focus of pharmacovigilance?

    <p>To detect, assess, and prevent adverse effects of pharmaceuticals</p> Signup and view all the answers

    Which of the following is classified as a risk factor for coronary artery disease that cannot be modified?

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

    Which phase of clinical trials primarily assesses initial safety and dosage?

    <p>Phase 01</p> Signup and view all the answers

    What is tachycardia characterized by?

    <p>A heart rate faster than normal (over 100 bpm)</p> Signup and view all the answers

    What is the main role of an emergency pharmacist?

    <p>To participate in resuscitation efforts and provide medication selection consultations</p> Signup and view all the answers

    In which clinical trial phase are hundreds of participants involved to evaluate effectiveness and side effects?

    <p>Phase 02</p> Signup and view all the answers

    Which diagnostic method is NOT commonly used for diagnosing ischemic heart disease (IHD)?

    <p>Blood pressure monitoring</p> Signup and view all the answers

    What is the main cause of unstable angina?

    <p>Thrombosis formation</p> Signup and view all the answers

    Which of the following is NOT an issue addressed by pharmacovigilance?

    <p>Long-term effectiveness of drugs</p> Signup and view all the answers

    What is the primary activity during Phase 03 of clinical trials?

    <p>Comparing the experimental drug to standard treatment</p> Signup and view all the answers

    What generally describes the pathophysiology of ischemic heart disease?

    <p>Exact mechanisms are unknown but often linked to hypercholesterolemia.</p> Signup and view all the answers

    Which symptom is NOT commonly associated with coronary artery disease?

    <p>Severe headache</p> Signup and view all the answers

    Which condition is NOT typically treated under the specialty of emergency pharmacy?

    <p>Chronic migraine</p> Signup and view all the answers

    Which healthcare professionals are typically included in a code blue response team?

    <p>Doctors, nurses, respiratory therapist, and pharmacist</p> Signup and view all the answers

    During which phase of clinical trials is long-term use of the drug evaluated post-approval?

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

    Study Notes

    Pharmacovigilance

    • Pharmacovigilance is the science of detecting, assessing, and preventing adverse effects of pharmaceutical products.
    • Scope includes: adverse drug reactions (ADRs), reporting and surveillance of products post-marketing, and legislation.
    • Key issues include medication errors, substandard medication, lack of efficiency reports, inappropriate use of medicine, acute and chronic poisonings, drug-related diseases, misuse/abuse of medication, and drug interactions with other medicines or food.

    Clinical Trials

    • Clinical trials are research studies testing new medical approaches in people.
    • Phases of trials:
      • Phase 01: Assesses initial safety and dosage.
      • Phase 02: Evaluates effectiveness and side effects.
      • Phase 03: Confirms efficiency compared to a standard treatment.
      • Phase 04: Allows for long-term use approval.
      • Phase 01 participants typically fewer than 100 and may be healthy or diseased; this phase is about pharmacokinetics.

    Emergency Pharmacy

    • Emergency pharmacy is a medical specialty focused on emergency treatment.
    • Responsibilities include participating in resuscitation efforts, providing evidence-based medication selection, consulting on dosage, providing drug information, monitoring patients, and monitoring for adverse drug reactions.

    Types of Emergency Treatment

    • First aid: Basic skills taught to the public.
    • Basic Life Support (BLS): Provided by emergency care assistants.
    • Intermediate Life Support (ILS): A BLS provider with expanded skills.
    • Advanced Life Support (ALS): Extensive skills like IV therapy.
    • Critical Care Transport (CCT): Often involves transporting patients in critical condition.

    Emergency Care Protocols

    • Triage: Determines severity of patient's condition, using a Level 1-5 scale (Level 1 = immediate life-saving).
    • Registration: Collects patient information for records and consent.
    • Treatment: Provides comfortable and informed care.
    • Re-evaluation: By physician or mid-level practitioner to determine hospital admission or home treatment.
    • Discharge: Patients receive written home-care instructions following discharge.

    Cardiopulmonary Resuscitation (CPR)

    • CPR is used when a person suffers cardiac arrest and breathing stops.
    • Before commencing CPR:
      • Check for rescuer safety.
      • Check for response and movement in patient.
      • Call for emergency.
      • Obtain an Automated External Defibrillator (AED) if available and possible.
      • Check carotid pulse.
    • Hospitals use codes like "code blue" for medical emergencies.
    • Code blue teams include doctors, nurses, respiratory therapists and pharmacists.

    Ischemia Heart Disease (IHD)

    • IHD is a condition where blood supply is reduced to organs, particularly the heart muscles.
    • Causes: atherosclerosis, fatty acid deposition, blood clots.
    • Signs and Symptoms: chest discomfort, pain, stiffness, tightness, heaviness, shortness of breath, irregular heartbeat (dyshythmias).
    • IHD can cause tachycardia (the heart beats faster than normal). The opposite, a slower than normal heart rate is called bradycardia.
    • Common types of IHD are Coronary Heart Disease (CHD) and Coronary Artery Disease (CAD).

    IHD Diagnostic Methods

    • Electrocardiogram (ECG), Echocardiogram (ECHO).
    • Computerized tomography (CT) scanning, Magnetic resonance imaging (MRI), and angiography.

    IHD Risk Factors

    • Modifiable: High cholesterol, obesity, lack of estrogen in females, low physical activity, lack of exercise.
    • Nonmodifiable: age, gender, race, hereditary factors.

    IHD Management

    • Principles of management are to prevent risk factors and diseases, and sympathetic treatment.
    • Treatments include: medications like aspirin, clopidogrel, beta-blockers, nitrates, lipid-lowering drugs, ACE inhibitors.

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    Related Documents

    Emergency Pharmacy PDF

    Description

    This quiz explores the essential aspects of pharmacovigilance and the phases of clinical trials. It covers the detection and prevention of adverse drug reactions as well as the safety and efficacy assessments in drug testing. Test your knowledge on these critical components of pharmaceutical care and research.

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