Podcast
Questions and Answers
What is the primary focus of pharmacovigilance?
What is the primary focus of pharmacovigilance?
Which phase of clinical trials involves the assessment of effectiveness and side effects?
Which phase of clinical trials involves the assessment of effectiveness and side effects?
What is a significant issue associated with pharmacovigilance?
What is a significant issue associated with pharmacovigilance?
In which phase of clinical trials are thousands of participants typically involved?
In which phase of clinical trials are thousands of participants typically involved?
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What is a key responsibility of pharmacists in emergency pharmacy?
What is a key responsibility of pharmacists in emergency pharmacy?
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What type of study is conducted in Phase 01 of clinical trials?
What type of study is conducted in Phase 01 of clinical trials?
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What does a post-marketing surveillance program aim to address?
What does a post-marketing surveillance program aim to address?
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In which clinical trial phase is the drug assessed for long-term use after approval?
In which clinical trial phase is the drug assessed for long-term use after approval?
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What does a code blue signify in a hospital setting?
What does a code blue signify in a hospital setting?
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Which of the following is NOT a typical sign or symptom of coronary artery disease?
Which of the following is NOT a typical sign or symptom of coronary artery disease?
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What is the primary role of a respiratory therapist in a code blue situation?
What is the primary role of a respiratory therapist in a code blue situation?
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Which of the following is a modified risk factor for coronary artery disease?
Which of the following is a modified risk factor for coronary artery disease?
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Stable angina is typically characterized by which condition?
Stable angina is typically characterized by which condition?
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What diagnostic method uses high-frequency sound waves to create images of the heart?
What diagnostic method uses high-frequency sound waves to create images of the heart?
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What effect does low-density lipoprotein (LDL) have on endothelial cells?
What effect does low-density lipoprotein (LDL) have on endothelial cells?
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Which symptom is primarily associated with unstable angina?
Which symptom is primarily associated with unstable angina?
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What is the primary purpose of the triage process in emergency care?
What is the primary purpose of the triage process in emergency care?
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During the registration process in emergency care, what two things does staff aim to accomplish?
During the registration process in emergency care, what two things does staff aim to accomplish?
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What are the correct steps to follow before commencing CPR?
What are the correct steps to follow before commencing CPR?
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Which of the following is NOT a level in the triage scale?
Which of the following is NOT a level in the triage scale?
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What should be included in the home-care instructions given to discharged patients?
What should be included in the home-care instructions given to discharged patients?
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Which of the following correctly describes the function of an AED?
Which of the following correctly describes the function of an AED?
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What action should be taken if a pulse is not found during the initial assessment of a patient?
What action should be taken if a pulse is not found during the initial assessment of a patient?
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What is the first step in emergency care protocols?
What is the first step in emergency care protocols?
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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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Description
Explore the essential concepts of pharmacovigilance and clinical trials in this quiz. Focus on the detection, assessment, and prevention of adverse drug reactions (ADRs) as well as the phases of clinical trials from initial safety testing to long-term monitoring. Test your knowledge on key issues and processes involved in drug safety and efficacy.
