Adverse events Flashcards
(61 cards)
What is an adverse event?
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
True or False: All adverse events are caused by the medication.
False
Fill in the blank: An adverse event can occur during ________ of a medical intervention.
any phase
What is the difference between an adverse event and a serious adverse event?
A serious adverse event results in death, a life-threatening condition, hospitalization, disability, or significant medical intervention.
Multiple Choice: Which of the following is NOT considered an adverse event? A) Rash B) Nausea C) Improved health D) Headache
C) Improved health
What does the acronym SAE stand for?
Serious Adverse Event
True or False: Adverse events can be reported by healthcare professionals only.
False
Fill in the blank: Adverse events should be reported to ________ for further investigation.
regulatory authorities
What is the purpose of monitoring adverse events?
To ensure patient safety and assess the risk-benefit profile of a medical product.
Multiple Choice: Which of the following is a common method for reporting adverse events? A) Direct observation B) Patient interviews C) Online databases D) All of the above
D) All of the above
What is the role of pharmacovigilance?
To detect, assess, understand, and prevent adverse effects or any other drug-related problems.
True or False: Adverse events can only occur during clinical trials.
False
Fill in the blank: The ________ is responsible for regulating the safety of medical products in the United States.
FDA (Food and Drug Administration)
What is a common challenge in identifying adverse events?
Attribution of the event to the medical product versus other factors.
Multiple Choice: Which of the following factors can influence the reporting of adverse events? A) Patient demographics B) Severity of the event C) Healthcare provider’s awareness D) All of the above
D) All of the above
What does the term ‘causality assessment’ refer to?
The process of determining whether a reported adverse event was caused by a medical product.
True or False: Only prescription medications can have adverse events.
False
Fill in the blank: The ________ system is a tool used for reporting and monitoring adverse events.
MedWatch
What is the significance of a risk management plan?
To outline strategies to minimize the risks associated with a medical product.
Multiple Choice: Which of the following is a potential outcome of an adverse event? A) Withdrawal of the product B) Label changes C) Increased monitoring D) All of the above
D) All of the above
What is the importance of patient education regarding adverse events?
To empower patients to recognize and report any adverse events they experience.
True or False: Adverse events can have long-term implications for public health.
True
Fill in the blank: An adverse event report may include information about the patient’s ________ and any concomitant medications.
medical history
What is the purpose of a post-marketing surveillance study?
To monitor the safety of a medical product after it has been approved for use.
