AE/PC Identification
AE/PC Identification Quiz
Welcome to the AE/PC Identification Quiz! This quiz is designed to test your knowledge on adverse events and product complaints in the pharmaceutical industry.
By participating, you will:
- Enhance your understanding of critical safety reporting
- Learn to identify key terms and definitions
- Prepare for real-world scenarios involving patient safety and product quality
What one Adverse Event would also be considered a Product Complaint?
Drug Overdose
Handling Error
Special Reporting Situation
Lack of Effect
What is the name of certain safety information that may not meet the definition of an AE but is still subject to the same rules and timelines for reporting? (Initials only)
SRS
FAR
RSR
SRR
A patient stated that their Supprelin implant had been inserted for 12.5 months due to a scheduling conflict with their provider. This is a reportable AE.
True
False
A patient reported that his second injection of Aveed was received 3 weeks after the first injection. This is a reportable AE.
True
False
A patient called with a general inquiry regarding availability of his Lidoderm patches. During the call, the patient commented, "I had some nausea and vomiting yesterday, but I'm pretty sure it was a stomach virus." This is a reportable event.
True
False
An RN requested reimbursement for Xiaflex, because it was left unrefrigerated all night. Is this an:
AE
PC
Both AE and PC
Neither
A provider indicated dissatisfaction with the content of the product label. This fits the definition of a:
Adverse Event
Product Complaint
Labeling Complaint
SRS
FAR complaint
Which of the following is NOT a potential FAR complaint?
A patient states that his Testim gel was a different color than the last tube.
A patient reports her Lidoderm patch won't stick at all
A pharmacy reports a label is missing from a box of Xiaflex
An HCP reports that a vial of Xiaflex appears to have black particles in it.
A FAR complaint is listed as ____________ in the criticality field in the PC report.
Urgent
Immediate
Critical
Acute
A patient calls to ask about locating a place to get their prescription filled for Lidoderm, as their pharmacy states that it is on backorder. The patient states that their box is empty. Is this a reportable event?
Yes
No
Not enough information
Which of the following would NOT be reported in an SRS?
Pregnancy
Addiction
Abnormal EKG
Incorrect amount of drug administered
If a prescriber deems that off-label use of a medication is beneficial to the patient, this is not considered an adverse event.
True
False
SRS is an abbreviation for:
Special Reporting Situation
Standard Reporting Situation
Selected Reporting Situation
Special Reporting System
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