AE/Reporting Quiz

Product complaints are alleged deficiencies in the product or device dispensed to a patient. These deficiencies can be related to _______. Select ALL that apply

• Shipment, delivery, or carrier issues

• Physical/Chemical properties (ex. discolored tablets)

• Device malfunction

• Packaging/Label integrity

You are speaking to a patient, and they advise the medication in their Remodulin vial looks cloudy. What type of event is being described?

• Adverse Event

• Compliance Concern

• Product Complaint

• Patient Compliant

Which of these roles or departments is responsible for reporting an Adverse Event first, once we are made aware?

• CQSN

• Customer Service Representative

• Pharmacist

• The first employee to become aware of the event

Pick from the options below the best definition for an adverse event

• Anything a patient experiences that is out of the ordinary

• Any life-threatening event reported, such as being admitted to the hospital or a heart attack

• Notification of death from a caller

Yes or No: When transferring a caller to a clinician, the PCA who took the call is still responsible for starting the AE Assessment

• Yes, always

• No, unless you DID NOT communicate the adverse event information to the clinician upon transferring

• No

True or False: It is only necessary to submit a potential adverse event for review if the patient believes it is important enough to be reported

• True

• False

A patient calls in and states, "My medication should have arrived 3 days ago, and it's still not been delivered." Is this a product complaint?

• Yes

• No

Read the following statement: "Thanks for calling to refill my prescription, but I don't have time to talk. I’m on my way to the doctor." Is this an adverse event?

• Yes

• No

True or False: We should always stick to the patient's exact words/phrases (excluding profanity) when documenting an adverse event description.

• True

• False

In the event you are notified of a patient's death, what is the minimum information to be obtained and added in the chart notes? Select all that apply

• Date of death

• Cause of death

• Caller's full name

• Caller's relationship to the patient