Terms and Definitions
Any unintended medical occurrence associated with the use of a drug in humans, whether or not considered drug related
Adverse Event
Who needs to report an AE when it is discovered?
Everyone
Circumstances where a report does not include an AE, but nevertheless needs to be reported.
Events of special interest
The pharmacist informs you the patient discontinued taking their medication due to persistent headaches. The patient likely experienced this:
Adverse Event... surprise!
A group of Support Team members who pull submitted JIRA tickets to report AEs to manufacturers.
AE Team
Any unfavorable and/or unintended sign, symptom, or disease temporarily associated with the use of a drug whether or not considered related to that drug
Adverse Event. Again!
How soon after discovering an AE should a Support Team member complete the JIRA form to report the AE?
Immediately
A defect in the packaging of a medication, broken tablets, and atypical smell of a drug (among others) are all examples of:
Product quality complaints
True or False: A Core Support Account Coordinator was not able to gather all of the information on the JIRA form when recording an AE. She should report the event anyway.
True
They are responsible for updating the Confluence page containing manufacturer requirements and preferences for AE reports.
Pharma Account Managers
The act of taking a medication in a manner or dose other than prescribed; taking someone else’s prescription, even if for a legitimate medical complaint such as pain; or taking a medication to feel euphoria.
Patient Misuse
What is the time limit in which most manufacturers require a possible AE to be reported?
24 hours
During a routine call, a Hubbler learns the patient’s strength has been increased because the lower strength was not working for the patient. The Hubbler reports this as an AE because the patient experienced:
Drug Inefficacy
You learn the patient’s therapy was stopped after their last injection due to a rash at the injection site.
A condition in which the immune system reacts abnormally to a foreign substance is known as:
Allergic reaction
True or false:
An over-weight patient has reported to her doctor that she believes that her diabetes medication has helped her to lose some extra weight. She is happy about this, and the prescriber will not be taking the patient off the therapy. This side effect does not need to be reported because it is not negative.
False
The use of a pharmaceutical product for an unapproved indication or in an unapproved age group, dosage, or route of administration
Off-label use
After learning of a potential AE, Support Team members complete this to report the AE
JIRA Form
Patient admittance to the hospital or hospice should be reported as an AE; however, admittance to these two types of facilities is not considered an AE:
LTC Facility or Nursing Home
A commonly missed AE in which an expectant mother continues taking a medication she was on pre-pregnancy or starts a new medication while pregnant would be considered:
Exposure during pregnancy
All of these are considered AEs with the exception of:
Nausea, weight gain, anxiety, rash, constipation, previously known allergy, chills, perspiration, pregnancy, and death
Previously known allergy
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JIRA
When reporting an AE, it’s important to remember the acronym P.R.E.P. which stands for:
Patient
Reporter
Event
Product
An AE does NOT need to be reported when a medication’s dosage is increased as a standard therapy track. This increase in dosage is known as medication:
Titration
A medical assistant tells you the patient continued taking the medication after she started breastfeeding. What is this an example of?
Postnatal exposure
In an event where it’s unclear if a potential AE occurred as a direct result of the patient taking their medication (ex: patient death), it’s important to ask about this:
Causation