Terms and Definitions
Reporting AEs
Common Misconceptions
Events to Report
Miscellaneous
100

Any unintended medical occurrence associated with the use of a drug in humans, whether or not considered drug related

Adverse Event  

100

In an event where it’s unclear if a potential AE occurred as a direct result of the patient taking their medication, it’s important to ask about this:

Causation

200

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

200

They are responsible for updating the Confluence page containing manufacturer requirements and preferences for AE reports.

Pharma Account Managers

300

What is the time limit in which most manufacturers require a possible AE to be reported?

24 hours

300

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  

300

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

300

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

400

The use of a pharmaceutical product for an unapproved indication or in an unapproved age group, dosage, or route of administration

Off-label use  

400

After learning of a potential AE, Support Team members complete this to report the AE

JIRA Form

400

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

400

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

400

Circumstances where a report does not include an AE, but nevertheless needs to be reported.

Special Interest

500

An Atlassian product used by CMM for issue tracking, bug tracking, and project management. 

BONUS: derived from the Japanese word for Godzilla 

JIRA

500

When reporting an AE, it’s important to remember the acronym P.R.E.P. which stands for:

Patient 

Reporter 

Event 

Product 

500

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

500

A medical assistant tells you the patient continued taking the medication after she started breastfeeding. What is this an example of?

Postnatal exposure

500

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

M
e
n
u