Pharmacovigilance: Timely Information Regarding Medication Safety

1. Pharmacovigilance is defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug events or any other drug-related problem.

a) True
b) False

2. An Adverse Drug Event (ADE) is an unwanted effect or harm that occurs after using a medication where the medication is suspected as the cause.

a) True
b) False

3. Adverse Drug Event statistics for inpatient stays report which of the following:

a) Adverse Drug Events account for an estimated 1 in 3 of all hospital adverse events.
b) Adverse Drug Events affect about 2 million hospital stays each year.
c) Adverse Drug Events prolong hospital stays by 1.7 to 4.6 days.
d) All of the above.

4. In annual outpatient settings, Advanced Drug Events are associated with which of the following:

a) Over 3.5 Million physician office visits.
b) An estimated 1 million emergency department visits.
c) Approximately 125,000 hospital admissions.
d) All of the above.

5. An Adverse Drug Event (ADE) can result from a medication error but often occur with appropriate medication use.

a) True
b) False

6. There are 3 options for submitting an Adverse Drug Event: submit via online form (https://www.accessdata.fda.gov/scripts/medwatch/), download the FDA 3500 form, complete and mail/fax to MedWatch or document the patient’s medical record using the RPMA HER adverse event template-print and mail/fax to MedWatch.

a) True
b) False

7. There are 2 options to submit an adverse vaccine event to VAERS: using the online report or uploading and submitting a PDF form (this option enables you to begin the report, save it, and finish it at a later time.)

a) True
b) False