Pharmacovigilance
-the science and activities relating to detecting, assessing, understanding, and preventing adverse effects or any other possible drug-related problems.
Adverse Drug Reaction
•A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function
drug-drug interactions
What accounts for most Adverse Drug Reactions?
adverse event
-any medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment
a
What type of surveillance involves diseases/events being reported by the public or healthcare providers?
a) passive surveillance
b) active surveillance
b
What type of surveillance involves reports sought out by agencies?
a) passive surveillance
b) active surveillance
b
What type of surveillance ensures the completeness of data & a targeted approach to reporting?
a) passive surveillance
b) active surveillance
c) both
3 years; events in fewer than 1/10,000 will not be detected in RCT
How long must pharmaceutical companies report ADRs for? Why?
f; a potential safety issues has been identified, but not causal relationship
If a drug has been listed on the FDA website, that means they have identified a causal relationship between the drug and the listed risk. T/F?
Title IX, Section 921 of FDA Amendments Act of 2007
This act requires the FDA to publish a new list of potential signals of serious risks/ new safety information identified each quarter.
safety signal identified, refinement, formal signal evaluation
What are the steps of the safety signal process?
safety signals
a concern about an excess of adverse events compared to what would be expected to be associated with a product's use.
spontaneous adverse event reports, secondary data, active surveillance
What are some ways to identify safety signals?
risk evaluation and mitigation strategies
What does the acronym REMS stand for?
to ensure benefit outweighs the risk for a particular medication
What is the sole focus of REMS?
d
What group of medications do not require a REMS?
a) prescription drugs
b) biologics
c) generics
d) OTC
18 months, 3 years, 7 years
Brand-name drugs REMS must include a timetable for sponsors to submit REMS assessments to the FDA at what time periods?
Sentinel
•active surveillance system that uses routine querying tools and pre-existing electronic healthcare data from multiple sources to monitor the safety of regulated medical products
how many people are taking a drug, what is being used to treat a certain condition, what is the risk associated with the drug
What kind of information does Sentinel provide?
VAERS; MedWatch
Healthcare providers are required by law to _______, while reporting to _______ is voluntary.
MedWatch
Pharmacists are vital in reporting to ________.