Hosam Mohamed-
Pharmacovigilance
-the science and activities relating to detecting, assessing, understanding, and preventing adverse effects or any other possible drug-related problems.
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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
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drug-drug interactions
What accounts for most Adverse Drug Reactions?
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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
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a
What type of surveillance involves diseases/events being reported by the public or healthcare providers?
a) passive surveillance
b) active surveillance
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b
What type of surveillance involves reports sought out by agencies?
a) passive surveillance
b) active surveillance
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b
What type of surveillance ensures the completeness of data & a targeted approach to reporting?
a) passive surveillance
b) active surveillance
c) both
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3 years; events in fewer than 1/10,000 will not be detected in RCT
How long must pharmaceutical companies report ADRs for? Why?
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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?
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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.
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safety signal identified, refinement, formal signal evaluation
What are the steps of the safety signal process?
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safety signals
a concern about an excess of adverse events compared to what would be expected to be associated with a product's use.
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spontaneous adverse event reports, secondary data, active surveillance
What are some ways to identify safety signals?
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risk evaluation and mitigation strategies
What does the acronym REMS stand for?
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to ensure benefit outweighs the risk for a particular medication
What is the sole focus of REMS?
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d
What group of medications do not require a REMS?
a) prescription drugs
b) biologics
c) generics
d) OTC
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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?
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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
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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?
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VAERS; MedWatch
Healthcare providers are required by law to _______, while reporting to _______ is voluntary.
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MedWatch
Pharmacists are vital in reporting to ________.
