BCCCP EXAM 2024
GRADED A+
BCCCP
SEPTEMBER 23, 2024
EVATEE
,BCCCP EXAM 2024 GRADED A+
FDA-reportable ADE Answer - For reporting an ADE to the FDA, the FDA
defines ADEs as serious adverse events related to drugs
or devices in which "the patient outcome is death, life threatening (real risk of
dying), hospitalization
(initial or prolonged), disability (significant, persistent, or permanent),
congenital anomaly, or required
intervention to prevent permanent impairment or damage. Reportable serious
ADEs to the FDA may
include:
a. Phenytoin-induced toxic epidermal necrolysis
b. Linezolid-induced thrombocytopenia with genitourinary hemorrhage
c. Clopidogrel-induced thrombotic thrombocytic purpura with seizures and
hepatic failure and the
use of plasmapheresis
d. Rivaroxaban-induced intracranial hemorrhage
e. Olanzapine-induced torsades de pointes
f. Gentamicin-induced irreversible auditory ototoxicity
g. Acetaminophen-induced hepatotoxicity
Mild ADE (definition) Answer - Results in heightened need of patient
monitoring with or without a change in vital signs, but no
ultimate patient harm, or any adverse event that results in the need for
increased laboratory monitoring
, Moderate ADE (definition) Answer - Results in the need for aggressive
intervention with antidotes and/or increased length of
hospital stay (e.g., severe hypotension (e.g., BP < 90/50 mm Hg), bleeding
necessitating transfusions)
Severe ADE (definition) Answer - Results in harm to the patient, prolonged
hospitalization, transfer to a higher level of care,
permanent organ damage (e.g., irreversible hepatotoxicity or renal failure), or
death with probable ADE
causality nomogram score
ADE definition Answer - An ADE is an injury resulting from the use of a drug,
which includes harm caused by the drug (ADRs
and overdoses) and harm from the use of the drug, including dose reductions
and discontinuations of
drug therapy.
ADR definition Answer - any response to a drug that is noxious and
unintended, and that
occurs at doses used in humans for prophylaxis, diagnosis, or therapy,
excluding failure to accomplish
the intended purpose
Documentation formats Answer - 1. SOAP (subjective, objective, assessment,
plan)
2. TITRS (title, introduction, text, recommendation, signature)
3. FARM (findings, assessment, resolution, and monitoring)
GRADED A+
BCCCP
SEPTEMBER 23, 2024
EVATEE
,BCCCP EXAM 2024 GRADED A+
FDA-reportable ADE Answer - For reporting an ADE to the FDA, the FDA
defines ADEs as serious adverse events related to drugs
or devices in which "the patient outcome is death, life threatening (real risk of
dying), hospitalization
(initial or prolonged), disability (significant, persistent, or permanent),
congenital anomaly, or required
intervention to prevent permanent impairment or damage. Reportable serious
ADEs to the FDA may
include:
a. Phenytoin-induced toxic epidermal necrolysis
b. Linezolid-induced thrombocytopenia with genitourinary hemorrhage
c. Clopidogrel-induced thrombotic thrombocytic purpura with seizures and
hepatic failure and the
use of plasmapheresis
d. Rivaroxaban-induced intracranial hemorrhage
e. Olanzapine-induced torsades de pointes
f. Gentamicin-induced irreversible auditory ototoxicity
g. Acetaminophen-induced hepatotoxicity
Mild ADE (definition) Answer - Results in heightened need of patient
monitoring with or without a change in vital signs, but no
ultimate patient harm, or any adverse event that results in the need for
increased laboratory monitoring
, Moderate ADE (definition) Answer - Results in the need for aggressive
intervention with antidotes and/or increased length of
hospital stay (e.g., severe hypotension (e.g., BP < 90/50 mm Hg), bleeding
necessitating transfusions)
Severe ADE (definition) Answer - Results in harm to the patient, prolonged
hospitalization, transfer to a higher level of care,
permanent organ damage (e.g., irreversible hepatotoxicity or renal failure), or
death with probable ADE
causality nomogram score
ADE definition Answer - An ADE is an injury resulting from the use of a drug,
which includes harm caused by the drug (ADRs
and overdoses) and harm from the use of the drug, including dose reductions
and discontinuations of
drug therapy.
ADR definition Answer - any response to a drug that is noxious and
unintended, and that
occurs at doses used in humans for prophylaxis, diagnosis, or therapy,
excluding failure to accomplish
the intended purpose
Documentation formats Answer - 1. SOAP (subjective, objective, assessment,
plan)
2. TITRS (title, introduction, text, recommendation, signature)
3. FARM (findings, assessment, resolution, and monitoring)
