BCCCP – Comprehensive Study Guide and Exam Preparation
Material
FDA-reportable ADE - correct 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) - correct 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) - correct 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) - correct 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 - correct 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 - correct 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 - correct answer ✔✔ 1. SOAP (subjective, objective, assessment, plan)
2. TITRS (title, introduction, text, recommendation, signature)
3. FARM (findings, assessment, resolution, and monitoring)
The Naranjo Nomogram for Causality - correct answer ✔✔ ADE nomograms such as the Naranjo
nomogram are designed to evaluate ADEs, not drug-drug
, interactions; therefore, they should not be used to evaluate drug-drug interaction cases.
Drug Interaction Probability Scale (DIPS) - correct answer ✔✔ A series of 10 questions related to
the drug interaction are assessed with yes, no, unknown, or not available answers and then
scored
and tabulated. The total score determines the probability of the drug-drug interaction occurring
in the
patient and is scaled
Critical care pharmacist
Fundamental services - correct answer ✔✔ i. Distributive
ii. Order entry/verification duties
iii. Policy change - Tech-check-tech
Critical care pharmacist
Desirable services - correct answer ✔✔ i. Clinical
(a) Provide formal nutrition consultation.
(b) Respond to resuscitation events.
Practice Administration and Development: Protocol Development and Quality Assurance
ACCP Updates in Therapeutics® 2015: Critical Care Pharmacy Preparatory Review Course
2-201
ii. Educational
(a) Provide didactic lectures to health care professionals, students, residents, and fellows in
critical care pharmacology and therapeutics.
(b) Train pharmacy residents, students, and fellows through experiential critical care
rotations.
iii. Administrative
Material
FDA-reportable ADE - correct 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) - correct 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) - correct 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) - correct 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 - correct 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 - correct 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 - correct answer ✔✔ 1. SOAP (subjective, objective, assessment, plan)
2. TITRS (title, introduction, text, recommendation, signature)
3. FARM (findings, assessment, resolution, and monitoring)
The Naranjo Nomogram for Causality - correct answer ✔✔ ADE nomograms such as the Naranjo
nomogram are designed to evaluate ADEs, not drug-drug
, interactions; therefore, they should not be used to evaluate drug-drug interaction cases.
Drug Interaction Probability Scale (DIPS) - correct answer ✔✔ A series of 10 questions related to
the drug interaction are assessed with yes, no, unknown, or not available answers and then
scored
and tabulated. The total score determines the probability of the drug-drug interaction occurring
in the
patient and is scaled
Critical care pharmacist
Fundamental services - correct answer ✔✔ i. Distributive
ii. Order entry/verification duties
iii. Policy change - Tech-check-tech
Critical care pharmacist
Desirable services - correct answer ✔✔ i. Clinical
(a) Provide formal nutrition consultation.
(b) Respond to resuscitation events.
Practice Administration and Development: Protocol Development and Quality Assurance
ACCP Updates in Therapeutics® 2015: Critical Care Pharmacy Preparatory Review Course
2-201
ii. Educational
(a) Provide didactic lectures to health care professionals, students, residents, and fellows in
critical care pharmacology and therapeutics.
(b) Train pharmacy residents, students, and fellows through experiential critical care
rotations.
iii. Administrative
