2017-2018

PCP Exam
1. I have taken this exam on my own without the help of others.
• Yes
2. Module 1: Introduction to Clinical Pharmacology: A 65-year-old female is
hospitalized after a diagnosis of acute myocardial infarction complicated by
recurrent episodes of ventricular tachycardia while being monitored in the critical
care unit. The patient also has a history of congestive heart failure (CHF) and
physical examination revealed peripheral edema and a congested mildly tender
liver. The patients weighs 70 kg, and treatment is instituted with an initial 70 mg
dose of intravenous lidocaine infused slowly over 2 minutes. Estimated lidocaine
distribution volume (Vd) is 1.0 L/kg. Due to the diagnosis of CHF the elimination
half-life (T1/2) is estimated at 4 hours (approximately twice normal). What
maintenance infusion rate will provide a steady-state plasma lidocaine level of 5
micrograms/mL in this patient?
• 1.0 mg/min
• 2.5 mg/min
• 5.0 mg/min
• 10.0 mg/min
3. Module 1: Introduction to Clinical Pharmacology: Some clinical situations
require administration of a loading (initial) dose of a drug to establish a therapeutic
plasma concentration without delay. This may be done giving a large initial dose
orally but the intravenous (IV) route of administration is often required. Which of
the following is a determinant of the initial plasma concentration of a drug given by
rapid IV infusion (bolus dose)?
• The first-order distribution rate constant
• The elimination clearance rate
• The central compartment volume of distribution
• The intercompartmental clearance rate
4. Module 1: Introduction to Clinical Pharmacology: The antiepileptic
(anticonvulsant) drug phenytoin exhibits apparent first-order kinetics of
elimination when given at small doses that result in low plasma concentrations at
steady-state but its elimination proceeds at zero-order rate when high doses that
result in high plasma concentrations are given (loss of dose proportionality), with
resulting drug toxicity. Which of the following best explains this phenomenon in the
case of phenytoin?
• The high oral bioavailability of phenytoin
• The high degree of plasma protein binding of phenytoin
• The low Km (Michaelis-Menten constant) for phenytoin metabolism
• The low renal clearance rate for phenytoin
5. Module 1: Introduction to Clinical Pharmacology: A drug that competes with
an agonist for the same or overlapping site on the receptor is known as a
• Noncompetitive antagonist
• Competitive antagonist
• Functional antagonist
6. Module 1: Introduction to Clinical Pharmacology: Which of the following is
the most accurate definition of a side effect?
• An adverse effect secondary to the one intended
• A therapeutic effect secondary to the one intended
• An effect, whether therapeutic or adverse, that is secondary to the one
intended
• None of the above
7. Module 1: Introduction to Clinical Pharmacology: On an Rx, Sig reads: ½ tab
PO QAM. The tablet is not scored. Does ½ tablet contain ½ of the total amount of
drug in the original tablet?
• Yes
• No
• Cannot be sure
8. Module 1: Introduction to Clinical Pharmacology: A 40 pound, 3 year old, girl
has a strep pharyngitis. You are prescribing amoxicillin instead of penicillin because
it is acid stable and does not need to be taken on any empty stomach. The dose is 40
mg/kg/d given three times a day x 10 days. You write for:
• Rx Amoxicillin 250 mg caps #30. Sig: i PO TID x 10d. NR.
• Rx Amoxicillin 500 mg caps #30. Sig: i PO TID x 10d. NR.
• Rx Amoxicillin 250mg/5ml susp #200ml. Sig: i tsp PO TID x 10d. NR.
• Rx Amoxicillin 250mg/5ml susp # 200ml. Sig: 5 ml PO q8h x 10d. NR
9. Module 1: Introduction to Clinical Pharmacology: True or False: A drug is
cleared by a zero-order process. Therefore, the AUC of the drug will double if the
dose is doubled.
• True
• False
10. Module 1: Introduction to Clinical Pharmacology: The trough concentration
for an aminoglycoside from your patient is much higher than the target trough
concentration. After holding the next dose, you should:
• Decrease the dose
• Increase the dosage interval
11. Module 1: Introduction to Clinical Pharmacology: Pharmacogenomics can
explain, and prevent, deaths from
• Reduced TPMT activity in patients receiving 6-MP
• Increased TPMT activity in patients receiving 6-MP
• Increased CYP 2D6 activity in patients receiving codeine
• Reduced CYP 2D6 activity in patients receiving codeine
• B and C
• A and C
12. Module 2: Pharmacokinetics: A patient presents with Chronic Myelogenous
Leukemia (CML) and treatment is planned with imatinib. The medical history
suggests your patient used to be morbidly obese. She has undergone a gastric
bypass a year ago, and currently has a normal BMI. Which of the following is
correct?
• If you could get a blood sample analyzed, you could confirm whether
systemic exposure is similar to published values.
• Because she has a normal size now, the normal dose of imatinib can be
used.
• You have no idea what the effect of her specific surgical procedures is on the
absorption of imatinib.
• Like most drugs, imatinib gets absorbed from the intestine, so a “gastric”
bypass is not relevant for the absorption of imatinib.
• A and C
13. Module 2: Pharmacokinetics: A patient is taking an oral tyrosine kinase
inhibitor for cancer treatment. He is also slightly depressed and is telling you about
this herbal remedy, St. John’s Wort, he found on an internet forum. Which of the
following is correct?
• Anything from nature is good and harmless
• St. John’s Wort can block metabolism of the cancer treatment and increase
exposure, causing toxicity.
• St. John’s Wort can increase metabolism of the cancer treatment and
decrease exposure, causing loss of activity.
• The patient could take his drug with grapefruit juice to counter the effect of
the St. John’s Wort.
• The patient should stop taking the tyrosine kinase inhibitor.
14. Module 2: Pharmacokinetics: True or False: Positron emission tomography
(PET) studies involve the injection of a radioactively labeled drug that emits a
particle called a positron.
• True
• False
15. Module 2: Pharmacokinetics: True or False: Compartmental modeling of PET
data typically uses measurements over time of 1) PET images of the target tissue
and 2) concentrations of unchanged parent radioligand in plasma.
• True
• False
16. Module 2: Pharmacokinetics: Which of the following compounds is matched
incorrectly with its apparent volume of distribution?
• Albumin - plasma volume
• Inulin – extracellular fluid space
• Ethyl alcohol – total body water
• Caffeine - total body water
• Urea – total body water
17. Module 2: Pharmacokinetics: During the third trimester of pregnancy, the
percent protein binding of theophylline has been shown to be 13%. Typical fluid
volumes for such patients are 21 L for extracellular fluid space and 40 L for total
body water. Based on this data, what would be the expected distribution volume of
theophylline?
• 24 L
• 28 L
• 32 L
• 38 L
• 45
18. Module 2: Pharmacokinetics: Which of the following parameters is not
included in the Renkin equation?
• Blood flow
• Permeability coefficient
• Surface area
• Clearance
• Distribution volume
19. Module 2: Pharmacokinetics: Which of the following statements regarding
noncompartmental and compartment analysis is most accurate?
• Noncompartmental analysis of pharmacokinetic data is superior to
compartmental analysis because it requires substantially less assumptions.
• Compartmental and noncompartmental analysis can both be used to analyze
pharmacokinetic data, depending on whether the relevant assumptions apply.
• The noncompartmental model does not require instantaneous mixing and
kinetic homogeneity to be verified for the system being studied.
• Noncompartmental analysis results are unbiased even if the single sink /
single source hypotheses are not verified.
20. Module 2: Pharmacokinetics: True or False: The only difference between the
compartmental and noncompartmental methods of analysis is in how the
nonaccessible portion of the system is described.
• True
• False
21. Module 3: Drug Metabolism and Transport: Which of the following is true
regarding transporters?
• Transporters are membrane proteins that move substrates, including drugs,
into or out of cells
• Inhibition of intestinal uptake transporters does not change the absorption
of drugs
• Inhibition of intestinal efflux transporters will increase the bioavailability of
drugs administered intravenously
22. Module 3: Drug Metabolism and Transport: A drug, Drug X, is transported
across the intestinal luminal membrane by a facilitated transporter. Which of the
following statements is true about the transport process?
• At high concentrations, the rate of transport of Drug X will achieve a
maximum rate or Vmax.
• The rate of Drug X transport will increase linearly with concentration from
low to high concentrations.
• The rate of transport of Drug X will be greater if its hydrophobicity were
increased through chemical modification.
• Concomitantly administered drugs will not reduce the rate of transport of
Drug X.
• Transport of Drug X across the intestinal luminal membrane will require
energy.
23. Module 3: Drug Metabolism and Transport: During clinical trials, fedratinib, a
Janus Kinase inhibitor, was found to cause thiamine (Vitamin B1) deficiency in a
group of patients. Please indicate which of the following statements is most
consistent with this observation.
• Fedratinib inhibited the efflux pump, P-glycoprotein, which is localized to
the apical membrane of the intestine.
• Fedratinib inhibited the thiamine transporter, THTR2 (SLC19A3), found on
the apical membrane of the intestine.
• Fedratinib stimulated the thiamine transporter, THTR2 (SLC19A3), found on
the apical membrane of the intestine.
• Thiamine inhibited the efflux pump, P-glycoprotein, which is localized to the
apical membrane of the intestine.
• Fedratinib inhibited the active secretion of thiamine in the kidney by MATE1
(SLC47A1).
24. Module 3: Drug Metabolism and Transport: True or False: ATP Binding
Cassette transporters (ABC) are generally secondarily active relying on the sodium
gradient generated by sodium potassium ATPase to actively efflux their substrates.
• True
• False
25. Module 3: Drug Metabolism and Transport: Factors that determine drug
transport across the blood brain barrier include all of the following except
• Lipid solubility
• Charge at physiological pH
• Renal function
• Protein binding
• Presence of efflux transporters
26. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: The
extent to which drugs are removed from the body during hemodialysis therapy is
impaired by all but which one of the following?
• Binding to plasma proteins
• Drug partitioning from plasma into erythrocytes
• Large drug distribution volume
• Slow blood flow through the dialyzer
• Molecular weight of the drug greater than 6,000 daltons
27. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: Which
of the following produces the most appropriate estimate of dialysis clearance for
comparison with renal and other non-renal plasma clearance estimates?
• Renkin equation estimates using measured blood flow through the dialyzer.
• Fick equation estimates using plasma flow through the dialyzer and plasma
concentrations to calculate the extraction ratio.
• Fick equation estimates using blood flow through the dialyzer and plasma
concentrations to calculate the extraction ratio.
• Clearance estimates using blood concentrations and recovery of drug in the
dialysis bath fluid.
• Clearance estimates using plasma concentrations and recovery of drug in the
dialysis bath fluid.
28. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: Which
of the following increases the efficacy of hemodialysis in treating drug overdose but
decreases the total extent of drug removal during hemodialysis?
• Large drug distribution volume
• Decreased intercompartmental clearance during hemodialysis
• Decreased protein binding
• Increase in blood flow through dialyzer
• Extensive drug partitioning from plasma into erythrocytes
29. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: What
are the indications for continuous renal replacement therapy in a critically ill
patient?
• Removal of excess fluid because of fluid overload
• Clinical need to administer fluid to someone who is oliguric
• Administer nutrition solutions
• Administer parenteral antibiotics
• All of the above
30. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: The
advantages of SLED include
• Inflexible patient schedule
• Need for custom replacement solutions
• Hemodynamic stability
• Need for special support staff
• Need for expensive continuous renal replacement machines
31. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: The
basic principle of hemofiltration is
• Convection based on a pressure gradient
• Diffusion based on a concentration gradient
• Blood flow rate
• Degree of excess intravascular volume
• Residual renal clearance
32. Module 4: Pharmacokinetics and Drug Therapy in Special Populations:
Amoxicillin provides coverage for anthrax infection, but not during pregnancy. Why
is this true?
• The bacterial susceptibility patterns are different in pregnancy.
• Amoxicillin is hepatically cleared, and hepatic clearance is increased in
pregnancy.
• Amoxicillin is renally cleared, and renal clearance is increased in
pregnancy.
• Amoxicillin is highly protein bound, and protein binding is increased in
pregnancy which decreases the free fraction of drug.
33. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: Which
of the following statements regarding the care of pregnant women are true?
• Pregnant women have a higher mortality rate from influenza.
• Pregnant women may have opioid withdrawal signs and symptoms despite
taking the labeled dose of buprenorphine.
• Increased volume of distribution during pregnancy produces lower drug
concentrations.
• Increased clearance during pregnancy produces lower drug concentrations.
• Both A and B
• A, B, C, and D are all correct
34. Module 4: Pharmacokinetics and Drug Therapy in Special Populations: True
or False: Pravastatin was chosen instead of other HMG coA-reductase inhibitors to
treat pre-eclampsia in part because of its poor transfer through the placenta to the
fetus.
• True
• False
35. Module 5: Assessment of Drug Effects: What is the rate-limiting factor in
determining the right warfarin dose for a given patient?
• PK between-subject variability
• PK within-subject variability
• PD between-subject variability
• PD within-subject variability
36. Module 5: Assessment of Drug Effects: Which of the following are reasons for
developing a disease progression model?
• Clinical trial simulation for improving study designs
• Projecting patient improvement with different treatment options
• Development of a response surface provides more information to the
caregiver to individualize treatment with a new drug
• All of the above
• None of the above
37. Module 5: Assessment of Drug Effects: Which of the following are commonly
used to describe the effect of drugs in disease progression models?
• Symptomatic benefit models
• Square root models
• Drug interaction models
38. Module 5: Assessment of Drug Effects: Which of the following are common
problems with developing a model of disease progression?
• Clinical outcome data are not routinely collected
• Clinical outcome data are variable and need to be collected over a long
period of time
• Clinical studies do not usually evaluate placebo treatments
39. Module 5: Assessment of Drug Effects: All of the following represent
advantages of immunotherapy over conventional targeted therapy or chemotherapy
except
• Mutations represent opportunities for therapeutic intervention
• Fewer side effects
• Responses are durable
• Antigen spreading leads to a broader therapeutic response
40. Module 5: Assessment of Drug Effects: A patient with melanoma comes to
your office. He is coming back for his third dose of ipilimumab. His tumors on his
skin are obviously smaller and his only complaint is a 2-day history of severe
diarrhea with abdominal cramping. Which is the best course of action?
• Continue ipilimumab
• Continue ipilimumab but also prescribe loperamide (Imodium®)
• Continue ipilimumab but prescribe glucocorticoids
• Discontinue ipilimumab and initiate IV steroids
41. Module 6: Drug Discovery and Development: The fundamental particle of
quantum mechanics is the electron, as describing its motion and energetics is the
goal of the Schrödinger equation. What is the fundamental particle of molecular
mechanics?
• It is the same – the electron.
• It is the atom.
• It is the molecule.
• The Fermi boson.
• There are no particles.
42. Module 6: Drug Discovery and Development: Why do local minima form
during structure optimization?
• The local minima structures are valid structures, but are just not as ideal as
the global minimum structure.
• There are errors in the program code that force structures being minimized
into false non-optimal conformations.
• It is because that there are many different force field formalisms and what is
a local minimum in one might be global in another.
• It is because only structural changes that decrease the molecule’s energy are
allowed.
• All of the above.
43. Module 6: Drug Discovery and Development: True or False: Pediatric deaths
in the US in 1905 from patent medicines, and in 1936 from sulfanilamide dissolved
in diethylene glycol, and malformations in Europe and other countries from
thalidomide, were direct precursors to laws regulating drug safety and efficacy.
• True
• False
44. Module 6: Drug Discovery and Development: “if course of the disease and
effects of the drug are sufficiently similar in adults and pediatric patients…” then
• Safety can be extrapolated from adults to children
• Dosing can be extrapolated from adults to children
• Efficacy can be extrapolated from adults to children
45. Module 6: Drug Discovery and Development: True or False: The Six Minute
Walk Test is an example of a biomarker which has been accepted by FDA as an
indicator of functional capacity, but is not useful in drug development for pulmonary
hypertension in a two month old.
• True
• False
46. Module 6: Drug Discovery and Development: The four categories of the
Biopharmaceutics Classification System (BCS) is established based on two key
biopharmaceutical properties. They are:
• The intrinsic dissolution rate and partition rate of the drug
• The aqueous solubility in the human GI fluid and the intestinal permeability
of the drug
• The solubility in octanol solvent and the partition coefficient (Log P) of the
drug
• The aqueous solubility in the human GI fluid and the partition coefficient
(Log P) of the drug
47. Module 6: Drug Discovery and Development: The dose number is defined as:
Dose # = Dose/[Cs *250 mL]. Drug A possesses an aqueous solubility, Cs, of 0.1
mg/mL in human GI fluid. The dose number of Drug A with a targeted dose of 100
mg is:
• 40
• 10
• 4
• 0.4
48. Module 6: Drug Discovery and Development: The dissolution rate of a drug
(in solid form) is proportional to its total surface area. Reducing the particle size will
increase the total surface area, thus, improving the dissolution rate of the drug.
Assuming that Drug A (of a fixed dose) possesses crystalline particles in cubic shape
with an average side length of 10 micron (1 micron= 10-6 m) that is reduced to be
about 0.5 micron. What is the theoretical improvement of the dissolution rate of
Drug A?
• 20
• 0.05
• 8000
• 400
49. Module 6: Drug Discovery and Development: How many natural product
derived drugs were approved by the FDA between 2007-2012?
• 22
• 6
• 13
• 11
50. Module 6: Drug Discovery and Development: Which of the following research
area are important for the prioritization of natural product “hit” extracts?
• Biological
• Biochemical
• Chemical Metabolomics
• Taxonomic
• All of the above
51. Module 6: Drug Discovery and Development: Which of the following is a part
of the rationale for immunosuppressing patients immediately prior to T-Cell
transfer?
• To reduce toxicity of the immune response
• To stimulate the activation and proliferation of endogenous T-Cells
• To induce homeostatic cytokines
• To reduce the tumor burden
52. Module 6: Drug Discovery and Development: Administering T-cells
genetically engineered with retroviruses has been associated with the following
toxicities
• Leukemias in children with hereditary immunodeficiency
• Detection of replication competent retroviruses in some recipients
• Autonomous growth of T-cell clones
• None of the above
53. Module 6: Drug Discovery and Development: The U.S. FDA is responsible for
regulation of all of the following except:
• Pre-market safety of investigational drug and biologic products
• Cosmetic products
• Post-marketing safety of marketed drug and biologic products
• The cost of marketed drug and biologic products
• Veterinary products
54. Module 6: Drug Discovery and Development: Which of the following are
benefits of Overall Survival as a clinical trial endpoint:
• It is a direct measure of clinical benefit
• It facilitates smaller and more rapid clinical trials
• Is not confounded by crossover trial designs
• The interpretation of the event (death) is least prone to bias
• Both A and D
55. Module 6: Drug Discovery and Development: All of the following are
expedited programs at the FDA except:
• Accelerated Approval
• Special Protocol Assessment
• Breakthrough Therapy Designation
• Priority Review
• Fast Track Designation
56. Module 7: Pharmacogenomics and Pharmacotherapy: You would like to
initiate mercaptopurine in a patient with intermediate TPMT activity. Which of the
following is the most reasonable approach?
• Decrease the initial dose by 30-60%
• TMPT activity is not relevant in mercaptopurine dosing so no dose
adjustment is required
• Increase the initial dose by 30-60%
• Use of mercaptopurine is contraindicated in this population so therapy
should not be initiated
57. Module 7: Pharmacogenomics and Pharmacotherapy: True or False: CPIC
guidelines are intended to inform clinicians how to use genetic information to guide
prescribing, rather than to dictate which drugs must be accompanied by genetic
testing.
• True
• False
58. Module 7: Pharmacogenomics and Pharmacotherapy: All of the following are
considered to be clinically actionable gene/drug pairs for prescribing except for the
following:
• Mercaptopurine/TPMT
• Ondansetron/CYP2D6
• Cisplatin/GSTM1
• Tacrolimus/CYP3A5
• Fluorouracil/DPYD
59. Module 7: Pharmacogenomics and Pharmacotherapy: Consider a new drug
being developed for the treatment of a relatively common indication, such as
diabetes mellitus or high blood pressure. In vitro and preclinical studies indicate the
compound is extensively metabolized, primarily by CYP3A and partially by
CYP2C19. The compound does not appear to be an inducer or inhibitor of any
CYP450 enzymes, but it is a potential inhibitor of P-glycoprotein (P-gp). What in
vivo drug-drug interaction (DDI) studies should the company developing the
compound consider?
• A DDI study with digoxin, a sensitive P-gp substrate
• A DDI study with lansoprazole, a sensitive CYP2C19 substrate
• A DDI study with midazolam, a sensitive CYP3A4 substrate
• A, B, and C
• B and C
60. Module 7: Pharmacogenomics and Pharmacotherapy: True or False: The
incidence of adverse drug events can be determined through spontaneous reporting
systems.
• True
• False
61. Module 7: Pharmacogenomics and Pharmacotherapy: A safety signal could
be:
• New, previously unknown, adverse event
• New drug interaction
• An observed change in quantity, severity or the affected populations of a
known adverse event
• All of the above