CSP Clinical Patient Management & Counseling 2 — Questions and Answers
Question 1: Before a patient starts adalimumab for rheumatoid arthritis, which screening test is required?
- Serum uric acid
- HLA-B*5701 genotype
- Latent tuberculosis test (TST or IGRA) (Correct answer)
- Thiopurine methyltransferase activity
Correct answer: Latent tuberculosis test (TST or IGRA)
TNF inhibitors carry a boxed warning for serious infections, including TB reactivation, so latent TB screening is required before starting therapy.
Question 2: A patient starting ledipasvir/sofosbuvir takes omeprazole 20 mg daily. What is the most appropriate counseling?
- Take omeprazole 20 mg or less at the same time as ledipasvir/sofosbuvir on an empty stomach (Correct answer)
- Take omeprazole 12 hours after ledipasvir/sofosbuvir
- Double the omeprazole dose to protect the stomach
- Switch to esomeprazole 40 mg twice daily
Correct answer: Take omeprazole 20 mg or less at the same time as ledipasvir/sofosbuvir on an empty stomach
Ledipasvir solubility drops as gastric pH rises, so PPIs up to the equivalent of omeprazole 20 mg can be taken at the same time as the DAA under fasting conditions.
Question 3: Which drug interaction with sofosbuvir-containing HCV regimens can cause serious symptomatic bradycardia?
- Atorvastatin
- Amiodarone (Correct answer)
- Metformin
- Levothyroxine
Correct answer: Amiodarone
Giving amiodarone with sofosbuvir-based regimens has caused serious symptomatic bradycardia, including fatal cases.
Question 4: Before a patient starts a direct-acting antiviral for hepatitis C, which additional screening is recommended because of a boxed warning?
- HIV viral load
- Hepatitis A IgG
- Serum ferritin
- HBsAg and anti-HBc for hepatitis B (Correct answer)
Correct answer: HBsAg and anti-HBc for hepatitis B
HCV DAAs carry a boxed warning for hepatitis B reactivation, so all patients need HBV screening before treatment.
Question 5: A patient with multiple sclerosis is starting fingolimod. What monitoring is required after the first dose?
- At least 6 hours of observation for bradycardia, with an ECG before dosing and at the end of observation (Correct answer)
- A 24-hour urine collection
- Blood glucose checks every hour for 4 hours
- A chest X-ray the next morning
Correct answer: At least 6 hours of observation for bradycardia, with an ECG before dosing and at the end of observation
Fingolimod can cause bradycardia and AV block after the first dose, so 6-hour first-dose observation with ECGs is required.
Question 6: In specialty pharmacy adherence reporting, what proportion of days covered (PDC) threshold usually defines an adherent patient?
- 50% or higher
- 65% or higher
- 80% or higher (Correct answer)
- 100% only
Correct answer: 80% or higher
A PDC of 80% or higher is the standard adherence threshold used by PQA and most specialty pharmacy quality programs.
Question 7: Under the bosentan REMS, which monitoring is required every month during treatment?
- Serum potassium
- Liver aminotransferases (Correct answer)
- Serum creatinine
- Fasting lipid panel
Correct answer: Liver aminotransferases
Bosentan is hepatotoxic and requires monthly liver aminotransferase monitoring; patients who can become pregnant also need monthly pregnancy tests.
