Certified Specialty Pharmacist (CSP) Exam — Questions and Answers

Question 1: A commercial plan applies a $7,000 manufacturer copay card to a patient's claims but does not count those payments toward the deductible or out-of-pocket maximum. What is this program called?

Copay maximizer program
Copay accumulator adjustment program (Correct answer)
Coinsurance smoothing program
Alternative funding program

Correct answer: Copay accumulator adjustment program

Accumulator programs exclude manufacturer assistance from deductible and out-of-pocket accruals, so patients face full cost sharing once the card is used up.

Question 2: Olaparib is most appropriately used in which patient population?

BRCA-mutated ovarian, breast, prostate, or pancreatic cancer (Correct answer)
HER2-positive breast cancer
EGFR-mutated lung cancer
Philadelphia chromosome-positive ALL

Correct answer: BRCA-mutated ovarian, breast, prostate, or pancreatic cancer

PARP inhibitors exploit synthetic lethality in tumors with homologous recombination deficiency such as BRCA mutations.

Question 3: A manufacturer copay card covering the patient's out-of-pocket cost is generally prohibited for patients enrolled in which coverage?

Self-funded ERISA plans
Medicare Part D (Correct answer)
Employer-sponsored commercial insurance
Individual marketplace plans

Correct answer: Medicare Part D

OIG considers manufacturer copay coupons for federal health care program beneficiaries potential inducements under the Anti-Kickback Statute.

Question 4: How can a pharmacist help a patient who is struggling with medication side effects?

Increasing the dose of the medication.
Stopping the medication immediately.
Providing no solutions.
Suggesting alternatives and adjusting the dosage (Correct answer)

Correct answer: Suggesting alternatives and adjusting the dosage

When a patient experiences medication side effects, a specialty pharmacist's role is to assess the severity and impact, then collaborate with the prescriber. They can suggest strategies to mitigate side effects, such as adjusting the dosage, changing the timing of administration, or recommending alternative therapies. This ensures the patient can continue treatment safely and effectively, as stopping medication immediately without consultation can be dangerous.

Question 5: Which adverse effect is commonly reported with dupilumab in atopic dermatitis?

Conjunctivitis (Correct answer)
Hemorrhagic cystitis
Hyperkalemia
Peripheral neuropathy

Correct answer: Conjunctivitis

Conjunctivitis and keratitis are characteristic adverse effects of dupilumab in atopic dermatitis patients.

Question 6: When a specialty pharmacy counts oral chemotherapy tablets, which practice is recommended?

Use the same counting tray as for all other drugs
Count with bare hands for accuracy
Crush the tablets before counting
Use a dedicated counting tray that is cleaned after each use, and wear gloves (Correct answer)

Correct answer: Use a dedicated counting tray that is cleaned after each use, and wear gloves

Hazardous oral drugs should be counted on dedicated equipment with protective gloves to avoid cross-contamination.

Question 7: A new patient expresses significant anxiety about the high cost of their specialty medication during the onboarding call. What is the specialty pharmacy's MOST appropriate response?

Inform the patient about the pharmacy's financial assistance services and offer to investigate manufacturer co-pay programs or foundation support. (Correct answer)
Suggest the patient look for a different, cheaper medication.
Inform the patient that the pharmacy is not responsible for medication costs.
Advise the patient to call their insurance company directly without further assistance.

Correct answer: Inform the patient about the pharmacy's financial assistance services and offer to investigate manufacturer co-pay programs or foundation support.

A key service of specialty pharmacies is helping patients navigate financial barriers. The appropriate response is to acknowledge the patient's concern and proactively offer to help by exploring financial assistance options, such as manufacturer co-pay cards, patient assistance programs (PAPs), and grants from charitable foundations.

Question 8: A patient's PA is approved, but the payer mandates use of its exclusive specialty pharmacy. What is this arrangement called?

A 340B contract
A REMS restriction
A limited distribution agreement
A narrow or exclusive specialty pharmacy network (Correct answer)

Correct answer: A narrow or exclusive specialty pharmacy network

Payers or PBMs may require patients to use a designated specialty pharmacy, limiting which pharmacies can be reimbursed.

Question 9: A patient with a history of multiple sclerosis is being considered for psoriatic arthritis therapy. Which class warrants the most caution?

IL-23 inhibitors
TNF inhibitors (Correct answer)
IL-17 inhibitors
PDE4 inhibitors

Correct answer: TNF inhibitors

TNF inhibitors have been linked to new or worsening demyelinating disease and should be avoided in MS.

Question 10: A specialty pharmacy must evaluate whether to accept a new limited distribution agreement for a hepatitis C antiviral. Which factor is LEAST relevant to this decision?

Reimbursement rates and financial viability of the contract
Data reporting capabilities required by the manufacturer
The pharmacist-in-charge's personal preference for the drug class (Correct answer)
Pharmacy's existing patient population and payer mix

Correct answer: The pharmacist-in-charge's personal preference for the drug class

Business decisions about limited distribution agreements should be driven by operational, financial, and patient-care factors, not the personal preferences of individual staff members.

Question 11: A patient reports a damaged prefilled syringe on arrival. What is the right response?

Tell the patient to use it anyway
Ignore it unless the patient sends photos
Charge the patient for a replacement
Arrange a replacement, document the incident, and follow product-complaint and return processes (Correct answer)

Correct answer: Arrange a replacement, document the incident, and follow product-complaint and return processes

Damaged product should be replaced, with the incident documented and reported for quality tracking.

Question 12: What contraception counseling is required for patients of either sex taking ribavirin?

One barrier method during therapy only
No contraception needed if therapy lasts less than 12 weeks
Two reliable forms of contraception during therapy and for 6 months after (Correct answer)
Contraception only for female patients

Correct answer: Two reliable forms of contraception during therapy and for 6 months after

Ribavirin is teratogenic, so both female patients and female partners of male patients must use two forms of contraception during therapy and for 6 months after.

Question 13: A patient starting an oral oncolytic will begin at home. Which onboarding education item is most critical?

Safe handling and disposal of hazardous medication (Correct answer)
How to share leftover doses with family
How to store the medication in a bathroom cabinet
How to split tablets to save money

Correct answer: Safe handling and disposal of hazardous medication

Many oral chemotherapy agents are hazardous, so patients and caregivers need safe handling, storage, and disposal instructions.

Question 14: A specialty pharmacy receives a prior authorization (PA) denial for a biologic agent. What is the most appropriate FIRST step?

Initiate a peer-to-peer review request with the prescriber's office (Correct answer)
Switch to a formulary alternative without consulting the prescriber
Dispense the medication and bill later
Submit a grievance to the state insurance commissioner

Correct answer: Initiate a peer-to-peer review request with the prescriber's office

A peer-to-peer review allows the prescriber to discuss the clinical necessity directly with the payer's medical reviewer, which is typically the most effective first step in overturning a PA denial.

Question 15: A patient with phenylketonuria (PKU) is prescribed sapropterin (Kuvan). What is the standard method to assess response to this therapy?

Blood phenylalanine level measured after a 1-month therapeutic trial (Correct answer)
Urine amino acid panel weekly
Genetic testing to confirm PAH mutation type before continuing
Brain MRI at 6 months

Correct answer: Blood phenylalanine level measured after a 1-month therapeutic trial

Response to sapropterin is determined by measuring blood phenylalanine levels after a 1-month trial; only patients who respond (defined as a ≥30% reduction in phenylalanine) should continue therapy.

Question 16: A patient on a specialty multiple sclerosis therapy reports a new relapse despite a PDC of 95%. What does this suggest?

The drug should be stopped by the pharmacist immediately
Possible treatment failure warranting prescriber evaluation (Correct answer)
Definite nonadherence that refill data missed
The PDC calculation is invalid

Correct answer: Possible treatment failure warranting prescriber evaluation

High refill adherence with disease breakthrough suggests possible therapeutic failure, which should be referred to the prescriber for evaluation.

Question 17: Which method is the most reliable way to confirm a patient understood injection instructions given during counseling?

Have the patient sign an acknowledgment form
Provide a printed instruction leaflet
Ask the patient if they have any questions
Ask the patient to explain and demonstrate the steps back (teach-back) (Correct answer)

Correct answer: Ask the patient to explain and demonstrate the steps back (teach-back)

Teach-back with return demonstration directly verifies comprehension and technique rather than assuming understanding.

Question 18: White bagging refers to which distribution arrangement?

A specialty pharmacy dispenses a patient-specific drug and ships it to the provider site for administration (Correct answer)
The manufacturer ships free drug directly to the patient's home
The patient picks up the drug and carries it to the clinic
The clinic buys the drug from a wholesaler and bills the medical benefit

Correct answer: A specialty pharmacy dispenses a patient-specific drug and ships it to the provider site for administration

White bagging ships patient-specific medication from a specialty pharmacy directly to the administering provider, often billed under the pharmacy benefit.

Question 19: Belimumab is used in systemic lupus erythematosus to inhibit which target?

B-lymphocyte stimulator (BLyS/BAFF) (Correct answer)
Complement C5
CD20
Type I interferon receptor

Correct answer: B-lymphocyte stimulator (BLyS/BAFF)

Belimumab binds soluble BLyS, which reduces B-cell survival and differentiation.

Question 20: What is the main purpose of a budget impact analysis that a health plan requests before adding a new specialty drug?

Compare the drug's clinical efficacy with placebo
Measure patient willingness to pay
Estimate the financial effect of adoption on that plan's budget over a short time horizon (Correct answer)
Calculate cost per QALY gained over a lifetime

Correct answer: Estimate the financial effect of adoption on that plan's budget over a short time horizon

Budget impact analysis estimates the affordability of adopting a therapy for a specific payer population, usually over 1 to 5 years.

Question 21: What does the 340B duplicate discount prohibition prevent?

Contract pharmacies charging patients two copays
Covered entities buying 340B drugs through more than one wholesaler
A manufacturer giving both a 340B ceiling price and a Medicaid rebate on the same unit (Correct answer)
Payers applying both copay accumulators and maximizers

Correct answer: A manufacturer giving both a 340B ceiling price and a Medicaid rebate on the same unit

Manufacturers may not have to provide both a 340B discount and a Medicaid Drug Rebate Program rebate on the same drug unit.

Question 22: Which iPLEDGE requirement applies to isotretinoin dispensing?

No pregnancy testing required
Dispense up to a 90-day supply
Dispense within a defined window after the prescription is authorized in the system (Correct answer)
Automatic refills allowed

Correct answer: Dispense within a defined window after the prescription is authorized in the system

iPLEDGE limits dispensing to an authorization window, and supply is limited to 30 days.

Question 23: Absorption of which oral oncolytic is significantly reduced by concurrent proton pump inhibitors?

Dasatinib (Correct answer)
Olaparib
Enzalutamide
Abiraterone

Correct answer: Dasatinib

Dasatinib requires an acidic environment for solubility, so PPIs should be avoided and antacids spaced by 2 hours.

Question 24: Which metric is most commonly used to evaluate specialty pharmacy dispensing efficiency and patient safety?

Net promoter score (NPS)
Dispense as written (DAW) rate
Days on hand (DOH)
Medication error rate per 1,000 prescriptions (Correct answer)

Correct answer: Medication error rate per 1,000 prescriptions

Medication error rate per 1,000 prescriptions is a key safety metric that specialty pharmacies track to identify process breakdowns and prioritize quality improvement efforts.

Question 25: Enzalutamide should be used with caution in patients with which history?

Hypothyroidism
Asthma
Peptic ulcer disease
Seizure disorder (Correct answer)

Correct answer: Seizure disorder

Enzalutamide lowers the seizure threshold through GABA-A inhibition and is associated with seizures.

Question 26: Which USP chapter sets standards for handling hazardous drugs, including oral oncolytics, in specialty pharmacy settings?

USP <800> (Correct answer)
USP <825>
USP <797>
USP <795>

Correct answer: USP <800>

USP <800> addresses receipt, storage, compounding, dispensing, and disposal of hazardous drugs to protect personnel.

Question 27: A CSP is reviewing adherence data and finds that 30% of patients on an oral specialty oncology agent have not refilled within 7 days of their expected refill date. Which intervention is MOST appropriate?

Implement a proactive outreach program with pharmacist-led adherence counseling (Correct answer)
Discontinue the patients from the program and notify the prescriber
Reduce the days supply dispensed to force more frequent contact
Automatically dispense the next refill without patient contact

Correct answer: Implement a proactive outreach program with pharmacist-led adherence counseling

Proactive outreach with pharmacist-led adherence counseling addresses barriers to refill, such as side effects, cost, or misunderstanding of the regimen, to improve outcomes and adherence rates.

Question 28: In a CKD patient receiving epoetin alfa, at what hemoglobin level should the dose be reduced or held, per labeling?

Above 15 g/dL
Above 13 g/dL
Above 9 g/dL
Above 11 g/dL (Correct answer)

Correct answer: Above 11 g/dL

Epoetin labeling for CKD advises reducing or interrupting the dose when hemoglobin goes above 11 g/dL because of cardiovascular and thrombotic risk.

Question 29: A specialty pharmacist reviews a patient's dispensing history and sees an early refill overlapping the previous fill. Using PDC methodology, the overlapping days are:

Counted twice, increasing the PDC
Discarded entirely from the calculation
Treated as a gap in therapy
Shifted forward so the new fill starts after the prior supply ends (Correct answer)

Correct answer: Shifted forward so the new fill starts after the prior supply ends

PDC adjusts start dates for overlapping fills of the same drug so supply is carried forward rather than double counted.

Question 30: A Medicare Part D patient asks to use a manufacturer copay coupon for an expensive oral oncolytic. What is the correct response?

The coupon can be used only after the deductible is met
The coupon is allowed for oncology drugs only
The coupon cannot be used because manufacturer copay assistance for federal program beneficiaries may violate the Anti-Kickback Statute (Correct answer)
The coupon can be used if the pharmacy reports it to CMS

Correct answer: The coupon cannot be used because manufacturer copay assistance for federal program beneficiaries may violate the Anti-Kickback Statute

Manufacturer copay coupons are considered remuneration that could induce federal program business, so they are excluded for Medicare beneficiaries.

Question 31: Which documentation should the specialty pharmacy keep for each cold-chain shipment?

The pack-out used, ship date, carrier tracking, delivery confirmation, and any excursion reports (Correct answer)
Only the patient's phone number
The patient's preferred brand of cooler
Nothing once delivered

Correct answer: The pack-out used, ship date, carrier tracking, delivery confirmation, and any excursion reports

Shipment records support quality assurance, accreditation, and investigations.

Question 32: Why is certolizumab pegol often preferred for patients with immune-mediated disease during pregnancy?

It has the shortest half-life of all biologics
It lacks an Fc region, so very little crosses the placenta (Correct answer)
It is not an immunosuppressant
It is given orally

Correct answer: It lacks an Fc region, so very little crosses the placenta

Without an Fc portion, certolizumab is not actively transported across the placenta by the neonatal Fc receptor.

Question 33: Which component of the patient onboarding process is specifically designed to ensure that a prescribed specialty drug is medically necessary and appropriate for the patient's condition according to their health plan?

Welcome call scripting.
Prior Authorization (PA). (Correct answer)
Delivery scheduling.
Patient satisfaction survey.

Correct answer: Prior Authorization (PA).

Prior authorization is a utilization management process used by insurance companies to ensure that a prescribed medication is medically necessary, safe, and cost-effective before it is covered. Specialty pharmacies dedicate significant resources to managing the PA process, which involves collecting clinical documentation from the prescriber to justify the treatment to the payer.

Question 34: Which of the following best describes the role of a CSP in managing a patient on ozanimod (Zeposia) for relapsing MS who develops macular edema?

Recommend drug discontinuation and coordinate urgent ophthalmology evaluation, notifying the prescriber immediately (Correct answer)
Advise the patient to continue the drug and schedule routine ophthalmology follow-up in 1 year
Recommend over-the-counter lubricating eye drops and monitor symptoms
Switch the patient to a different S1P modulator without prescriber involvement

Correct answer: Recommend drug discontinuation and coordinate urgent ophthalmology evaluation, notifying the prescriber immediately

Macular edema is a serious, vision-threatening adverse effect of ozanimod that requires prompt discontinuation and urgent ophthalmology evaluation; the CSP must notify the prescriber immediately.

Question 35: Ustekinumab, used for psoriasis and Crohn's disease, targets which cytokine component?

IL-17A
TNF-alpha
IL-6 receptor
The shared p40 subunit of IL-12 and IL-23 (Correct answer)

Correct answer: The shared p40 subunit of IL-12 and IL-23

Ustekinumab binds the p40 subunit common to IL-12 and IL-23.

Question 36: What is the primary purpose of an 'accumulator adjustment program' that intake staff should identify during benefits investigation?

It lets the patient skip prior authorization
It converts a pharmacy benefit claim to a medical claim
It increases the payer's coverage to 100%
Manufacturer copay assistance does not count toward the patient's deductible or out-of-pocket maximum (Correct answer)

Correct answer: Manufacturer copay assistance does not count toward the patient's deductible or out-of-pocket maximum

Accumulator programs prevent copay card funds from counting toward deductibles, so patients may face large costs once assistance runs out.

Question 37: An independent charity patient assistance foundation complies with OIG guidance when it:

Defines disease funds broadly and does not let donors steer aid to their own products (Correct answer)
Limits assistance to patients using the donor manufacturer's drug
Shares patient-level data with donors to track product use
Allows donors to design narrow funds covering only their product

Correct answer: Defines disease funds broadly and does not let donors steer aid to their own products

OIG guidance requires independent charities to keep donors from influencing aid toward specific products and to define funds by broad disease categories.

Question 38: Natalizumab can be prescribed and dispensed only through the TOUCH program mainly because of the risk of which condition?

Progressive multifocal leukoencephalopathy (PML) (Correct answer)
Stevens-Johnson syndrome
Acute pancreatitis
Hemorrhagic stroke

Correct answer: Progressive multifocal leukoencephalopathy (PML)

The TOUCH Prescribing Program exists to reduce the risk of PML, an opportunistic JC virus brain infection linked to natalizumab.

Question 39: A health system values both the costs of a hepatitis C program and the avoided liver transplants in dollars. Which analysis is this?

Cost-of-illness analysis
Cost-utility analysis
Cost-effectiveness analysis
Cost-benefit analysis (Correct answer)

Correct answer: Cost-benefit analysis

Cost-benefit analysis expresses both inputs and outcomes in monetary units, allowing a net benefit or benefit-to-cost ratio.

Question 40: Which organizations offer specialty pharmacy accreditation commonly required by payers and manufacturers?

CMS and OIG
USP and NABP Purple Book
DEA and FDA
URAC and ACHC (Correct answer)

Correct answer: URAC and ACHC

URAC and ACHC are the leading specialty pharmacy accreditors, often required for limited distribution networks and payer contracts.

Question 41: Which federal law governs the licensure requirement for a specialty pharmacy dispensing across state lines?

The Drug Quality and Security Act (DQSA)
The Omnibus Budget Reconciliation Act (OBRA) of 1990
Each state's individual pharmacy practice act requiring non-resident licensure (Correct answer)
The Food, Drug, and Cosmetic Act (FD&C Act)

Correct answer: Each state's individual pharmacy practice act requiring non-resident licensure

Specialty pharmacies shipping medications to patients in other states must obtain non-resident pharmacy licensure in each destination state, as pharmacy practice is regulated at the state level.

Question 42: Which standard governs the handling of hazardous drugs, such as many oral oncolytics, in pharmacies?

USP <71>
USP <797>
USP <795>
USP <800> (Correct answer)

Correct answer: USP <800>

USP <800> sets the handling requirements for hazardous drugs to protect workers and the environment.

Question 43: Why can't a Medicare Part D beneficiary use a manufacturer copay coupon for a specialty drug?

Coupons are allowed only for generic drugs
It may induce purchases of federally reimbursed items, which implicates the Anti-Kickback Statute (Correct answer)
Coupons violate HIPAA
Medicare already covers 100% of specialty drugs

Correct answer: It may induce purchases of federally reimbursed items, which implicates the Anti-Kickback Statute

OIG considers manufacturer copay coupons for federal health care program beneficiaries potential remuneration under the Anti-Kickback Statute.

Question 44: A 340B covered entity dispenses a specialty drug to a Medicaid fee-for-service patient through a contract pharmacy; what risk must be prevented?

Duplicate discounts, where both a 340B price and a Medicaid rebate are taken (Correct answer)
Loss of the pharmacy's NCPDP number
Double billing of the patient's Medigap plan
Automatic AWP reimbursement

Correct answer: Duplicate discounts, where both a 340B price and a Medicaid rebate are taken

The 340B statute prohibits duplicate discounts, so entities must avoid claiming Medicaid rebates on drugs already purchased at 340B prices.

Question 45: Under which federal law did the FDA gain formal authority to require REMS programs?

Drug Quality and Security Act (DQSA) of 2013
Prescription Drug User Fee Act (PDUFA) of 1992
Omnibus Budget Reconciliation Act (OBRA) of 1990
Food and Drug Administration Amendments Act (FDAAA) of 2007 (Correct answer)

Correct answer: Food and Drug Administration Amendments Act (FDAAA) of 2007

The FDAAA of 2007 granted the FDA explicit statutory authority to require REMS when necessary to ensure benefits of a drug outweigh its risks.

Question 46: Which piece of information must appear on a dispensed prescription label under federal and typical state requirements?

The patient's name, the drug name, directions for use, the prescriber's name, the dispense date, and the Rx number (Correct answer)
The patient's diagnosis code
The drug's average wholesale price
The wholesaler's invoice number

Correct answer: The patient's name, the drug name, directions for use, the prescriber's name, the dispense date, and the Rx number

Required label elements include patient, drug, directions, prescriber, date, and prescription number.

Question 47: Specialty drug A costs $60,000 more than drug B and yields 1.5 additional QALYs. What is the ICER of A versus B?

$60,000 per QALY
$90,000 per QALY
$24,000 per QALY
$40,000 per QALY (Correct answer)

Correct answer: $40,000 per QALY

ICER = incremental cost / incremental effect = $60,000 / 1.5 QALYs = $40,000 per QALY.

Question 48: A patient with hereditary angioedema (HAE) is prescribed subcutaneous icatibant (Firazyr) for acute attacks. What is the MOST important self-management counseling point?

The drug must be refrigerated and cannot be carried for on-demand use
Avoid subcutaneous injection sites near the abdomen
Inject at the first signs of an acute attack and seek emergency care if symptoms do not improve within 6 hours (Correct answer)
Take the medication daily as prophylaxis to prevent attacks

Correct answer: Inject at the first signs of an acute attack and seek emergency care if symptoms do not improve within 6 hours

Icatibant is indicated for on-demand treatment of acute HAE attacks; prompt injection at symptom onset is critical, and patients should seek emergency care if response is inadequate within 6 hours.

Question 49: Beginning in 2025, the Inflation Reduction Act capped annual out-of-pocket Part D drug costs at what initial amount?

$3,250
$8,000
$2,000 (Correct answer)
$1,000

Correct answer: $2,000

The IRA set a $2,000 annual Part D out-of-pocket cap for 2025, indexed annually thereafter.

Question 50: A patient on sofosbuvir/velpatasvir needs a proton pump inhibitor. Why is this combination a concern?

PPIs induce CYP3A4 metabolism of sofosbuvir
PPIs increase the risk of HBV reactivation
Higher gastric pH lowers velpatasvir solubility and absorption (Correct answer)
Velpatasvir greatly raises PPI levels

Correct answer: Higher gastric pH lowers velpatasvir solubility and absorption

Velpatasvir solubility drops as pH rises, so if a PPI is needed, the DAA should be taken with food 4 hours before omeprazole 20 mg.

Question 51: Under the lenalidomide REMS, which pregnancy testing is required before a female of reproductive potential starts therapy?

No testing if she uses one form of contraception
A single urine test within 30 days
Two negative tests, one within 10-14 days and one within 24 hours before starting (Correct answer)
One test on the first day of therapy

Correct answer: Two negative tests, one within 10-14 days and one within 24 hours before starting

Thalidomide-analog REMS programs require two negative pregnancy tests, 10-14 days and 24 hours before the first dose.

Question 52: Which FDA resource lists biological products, including biosimilars and interchangeable biosimilars?

The Orange Book
The Green Book
The Purple Book (Correct answer)
The Red Book

Correct answer: The Purple Book

The Purple Book lists FDA-licensed biological products along with biosimilarity and interchangeability determinations.

Question 53: What is a manufacturer 'hub' service primarily designed to do during patient onboarding?

Coordinate benefits verification, PA support, financial assistance, and pharmacy triage (Correct answer)
Replace the prescriber's clinical decisions
Perform state pharmacy licensure inspections
Manufacture the drug at a local facility

Correct answer: Coordinate benefits verification, PA support, financial assistance, and pharmacy triage

Hub services centralize access support such as benefits investigation, PA assistance, and copay or PAP enrollment.

Question 54: Which pharmacogenomic test identifies patients at increased risk of severe or fatal toxicity from capecitabine?

CYP2D6 genotyping
UGT1A1 genotyping
DPYD genotyping (Correct answer)
TPMT genotyping

Correct answer: DPYD genotyping

DPYD variants reduce dihydropyrimidine dehydrogenase activity, impairing fluoropyrimidine clearance and causing severe toxicity.

Question 55: Which code set is used to bill a physician-administered specialty drug on a medical claim?

DRG codes
NCPDP reject codes
HCPCS Level II J-codes (Correct answer)
CPT Category III codes

Correct answer: HCPCS Level II J-codes

Physician-administered drugs are typically billed under the medical benefit using HCPCS Level II J-codes with units and NDCs.

Question 56: Which of the following best describes 'white bagging' in specialty pharmacy?

Repackaging bulk specialty drugs into unit-dose containers
Shipping a specialty drug directly to the physician office or infusion center for administration (Correct answer)
Dispensing a specialty drug to the patient who self-administers at home
Providing drug samples to patients through a specialty pharmacy

Correct answer: Shipping a specialty drug directly to the physician office or infusion center for administration

White bagging refers to specialty pharmacies dispensing medications directly to the provider (physician office or infusion center) rather than to the patient, who then receives administration at the provider site.

Question 57: A specialty pharmacy receives a prescription for a drug it cannot access because of limited distribution. What is the appropriate action?

Transfer or triage the prescription to an in-network dispensing pharmacy and coordinate with the patient and prescriber (Correct answer)
Hold the prescription indefinitely
Tell the patient to buy it online
Substitute a different drug without consulting anyone

Correct answer: Transfer or triage the prescription to an in-network dispensing pharmacy and coordinate with the patient and prescriber

Timely triage to an authorized pharmacy prevents delays in starting therapy.

Question 58: How does pharmacoeconomics influence healthcare policy?

It guides policy decisions based on the cost-effectiveness of treatments (Correct answer)
It focuses only on reducing healthcare costs.
It prioritizes patient demand for drugs.
It determines which medications are allowed.

Correct answer: It guides policy decisions based on the cost-effectiveness of treatments

Pharmacoeconomics significantly influences healthcare policy by providing evidence on the value and cost-effectiveness of various treatments and interventions. Policymakers use this data to make informed decisions about drug formularies, treatment guidelines, and resource allocation. This ensures that policies promote the use of therapies that offer the best health outcomes for the available budget, optimizing public health spending.

Question 59: Under the DSCSA, which data elements make up the product identifier on a prescription drug package?

NDC, manufacturer name, and wholesaler ID
Serial number, price, and DEA schedule
Lot number, ship date, and dispenser license number
NDC, serial number, lot number, and expiration date (Correct answer)

Correct answer: NDC, serial number, lot number, and expiration date

The DSCSA product identifier includes the NDC, a unique serial number, lot number, and expiration date, encoded in a 2D data matrix barcode.

Question 60: Which shipping approach best fits a patient in a rural area with a refrigerated drug due Monday?

Two-day shipping on Thursday
Overnight shipping early in the week, avoiding weekend transit (Correct answer)
Ground shipping on Friday
Standard mail with no cold packs

Correct answer: Overnight shipping early in the week, avoiding weekend transit

Overnight shipping early in the week avoids weekend delays that could cause temperature excursions.

Question 61: Under most REMS programs with ETASU, a specialty pharmacy may NOT dispense a REMS medication if which condition exists?

The patient has a prior authorization denial pending appeal
The patient is currently hospitalized
The prescription is written for a quantity exceeding a 90-day supply
The prescriber is not enrolled in the REMS program (Correct answer)

Correct answer: The prescriber is not enrolled in the REMS program

If a REMS program requires prescriber certification, a pharmacy cannot legally dispense the medication unless the prescriber is enrolled and authorized under that REMS.

Question 62: Which clinical finding would MOST warrant a CSP recommending a dose interruption or reduction in a patient on siponimod (Mayzent) for secondary progressive MS?

Mild elevation in liver enzymes at 3-month follow-up
New onset of symptomatic bradycardia or second-degree AV block (Correct answer)
Transient injection site erythema
Mild headache reported in the first week of therapy

Correct answer: New onset of symptomatic bradycardia or second-degree AV block

Siponimod, like other S1P modulators, can cause cardiac conduction effects; symptomatic bradycardia or AV block warrants dose interruption and urgent prescriber notification.

Question 63: Mycophenolate products require a REMS program primarily due to which risk?

Embryofetal toxicity (Correct answer)
Ototoxicity
Hypercalcemia
Serotonin syndrome

Correct answer: Embryofetal toxicity

Mycophenolate causes pregnancy loss and congenital malformations, so the REMS requires contraception counseling.

Question 64: Under the Affordable Care Act, how long does a provider have to report and return an identified Medicare or Medicaid overpayment?

30 days after the claim was paid
1 year after the date of service
6 months after the audit
60 days after identification (Correct answer)

Correct answer: 60 days after identification

Identified overpayments must be reported and returned within 60 days, or they may become False Claims Act liabilities.

Question 65: Anakinra, used for some autoinflammatory conditions, works by which mechanism?

Anti-IL-17A monoclonal antibody
Anti-CD20 antibody
IL-1 receptor antagonist (Correct answer)
IL-6 receptor antagonist

Correct answer: IL-1 receptor antagonist

Anakinra is a recombinant IL-1 receptor antagonist given by daily subcutaneous injection.

Question 66: A specialty pharmacy contracts with an outside vendor to run its patient refill-reminder calls using PHI. What document is required under HIPAA?

Data Use Agreement
Patient authorization for each call
Business Associate Agreement (Correct answer)
Notice of Privacy Practices

Correct answer: Business Associate Agreement

A vendor that creates, receives, or transmits PHI on behalf of a covered entity is a business associate and requires a BAA.

Question 67: A patient newly prescribed oral methotrexate for rheumatoid arthritis needs counseling. Which point is most critical for safety?

Stop folic acid while on therapy
Double the next dose if one is missed
Take it with grapefruit juice
Take it once a week, never daily (Correct answer)

Correct answer: Take it once a week, never daily

Taking low-dose methotrexate daily instead of weekly is a well-known cause of fatal toxicity, so the weekly schedule is the top counseling point.

Question 68: A patient will be traveling during the scheduled delivery date. What is the best pharmacy action?

Cancel therapy until the patient returns
Ship anyway and hope a neighbor accepts it
Reschedule or redirect the delivery to a confirmed address and time when the patient can receive it (Correct answer)
Mail the drug without cold packs to save weight

Correct answer: Reschedule or redirect the delivery to a confirmed address and time when the patient can receive it

Coordinating a confirmed delivery prevents product loss, excursions, and gaps in therapy.

Question 69: Before the first fill of a specialty medication, which step usually comes before dispensing?

Closing the patient's case
Benefits investigation and prior authorization approval (Correct answer)
Ordering a refill
Choosing the patient's pharmacy benefit manager

Correct answer: Benefits investigation and prior authorization approval

Benefits verification and prior authorization are typically needed before a specialty fill can be dispensed and paid for.

Question 70: A specialty drug requires enrollment in a REMS program before dispensing. Which intake step must be completed first?

Confirm the patient's preferred language only
Obtain only the patient's verbal consent
Ship the medication and enroll the patient afterward
Verify that the prescriber, pharmacy, and patient (if required) are certified/enrolled in the REMS (Correct answer)

Correct answer: Verify that the prescriber, pharmacy, and patient (if required) are certified/enrolled in the REMS

REMS with ETASU require verification of required certifications and enrollments before the drug can be dispensed.

Question 71: Which consent is typically obtained during onboarding to allow the pharmacy to enroll a patient in a manufacturer hub program?

Power of attorney
Informed consent for surgery
Consent for clinical trial participation
Patient authorization (HIPAA authorization) to share PHI with the hub (Correct answer)

Correct answer: Patient authorization (HIPAA authorization) to share PHI with the hub

Sharing PHI with a manufacturer hub for non-treatment purposes generally requires a signed patient HIPAA authorization.

Question 72: A patient stops taking an oral anticancer agent because she believes the nausea outweighs the benefit. This is classified as:

Unintentional nonadherence
Intentional nonadherence (Correct answer)
Pharmacy-driven nonadherence
Primary nonadherence

Correct answer: Intentional nonadherence

A deliberate decision to stop or alter therapy based on beliefs or side effects is intentional nonadherence.

Question 73: After the initiation injections, how often is long-acting cabotegravir (Apretude) for PrEP given?

Every 6 months
Every 3 months
Every 2 months (Correct answer)
Every month

Correct answer: Every 2 months

Apretude starts with two IM injections one month apart, then continues every 2 months.

Question 74: A specialty pharmacy contract pays AWP minus 18% plus a $1.50 dispensing fee. If the claim's AWP is $10,000, what is the reimbursement?

$8,198.50
$8,200.00
$11,801.50
$8,201.50 (Correct answer)

Correct answer: $8,201.50

$10,000 × 0.82 = $8,200, plus the $1.50 fee, equals $8,201.50.

Question 75: Why does a specialty pharmacy check employees against the OIG List of Excluded Individuals/Entities (LEIE)?

To meet USP <800> training requirements
Federal health care programs will not pay for items or services furnished by excluded individuals (Correct answer)
To verify DEA registration
To confirm state pharmacist licensure

Correct answer: Federal health care programs will not pay for items or services furnished by excluded individuals

Employing excluded individuals can lead to civil monetary penalties and repayment of federal program claims.

Question 76: A payer requires a patient with rheumatoid arthritis to fail methotrexate and adalimumab before covering a JAK inhibitor. What utilization management tool is this?

Specialty tier placement
Step therapy (Correct answer)
Quantity limit
Retrospective DUR

Correct answer: Step therapy

Step therapy requires trial and failure of preferred agents before a non-preferred therapy is covered.

Question 77: Abatacept treats rheumatoid arthritis by which mechanism?

Blocking TNF-alpha
Depleting CD20-positive B cells
Inhibiting JAK1 and JAK3
Blocking T-cell costimulation by binding CD80/CD86 (Correct answer)

Correct answer: Blocking T-cell costimulation by binding CD80/CD86

Abatacept is a CTLA-4-Ig fusion protein that binds CD80/CD86 and prevents CD28-mediated T-cell activation.

Question 78: A patient on an oral chemotherapy agent with a 21-days-on, 7-days-off cycle reports taking it daily without breaks. The most appropriate pharmacist action is to:

Advise the patient to skip the next full cycle
Reduce the next dispensed quantity without notifying the prescriber
Contact the prescriber and patient immediately, assess toxicity, and re-educate on the schedule (Correct answer)
Document the issue at the next scheduled refill call

Correct answer: Contact the prescriber and patient immediately, assess toxicity, and re-educate on the schedule

Over-adherence to a cyclic oncolytic can cause serious toxicity, requiring prompt prescriber communication, toxicity assessment, and re-education.

Question 79: Under the HIPAA Safe Harbor method, how is PHI de-identified?

Removing the 18 specified identifiers with no actual knowledge that the rest could identify the person (Correct answer)
Encrypting the entire record with AES-256
Replacing names with initials
Getting written patient consent

Correct answer: Removing the 18 specified identifiers with no actual knowledge that the rest could identify the person

Safe Harbor requires removing 18 listed identifiers, with no actual knowledge that the remaining data could identify the individual.

Question 80: Why is regulatory compliance crucial for healthcare professionals?

To limit patient access to treatments.
To increase pharmaceutical profits.
To prevent legal issues and maintain patient safety (Correct answer)
To reduce the number of healthcare workers.

Correct answer: To prevent legal issues and maintain patient safety

Regulatory compliance is crucial for healthcare professionals because it ensures they operate within legal and ethical boundaries, thereby preventing malpractice lawsuits, fines, and loss of licensure. More importantly, adherence to regulations, such as those for patient privacy, drug safety, and quality standards, directly safeguards patient well-being and promotes high-quality care.

Question 81: A patient is HBsAg-negative and anti-HBc-positive, and is about to start a TNF inhibitor. What is the best approach?

Give hepatitis B vaccine and proceed without monitoring
Monitor HBV DNA and ALT or give antiviral prophylaxis per hepatology guidance (Correct answer)
Check anti-HCV only
Never start any biologic

Correct answer: Monitor HBV DNA and ALT or give antiviral prophylaxis per hepatology guidance

A resolved HBV infection can reactivate under immunosuppression, so monitoring or prophylaxis is recommended.

Question 82: A patient is being initiated on sofosbuvir/velpatasvir for Hepatitis C genotype 1. Their current medication list includes amlodipine, lisinopril, rosuvastatin 20 mg daily, and omeprazole 40 mg daily. Which of the following recommendations is most appropriate for the specialty pharmacist to make?

Advise the patient to take the sofosbuvir/velpatasvir with food, four hours before the omeprazole. (Correct answer)
Discontinue rosuvastatin for the duration of Hepatitis C therapy.
Switch omeprazole to famotidine 40 mg twice daily.
Recommend taking sofosbuvir/velpatasvir and omeprazole at the same time to improve adherence.

Correct answer: Advise the patient to take the sofosbuvir/velpatasvir with food, four hours before the omeprazole.

Velpatasvir's absorption is pH-dependent and is reduced by acid-lowering agents. Co-administration with proton-pump inhibitors (PPIs) like omeprazole is generally not recommended. However, if medically necessary, sofosbuvir/velpatasvir should be administered with food and taken 4 hours before a low dose of omeprazole (e.g., 20 mg).

Question 83: A patient with spinal muscular atrophy (SMA) is prescribed nusinersen (Spinraza). What is a key specialty pharmacy role in managing this therapy?

Performing the lumbar puncture procedure required for administration
Coordinating benefits, site-of-care logistics, and patient support for this high-cost intrathecal therapy (Correct answer)
Dispensing the medication to the patient for self-administration at home
Compounding the intrathecal formulation on-site

Correct answer: Coordinating benefits, site-of-care logistics, and patient support for this high-cost intrathecal therapy

Nusinersen is an intrathecal injection administered by a neurologist; the specialty pharmacy's role centers on benefits investigation, authorization, site-of-care coordination, and patient/caregiver support.

Question 84: How is HCV cure (sustained virologic response) defined?

Negative HCV antibody 6 months after therapy
Undetectable HCV RNA at week 4 of therapy
Normal ALT at the end of therapy
Undetectable HCV RNA 12 weeks after the end of therapy (Correct answer)

Correct answer: Undetectable HCV RNA 12 weeks after the end of therapy

SVR12, meaning undetectable HCV RNA 12 weeks after completing treatment, is considered a virologic cure.

Question 85: Which of the following is a limitation of using pharmacy refill data to assess adherence?

It requires direct observation of dosing
It always overestimates nonadherence for mail-order patients
It confirms medication was obtained but not that it was actually taken (Correct answer)
It cannot be calculated for chronic medications

Correct answer: It confirms medication was obtained but not that it was actually taken

Refill-based measures show possession of medication, not actual ingestion or administration.

Question 86: A patient on oral rilpivirine-containing therapy wants daily omeprazole for GERD. What is the right recommendation?

Take omeprazole 2 hours after rilpivirine
PPIs are contraindicated with rilpivirine; consider alternatives such as properly timed H2 blockers (Correct answer)
Double the rilpivirine dose
No interaction exists; proceed

Correct answer: PPIs are contraindicated with rilpivirine; consider alternatives such as properly timed H2 blockers

PPIs greatly reduce rilpivirine absorption and are contraindicated, while H2 blockers can be used with dose separation.

Question 87: What is the main advantage of a centralized clinical call center model within a large specialty pharmacy organization?

It eliminates the need for pharmacist oversight of dispensing
It removes the requirement for REMS certification
It allows non-pharmacist staff to make clinical decisions independently
It provides consistent, standardized patient counseling and clinical monitoring at scale (Correct answer)

Correct answer: It provides consistent, standardized patient counseling and clinical monitoring at scale

A centralized clinical call center enables specialty pharmacies to deliver standardized, high-quality pharmacist counseling and monitoring to large patient populations while maintaining compliance with accreditation standards.

Question 88: What is the role of a pharmacist in educating patients about new medications?

Prescribing new medications.
Providing clear instructions on the use of medications (Correct answer)
Only providing medications during hospital stays.
Filling prescriptions without patient interaction.

Correct answer: Providing clear instructions on the use of medications

Pharmacists are the medication experts and play a vital role in educating patients about new medications. This includes explaining the drug's purpose, proper dosage, administration technique, potential side effects, and important drug interactions. Clear, comprehensive instructions ensure patients understand how to use their medication safely and effectively, maximizing therapeutic benefits and minimizing risks.

Question 89: A patient reports that a cold-chain package arrived with an indicator showing a temperature excursion. What should the pharmacy do first?

Instruct the patient not to use it, quarantine it, and check stability data with the manufacturer (Correct answer)
Tell the patient to put it in the freezer right away
Ask the patient to return it by regular mail for a refund
Tell the patient to use the drug if it looks normal

Correct answer: Instruct the patient not to use it, quarantine it, and check stability data with the manufacturer

Excursions require quarantine and a stability check with the manufacturer before anyone decides whether the product can be used.

Question 90: During the patient welcome call, which topic is most essential to cover before the first shipment?

Explaining the manufacturer's stock price
Discussing the prescriber's malpractice history
Confirming delivery address, date, and someone available to receive cold-chain shipments (Correct answer)
Reviewing the pharmacy's annual revenue

Correct answer: Confirming delivery address, date, and someone available to receive cold-chain shipments

Confirming delivery logistics prevents lost or temperature-compromised shipments of high-cost medications.

Question 91: Under the standard Medicare Part B payment methodology, most separately payable physician-administered drugs are reimbursed at what rate?

NADAC plus a dispensing fee
AWP minus 15%
ASP plus 6% (Correct answer)
WAC plus 3%

Correct answer: ASP plus 6%

Medicare Part B pays most separately billable drugs at Average Sales Price plus a 6% add-on.

Question 92: What is the main purpose of a refill reminder call ahead of a specialty shipment?

Confirming the patient still needs therapy and checking adherence, side effects, and delivery details (Correct answer)
Upselling extra products
Replacing the pharmacist's clinical assessment
Sending the dispensing fee invoice

Correct answer: Confirming the patient still needs therapy and checking adherence, side effects, and delivery details

Refill calls check ongoing need, adherence, side effects, and delivery details before the pharmacy ships.

Question 93: Which adverse effect of ibrutinib warrants periodic cardiac monitoring and patient counseling?

Bradycardia from AV block only
Pericardial effusion
Atrial fibrillation (Correct answer)
Dilated cardiomyopathy from anthracycline-like toxicity

Correct answer: Atrial fibrillation

Ibrutinib is associated with atrial fibrillation and bleeding, so palpitations should be reported and anticoagulant use carefully assessed.

Question 94: When measuring medication adherence using pharmacy claims data, which metric is generally preferred by quality organizations like the Pharmacy Quality Alliance (PQA) because it avoids overestimating adherence in patients who refill prescriptions early?

Pill Count Ratio (PCR)
Medication Possession Ratio (MPR)
Proportion of Days Covered (PDC) (Correct answer)
Self-Reported Adherence Rate (SRA)

Correct answer: Proportion of Days Covered (PDC)

Proportion of Days Covered (PDC) is often preferred over Medication Possession Ratio (MPR) because it caps the daily value at 1, preventing the numerator (days covered) from exceeding the denominator (days in the period) and thus avoiding an overestimation of adherence. Quality organizations like PQA and the National Committee for Quality Assurance (NCQA) use PDC for their performance measures.

Question 95: For a patient with Gaucher disease type 1 starting enzyme replacement therapy (ERT) with imiglucerase (Cerezyme), what is the MOST important pharmacist counseling point regarding administration?

The patient must avoid all live vaccines while on therapy
Infusion reactions may occur, and premedication and close monitoring during infusions are recommended (Correct answer)
The medication can be self-injected subcutaneously at home without training
The drug should be taken with food to improve absorption

Correct answer: Infusion reactions may occur, and premedication and close monitoring during infusions are recommended

Infusion-related reactions are the most common adverse effects of imiglucerase; patients should be informed about symptoms and the importance of premedication and monitoring at the infusion site.

Question 96: Which laboratory change is an expected effect of tocilizumab that needs monitoring?

Increased hemoglobin A1c
Decreased serum calcium
Increased total and LDL cholesterol (Correct answer)
Decreased serum potassium

Correct answer: Increased total and LDL cholesterol

IL-6 blockade raises lipid levels, so lipids are checked about 4-8 weeks after starting and then periodically.

Question 97: A Medicare beneficiary is prescribed oral capecitabine. Under which benefit may it be covered because it has an injectable equivalent (fluorouracil)?

Part C supplemental benefit only
Medigap Plan G
Part B (Correct answer)
Part A

Correct answer: Part B

Part B covers oral anticancer drugs that have the same active ingredient or are prodrugs of an injectable equivalent, such as capecitabine.

Question 98: A specialty pharmacy determines that a product it received is illegitimate under the DSCSA. Within what time frame must it notify FDA and affected trading partners?

Within 7 days
Within 30 days
Within 24 hours (Correct answer)
Within 72 hours

Correct answer: Within 24 hours

Once a product is determined illegitimate, FDA and trading partners must be notified within 24 hours, typically using FDA Form 3911.

Question 99: Which pricing benchmark is the manufacturer's list price to wholesalers or direct purchasers, excluding discounts and rebates?

Average Manufacturer Price (AMP)
Federal Upper Limit (FUL)
Average Sales Price (ASP)
Wholesale Acquisition Cost (WAC) (Correct answer)

Correct answer: Wholesale Acquisition Cost (WAC)

WAC is the manufacturer's published list price to wholesalers and does not include prompt-pay or other discounts.

Question 100: Which of the following is the PRIMARY purpose of a 'hub service' in the context of specialty pharmacy fulfillment?

To act as the sole distributor for all limited distribution drugs.
To exclusively manage the cold chain logistics for temperature-sensitive medications.
To centralize and streamline patient access services like benefits investigation and prior authorization. (Correct answer)
To provide clinical trial enrollment services for new specialty drugs.

Correct answer: To centralize and streamline patient access services like benefits investigation and prior authorization.

Hub services act as a central coordination point to help patients navigate the complex process of starting a specialty medication. Their primary function is to manage patient access services, which includes benefits verification, navigating the prior authorization process, and identifying financial assistance programs. This support helps to reduce delays and ensure patients can start therapy as quickly as possible.

Question 101: Which specialty pharmacy accreditation standard most directly requires documentation of patient-specific clinical interventions?

DEA Schedule II record-keeping requirements
USP <797> sterile compounding guidelines
URAC/ACHC clinical management standards (Correct answer)
HIPAA Privacy Rule

Correct answer: URAC/ACHC clinical management standards

URAC and ACHC clinical management accreditation standards require specialty pharmacies to document patient-specific pharmacist interventions, including clinical assessments, counseling, and follow-up actions.

Question 102: A specialty pharmacy dispenses a 30-day supply of a high-cost injectable biologic and the patient calls three days later saying it was damaged in transit. What is the BEST course of action?

Immediately replace the shipment, file a carrier claim, and document the incident (Correct answer)
Advise the patient to use the damaged product and report the issue later
Ask the patient to return the product before replacement is considered
Inform the patient that replacement is the prescriber's responsibility

Correct answer: Immediately replace the shipment, file a carrier claim, and document the incident

Specialty pharmacies must ensure patients have uninterrupted therapy; replacing damaged product immediately, filing a carrier claim, and documenting the incident addresses patient safety, financial recovery, and quality reporting.

Question 103: Which statement best describes emicizumab for hemophilia A?

A subcutaneous bispecific antibody that mimics factor VIIIa and works with or without inhibitors (Correct answer)
A gene therapy given as a single IV infusion for hemophilia B
An IV recombinant factor IX product dosed daily
An oral factor Xa inhibitor used for prophylaxis

Correct answer: A subcutaneous bispecific antibody that mimics factor VIIIa and works with or without inhibitors

Emicizumab bridges factors IXa and X to replace factor VIIIa function and is effective in patients with inhibitors.

Question 104: Which adherence tool aligns all of a patient's chronic medication refills to a single monthly pickup or delivery date?

Prior authorization renewal
Automatic refill authorization
Medication synchronization (Correct answer)
Therapeutic interchange

Correct answer: Medication synchronization

Medication synchronization coordinates refill dates so patients obtain all medications on one day, reducing missed refills.

Question 105: Which vaccine should generally be avoided in a patient actively receiving a biologic immunosuppressant such as infliximab?

Inactivated influenza vaccine
Recombinant zoster vaccine (Shingrix)
Measles, mumps, rubella (MMR) (Correct answer)
Pneumococcal conjugate vaccine

Correct answer: Measles, mumps, rubella (MMR)

Live attenuated vaccines like MMR are contraindicated during biologic immunosuppression, while inactivated and recombinant vaccines can be given.

Question 106: A specialty pharmacist is reviewing a prescription for lenalidomide (Revlimid). What REMS program governs its dispensing?

REVLIMID REMS (formerly RevAssist) (Correct answer)
LEN-SAFE program
LENALID REMS Access
IMiDs REMS Consortium

Correct answer: REVLIMID REMS (formerly RevAssist)

Lenalidomide is dispensed under the REVLIMID REMS (formerly RevAssist), which requires patient enrollment, pregnancy prevention for females, and confirmation of negative pregnancy tests before each dispense.

Question 107: Under the bosentan REMS, which monitoring is required every month during treatment?

Liver aminotransferases (Correct answer)
Fasting lipid panel
Serum potassium
Serum creatinine

Correct answer: Liver aminotransferases

Bosentan is hepatotoxic and requires monthly liver aminotransferase monitoring; patients who can become pregnant also need monthly pregnancy tests.

Question 108: Which screening is required before initiating a TNF inhibitor such as adalimumab?

HLA-B*5801 genotyping
TPMT activity
G6PD level
Latent tuberculosis testing (Correct answer)

Correct answer: Latent tuberculosis testing

TNF inhibitors carry a boxed warning for serious infections, including TB reactivation, so latent TB screening is required.

Question 109: A specialty pharmacy employee accidentally sends an email containing a patient's PHI to an incorrect recipient. The pharmacy immediately contacts the recipient, confirms the email was deleted, and performs a risk assessment. The assessment concludes there is a low probability of compromise because the recipient is a known business associate under a BAA who acted in good faith and did not further disclose the information. According to the HIPAA Breach Notification Rule, what is the pharmacy's required action?

Notify the patient and the media within 60 days.
Report the incident to the Office for Civil Rights (OCR) immediately.
Offer complimentary credit monitoring to the affected patient for one year.
Document the incident and the risk assessment; no formal notification is required. (Correct answer)

Correct answer: Document the incident and the risk assessment; no formal notification is required.

An impermissible disclosure of PHI is presumed to be a breach unless the covered entity can demonstrate a 'low probability that the PHI has been compromised' through a documented, four-factor risk assessment. If the assessment concludes a low probability of compromise, the event is not considered a reportable breach, and notification to the patient or HHS is not required. However, the entity must maintain documentation of the incident and the risk assessment that led to this conclusion.

Question 110: Which drug interaction with sofosbuvir-containing HCV regimens can cause serious symptomatic bradycardia?

Atorvastatin
Metformin
Amiodarone (Correct answer)
Levothyroxine

Correct answer: Amiodarone

Giving amiodarone with sofosbuvir-based regimens has caused serious symptomatic bradycardia, including fatal cases.

Question 111: Which element is most important in the initial clinical assessment during specialty patient onboarding?

Confirming the patient's social media accounts
Reviewing current medications, allergies, and comorbidities for interactions and contraindications (Correct answer)
Verifying the patient's credit score
Collecting the patient's employer history

Correct answer: Reviewing current medications, allergies, and comorbidities for interactions and contraindications

A baseline clinical assessment identifies drug interactions, contraindications, and monitoring needs before therapy starts.

Question 112: A patient with psoriasis also has active Crohn's disease. Which drug class should generally be avoided?

IL-17A inhibitors (Correct answer)
TNF inhibitors
IL-23 inhibitors
IL-12/23 inhibitors

Correct answer: IL-17A inhibitors

IL-17 inhibitors such as secukinumab and ixekizumab have been linked to new onset or worsening of inflammatory bowel disease.

Question 113: According to the 2021 IDSA/SHEA guidelines for an initial episode of non-severe Clostridioides difficile infection (CDI), which of the following is the preferred treatment?

Fidaxomicin 200 mg orally twice daily for 10 days (Correct answer)
Vancomycin 125 mg orally four times daily for 10 days
Rifaximin 400 mg orally three times daily for 20 days following a course of vancomycin
Metronidazole 500 mg orally three times daily for 10 days

Correct answer: Fidaxomicin 200 mg orally twice daily for 10 days

The 2021 focused update from IDSA/SHEA suggests using fidaxomicin over a standard course of vancomycin for an initial CDI episode. This is a conditional recommendation based on moderate certainty of evidence, placing a high value on fidaxomicin's beneficial effects, though vancomycin remains an acceptable alternative.

Question 114: A shipment needs a signature on delivery. Why is this commonly required for high-cost specialty medications?

To confirm receipt, make sure the drug is not left unattended, and reduce diversion or loss (Correct answer)
To collect copays at the door
To speed up delivery
Because the law requires it for all prescriptions

Correct answer: To confirm receipt, make sure the drug is not left unattended, and reduce diversion or loss

Signature confirmation provides chain-of-custody documentation and protects costly or temperature-sensitive drugs.

Question 115: A specialty pharmacy's limited distribution drug (LDD) contract requires it to report dispensing data to the manufacturer monthly. This is BEST described as a requirement of which program type?

Medicaid rebate agreement
340B program
REMS program
Limited Distribution Network (LDN) agreement (Correct answer)

Correct answer: Limited Distribution Network (LDN) agreement

Limited Distribution Network agreements between manufacturers and select specialty pharmacies typically include data reporting obligations as a condition of participation.

Question 116: In the context of a specialty pharmacy's patient management program, which activity best demonstrates the pharmacist's role in improving patient outcomes beyond simply measuring adherence?

Ensuring all prescriptions are filled and shipped within the pharmacy's turnaround time goals.
Proactively assessing for side effects and collaborating with the prescriber to manage them. (Correct answer)
Generating a monthly report of the pharmacy's average Proportion of Days Covered (PDC).
Confirming the patient's shipping address and payment details before each refill.

Correct answer: Proactively assessing for side effects and collaborating with the prescriber to manage them.

Improving outcomes requires more than ensuring the patient has the medication. Proactive clinical management, such as assessing and managing side effects, addresses a key therapy-related barrier to adherence. This collaborative action helps the patient tolerate the therapy, remain adherent, and achieve the desired clinical goals, directly impacting their health outcome. The other options are primarily operational or administrative tasks.

Question 117: Before starting tofacitinib, which vaccine is recommended because of increased infection risk with JAK inhibitors?

Live zoster vaccine during therapy
Oral typhoid vaccine
Yellow fever vaccine
Recombinant zoster vaccine (Correct answer)

Correct answer: Recombinant zoster vaccine

JAK inhibitors raise the risk of herpes zoster, and the non-live recombinant zoster vaccine is preferred before or during therapy.

Question 118: A specialty pharmacy receives an e-prescription for a limited distribution drug (LDD) that the pharmacy is not in the manufacturer's network to dispense. What is the most appropriate intake action?

Transfer the prescription to an in-network specialty pharmacy and notify the prescriber and patient (Correct answer)
Return the prescription to the prescriber with no further communication
Hold the prescription until the manufacturer adds the pharmacy to its network
Order the drug from a wholesaler and dispense it anyway

Correct answer: Transfer the prescription to an in-network specialty pharmacy and notify the prescriber and patient

LDDs can only be dispensed by pharmacies in the manufacturer's network, so prompt transfer with notification prevents delays in therapy.

Question 119: A specialty pharmacy that ships to patients in multiple states typically must hold:

Only URAC accreditation
Only a license in its home state
Only a DEA registration
A nonresident pharmacy license in each state where it ships, as state law requires (Correct answer)

Correct answer: A nonresident pharmacy license in each state where it ships, as state law requires

Most states require out-of-state pharmacies shipping into the state to obtain a nonresident pharmacy license or registration.

Question 120: What is the importance of patient-centered care in counseling?

Focusing only on prescribing medications.
Incorporating the patient's values into treatment decisions (Correct answer)
Focusing only on the disease.
Forcing the patient to follow treatment.

Correct answer: Incorporating the patient's values into treatment decisions

Patient-centered care emphasizes treating the whole person, not just the disease. In counseling, this means actively listening to the patient's preferences, beliefs, and values, and integrating them into the shared decision-making process regarding their treatment plan. This approach respects patient autonomy, improves satisfaction, and enhances adherence by aligning care with what matters most to the individual.

Question 121: In specialty pharmacy, what does the term 'days supply at risk' refer to?

The value of medication inventory that may not be reimbursed due to patient non-adherence or therapy discontinuation (Correct answer)
The number of days a medication has been outside required storage conditions
The days remaining on a pharmacist's DEA registration
The expiration dating window for compounded specialty products

Correct answer: The value of medication inventory that may not be reimbursed due to patient non-adherence or therapy discontinuation

Days supply at risk quantifies the financial exposure from dispensed medication that a specialty pharmacy may not recover payment for if a patient discontinues therapy or insurance coverage lapses.

Question 122: Under URAC specialty pharmacy accreditation standards, how frequently must a pharmacist-conducted clinical review occur for patients on complex specialty therapies?

Every 90 days
Per URAC standards, at least annually with more frequent review based on clinical need (Correct answer)
At every refill
Only at initiation of therapy

Correct answer: Per URAC standards, at least annually with more frequent review based on clinical need

URAC requires at minimum an annual clinical pharmacist review, but standards call for more frequent review when patient complexity, adverse effects, or adherence issues warrant it.

Question 123: Which factor is MOST likely to contribute to unintentional nonadherence in an elderly patient on a complex regimen?

Belief that the drug is unnecessary
Distrust of the prescriber
Concern about long-term side effects
Forgetfulness and regimen complexity (Correct answer)

Correct answer: Forgetfulness and regimen complexity

Unintentional nonadherence typically stems from forgetfulness, confusion, or complex dosing schedules rather than deliberate choice.

Question 124: Which screening test is required before initiating adalimumab therapy?

Latent tuberculosis test (IGRA or TST) (Correct answer)
Thyroid-stimulating hormone
Serum ferritin
Antinuclear antibody titer

Correct answer: Latent tuberculosis test (IGRA or TST)

TNF inhibitors carry a boxed warning for serious infections including TB reactivation, so latent TB screening is required before starting.

Question 125: A CMV-seropositive HSCT recipient starts letermovir prophylaxis. Which additional antiviral prophylaxis is still needed?

None; letermovir covers all herpesviruses
Ganciclovir, given together for synergy
Acyclovir for HSV/VZV, because letermovir has no activity against them (Correct answer)
Oseltamivir year-round

Correct answer: Acyclovir for HSV/VZV, because letermovir has no activity against them

Letermovir targets the CMV terminase complex and does not cover HSV or VZV, so acyclovir prophylaxis continues.

Question 126: PBM spread pricing occurs when the PBM does what?

Sets copays equal to the drug's WAC
Charges the plan sponsor more than it reimburses the pharmacy and keeps the difference (Correct answer)
Passes all rebates to the patient at the point of sale
Pays pharmacies above the plan sponsor's billed amount

Correct answer: Charges the plan sponsor more than it reimburses the pharmacy and keeps the difference

In spread pricing, the PBM retains the margin between what it bills the plan and what it pays the pharmacy.

Question 127: A specialty pharmacy is evaluating 'time to fill' as an intake metric. What does it measure?

Time a medication spends in refrigeration
Time between refills
Time the patient spends on hold with customer service
Time from referral receipt to medication dispensing or shipment (Correct answer)

Correct answer: Time from referral receipt to medication dispensing or shipment

Turnaround or time-to-fill tracks how quickly a referral moves through benefits investigation, authorization, and dispensing.

Question 128: A patient enrolled in the mycophenolate (CellCept/Myfortic) REMS program must be counseled about which primary risk?

Hepatic veno-occlusive disease
QT interval prolongation
Serotonin syndrome
Teratogenicity and pregnancy loss (Correct answer)

Correct answer: Teratogenicity and pregnancy loss

The mycophenolate REMS focuses on teratogenicity; the drug causes pregnancy loss and congenital malformations, requiring females to use contraception and avoid pregnancy.

Question 129: Under the Drug Supply Chain Security Act (DSCSA), what must dispensers be able to do with prescription drug packages?

Ship only via U.S. Postal Service
Verify product identifiers and exchange transaction data electronically (Correct answer)
Re-label them with pharmacy NDCs
Keep products for 10 years after dispensing

Correct answer: Verify product identifiers and exchange transaction data electronically

DSCSA requires interoperable electronic tracing and verification of product identifiers across the supply chain.

Question 130: What is the importance of understanding pharmacoeconomics for healthcare professionals?

It increases medication prices.
It helps make informed decisions on therapy, balancing cost and outcomes (Correct answer)
It reduces the need for healthcare education.
It focuses only on cost reduction.

Correct answer: It helps make informed decisions on therapy, balancing cost and outcomes

Understanding pharmacoeconomics is essential for healthcare professionals because it empowers them to make informed decisions about patient care that balance clinical effectiveness with economic considerations. This knowledge helps in selecting therapies that offer the best outcomes for patients while being mindful of resource constraints and healthcare system sustainability. Ultimately, it leads to more efficient and equitable healthcare delivery.

Question 131: Oral rilpivirine is contraindicated with which medication class?

Thiazide diuretics
Statins
Proton pump inhibitors (Correct answer)
SSRIs

Correct answer: Proton pump inhibitors

PPIs raise gastric pH and sharply lower rilpivirine absorption, which can lead to virologic failure and resistance.

Question 132: A specialty pharmacy's quality assurance program identifies a trend of incorrect dosing for a weight-based biologic. What is the MOST systematic corrective action?

Discontinue dispensing the biologic until the issue resolves
Implement a mandatory pharmacist double-check workflow and update the dispensing system to prompt weight-based dose verification (Correct answer)
Report the errors to the FDA and wait for guidance
Retrain individual pharmacists identified in the errors

Correct answer: Implement a mandatory pharmacist double-check workflow and update the dispensing system to prompt weight-based dose verification

Systematic corrective actions such as workflow redesign and system-level prompts address root causes more effectively than individual retraining alone, reducing recurrence across the entire organization.

Question 133: A commercially insured patient cannot afford a $3,000 specialty copay. Which resource is typically the first option to check for this patient?

Manufacturer copay assistance card (Correct answer)
Medicaid spend-down program
Medicare Extra Help (LIS)
State pharmaceutical assistance program for seniors

Correct answer: Manufacturer copay assistance card

Manufacturer copay cards are generally available to commercially insured patients and can sharply reduce out-of-pocket costs.

Question 134: What is the primary purpose of regulatory compliance in healthcare?

To make healthcare more profitable.
To reduce the need for medications.
To increase healthcare costs.
To ensure patient safety and maintain quality standards (Correct answer)

Correct answer: To ensure patient safety and maintain quality standards

Regulatory compliance in healthcare involves adhering to laws, regulations, and guidelines set by government bodies and professional organizations. Its primary purpose is to protect patients by ensuring that healthcare services, products, and practices meet established safety, efficacy, and quality standards. This minimizes risks and promotes optimal care.

Question 135: Omalizumab carries a boxed warning for which reaction, so patients must be observed after dosing?

Progressive multifocal leukoencephalopathy
Hepatic failure
Anaphylaxis (Correct answer)
Lactic acidosis

Correct answer: Anaphylaxis

Anaphylaxis can happen after any dose, including late in therapy, so observation after injection and an epinephrine prescription are recommended.

Question 136: Routinely waiving copayments for Medicare beneficiaries without a documented financial hardship assessment may violate:

Only state consumer protection laws
The Anti-Kickback Statute and Civil Monetary Penalties Law beneficiary inducement provisions (Correct answer)
USP <797> standards
DSCSA product tracing rules

Correct answer: The Anti-Kickback Statute and Civil Monetary Penalties Law beneficiary inducement provisions

Routine copay waivers can be treated as inducements under the AKS and the beneficiary inducement CMP, unless based on individualized financial need.

Question 137: Which type of product typically requires cryogenic or ultra-cold shipment, unlike most refrigerated biologics?

Etanercept prefilled syringes
Adalimumab prefilled pens
Autologous cell therapies such as CAR-T products (Correct answer)
Insulin glargine pens

Correct answer: Autologous cell therapies such as CAR-T products

CAR-T and other cell therapies are shipped cryopreserved in liquid-nitrogen vapor dry shippers.

Question 138: Which outcome would a specialty pharmacy track as a clinical outcome for a rheumatoid arthritis patient on a biologic?

Disease activity score (e.g., DAS28) (Correct answer)
Number of refill reminder calls
Copay assistance dollars secured
Days to dispense

Correct answer: Disease activity score (e.g., DAS28)

DAS28 measures RA disease activity and is a clinical outcome, while the others are operational or economic metrics.

Question 139: Which HCV regimen is contraindicated in a patient with decompensated (Child-Pugh B or C) cirrhosis?

Sofosbuvir/velpatasvir plus ribavirin
Glecaprevir/pibrentasvir (Correct answer)
Sofosbuvir/velpatasvir
Ledipasvir/sofosbuvir

Correct answer: Glecaprevir/pibrentasvir

Regimens containing an NS3/4A protease inhibitor, such as glecaprevir, are contraindicated in decompensated cirrhosis because of hepatotoxicity risk.

Question 140: What is the primary purpose of a cold chain audit in specialty pharmacy operations?

To ensure temperature-sensitive medications were maintained within required ranges during shipping (Correct answer)
To confirm that pharmacists are licensed in the patient's state
To validate that copay assistance was correctly applied
To verify patient insurance eligibility

Correct answer: To ensure temperature-sensitive medications were maintained within required ranges during shipping

Cold chain audits verify that temperature-sensitive biologics and other specialty products remained within required temperature ranges from manufacturer to patient, protecting drug integrity and patient safety.

Question 141: Coadministration of sofosbuvir-containing regimens with which drug can cause symptomatic bradycardia?

Metoprolol tartrate at low dose
Lisinopril
Amiodarone (Correct answer)
Atorvastatin

Correct answer: Amiodarone

Serious symptomatic bradycardia has been reported when amiodarone is combined with sofosbuvir-based regimens.

Question 142: Venetoclax for CLL is started with a 5-week dose ramp-up primarily to reduce the risk of which complication?

Hepatotoxicity
Tumor lysis syndrome (Correct answer)
Interstitial lung disease
Cardiac arrhythmia

Correct answer: Tumor lysis syndrome

Venetoclax rapidly kills CLL cells, so gradual titration from 20 mg to 400 mg with hydration and monitoring mitigates TLS.

Question 143: What is an independent charitable foundation's key requirement when assisting Medicare beneficiaries with specialty drug cost sharing?

It can only assist patients with commercial insurance
It must require the patient to use a specific manufacturer's product
It must be owned by the dispensing pharmacy
It must not be controlled by a donating manufacturer or steer patients to specific products (Correct answer)

Correct answer: It must not be controlled by a donating manufacturer or steer patients to specific products

OIG guidance requires independent foundations to be free of donor control and to define disease funds broadly without favoring a donor's drug.

Question 144: Under the Inflation Reduction Act, how are qualifying biosimilars temporarily reimbursed under Medicare Part B?

Biosimilar ASP plus 8% of the reference product's ASP (Correct answer)
Reference product WAC plus 3%
Biosimilar AWP minus 10%
Biosimilar ASP plus 6% of the biosimilar's ASP

Correct answer: Biosimilar ASP plus 8% of the reference product's ASP

The IRA raised the add-on for qualifying biosimilars from 6% to 8% of the reference product's ASP for five years.

Question 145: What is the primary goal of specialty drug therapies in managing complex diseases?

To manage symptoms and improve quality of life (Correct answer)
To eliminate the need for other treatments.
To cure the disease.
To prevent recurrence.

Correct answer: To manage symptoms and improve quality of life

Specialty drug therapies are often used for complex, chronic, or rare diseases that require specialized handling, administration, and monitoring. While they may not always offer a cure, their primary goal is to effectively manage disease symptoms, slow progression, prevent complications, and ultimately enhance the patient's overall quality of life.

Question 146: Which final check is performed by the pharmacist before a specialty prescription is released for shipment?

Approving the manufacturer rebate
Verifying the patient's credit score
Choosing the shipping carrier
Product verification: correct drug, strength, quantity, labeling, and the clinical appropriateness of the prescription (Correct answer)

Correct answer: Product verification: correct drug, strength, quantity, labeling, and the clinical appropriateness of the prescription

Final pharmacist verification confirms dispensing accuracy and clinical appropriateness before release.

Question 147: Osimertinib is preferred in non-small cell lung cancer harboring which mutation, including resistance mutations?

ALK rearrangement
EGFR mutations including T790M (Correct answer)
KRAS G12C
BRAF V600E

Correct answer: EGFR mutations including T790M

Osimertinib is a third-generation EGFR TKI active against sensitizing EGFR mutations and T790M resistance.

Question 148: A patient starting sofosbuvir/velpatasvir also takes amiodarone. What is the primary safety concern?

Serious symptomatic bradycardia (Correct answer)
QT prolongation with torsades de pointes
Increased risk of HCV virologic failure
Severe hepatotoxicity

Correct answer: Serious symptomatic bradycardia

Giving sofosbuvir with amiodarone can cause serious, sometimes fatal, symptomatic bradycardia.

Question 149: Under the HIPAA Breach Notification Rule, a breach affecting 500 or more residents of a state requires notification of which party in addition to individuals and HHS?

The patient's insurer
The state board of pharmacy only
Prominent media outlets serving that state (Correct answer)
The drug manufacturer

Correct answer: Prominent media outlets serving that state

Breaches affecting more than 500 residents of a state or jurisdiction require notice to prominent media outlets in that area.

Question 150: A modeler draws all input parameters at once from probability distributions over 10,000 Monte Carlo iterations. Which technique is this?

Scenario analysis
Threshold analysis
Probabilistic sensitivity analysis (Correct answer)
One-way sensitivity analysis

Correct answer: Probabilistic sensitivity analysis

Probabilistic sensitivity analysis varies all uncertain parameters at once using distributions and often produces cost-effectiveness acceptability curves.

Question 151: A specialty pharmacist is counseling a patient starting on an interleukin-6 (IL-6) inhibitor, such as tocilizumab or sarilumab, for rheumatoid arthritis. In addition to the risk of serious infections, which of the following laboratory parameters requires routine monitoring with this class of medication?

Absolute neutrophil count (ANC) and liver function tests (LFTs) (Correct answer)
Creatine phosphokinase (CPK)
Serum uric acid
Serum creatinine and BUN

Correct answer: Absolute neutrophil count (ANC) and liver function tests (LFTs)

Interleukin-6 (IL-6) inhibitors are associated with hematologic and hepatic adverse effects. Routine monitoring of the absolute neutrophil count (ANC) for neutropenia and liver function tests (LFTs) for transaminitis is required. Dose adjustments or discontinuation may be necessary based on these lab values. Hyperlipidemia is also a concern, but neutropenia and LFT elevations are key monitoring parameters that can lead to immediate changes in therapy.

Question 152: What is the first step in patient counseling for a newly diagnosed disease?

Listening to the patient and explaining treatment options (Correct answer)
Prescribing medications immediately.
Providing medication without discussion.
Discussing the cost of treatment.

Correct answer: Listening to the patient and explaining treatment options

The first step in patient counseling for a newly diagnosed disease is to establish trust and understand the patient's perspective, concerns, and existing knowledge. By actively listening, the pharmacist can then tailor explanations of the disease and treatment options to the patient's individual needs. This fosters engagement and informed decision-making, establishing a foundational patient-centered approach.

Question 153: For patients with Fabry disease receiving agalsidase beta (Fabrazyme), which adverse effect requires pharmacist patient education BEFORE each infusion?

Nephrotoxicity requiring dose adjustment based on eGFR
Severe hepatotoxicity requiring liver function monitoring
Photosensitivity requiring sunscreen application
Infusion-associated reactions including fever, chills, hypertension, and urticaria (Correct answer)

Correct answer: Infusion-associated reactions including fever, chills, hypertension, and urticaria

Infusion-associated reactions are among the most common adverse effects with agalsidase beta; patients should be premedicated and counseled to report symptoms such as fever, chills, and skin reactions during infusion.

Question 154: Under the 2023 revision of USP <797>, what is the maximum beyond-use date for a Category 1 compounded sterile preparation stored in a refrigerator?

4 days
9 days
24 hours (Correct answer)
12 hours

Correct answer: 24 hours

Category 1 CSPs have a BUD of no more than 12 hours at controlled room temperature or 24 hours refrigerated.

Question 155: Which counseling point is correct for nilotinib?

Crush and mix with applesauce for better tolerability
Take on an empty stomach, avoiding food 2 hours before and 1 hour after each dose (Correct answer)
Take with a high-fat meal to improve absorption
Take once daily at bedtime with milk

Correct answer: Take on an empty stomach, avoiding food 2 hours before and 1 hour after each dose

Food markedly increases nilotinib exposure and QT prolongation risk, so it must be taken on an empty stomach.

Question 156: A specialty pharmacist receives a prescription for edaravone (Radicava) for ALS. What is the MOST important logistical consideration for this therapy?

The therapy requires IV infusion in cycles and coordination with an infusion center or home infusion service (Correct answer)
The drug must be administered at a hospital inpatient unit
The prescription requires DEA Schedule II documentation
The drug is self-administered orally once daily with no special handling

Correct answer: The therapy requires IV infusion in cycles and coordination with an infusion center or home infusion service

Edaravone is administered as IV infusions in 28-day cycles (10 infusions per cycle initially); the specialty pharmacy must coordinate with infusion centers or home infusion providers for ongoing access.

Question 157: Under the Medicaid Drug Rebate Program, the basic rebate for single-source and innovator multiple-source drugs is the greater of 23.1% of AMP or what other amount?

AWP minus 15%
WAC minus ASP
ASP plus 6%
AMP minus best price (Correct answer)

Correct answer: AMP minus best price

The basic rebate equals the greater of 23.1% of AMP or the difference between AMP and best price, plus any inflation-based additional rebate.

Question 158: Under the CARA amendments, a Schedule II prescription may be partially filled at the request of the patient or prescriber. What is the limit for dispensing the rest?

6 months, with up to 5 partial fills
90 days from the date written
30 days from the date the prescription was written (Correct answer)
72 hours from the first partial fill

Correct answer: 30 days from the date the prescription was written

CARA allows partial fills of C-II prescriptions, with the total dispensed within 30 days of the date written.

Question 159: Under 21 CFR Part 208, when must a pharmacy give a patient an FDA-required Medication Guide?

Only for Schedule II drugs
Each time the drug is dispensed (Correct answer)
Only on the first fill
Only if the patient asks

Correct answer: Each time the drug is dispensed

Medication Guides must be provided with each dispensing of a drug that requires one, including refills.

Question 160: How is long-acting cabotegravir/rilpivirine (Cabenuva) given for HIV treatment?

Deltoid intramuscular injection weekly
Intravenous infusion every 4 weeks
Gluteal intramuscular injections monthly or every 2 months (Correct answer)
Subcutaneous abdominal injection every 6 months

Correct answer: Gluteal intramuscular injections monthly or every 2 months

Cabenuva is given as two separate gluteal IM injections, either monthly or every 2 months after initiation.

Question 161: A caregiver will give a patient an oral chemotherapy tablet at home. Which safe-handling instruction is correct?

Store tablets in a shared pill organizer with other family medicines
Throw unused tablets in household trash
Wear disposable gloves when handling the tablets (Correct answer)
Crush tablets to make swallowing easier

Correct answer: Wear disposable gloves when handling the tablets

Oral antineoplastics are hazardous drugs, so caregivers should wear gloves, avoid crushing, and follow specific disposal instructions.

Question 162: How long must dispensers retain DSCSA transaction documentation?

At least 10 years
At least 3 years
At least 6 years (Correct answer)
At least 2 years

Correct answer: At least 6 years

DSCSA requires trading partners to keep transaction information, history, and statements for no less than 6 years.

Question 163: Which adverse effect is characteristically associated with dasatinib?

Pleural effusion (Correct answer)
Peripheral neuropathy
Hyperglycemia
Hemorrhagic cystitis

Correct answer: Pleural effusion

Dasatinib commonly causes fluid retention including pleural effusions, sometimes requiring dose interruption or reduction.

Question 164: Which HCV regimen is pangenotypic and typically given for 12 weeks?

Ribavirin monotherapy
Elbasvir/grazoprevir
Ledipasvir/sofosbuvir
Sofosbuvir/velpatasvir (Correct answer)

Correct answer: Sofosbuvir/velpatasvir

Sofosbuvir/velpatasvir covers genotypes 1 to 6 with a standard 12-week course.

Question 165: Why can't manufacturer copay coupons be used by Medicare Part D beneficiaries?

The pharmacy chooses not to accept them
The federal Anti-Kickback Statute prohibits them for federal healthcare program beneficiaries (Correct answer)
Medicare covers all specialty drugs in full
They expire too fast

Correct answer: The federal Anti-Kickback Statute prohibits them for federal healthcare program beneficiaries

The Anti-Kickback Statute bars manufacturer copay assistance for federal program enrollees.

Question 166: Which oral chemotherapy agent carries a boxed warning for increased bleeding risk and INR elevation when given with warfarin?

Abiraterone
Temozolomide
Anastrozole
Capecitabine (Correct answer)

Correct answer: Capecitabine

Capecitabine can markedly raise INR in patients on warfarin, so frequent INR monitoring is required.

Question 167: Why is the reimbursement process important in pharmacoeconomics?

It ensures that providers are paid for services while managing cost-effectiveness (Correct answer)
It eliminates the need for patient education.
It decreases healthcare access.
It increases the cost of healthcare.

Correct answer: It ensures that providers are paid for services while managing cost-effectiveness

The reimbursement process is vital in pharmacoeconomics as it determines how healthcare providers and pharmaceutical companies are compensated for services and medications. By linking reimbursement decisions to cost-effectiveness data, payers can ensure that treatments offering good value are covered, while managing overall healthcare expenditures. This mechanism encourages the adoption of efficient and effective therapies while controlling costs.

Question 168: In a motivational interviewing session, which pharmacist statement is an example of reflective listening?

Most patients don't have any trouble with this drug.
You need to take your injection every week.
It sounds like you're worried the injections will interfere with your work schedule. (Correct answer)
Why haven't you been taking your medication?

Correct answer: It sounds like you're worried the injections will interfere with your work schedule.

Reflective listening restates the patient's feelings or concerns, which builds engagement without judgment.

Question 169: Why do manufacturers often use limited distribution networks for specialty drugs?

To control handling and data reporting, and to support REMS or complex patient support (Correct answer)
To let any retail pharmacy dispense the drug
To lower the drug's list price
To avoid FDA approval requirements

Correct answer: To control handling and data reporting, and to support REMS or complex patient support

Limited distribution lets manufacturers make sure handling, patient support, and data reporting are done properly.

Question 170: A patient on nivolumab develops asymptomatic hypothyroidism with elevated TSH. What is the most appropriate management?

Permanently discontinue nivolumab
Continue nivolumab and start levothyroxine replacement (Correct answer)
Start methimazole
Start high-dose prednisone

Correct answer: Continue nivolumab and start levothyroxine replacement

Immune-related hypothyroidism is managed with hormone replacement, and immunotherapy can usually continue.

Question 171: What is the purpose of cost-benefit analysis in pharmacoeconomics?

To simplify reimbursement procedures.
To increase treatment costs.
To compare the benefits of a drug to its costs (Correct answer)
To evaluate patient satisfaction.

Correct answer: To compare the benefits of a drug to its costs

Cost-benefit analysis in pharmacoeconomics aims to compare the total monetary costs of a drug or intervention with its total monetary benefits. Unlike cost-effectiveness, which measures benefits in natural units (e.g., life-years), cost-benefit analysis converts all outcomes, including health benefits, into monetary terms. This allows for a direct comparison to determine if the monetary benefits outweigh the costs, providing a clear economic justification for an intervention.

Question 172: Which counseling point is most important for a patient starting omalizumab?

Expect hair loss in the first month
Avoid all dairy products
Recognize anaphylaxis symptoms, which can occur even after several doses (Correct answer)
Take it with food to prevent nausea

Correct answer: Recognize anaphylaxis symptoms, which can occur even after several doses

Omalizumab has a boxed warning for anaphylaxis, which can happen after any dose, including late in therapy.

Question 173: What is the significance of a collaborative approach in patient management?

It improves patient outcomes through teamwork (Correct answer)
It forces the patient to follow the treatment plan.
It delays the treatment process.
It focuses on individual treatment from one provider.

Correct answer: It improves patient outcomes through teamwork

A collaborative approach in patient management involves healthcare professionals from different disciplines working together, sharing information, and coordinating care. This teamwork ensures a holistic view of the patient's needs, reduces medical errors, and optimizes treatment plans. Ultimately, it leads to better, more integrated care and improved health outcomes.

Question 174: For Medicare Part D, the specialty tier cost threshold in 2025 and 2026 is based on a drug's negotiated price exceeding what monthly amount?

$670 per 30-day supply
$100 per 30-day supply
$2,000 per 30-day supply
$950 per 30-day supply (Correct answer)

Correct answer: $950 per 30-day supply

CMS set the Part D specialty tier threshold at $950 per month for recent plan years.

Question 175: A patient on bictegravir/emtricitabine/TAF needs rifampin for latent TB. What is the right action?

Double the Biktarvy dose
Separate the doses by 12 hours
Combine without changes
Do not combine; rifampin greatly lowers bictegravir and TAF levels (Correct answer)

Correct answer: Do not combine; rifampin greatly lowers bictegravir and TAF levels

Rifampin strongly induces CYP3A, UGT1A1, and P-gp, which lowers bictegravir and TAF levels, so the combination is contraindicated.

Question 176: Why do packaging validation studies for cold-chain shippers test both summer and winter profiles?

To qualify for ground shipping discounts
To make sure the product stays in range across extreme ambient temperatures, including freezing risk (Correct answer)
To meet holiday shipping rules
To reduce box size

Correct answer: To make sure the product stays in range across extreme ambient temperatures, including freezing risk

Validation in both seasons shows that the pack-out protects against overheating and against freezing.

Certified Specialty Pharmacist (CSP) Exam

The CSP examination certifies pharmacists who demonstrate advanced knowledge and expertise in the specialized practice of specialty pharmacy.

175

Questions

240 min

Time Limit

70%

To Pass

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