Certified Specialty Pharmacist (CSP) Exam — Questions and Answers

Question 1: Before the first fill of a specialty medication, which step usually comes before dispensing?

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

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 2: What is the significance of the Drug Enforcement Administration (DEA) in healthcare?

Monitoring the costs of medications.
Regulating the use of over-the-counter drugs.
Approving all drugs for market release.
Regulating controlled substances to prevent abuse (Correct answer)

Correct answer: Regulating controlled substances to prevent abuse

The Drug Enforcement Administration (DEA) is a federal agency responsible for enforcing the controlled substances laws and regulations of the United States. Its primary significance in healthcare is to prevent the diversion and abuse of controlled substances by regulating their manufacturing, distribution, and dispensing. This helps combat drug addiction and illicit drug trafficking.

Question 3: 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 store the medication in a bathroom cabinet
How to share leftover doses with family
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 4: Which benchmark is derived from CMS surveys of retail pharmacy invoice costs and is used by many state Medicaid programs for ingredient cost reimbursement?

NADAC (Correct answer)
WAC
ASP
AWP

Correct answer: NADAC

NADAC reflects surveyed retail pharmacy acquisition costs and is widely used by state Medicaid programs.

Question 5: A patient on a biologic immunosuppressant asks about vaccines. Which should generally be avoided during therapy?

Recombinant zoster vaccine
Pneumococcal conjugate vaccine
Live vaccines such as MMR (Correct answer)
Inactivated influenza vaccine

Correct answer: Live vaccines such as MMR

Live vaccines may cause disseminated infection in immunosuppressed patients and should be avoided during biologic therapy.

Question 6: A specialty pharmacy is seeking URAC accreditation and is developing its Patient Management program. A core component of these standards requires the pharmacy to have documented processes for which of the following activities?

Offering financial incentives to prescribers for detailed clinical notes.
Compounding non-sterile preparations for off-label indications.
Measuring, monitoring, and reporting on clinical outcomes and patient satisfaction. (Correct answer)
Establishing a marketing program to attract patients from competing pharmacies.

Correct answer: Measuring, monitoring, and reporting on clinical outcomes and patient satisfaction.

URAC's Specialty Pharmacy Accreditation standards place a strong emphasis on demonstrating value and quality through patient-centered care. A fundamental requirement of the Patient Management (PM) standards is that the pharmacy must have a structured program to measure, monitor, analyze, and report on key performance metrics, including patient satisfaction, quality of life, and clinical outcomes.

Question 7: What is the CMS timeframe for a standard Part D coverage determination on a drug request?

30 calendar days
24 hours
72 hours after receiving the request (Correct answer)
14 calendar days

Correct answer: 72 hours after receiving the request

Part D plans must decide standard coverage requests within 72 hours and expedited requests within 24 hours.

Question 8: 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
Pharmacy's existing patient population and payer mix
Data reporting capabilities required by the manufacturer
The pharmacist-in-charge's personal preference for the drug class (Correct answer)

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 9: 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
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)
Obtain only the patient's verbal consent

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 10: Imatinib exerts its therapeutic effect in chronic myeloid leukemia primarily by inhibiting which target?

Janus kinase 2
EGFR tyrosine kinase
BCR-ABL tyrosine kinase (Correct answer)
Bruton's tyrosine kinase

Correct answer: BCR-ABL tyrosine kinase

Imatinib inhibits the constitutively active BCR-ABL tyrosine kinase produced by the Philadelphia chromosome.

Question 11: A CSP is counseling a patient newly prescribed fingolimod (Gilenya) for relapsing MS. Which assessment must be completed BEFORE the first dose?

Cardiac evaluation including ECG and first-dose observation for bradycardia (Correct answer)
Pulmonary function testing
Colonoscopy to assess GI tolerability
Bone mineral density scan

Correct answer: Cardiac evaluation including ECG and first-dose observation for bradycardia

Fingolimod causes bradycardia and AV block with the first dose; an ECG is required beforehand and patients must be observed for at least 6 hours after the first dose for cardiac effects.

Question 12: How can a pharmacist help improve medication adherence in patients with complex regimens?

By prescribing more medications.
By simplifying regimens and providing reminders (Correct answer)
By reducing the number of doctor visits.
By telling patients to skip doses.

Correct answer: By simplifying regimens and providing reminders

Complex medication regimens are a significant barrier to adherence. Specialty pharmacists can improve adherence by working with prescribers to simplify dosing schedules, consolidate medications, or suggest alternative formulations. Additionally, they can provide tools like pill organizers, medication calendars, or digital reminders to help patients remember to take their medications consistently.

Question 13: Why is regulatory compliance crucial for healthcare professionals?

To increase pharmaceutical profits.
To limit patient access to treatments.
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 14: 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?

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.
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)

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

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

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 16: When a new REMS element is added to an existing REMS program, how should a specialty pharmacy respond?

Continue dispensing under the original REMS terms until the next contract renewal
Update internal SOPs and staff training to reflect the new requirements before continuing to dispense (Correct answer)
Notify patients but continue dispensing under the prior protocol
Wait for the manufacturer to update the pharmacy's certification automatically

Correct answer: Update internal SOPs and staff training to reflect the new requirements before continuing to dispense

Pharmacies must update their SOPs and train staff on any modifications to a REMS program before continuing to dispense, as new requirements are binding upon implementation.

Question 17: A patient's serum creatinine rises slightly and stays stable after starting a cobicistat-boosted regimen. What is the most likely explanation?

Dehydration from GI side effects
Cobicistat inhibits tubular secretion of creatinine without changing true GFR (Correct answer)
Acute tubular necrosis from cobicistat
Cobicistat-induced rhabdomyolysis

Correct answer: Cobicistat inhibits tubular secretion of creatinine without changing true GFR

Cobicistat, like dolutegravir and bictegravir, inhibits tubular creatinine secretion, which raises serum creatinine without real renal impairment.

Question 18: A patient with rheumatoid arthritis receives a physician-administered intravenous biologic in a hospital outpatient clinic. The specialty pharmacy supplies the medication to the clinic. Under which benefit is this drug MOST likely to be reimbursed, and what is the common payment methodology used by Medicare for it?

Medical Benefit; based on Average Sales Price (ASP) plus a percentage. (Correct answer)
Pharmacy Benefit; based on Wholesale Acquisition Cost (WAC) plus a dispensing fee.
Medical Benefit; based on a flat per-member-per-month capitation fee.
Pharmacy Benefit; based on Average Wholesale Price (AWP) minus a percentage.

Correct answer: Medical Benefit; based on Average Sales Price (ASP) plus a percentage.

Drugs administered by a healthcare professional in a clinical setting, such as a hospital outpatient department or a physician's office, are typically covered under the patient's medical benefit, not the pharmacy benefit. The standard reimbursement methodology used by Medicare Part B for these drugs is based on the Average Sales Price (ASP) plus a percentage add-on (currently 6%).

Question 19: Before lenalidomide can be dispensed, which requirement must be satisfied?

Prescriber, patient, and pharmacy must be enrolled in the lenalidomide REMS program (Correct answer)
The patient must have HLA-B*5701 testing
The patient must sign a generic manufacturer copay form
Only a baseline CBC must be documented

Correct answer: Prescriber, patient, and pharmacy must be enrolled in the lenalidomide REMS program

Lenalidomide is distributed under a REMS due to embryo-fetal toxicity, requiring certified prescribers, pharmacies, and enrolled patients.

Question 20: In a motivational interviewing session, which pharmacist statement is an example of reflective listening?

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

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 21: Which combination of interventions has the strongest evidence for improving adherence in chronic specialty therapy?

A single counseling session at therapy start
Written education materials alone
Automatic refills without patient contact
Multifaceted approaches combining education, behavioral support, and follow-up (Correct answer)

Correct answer: Multifaceted approaches combining education, behavioral support, and follow-up

Evidence shows multicomponent interventions outperform single-strategy approaches for sustaining adherence.

Question 22: Omalizumab carries a boxed warning for which reaction, so patients must be observed after dosing?

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

Correct answer: Anaphylaxis

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

Question 23: 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-benefit analysis (Correct answer)
Cost-effectiveness analysis

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

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

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 25: How does a specialty pharmacist manage the challenges of drug interactions in complex therapies?

By increasing the dosage of the most effective drugs.
By avoiding drug treatments altogether.
By prescribing drugs without checking for interactions.
By adjusting dosages or changing therapies to minimize interactions (Correct answer)

Correct answer: By adjusting dosages or changing therapies to minimize interactions

Specialty pharmacists possess in-depth knowledge of complex drug profiles and potential interactions, which are common in patients on multiple medications. They proactively identify and assess drug interaction risks, then collaborate with prescribers to modify treatment plans. This ensures patient safety and optimal therapeutic efficacy through careful monitoring and clinical judgment.

Question 26: A drug with an FDA-approved REMS that includes Elements to Assure Safe Use (ETASU) may require which of the following?

Pharmacy certification and documentation of safe-use conditions before dispensing (Correct answer)
Only a Dear Healthcare Provider letter
Only a Medication Guide at dispensing
A DEA Form 222 for every order

Correct answer: Pharmacy certification and documentation of safe-use conditions before dispensing

ETASU can require prescriber and pharmacy certification, patient enrollment, and documented safe-use conditions such as lab results before dispensing.

Question 27: Why can't a Medicare Part D beneficiary use a manufacturer copay coupon for a specialty drug?

Coupons violate HIPAA
It may induce purchases of federally reimbursed items, which implicates the Anti-Kickback Statute (Correct answer)
Medicare already covers 100% of specialty drugs
Coupons are allowed only for generic 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 28: Which of the following specialty pharmacy services is MOST critical for ensuring patient access to ultra-high-cost gene therapies such as betibeglogene spartacus (Zynteglo) for beta-thalassemia?

Daily automated refill reminders
Outcomes-based contracting facilitation and manufacturer financial assistance coordination (Correct answer)
Biosimilar substitution to reduce cost
Compounding the gene therapy in-house to reduce acquisition cost

Correct answer: Outcomes-based contracting facilitation and manufacturer financial assistance coordination

Gene therapies with multi-million-dollar price tags require specialty pharmacies to navigate outcomes-based contracts and manufacturer assistance programs to make therapy financially feasible for payers and patients.

Question 29: In a REMS program that requires a Medication Guide, which party is responsible for distributing it to the patient?

The dispensing pharmacist or pharmacy (Correct answer)
The FDA MedWatch program
The prescribing physician
The drug manufacturer

Correct answer: The dispensing pharmacist or pharmacy

The dispensing pharmacist or pharmacy is responsible for providing the FDA-approved Medication Guide to patients each time a REMS medication is dispensed.

Question 30: Routinely waiving copayments for Medicare beneficiaries without a documented financial hardship assessment may violate:

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

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 31: The 21st Century Cures Act information blocking provisions primarily aim to:

Restrict pharmacies from sharing data with payers
Prevent practices that interfere with access, exchange, or use of electronic health information (Correct answer)
Require paper copies of all prescriptions
Limit patients' access to their own lab results

Correct answer: Prevent practices that interfere with access, exchange, or use of electronic health information

Information blocking rules prohibit practices likely to interfere with legitimate access to, exchange of, or use of EHI, subject to defined exceptions.

Question 32: Isavuconazonium sulfate is contraindicated in which patient?

A patient with familial short QT syndrome (Correct answer)
A patient with moderate hepatic impairment
A patient with a baseline QTc of 470 ms
A patient with CrCl of 25 mL/min

Correct answer: A patient with familial short QT syndrome

Isavuconazole shortens the QT interval, so it is contraindicated in familial short QT syndrome.

Question 33: A specialty pharmacy is evaluating 'time to fill' as an intake metric. What does it measure?

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

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 34: 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
$24,000 per QALY
$40,000 per QALY (Correct answer)
$90,000 per QALY

Correct answer: $40,000 per QALY

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

Question 35: Which strategy is most appropriate when cost is identified as the primary barrier for a commercially insured patient starting a specialty drug?

Dispense a smaller quantity without informing the prescriber
Refer the patient to Medicare Extra Help
Recommend the patient take every other dose
Enroll the patient in a manufacturer copay assistance program (Correct answer)

Correct answer: Enroll the patient in a manufacturer copay assistance program

Commercially insured patients are generally eligible for manufacturer copay programs, which can substantially reduce out-of-pocket costs.

Question 36: Which CDK4/6 inhibitor is most associated with diarrhea as a dose-limiting toxicity?

Palbociclib
Alpelisib
Abemaciclib (Correct answer)
Ribociclib

Correct answer: Abemaciclib

Abemaciclib causes frequent early-onset diarrhea, and patients should start loperamide at the first loose stool.

Question 37: Why is the reimbursement process important in pharmacoeconomics?

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

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 38: A self-injectable is shipped with a sharps container. Why?

The FDA requires all pharmacies to sell sharps containers
It supports the safe disposal of needles and syringes at home (Correct answer)
It is a marketing item
It is used to store the medication

Correct answer: It supports the safe disposal of needles and syringes at home

Providing sharps containers promotes safe needle disposal and reduces injury risk.

Question 39: Under the Stark Law, outpatient prescription drugs fall into which category?

Non-covered items
Durable medical equipment only
Designated health services (DHS) (Correct answer)
Exempt ancillary services

Correct answer: Designated health services (DHS)

Outpatient prescription drugs are designated health services, so physician self-referral to pharmacies they have financial relationships with is restricted.

Question 40: Which of these is a boxed warning for tofacitinib?

Thrombosis, including pulmonary embolism (Correct answer)
Tendon rupture
Lactic acidosis
Ototoxicity

Correct answer: Thrombosis, including pulmonary embolism

JAK inhibitors such as tofacitinib carry boxed warnings for serious infections, mortality, malignancy, MACE, and thrombosis.

Question 41: 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)
They expire too fast
Medicare covers all specialty drugs in full

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 42: 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 medication can be self-injected subcutaneously at home without training
Infusion reactions may occur, and premedication and close monitoring during infusions are recommended (Correct answer)
The patient must avoid all live vaccines while on therapy
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 43: Before starting direct-acting antiviral therapy for HCV, which screening is required because of a boxed warning?

HLA-B*5701 genotype
CYP2C19 metabolizer status
Baseline NS5A resistance testing for all genotypes
HBsAg and anti-HBc to assess hepatitis B reactivation risk (Correct answer)

Correct answer: HBsAg and anti-HBc to assess hepatitis B reactivation risk

HCV DAAs carry a boxed warning for HBV reactivation, so all patients need HBV screening first.

Question 44: Which iPLEDGE requirement applies to isotretinoin dispensing?

Dispense within a defined window after the prescription is authorized in the system (Correct answer)
No pregnancy testing required
Dispense up to a 90-day supply
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 45: Natalizumab for multiple sclerosis is available only through a restricted program primarily because of which risk?

Severe hypertension
Pure red cell aplasia
Tendon rupture
Progressive multifocal leukoencephalopathy (PML) (Correct answer)

Correct answer: Progressive multifocal leukoencephalopathy (PML)

Natalizumab is distributed through the TOUCH program due to PML risk, with JCV antibody monitoring.

Question 46: 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?

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

Correct answer: $950 per 30-day supply

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

Question 47: When a specialty pharmacy is evaluating a prescription for ataluren (Translarna) for DMD, which condition would make the patient INELIGIBLE for this therapy?

Age under 5 years
Concurrent use of oral corticosteroids
Patient is ambulatory
Non-sense mutation in the dystrophin gene (Correct answer)

Correct answer: Non-sense mutation in the dystrophin gene

Ataluren works specifically for non-sense (stop codon) mutations in the dystrophin gene; patients without this mutation type would not benefit and are not candidates for therapy.

Question 48: Starting January 1, 2024, how must Part D pharmacy price concessions (formerly retroactive DIR fees) be handled?

They are eliminated entirely
They are collected quarterly by the Medicaid program
They are paid by the beneficiary at the pharmacy counter
They must be reflected in the negotiated price at the point of sale (Correct answer)

Correct answer: They must be reflected in the negotiated price at the point of sale

CMS redefined the negotiated price so that all pharmacy price concessions are applied at the point of sale instead of retroactively.

Question 49: What is the primary consequence for a specialty pharmacy that dispenses a REMS-required medication without complying with REMS requirements?

The pharmacy must issue a voluntary recall of the dispensed medication
The pharmacy may face FDA enforcement action, including warning letters, injunctions, or civil monetary penalties (Correct answer)
The pharmacy must only notify the prescriber of the non-compliance
The pharmacy is automatically removed from the manufacturer's preferred network

Correct answer: The pharmacy may face FDA enforcement action, including warning letters, injunctions, or civil monetary penalties

Non-compliance with REMS requirements can subject a pharmacy to FDA enforcement actions including warning letters, injunctions, seizures, and civil monetary penalties.

Question 50: Under most REMS programs with ETASU, a specialty pharmacy may NOT dispense a REMS medication if which condition exists?

The prescription is written for a quantity exceeding a 90-day supply
The patient has a prior authorization denial pending appeal
The patient is currently hospitalized
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 51: An uninsured patient with low income is prescribed a costly specialty biologic. Which resource is most appropriate?

Medicare Part D coverage gap discount
A pharmacy loyalty discount card
Manufacturer patient assistance program (PAP) providing free drug (Correct answer)
Manufacturer copay card

Correct answer: Manufacturer patient assistance program (PAP) providing free drug

PAPs provide free or low-cost medication to uninsured or underinsured patients meeting income criteria, whereas copay cards require insurance.

Question 52: A 45-year-old male with Crohn's disease is receiving an infliximab infusion at an infusion center. 15 minutes into the infusion, he complains of flushing, itching, and shortness of breath. The nurse stops the infusion. What is the most appropriate immediate next step?

Administer epinephrine immediately
Restart the infusion at a slower rate
Obtain trough and anti-drug antibody levels
Administer intravenous corticosteroids and antihistamines (Correct answer)

Correct answer: Administer intravenous corticosteroids and antihistamines

For a mild-to-moderate infusion-related reaction (IRR), the standard procedure is to stop the infusion and provide supportive care, which typically includes administering intravenous corticosteroids (e.g., methylprednisolone) and antihistamines (e.g., diphenhydramine). Epinephrine is reserved for severe, anaphylactic reactions. Restarting the infusion without treatment is inappropriate, and while lab levels are important for long-term management, they are not the immediate priority during an acute reaction.

Question 53: Which TNF inhibitor is NOT effective for Crohn's disease?

Infliximab
Certolizumab pegol
Etanercept (Correct answer)
Adalimumab

Correct answer: Etanercept

Etanercept, a soluble TNF receptor fusion protein, failed to show efficacy in Crohn's disease and is not approved for IBD.

Question 54: Under HIPAA, within how many days must a covered entity generally act on a patient's request to access their PHI?

15 days with no extension
45 days
30 days, with one 30-day extension allowed (Correct answer)
60 days

Correct answer: 30 days, with one 30-day extension allowed

The Privacy Rule requires action within 30 days, with one 30-day extension if the individual is notified in writing.

Question 55: 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
Manufacturer copay assistance does not count toward the patient's deductible or out-of-pocket maximum (Correct answer)
It increases the payer's coverage to 100%
It converts a pharmacy benefit claim to a medical claim

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 56: A specialty pharmacist is dispensing a medication for which the patient's insurance has issued a prior authorization denial. The denial states 'step therapy requirements not met.' Which of the following is the most appropriate next step for the pharmacist to take?

Contact the prescriber to discuss the denial and assist in appealing or providing clinical rationale for the prescribed drug. (Correct answer)
Inform the patient that they will have to pay the full cash price for the medication.
Advise the patient to switch to a different insurance plan.
Dispense a 7-day supply of the medication while the issue is resolved.

Correct answer: Contact the prescriber to discuss the denial and assist in appealing or providing clinical rationale for the prescribed drug.

When a prior authorization is denied due to step therapy, it means the insurer requires the patient to try one or more preferred, often lower-cost, alternative medications first. The specialty pharmacist's role is to collaborate with the prescriber. This involves communicating the reason for denial and working with the prescriber's office to either submit an appeal with clinical justification for bypassing step therapy (e.g., contraindication, history of failure with the preferred agent) or to select an appropriate alternative.

Question 57: What is the significance of a collaborative approach in patient management?

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

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 58: What is one of the main barriers to medication adherence in patients with chronic diseases?

Lack of knowledge about the disease.
Having too many appointments.
Frequent checkups.
Complexity of the medication regimen (Correct answer)

Correct answer: Complexity of the medication regimen

Patients with chronic diseases often manage multiple medications, varying dosages, and specific administration instructions, leading to complex regimens. This complexity can overwhelm patients, making it difficult to remember doses, understand timing, and integrate medications into daily life. This significantly hinders adherence, making simplification and clear instructions key pharmacist interventions.

Question 59: A commercially insured patient cannot afford a $3,000 specialty copay. Which resource is typically the first option to check for this patient?

Medicare Extra Help (LIS)
Manufacturer copay assistance card (Correct answer)
Medicaid spend-down program
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 60: Which screening is required before initiating a TNF inhibitor such as adalimumab?

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

Correct answer: Latent tuberculosis testing

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

Question 61: Before starting tofacitinib, which vaccine is recommended because of increased infection risk with JAK inhibitors?

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

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 62: Which administration counseling is recommended for imatinib to reduce GI irritation?

Take on an empty stomach 2 hours before meals
Take at bedtime with an antacid
Take with a meal and a large glass of water (Correct answer)
Crush the tablet and sprinkle it on applesauce

Correct answer: Take with a meal and a large glass of water

Imatinib should be taken with food and a large glass of water to reduce nausea and GI irritation.

Question 63: Osimertinib is preferred in non-small cell lung cancer harboring which mutation, including resistance mutations?

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

Correct answer: EGFR mutations including T790M

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

Question 64: 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?

Inform the patient that replacement is the prescriber's responsibility
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

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

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

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

The drug must be administered at a hospital inpatient unit
The therapy requires IV infusion in cycles and coordination with an infusion center or home infusion service (Correct answer)
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 67: A patient never picks up a newly prescribed biologic after the prescription is processed. This is best described as:

Intentional dose skipping
Primary nonadherence (Correct answer)
Secondary nonadherence
Non-persistence

Correct answer: Primary nonadherence

Primary nonadherence occurs when a new prescription is never filled or never picked up.

Question 68: Which of the following laboratory parameters is essential to obtain at baseline before initiating any direct-acting antiviral (DAA) regimen for Hepatitis C virus (HCV) infection?

Hepatitis A total antibody
Serum Vitamin D level
Urinalysis for protein
Complete blood count (CBC) and a hepatic function panel (Correct answer)

Correct answer: Complete blood count (CBC) and a hepatic function panel

Guidelines recommend several baseline laboratory tests within 6 months of starting DAA therapy, including a complete blood count (CBC), international normalized ratio (INR), and a hepatic function panel (albumin, bilirubin, ALT, AST). These tests help assess the patient's liver disease severity and overall health status before treatment.

Question 69: 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)
Keep products for 10 years after dispensing
Re-label them with pharmacy NDCs

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

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

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 71: Why is adherence to specialty drug therapy important in the management of chronic diseases?

It is not as important as other aspects of treatment.
It eliminates the need for additional medications.
It ensures the therapy remains effective and prevents complications (Correct answer)
It allows for faster recovery.

Correct answer: It ensures the therapy remains effective and prevents complications

Adherence to specialty drug therapy is paramount because these medications often treat serious, progressive chronic diseases. Consistent and correct medication use ensures the drug maintains therapeutic levels in the body, preventing disease progression and reducing the risk of complications. Non-adherence can lead to treatment failure and worsening health, making adherence critical for maximizing treatment effectiveness.

Question 72: A patient starting sofosbuvir/velpatasvir also takes amiodarone. What is the primary safety concern?

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

Correct answer: Serious symptomatic bradycardia

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

Question 73: A patient on erlotinib develops a grade 2 acneiform rash on the face and chest. What is the most appropriate management?

Permanently discontinue erlotinib
Oral isotretinoin and dose escalation
Oral doxycycline or minocycline plus topical corticosteroid while continuing therapy (Correct answer)
Topical benzoyl peroxide only

Correct answer: Oral doxycycline or minocycline plus topical corticosteroid while continuing therapy

Tetracycline antibiotics with low-potency topical steroids manage EGFR inhibitor rash, which often correlates with response.

Question 74: Under URAC specialty pharmacy accreditation standards, how frequently must a pharmacist-conducted clinical review occur for patients on complex specialty therapies?

Per URAC standards, at least annually with more frequent review based on clinical need (Correct answer)
Every 90 days
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 75: A patient with multiple sclerosis is starting fingolimod. What monitoring is required after the first dose?

At least 6 hours of observation for bradycardia, with an ECG before dosing and at the end of observation (Correct answer)
Blood glucose checks every hour for 4 hours
A chest X-ray the next morning
A 24-hour urine collection

Correct answer: At least 6 hours of observation for bradycardia, with an ECG before dosing and at the end of observation

Fingolimod can cause bradycardia and AV block after the first dose, so 6-hour first-dose observation with ECGs is required.

Question 76: What is the primary challenge in managing patients on specialty drug therapies?

Ensuring adherence, managing side effects, and cost (Correct answer)
Providing routine tests and diagnostics.
Managing simple medication regimens.
Scheduling appointments for check-ups.

Correct answer: Ensuring adherence, managing side effects, and cost

Specialty drug therapies are often complex, expensive, and associated with significant side effects, making patient adherence a major challenge. Specialty pharmacists must address these multifaceted issues by providing extensive patient education, support for side effect management, and assistance with financial burdens. These three factors are consistently identified as primary hurdles to successful treatment outcomes.

Question 77: What is the primary function of a specialty pharmacy's patient assistance program (PAP) coordination service?

To substitute brand drugs with less expensive biosimilars
To bill Medicare Part D on behalf of the patient
To help financially eligible patients access free or reduced-cost specialty medications from manufacturers (Correct answer)
To negotiate lower drug acquisition costs for the pharmacy

Correct answer: To help financially eligible patients access free or reduced-cost specialty medications from manufacturers

PAP coordination connects patients who meet manufacturer income and insurance eligibility criteria with free or reduced-cost medication programs to eliminate financial barriers to specialty therapy.

Question 78: What is the outside deadline for notifying affected individuals of a breach of unsecured PHI under HIPAA?

No later than 10 business days after discovery
By the end of the calendar year
No later than 90 days after discovery
No later than 60 calendar days after discovery (Correct answer)

Correct answer: No later than 60 calendar days after discovery

Notice must be given without unreasonable delay and no later than 60 calendar days after discovery of the breach.

Question 79: 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.
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)
Report the incident to the Office for Civil Rights (OCR) immediately.

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 80: Which intervention best addresses nonadherence caused by a patient's low health literacy?

Using plain language, pictograms, and teach-back (Correct answer)
Providing a detailed package insert
Switching to a brand-name product
Increasing the number of refills authorized

Correct answer: Using plain language, pictograms, and teach-back

Plain-language communication, visual aids, and teach-back are evidence-based strategies for patients with limited health literacy.

Question 81: The TIRF REMS Access program applies to which class of medications?

Transdermal intermediate-release fentanyl patches
Transmucosal immediate-release fentanyl products (Correct answer)
Topical immunosuppressive fentanyl formulations
Timed-release intrathecal fentanyl devices

Correct answer: Transmucosal immediate-release fentanyl products

TIRF REMS Access covers transmucosal immediate-release fentanyl products (e.g., lozenges, buccal films, nasal sprays) due to serious risk of misuse, abuse, and fatal overdose.

Question 82: How does pharmacoeconomics influence healthcare policy?

It prioritizes patient demand for drugs.
It guides policy decisions based on the cost-effectiveness of treatments (Correct answer)
It focuses only on reducing healthcare costs.
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 83: Which specialty pharmacy accreditation standard most directly requires documentation of patient-specific clinical interventions?

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

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 84: A CSP is counseling the caregiver of a child with spinal muscular atrophy who will receive onasemnogene abeparvovec (Zolgensma). Which statement about this gene therapy is MOST accurate?

It is a one-time IV gene therapy that requires corticosteroid pretreatment to prevent liver toxicity (Correct answer)
The drug is indicated for children over 12 years of age only
The therapy is administered as a weekly subcutaneous injection for life
The patient must receive the therapy at a specialty pharmacy infusion suite

Correct answer: It is a one-time IV gene therapy that requires corticosteroid pretreatment to prevent liver toxicity

Zolgensma is a single-dose IV gene therapy; corticosteroid pretreatment and monitoring are required due to the risk of acute liver injury associated with adeno-associated virus vector delivery.

Question 85: Under iPLEDGE, how many forms of contraception must females of childbearing potential who are not abstinent use while taking isotretinoin?

One form of contraception
Contraception is recommended but not mandatory for females
Two forms of contraception simultaneously (Correct answer)
Three forms of contraception

Correct answer: Two forms of contraception simultaneously

iPLEDGE requires females of childbearing potential to use two simultaneous forms of contraception starting one month before, during, and one month after isotretinoin therapy.

Question 86: A patient starting ledipasvir/sofosbuvir takes omeprazole 20 mg daily. What is the most appropriate counseling?

Switch to esomeprazole 40 mg twice daily
Take omeprazole 20 mg or less at the same time as ledipasvir/sofosbuvir on an empty stomach (Correct answer)
Double the omeprazole dose to protect the stomach
Take omeprazole 12 hours after ledipasvir/sofosbuvir

Correct answer: Take omeprazole 20 mg or less at the same time as ledipasvir/sofosbuvir on an empty stomach

Ledipasvir solubility drops as gastric pH rises, so PPIs up to the equivalent of omeprazole 20 mg can be taken at the same time as the DAA under fasting conditions.

Question 87: Limited distribution drug (LDD) networks are commonly used by manufacturers to:

Bypass state pharmacy licensure
Avoid FDA approval requirements
Control dispensing to pharmacies able to meet REMS, data, and patient support requirements (Correct answer)
Increase the number of pharmacies stocking a drug

Correct answer: Control dispensing to pharmacies able to meet REMS, data, and patient support requirements

Manufacturers restrict LDDs to selected specialty pharmacies capable of handling complex handling, REMS compliance, and data reporting.

Question 88: Which adherence measurement method is considered most objective but is often impractical for routine specialty pharmacy use?

Patient self-report
Refill reminder call logs
Directly observed therapy or drug level measurement (Correct answer)
Pill counts by the patient at home

Correct answer: Directly observed therapy or drug level measurement

Directly observed therapy and biologic drug levels provide direct evidence of intake but are costly and impractical for routine monitoring.

Question 89: A specialty pharmacy receives a new prescription for a patient recently diagnosed with a complex, rare disease. Which of the following is the MOST critical initial step in the patient intake process?

Scheduling the first delivery of the medication.
Dispensing a 7-day supply to initiate therapy immediately.
Conducting a benefits investigation and verifying insurance coverage. (Correct answer)
Providing the patient with a comprehensive list of all potential side effects.

Correct answer: Conducting a benefits investigation and verifying insurance coverage.

Before any medication can be dispensed or delivered, the specialty pharmacy must first conduct a thorough benefits investigation to verify the patient's insurance coverage and determine if a prior authorization is required. This step is crucial for identifying the patient's financial responsibility, preventing claim rejections, and avoiding significant delays in therapy.

Question 90: 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?

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

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 91: What should a patient do before injecting a refrigerated etanercept prefilled syringe to reduce injection-site discomfort?

Shake it hard to mix the solution
Freeze it briefly to numb the site
Warm it in a microwave for 10 seconds
Leave it at room temperature for about 15-30 minutes (Correct answer)

Correct answer: Leave it at room temperature for about 15-30 minutes

Letting a biologic syringe reach room temperature reduces injection pain, and it should never be heated, shaken, or frozen.

Question 92: 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?

Alternative funding program
Copay maximizer program
Copay accumulator adjustment program (Correct answer)
Coinsurance smoothing 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 93: What is the minimum creatinine clearance for starting emtricitabine/TDF (Truvada) for PrEP?

15 mL/min
60 mL/min (Correct answer)
90 mL/min
30 mL/min

Correct answer: 60 mL/min

F/TDF PrEP needs CrCl of at least 60 mL/min, while F/TAF can be used down to 30 mL/min.

Question 94: Which federal law makes it a crime to knowingly offer or receive remuneration to induce referrals for items reimbursed by federal health care programs?

Sherman Antitrust Act
Stark Law
Anti-Kickback Statute (Correct answer)
Robinson-Patman Act

Correct answer: Anti-Kickback Statute

The Anti-Kickback Statute is a criminal intent-based law covering remuneration for federal program referrals by anyone.

Question 95: What does 'days supply' accuracy on a specialty claim affect most directly?

The manufacturer's WAC
The drug's expiration date
Shipping box size
Refill timing, adherence measures such as PDC, and audit risk from the payer (Correct answer)

Correct answer: Refill timing, adherence measures such as PDC, and audit risk from the payer

An incorrect days supply distorts refill timing and adherence metrics and can trigger payer audit recoupments.

Question 96: When dispensing a specialty medication that requires a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU), which of the following is a mandatory action for the pharmacy?

Verify that the prescriber and pharmacy are certified in the REMS program before dispensing. (Correct answer)
Provide the patient with a 90-day supply to improve adherence.
Enroll the patient in the manufacturer's co-pay assistance program.
Ship the medication exclusively through a single, designated courier.

Correct answer: Verify that the prescriber and pharmacy are certified in the REMS program before dispensing.

REMS programs with ETASU are designed for drugs with significant risks, and they include specific, required interventions beyond standard labeling. A common requirement is that healthcare providers who prescribe and pharmacies that dispense the medication must be specially certified. The dispensing pharmacy has a responsibility to verify its own certification and that of the prescriber before fulfilling the prescription to ensure all safety requirements are met.

Question 97: What is the importance of patient-centered care in counseling?

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

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

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

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

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

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

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

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 101: A refrigerated biologic must be stored at which temperature range per USP labeling conventions?

8-15°C (46-59°F)
2-8°C (36-46°F) (Correct answer)
-25 to -10°C (-13 to 14°F)
20-25°C (68-77°F)

Correct answer: 2-8°C (36-46°F)

USP defines 'refrigerator' storage as 2-8°C (36-46°F).

Question 102: How is HCV cure (sustained virologic response) defined?

Normal ALT at the end of therapy
Undetectable HCV RNA at week 4 of therapy
Negative HCV antibody 6 months after 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 103: What does the Medicare Prescription Payment Plan, created by the Inflation Reduction Act, let Part D enrollees do?

Skip prior authorization for specialty drugs
Use manufacturer copay cards
Import specialty drugs from Canada
Spread out-of-pocket drug costs into monthly payments over the plan year (Correct answer)

Correct answer: Spread out-of-pocket drug costs into monthly payments over the plan year

Starting in 2025, enrollees can opt in to pay out-of-pocket Part D costs in monthly installments instead of all at the pharmacy.

Question 104: Which shipping approach best fits a patient in a rural area with a refrigerated drug due Monday?

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

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 105: A patient being treated with a direct-acting antiviral (DAA) for HCV calls the specialty pharmacy concerned because they had a quantitative HCV RNA level drawn at week 4 of therapy, and it was still detectable, though low. What is the most appropriate response from the pharmacist?

Inform the patient this indicates imminent treatment failure and to contact their provider immediately.
Reassure the patient that low-level quantifiable HCV RNA during DAA therapy does not predict treatment failure and to continue the regimen as prescribed. (Correct answer)
Advise the patient to stop therapy, as it is clearly not working.
Recommend doubling the dose of the DAA for the remainder of the treatment course.

Correct answer: Reassure the patient that low-level quantifiable HCV RNA during DAA therapy does not predict treatment failure and to continue the regimen as prescribed.

Unlike older interferon-based therapies, on-treatment virologic monitoring is not typically necessary with DAA regimens because a detectable viral load during treatment, especially early on, does not predict failure. The key measure of success is achieving a sustained virologic response (SVR), which is an undetectable viral load 12 weeks after completing therapy.

Question 106: Which clinical outcome best confirms treatment success for a patient completing direct-acting antiviral therapy for hepatitis C?

Undetectable HCV RNA at the end of treatment only
Negative HCV antibody test after therapy
Undetectable HCV RNA 12 weeks after therapy ends (SVR12) (Correct answer)
Normalized ALT at week 4 of therapy

Correct answer: Undetectable HCV RNA 12 weeks after therapy ends (SVR12)

Sustained virologic response at 12 weeks post-treatment (SVR12) is the accepted marker of HCV cure.

Question 107: Which hepatitis B antiviral is no longer recommended as first-line therapy because of its high rate of resistance?

Entecavir
Lamivudine (Correct answer)
Tenofovir alafenamide
Tenofovir disoproxil fumarate

Correct answer: Lamivudine

Entecavir, TDF, and TAF are preferred for HBV because of their high resistance barrier, while lamivudine resistance develops often.

Question 108: What role do pharmaceutical manufacturers play in pharmacoeconomics?

They administer health insurance plans.
They provide treatment recommendations.
They regulate healthcare pricing.
They provide cost data and support drug development (Correct answer)

Correct answer: They provide cost data and support drug development

Pharmaceutical manufacturers play a critical role in pharmacoeconomics by conducting and funding studies that generate cost-effectiveness data for their products. They provide essential cost data related to drug development, production, and distribution, which is crucial for economic evaluations. This information helps demonstrate the value of new drugs to payers and healthcare systems, supporting market access and reimbursement decisions.

Question 109: Under which circumstances is it appropriate for a specialty pharmacy to dispense a specialty medication without a valid, verified prescription?

When the drug is commercially available over the counter in the patient's state
Under no circumstances — a verified prescription is always required before dispensing (Correct answer)
When the patient reports the prescription was sent by fax
When the prescriber's office verbally confirms the order over the phone without follow-up documentation for a non-controlled drug

Correct answer: Under no circumstances — a verified prescription is always required before dispensing

A valid, verified prescription is always required before a specialty pharmacy dispenses a prescription drug, as dispensing without one violates federal and state pharmacy law.

Question 110: 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)
PDE4 inhibitors
IL-17 inhibitors

Correct answer: TNF inhibitors

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

Question 111: A patient is prescribed an oral oncolytic that is covered under their pharmacy benefit. The reimbursement that the specialty pharmacy receives from the PBM is most commonly based on which of the following models?

Average Sales Price (ASP) plus a 6% administration fee.
A discount off a benchmark price, such as Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC), plus a dispensing fee. (Correct answer)
A per-diem rate for each day the patient is on therapy.
A bundled payment covering the drug, counseling, and all ancillary supplies.

Correct answer: A discount off a benchmark price, such as Average Wholesale Price (AWP) or Wholesale Acquisition Cost (WAC), plus a dispensing fee.

For self-administered drugs dispensed by a pharmacy and billed under the pharmacy benefit, the traditional reimbursement model is fee-for-service. This typically involves the PBM paying the pharmacy based on a contracted discount off a list price benchmark like AWP or WAC, plus a negotiated professional dispensing fee. ASP-based reimbursement is used for drugs billed under the medical benefit (e.g., Medicare Part B).

Question 112: Which standard governs the handling of hazardous drugs, such as many oral oncolytics, in pharmacies?

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

Correct answer: USP <800>

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

Question 113: 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
Limited Distribution Network (LDN) agreement (Correct answer)
REMS program

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 114: 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?

Hold the prescription until the manufacturer adds the pharmacy to its network
Order the drug from a wholesaler and dispense it anyway
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

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 115: 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?

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

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 116: What is the standard secukinumab dosing for adult plaque psoriasis?

300 mg at weeks 0, 1, 2, 3, and 4, then every 4 weeks (Correct answer)
150 mg every 8 weeks
300 mg once, then as needed
45 mg at weeks 0 and 4, then every 12 weeks

Correct answer: 300 mg at weeks 0, 1, 2, 3, and 4, then every 4 weeks

Secukinumab is loaded weekly for 5 doses and then given every 4 weeks as maintenance.

Question 117: What contraception counseling is required for patients of either sex taking ribavirin?

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

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

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

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

Tell the patient to buy it online
Hold the prescription indefinitely
Transfer or triage the prescription to an in-network dispensing pharmacy and coordinate with the patient and prescriber (Correct answer)
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 120: What does the term 'hub services' refer to in specialty pharmacy?

A centralized distribution warehouse for specialty drugs
A pharmacy software platform for managing high-cost medications
Manufacturer-sponsored programs providing patient support, benefits investigation, and PA assistance (Correct answer)
REMS coordination centers operated by the FDA

Correct answer: Manufacturer-sponsored programs providing patient support, benefits investigation, and PA assistance

Hub services are manufacturer-sponsored patient support programs that assist with benefits verification, prior authorization, copay assistance, and patient education for specific specialty products.

Question 121: A step therapy edit on a specialty drug requires which action before approval?

Submission of the patient's tax return
Payment of a non-formulary penalty upfront
Enrollment in a clinical trial
Trial and failure of one or more preferred therapies (Correct answer)

Correct answer: Trial and failure of one or more preferred therapies

Step therapy requires the patient to try preferred, often lower-cost, agents first unless an exception criterion is met.

Question 122: A patient will be traveling during the scheduled delivery date. What is the best pharmacy action?

Cancel therapy until the patient returns
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
Ship anyway and hope a neighbor accepts it

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 123: Abatacept treats rheumatoid arthritis by which mechanism?

Depleting CD20-positive B cells
Blocking TNF-alpha
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 124: Before a patient starts a direct-acting antiviral for hepatitis C, which additional screening is recommended because of a boxed warning?

Hepatitis A IgG
HIV viral load
HBsAg and anti-HBc for hepatitis B (Correct answer)
Serum ferritin

Correct answer: HBsAg and anti-HBc for hepatitis B

HCV DAAs carry a boxed warning for hepatitis B reactivation, so all patients need HBV screening before treatment.

Question 125: A specialty pharmacy has a contract pharmacy relationship with a 340B-covered entity. To maintain compliance and prevent diversion, what is the most critical responsibility of the pharmacy?

Ensuring the 340B-acquired drugs are dispensed only to individuals who are eligible patients of the covered entity. (Correct answer)
Using a separate wholesaler for 340B drug purchases than for its own GPO purchases.
Charging all patients the same acquisition cost for the medication.
Reporting all 340B dispensing activity to the state board of pharmacy on a monthly basis.

Correct answer: Ensuring the 340B-acquired drugs are dispensed only to individuals who are eligible patients of the covered entity.

The core principle of the 340B program is to provide discounted drugs to eligible patients of covered entities. Diversion, a major compliance violation, occurs when a 340B-purchased drug is provided to an individual who does not meet the HRSA definition of an eligible patient. The covered entity is ultimately responsible, but the contract pharmacy must have systems in place to ensure 340B drugs are not diverted.

Question 126: 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?

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

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 127: A specialty pharmacy finds a product recall for a lot it dispensed. What should it do first?

Identify affected patients by lot number and notify them as directed by the recall class (Correct answer)
Ignore it if no complaints were received
Wait for the patient's next refill
Destroy all inventory of the drug, regardless of lot

Correct answer: Identify affected patients by lot number and notify them as directed by the recall class

Lot-level tracking lets the pharmacy notify affected patients promptly, as the recall guidance directs.

Question 128: A patient reports that a cold-chain package arrived with an indicator showing a temperature excursion. What should the pharmacy do first?

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

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 129: Under USP <800>, how often must an entity review its Assessment of Risk for hazardous drugs it chooses not to handle with all containment requirements?

Every 6 months
Every 3 years
At least every 12 months (Correct answer)
Only when the NIOSH list is updated

Correct answer: At least every 12 months

USP <800> requires the Assessment of Risk to be reviewed at least every 12 months and documented.

Question 130: Under 21 CFR Part 208, when must a pharmacy give a patient an FDA-required Medication Guide?

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

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 131: What does the FDA's role in drug approval include?

Regulating hospital staff.
Only approving the price of drugs.
Evaluating drug safety, effectiveness, and manufacturing standards (Correct answer)
Setting drug prices.

Correct answer: Evaluating drug safety, effectiveness, and manufacturing standards

The FDA's role in drug approval is comprehensive, involving a thorough review process. This includes evaluating extensive clinical trial data to determine if a drug is safe and effective for its intended use. Additionally, the FDA inspects manufacturing facilities to ensure they meet strict quality and production standards, with this multi-faceted assessment protecting public health.

Question 132: A theft of Schedule II drugs is discovered at a specialty pharmacy. What must happen first under DEA rules?

File DEA Form 41 within 30 days
Notify the DEA Field Division Office in writing within one business day of discovery (Correct answer)
Notify the state board only
Wait until the biennial inventory to reconcile

Correct answer: Notify the DEA Field Division Office in writing within one business day of discovery

Registrants must notify DEA in writing within one business day of discovering a significant theft or loss, then complete DEA Form 106.

Question 133: Which pharmacogenomic test is required before starting abacavir?

UGT1A1*28
HLA-B*1502
HLA-B*5701 (Correct answer)
CYP2C19 genotype

Correct answer: HLA-B*5701

Patients positive for HLA-B*5701 are at high risk of abacavir hypersensitivity and must not receive the drug.

Question 134: What does the 340B duplicate discount prohibition prevent?

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

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 135: A Part D plan denies coverage of a non-formulary specialty drug; what is the standard timeframe for the plan to issue a coverage determination after receiving the prescriber's supporting statement?

14 calendar days
24 hours
30 calendar days
72 hours (Correct answer)

Correct answer: 72 hours

Standard Part D coverage determinations must be made within 72 hours, while expedited requests require 24 hours.

Question 136: What does the concept of health technology assessment (HTA) involve?

Assessing the clinical and economic impacts of health technologies (Correct answer)
Evaluating the cost of healthcare technology only.
Testing new drugs for approval.
Evaluating the aesthetic appeal of health products.

Correct answer: Assessing the clinical and economic impacts of health technologies

Health Technology Assessment (HTA) is a multidisciplinary process that systematically evaluates the properties, effects, and impacts of health technologies. This includes assessing their clinical effectiveness, safety, organizational implications, and economic impacts. HTA provides evidence-based information to support decision-making regarding the adoption and use of health technologies within healthcare systems.

Question 137: How frequently must a REMS sponsor typically submit the first REMS assessment to the FDA after approval?

Only when a serious adverse event is identified
At 18 months, 3 years, and 7 years after approval (Correct answer)
Annually for the first 5 years
Every 6 months for the first 2 years

Correct answer: At 18 months, 3 years, and 7 years after approval

The standard REMS assessment timetable requires submissions at 18 months, 3 years, and 7 years after approval, unless the FDA specifies otherwise.

Question 138: Under the 340B Drug Pricing Program, what is the 'duplicate discount' prohibition designed to prevent?

A manufacturer paying both a 340B discount and a Medicaid rebate on the same drug (Correct answer)
Pharmacies billing two commercial payers
Patients receiving two copay cards at once
Wholesalers applying two chargebacks per invoice

Correct answer: A manufacturer paying both a 340B discount and a Medicaid rebate on the same drug

340B law prohibits manufacturers from giving both a 340B discount and a Medicaid drug rebate on the same unit.

Question 139: Within how many hours must a dispenser notify FDA after determining a product is illegitimate under DSCSA?

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

Correct answer: 24 hours

DSCSA requires notification to FDA (via Form 3911) and affected trading partners within 24 hours of determining a product is illegitimate.

Question 140: What monitoring is required after the first dose of fingolimod?

At least 6 hours of observation for bradycardia (Correct answer)
Daily blood glucose for a week
Weekly serum potassium for a month
24-hour Holter for QT shortening only

Correct answer: At least 6 hours of observation for bradycardia

Fingolimod can cause first-dose bradycardia and AV block, requiring 6-hour monitoring with ECG.

Question 141: Which statute imposes civil liability, including treble damages, for knowingly submitting false claims to the federal government?

False Claims Act (Correct answer)
HIPAA Privacy Rule
Anti-Kickback Statute
Controlled Substances Act

Correct answer: False Claims Act

The False Claims Act imposes treble damages and per-claim penalties and allows whistleblower (qui tam) suits.

Question 142: 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 11 g/dL (Correct answer)
Above 13 g/dL
Above 9 g/dL

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 143: 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)
Retrain individual pharmacists identified in the errors
Report the errors to the FDA and wait for guidance

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 144: Mandatory reporting of serious adverse events to FDA within 15 calendar days applies to which party?

Patients
Specialty pharmacy accreditation bodies
Manufacturers and application holders (Correct answer)
Individual pharmacists

Correct answer: Manufacturers and application holders

Manufacturers must submit 15-day Alert reports for serious, unexpected adverse events, while pharmacist reporting via MedWatch is voluntary.

Question 145: Which situation would most appropriately qualify for an expedited (urgent) prior authorization review?

The patient prefers faster shipping
The pharmacy wants to meet a monthly revenue target
The prescriber is going on vacation
A delay could seriously jeopardize the patient's life or health (Correct answer)

Correct answer: A delay could seriously jeopardize the patient's life or health

Expedited reviews are reserved for cases in which standard timeframes could seriously jeopardize the patient's life, health, or function.

Question 146: Mycophenolate products require a REMS program primarily due to which risk?

Embryofetal toxicity (Correct answer)
Serotonin syndrome
Hypercalcemia
Ototoxicity

Correct answer: Embryofetal toxicity

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

Question 147: A patient with CLL on ibrutinib reports palpitations. Which adverse effect of ibrutinib is most likely responsible?

Hypoglycemia
QT shortening
Atrial fibrillation (Correct answer)
Hypertensive crisis from tyramine

Correct answer: Atrial fibrillation

Ibrutinib is associated with atrial fibrillation and bleeding risk.

Question 148: Which federal law governs the licensure requirement for a specialty pharmacy dispensing across state lines?

The Food, Drug, and Cosmetic Act (FD&C Act)
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)

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

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

Correct answer: DPYD genotyping

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

Question 150: Which of the following is a primary role of a specialty pharmacist in managing patients on oral chemotherapy?

Performing diagnostic imaging to assess tumor response.
Proactively monitoring for and managing treatment-related adverse events and adherence. (Correct answer)
Administering intravenous supportive care medications in the clinic.
Prescribing the initial oral chemotherapy regimen.

Correct answer: Proactively monitoring for and managing treatment-related adverse events and adherence.

A key function of a specialty pharmacist in oncology is the ongoing management of patients on oral anticancer agents. This includes proactive patient education, monitoring for side effects, managing toxicities, assessing adherence, and communicating with the provider to optimize therapy. Prescribing, administering IV drugs, and ordering imaging are typically outside the pharmacist's scope of practice.

Question 151: Under the Inflation Reduction Act, what was the annual out-of-pocket cap for covered Part D drugs in 2025?

$2,000 (Correct answer)
$3,250
$1,500
$8,000

Correct answer: $2,000

Starting in 2025, the IRA capped Part D beneficiary out-of-pocket spending at $2,000 and indexed the cap annually after that.

Question 152: What is the role of motivational interviewing in patient counseling?

It forces patients to follow treatment plans.
It focuses only on changing patient behavior.
It discourages patients from making decisions.
It helps patients make informed choices by addressing their motivations (Correct answer)

Correct answer: It helps patients make informed choices by addressing their motivations

Motivational interviewing is a patient-centered counseling approach that helps individuals explore and resolve ambivalence about behavior change. In pharmacy, it empowers patients to identify their own reasons for adhering to therapy or making lifestyle changes, fostering intrinsic motivation rather than imposing solutions. This collaborative approach leads to more sustainable and informed health decisions.

Question 153: Which monitoring is required for patients receiving trastuzumab?

Baseline and periodic LVEF assessment (e.g., every 3 months) (Correct answer)
Monthly pulmonary function tests
Annual audiometry
Weekly serum potassium

Correct answer: Baseline and periodic LVEF assessment (e.g., every 3 months)

Trastuzumab can cause cardiomyopathy, so LVEF is assessed at baseline and periodically during treatment.

Question 154: Olaparib is most appropriately used in which patient population?

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

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 155: A qualifying biosimilar under the Inflation Reduction Act temporarily receives which Part B add-on payment?

AWP minus 20%
ASP plus 6% of its own ASP
WAC plus 10%
ASP plus 8% of the reference product's ASP (Correct answer)

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

The IRA raised the add-on for qualifying biosimilars to 8% of the reference product's ASP for a five-year period.

Question 156: What is the main purpose of a budget impact analysis that a health plan requests before adding a new specialty drug?

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
Compare the drug's clinical efficacy with placebo
Measure patient willingness to pay

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 157: A patient with severe plaque psoriasis has been stable on adalimumab for two years. They call the specialty pharmacy to report that their symptoms have been worsening over the last three months despite adherence to their injections. What is the most likely immunological reason for this secondary loss of response?

Tachyphylaxis due to receptor downregulation
Disease progression to a non-TNF-mediated pathway
Increased drug clearance due to metabolic changes
Formation of anti-drug antibodies (ADAs) (Correct answer)

Correct answer: Formation of anti-drug antibodies (ADAs)

A secondary loss of response to a tumor necrosis factor (TNF) inhibitor like adalimumab is often due to the development of anti-drug antibodies (ADAs). These antibodies can neutralize the drug's activity or increase its clearance, leading to subtherapeutic drug levels and reduced efficacy. Therapeutic drug monitoring to check for trough concentrations and ADA levels can help confirm this and guide subsequent treatment decisions.

Question 158: Which outcome would a specialty pharmacy track as a clinical outcome for a rheumatoid arthritis patient on a biologic?

Number of refill reminder calls
Disease activity score (e.g., DAS28) (Correct answer)
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 159: An independent charity patient assistance foundation complies with OIG guidance when it:

Allows donors to design narrow funds covering only their product
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

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 160: What role does a pharmacist play in managing specialty drug therapies?

Performing surgery to treat conditions.
Administering medications to patients.
Prescribing new medications.
Monitoring patients for side effects and ensuring adherence (Correct answer)

Correct answer: Monitoring patients for side effects and ensuring adherence

Specialty pharmacists manage complex drug regimens, which often involve potent medications with significant side effects. Their role is crucial in actively monitoring patients for adverse reactions and providing education and support. This ensures consistent medication use, which is vital for therapeutic success and patient safety.

Question 161: Which type of product typically requires cryogenic or ultra-cold shipment, unlike most refrigerated biologics?

Etanercept prefilled syringes
Autologous cell therapies such as CAR-T products (Correct answer)
Insulin glargine pens
Adalimumab prefilled 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 162: 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?

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

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 163: A patient is starting on a new injectable specialty medication that requires refrigeration. During the final dispensing check, the pharmacist is reviewing the contents of the shipment. In addition to the medication, ancillary supplies, and patient education materials, what other critical item should be included in the patient's first shipment?

A sharps container for proper needle disposal. (Correct answer)
A return label for unused medication.
A detailed invoice for the full cost of the drug.
A list of alternative, non-injectable medications.

Correct answer: A sharps container for proper needle disposal.

Patient safety is paramount in specialty pharmacy. When dispensing an injectable medication, it is the pharmacy's responsibility to provide the means for safe disposal of needles and syringes. Including a sharps container in the first shipment ensures the patient can immediately and properly dispose of biohazardous waste, preventing accidental needlesticks and protecting the community.

Question 164: Which of the following best describes 'white bagging' in specialty pharmacy?

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

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 165: 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 72 hours
Within 7 days
Within 30 days
Within 24 hours (Correct answer)

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 166: Which counseling point is correct for nilotinib?

Take once daily at bedtime with milk
Take with a high-fat meal to improve absorption
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)

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 167: During a benefit investigation, which information is most important for determining whether a self-injected biologic falls under the pharmacy or medical benefit?

The plan's benefit design and the route/site of administration (Correct answer)
The drug's color and packaging
The prescriber's medical school
The pharmacy's square footage

Correct answer: The plan's benefit design and the route/site of administration

Whether a drug is covered under pharmacy or medical benefit depends on plan design and how and where it is administered.

Question 168: A patient is prescribed a specialty medication that is part of a limited distribution network and also has a Risk Evaluation and Mitigation Strategy (REMS) program. What is the primary reason a manufacturer would implement these two restrictions concurrently?

To streamline the prior authorization process with insurance payers.
To ensure enhanced safety monitoring and control over the dispensing process for a high-risk drug. (Correct answer)
To increase the market price of the medication by creating scarcity.
To limit the administrative burden on prescribing physicians.

Correct answer: To ensure enhanced safety monitoring and control over the dispensing process for a high-risk drug.

Manufacturers use limited distribution networks for drugs with complex handling, storage, or administration requirements. When a drug also carries a significant safety risk, an FDA-mandated REMS program is required to ensure the benefits outweigh the risks. Combining these two strategies allows the manufacturer to maintain tight control over the distribution, ensuring that only trained, certified pharmacies dispense the medication and that all safety protocols, such as patient monitoring and education, are strictly followed.

Question 169: Why is vedolizumab considered to have a lower PML risk than natalizumab?

It selectively blocks gut-specific alpha4-beta7 integrin (Correct answer)
It depletes B cells only in the colon
It is given orally rather than IV
It is a TNF inhibitor rather than an integrin blocker

Correct answer: It selectively blocks gut-specific alpha4-beta7 integrin

Vedolizumab's gut-selective alpha4-beta7 targeting avoids broad CNS immune surveillance effects.

Question 170: Starting in 2024, how did CMS change the treatment of pharmacy price concessions (DIR) in Part D?

All pharmacy price concessions must be reflected in the negotiated price at the point of sale (Correct answer)
DIR fees were shifted to Medicare Part B
DIR fees were doubled to offset rebates
Pharmacies were required to bill DIR directly to patients

Correct answer: All pharmacy price concessions must be reflected in the negotiated price at the point of sale

CMS required all pharmacy price concessions to be applied at the point of sale beginning January 1, 2024, reducing retroactive clawbacks.

Question 171: What PDC threshold is most commonly used by PQA and CMS Star Ratings to define a patient as adherent?

80% (Correct answer)
90%
70%
95%

Correct answer: 80%

The Pharmacy Quality Alliance standard defines adherence as PDC of at least 80% for most chronic medication classes.

Question 172: A specialty product is dispensed in its original manufacturer packaging. Why is this often preferred?

It preserves stability, protection from light or moisture, the lot and expiration information, and serialization (Correct answer)
Patients prefer unbranded vials
Repackaging is always illegal
It is cheaper for the pharmacy

Correct answer: It preserves stability, protection from light or moisture, the lot and expiration information, and serialization

Keeping original packaging maintains product integrity and traceability for many specialty drugs.

Question 173: Oral rilpivirine is contraindicated with which medication class?

Statins
Proton pump inhibitors (Correct answer)
Thiazide diuretics
SSRIs

Correct answer: Proton pump inhibitors

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

Question 174: A patient calls the specialty pharmacy saying they cannot afford the required pregnancy test before their next REMS medication refill. What is the pharmacist's most appropriate response?

Accept the patient's verbal confirmation that she is not pregnant and dispense the medication
Contact the prescriber to request a waiver of the pregnancy testing requirement
Assist the patient in finding low-cost or free testing resources and explain the prescription cannot be dispensed without a confirmed negative test (Correct answer)
Dispense a 7-day bridge supply until the patient can obtain the test

Correct answer: Assist the patient in finding low-cost or free testing resources and explain the prescription cannot be dispensed without a confirmed negative test

REMS pregnancy testing requirements are mandatory and cannot be waived; the pharmacist must help the patient access resources while withholding the medication until the test is completed.

Question 175: Which Medicare program reduces premiums and cost sharing for low-income Part D beneficiaries?

The 340B Drug Pricing Program
Medicare Advantage Special Needs Plan only
Medigap Plan G
Extra Help (Low-Income Subsidy) (Correct answer)

Correct answer: Extra Help (Low-Income Subsidy)

The Low-Income Subsidy, known as Extra Help, lowers Part D premiums, deductibles, and copayments for eligible beneficiaries.

Question 176: A specialty pharmacy receives a new prescription for palbociclib (Ibrance) for a patient with HR+, HER2- metastatic breast cancer. The pharmacist notes the patient is also taking ketoconazole, a strong CYP3A4 inhibitor. What is the most appropriate clinical intervention?

Recommend discontinuing ketoconazole and starting a non-interacting antifungal. (Correct answer)
Advise the patient to separate the administration times by at least 12 hours.
Dispense both medications as prescribed with a warning to monitor for liver toxicity.
Recommend increasing the dose of palbociclib to overcome the interaction.

Correct answer: Recommend discontinuing ketoconazole and starting a non-interacting antifungal.

Palbociclib is a substrate of the CYP3A4 enzyme. Co-administration with strong CYP3A4 inhibitors like ketoconazole can significantly increase palbociclib concentrations and the risk of toxicity, such as neutropenia. The prescribing information recommends avoiding concomitant use. The best intervention is to recommend an alternative agent that does not inhibit CYP3A4. Dose reduction of palbociclib is an option if concomitant use is unavoidable, but switching the interacting agent is preferred.

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%

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