Specialty pharmacy is a fast-growing area of practice focused on managing high-cost, high-complexity medications used to treat chronic and rare conditions. These therapies often require special handling, intensive patient monitoring, and adherence support. For PharmD students, understanding the principles of specialty pharmacy management—from network design and utilization management to patient support programs and accreditation standards—is essential for navigating this critical component of the healthcare system.
1. Which of the following is a defining characteristic of a specialty drug?
- Availability as an over-the-counter product
- High cost per patient
- Simple, once-daily oral administration
- Lack of any side effects
Answer: High cost per patient
2. A health plan or PBM may use a limited specialty pharmacy network as a management strategy to:
- Increase the number of pharmacies dispensing a specialty drug
- Ensure that patients receive care from pharmacies with specific expertise and data reporting capabilities
- Make it more difficult for patients to obtain their medication
- Increase the overall cost of the specialty drug for the plan
Answer: Ensure that patients receive care from pharmacies with specific expertise and data reporting capabilities
3. The term “white bagging” in specialty pharmacy refers to the practice of:
- A physician purchasing a drug and billing the insurer directly
- A patient picking up a specialty drug and taking it to their physician’s office
- A specialty pharmacy shipping a patient-specific drug directly to the physician’s office for administration
- A hospital pharmacy dispensing a drug for a patient to take home at discharge
Answer: A specialty pharmacy shipping a patient-specific drug directly to the physician’s office for administration
4. Why are specialty drug cost trends a major concern for plan sponsors?
- These drugs represent a small and shrinking portion of total drug spend
- These drugs are typically very inexpensive
- These high-cost drugs are a significant driver of the overall increase in healthcare spending
- There are no new specialty drugs being developed
Answer: These high-cost drugs are a significant driver of the overall increase in healthcare spending
5. Organizations like URAC and the Accreditation Commission for Health Care (ACHC) provide what for specialty pharmacies?
- Drug information resources
- Group purchasing services
- Accreditation programs that signify quality and high standards of care
- Marketing and advertising services
Answer: Accreditation programs that signify quality and high standards of care
6. Which of the following is a common strategy used to manage access to specialty drugs?
- Making all specialty drugs available without restrictions
- Implementing prior authorization to ensure appropriate use
- Removing all copayments for specialty medications
- Allowing automatic refills for all specialty drugs
Answer: Implementing prior authorization to ensure appropriate use
7. “Brown bagging” is a specialty pharmacy distribution model where:
- The physician administers a drug supplied by the hospital
- The patient picks up the specialty drug from a pharmacy and transports it to the physician’s office for administration
- The pharmacy delivers the drug directly to the patient’s home for self-injection
- The manufacturer ships the drug directly to the patient
Answer: The patient picks up the specialty drug from a pharmacy and transports it to the physician’s office for administration
8. In a tiered formulary, specialty drugs are often placed on:
- The lowest tier with a small, fixed copayment
- A dedicated “specialty tier” with a high coinsurance percentage
- A tier reserved for over-the-counter products
- The same tier as generic drugs
Answer: A dedicated “specialty tier” with a high coinsurance percentage
9. A key service provided by a specialty pharmacy that goes beyond traditional dispensing is:
- Providing intensive patient education and adherence monitoring
- Offering a wide variety of greeting cards and gifts
- Compounding non-sterile preparations
- Selling durable medical equipment like walkers and canes
Answer: Providing intensive patient education and adherence monitoring
10. Drugs administered in a physician’s office and billed by the physician are typically covered under the:
- Pharmacy benefit
- Medical benefit
- Dental benefit
- Vision benefit
Answer: Medical benefit
11. Which disease state is commonly treated with specialty drugs?
- The common cold
- Seasonal allergies
- Rheumatoid arthritis and Multiple Sclerosis
- A minor headache
Answer: Rheumatoid arthritis and Multiple Sclerosis
12. What is a primary reason a health plan might prefer to use a specialty pharmacy for a complex drug?
- The specialty pharmacy can collect valuable data on patient outcomes and adherence
- Community pharmacies are not legally allowed to dispense specialty drugs
- Specialty pharmacies always have lower dispensing fees
- Patients prefer the inconvenience of using a separate pharmacy
Answer: The specialty pharmacy can collect valuable data on patient outcomes and adherence
13. The “buy and bill” model of specialty drug distribution involves:
- The patient buying the drug and billing their own insurance
- The pharmacy buying the drug and billing the manufacturer
- The physician’s practice purchasing, storing, and billing for the drug
- The PBM purchasing the drug for the physician
Answer: The physician’s practice purchasing, storing, and billing for the drug
14. A significant challenge in specialty pharmacy management is ensuring proper handling and storage, often requiring:
- Room temperature storage at all times
- A “cold chain” to maintain refrigeration or frozen states
- Exposure to direct sunlight
- Storage in a humid environment
Answer: A “cold chain” to maintain refrigeration or frozen states
15. A Patient Assistance Program (PAP) is often a critical component of specialty pharmacy access, helping patients to:
- Understand the drug’s mechanism of action
- Navigate the high out-of-pocket costs of their medication
- Choose a different medication
- Get their prescription delivered faster
Answer: Navigate the high out-of-pocket costs of their medication
16. A key role for a pharmacist in a specialty pharmacy is:
- To provide in-depth, disease-specific patient counseling
- To manage the front-end sales of over-the-counter products
- To work exclusively on sterile compounding
- To negotiate rebate contracts with manufacturers
Answer: To provide in-depth, disease-specific patient counseling
17. What does a specialty pharmacy accreditation from an organization like URAC signify to a health plan?
- The pharmacy offers the lowest prices
- The pharmacy has met rigorous standards for quality, patient safety, and service
- The pharmacy is located in a specific geographic area
- The pharmacy has been in business for over 50 years
Answer: The pharmacy has met rigorous standards for quality, patient safety, and service
18. Payer and PBM management of specialty drugs often involves creating a ________ to ensure only appropriate patients receive the therapy.
- set of clinical criteria for prior authorization
- preferred pharmacy network for generic drugs
- patient support group
- marketing campaign
Answer: set of clinical criteria for prior authorization
19. A major trend in drug spending is the disproportionate growth in the cost of:
- Generic medications
- Over-the-counter medications
- Specialty drugs
- Brand-name drugs for common conditions
Answer: Specialty drugs
20. A bundled reimbursement mechanism is a payment strategy where:
- Each individual service and drug is paid for separately
- A single, comprehensive payment is made for all services related to a course of treatment or episode of care
- The patient pays the full cost upfront
- The manufacturer pays the physician directly
Answer: A single, comprehensive payment is made for all services related to a course of treatment or episode of care
21. Which of the following is NOT a typical characteristic of a specialty drug?
- Complex method of administration (e.g., injectable)
- Requires close patient monitoring
- Treats a common, acute condition like a sore throat
- Has a high per-patient cost
Answer: Treats a common, acute condition like a sore throat
22. Site of care management is a strategy used by payers to:
- Require patients to receive infusions in the most expensive setting possible
- Encourage the administration of infused drugs in more cost-effective settings, like the home or an infusion suite
- Ensure all drugs are administered in a hospital
- Allow patients to choose any location for their infusions
Answer: Encourage the administration of infused drugs in more cost-effective settings, like the home or an infusion suite
23. The NCCN Task Force Report on specialty pharmacy provides guidance on:
- The marketing of specialty drugs
- The role and value of various stakeholders in the specialty pharmacy channel
- The pricing of generic medications
- How to compound non-sterile preparations
Answer: The role and value of various stakeholders in the specialty pharmacy channel
24. The complex nature of specialty drugs often requires coordination between:
- The specialty pharmacy, the prescriber, the patient, and the payer
- Only the patient and the manufacturer
- Only the pharmacy and the wholesaler
- Only the prescriber and the PBM
Answer: The specialty pharmacy, the prescriber, the patient, and the payer
25. A key performance indicator for a specialty pharmacy is:
- The number of prescriptions returned to stock
- Medication adherence rates for its patients
- The average time a patient spends on hold during a phone call
- The number of different drugs in its inventory
Answer: Medication adherence rates for its patients
26. Why would a manufacturer want to limit the distribution of their specialty drug to a select few specialty pharmacies?
- To ensure proper handling, data collection, and patient education for a complex product
- To make the drug harder for patients to find
- To increase competition among pharmacies
- To lower the overall price of the drug
Answer: To ensure proper handling, data collection, and patient education for a complex product
27. The management of drugs under the medical benefit (buy-and-bill) can be challenging for payers due to:
- The lack of control over pricing and utilization compared to the pharmacy benefit
- The simplicity of the billing codes used
- The low cost of these drugs
- The absence of pharmacists in the process
Answer: The lack of control over pricing and utilization compared to the pharmacy benefit
28. A pharmacist at a specialty pharmacy often spends a significant amount of time on:
- Helping patients with prior authorizations and enrollment in assistance programs
- Stocking over-the-counter shelves
- Compounding simple suspensions
- Managing the pharmacy’s social media account
Answer: Helping patients with prior authorizations and enrollment in assistance programs
29. The rise of specialty drugs has led to an increased focus on which aspect of formulary management?
- The management of generic drugs
- The use of coinsurance instead of copayments for high-cost tiers
- The elimination of all utilization management tools
- The coverage of all over-the-counter products
Answer: The use of coinsurance instead of copayments for high-cost tiers
30. Which of the following best describes the services provided by a specialty pharmacy?
- Dispensing only
- Dispensing plus comprehensive clinical and patient support services
- Clinical services only, with no dispensing
- Over-the-counter counseling only
Answer: Dispensing plus comprehensive clinical and patient support services
31. A “Risk Evaluation and Mitigation Strategy” (REMS) is an FDA requirement for some specialty drugs to:
- Ensure the benefits of a drug outweigh its risks
- Increase the price of the drug
- Limit the drug’s patent life
- Make the drug available over-the-counter
Answer: Ensure the benefits of a drug outweigh its risks
32. The management of specialty drug trend is a primary concern for:
- Plan sponsors like employers and health plans
- Uninsured patients
- Community pharmacies that do not dispense specialty drugs
- Pharmaceutical wholesalers
Answer: Plan sponsors like employers and health plans
33. A specialty pharmacy may employ nurses to:
- Provide in-home infusion services or patient training
- Prescribe medications
- Manage the pharmacy’s finances
- Negotiate contracts with payers
Answer: Provide in-home infusion services or patient training
34. The shift of some specialty drugs from the medical benefit to the pharmacy benefit is a strategy payers use to:
- Increase the cost of the drug
- Gain more control over utilization and cost through PBM management tools
- Make the drug easier for physicians to bill for
- Eliminate the need for a specialty pharmacy
Answer: Gain more control over utilization and cost through PBM management tools
35. A challenge for hospitals when specialty drugs are “white bagged” is that the hospital:
- Makes a large profit on the drug
- Cannot bill for the drug and loses revenue associated with its own buy-and-bill process
- Is not allowed to administer the drug
- Must store the drug for an indefinite period
Answer: Cannot bill for the drug and loses revenue associated with its own buy-and-bill process
36. A key reason for a prior authorization on a specialty drug for an autoimmune condition might be to:
- Confirm the patient has tried and failed more conventional therapies first
- Ensure the patient is at least 65 years old
- Verify the patient has private insurance
- Check if the patient has a preferred pharmacy
Answer: Confirm the patient has tried and failed more conventional therapies first
37. The complexity of specialty drug regimens necessitates a higher level of _______ from the pharmacy team.
- patient engagement and education
- disinterest in patient outcomes
- simple dispensing without counseling
- focus on speed over accuracy
Answer: patient engagement and education
38. Which of the following is an example of a specialty drug?
- Metformin for diabetes
- Lisinopril for hypertension
- Infliximab for Crohn’s disease
- Ibuprofen for pain
Answer: Infliximab for Crohn’s disease
39. Managing the transition of a patient’s specialty drug coverage when they change insurance plans is a key role for:
- The manufacturer’s sales representative
- The specialty pharmacy’s care coordination team
- The patient’s primary care physician exclusively
- The hospital’s billing department
Answer: The specialty pharmacy’s care coordination team
40. A specialty pharmacy’s ability to provide detailed data back to manufacturers and payers is a key part of their:
- Value proposition
- Marketing plan
- Dispensing process
- Patient counseling
Answer: Value proposition
41. The high touch nature of specialty pharmacy management is designed to improve:
- Medication adherence and patient outcomes
- The manufacturer’s profit margin
- The speed of prescription filling
- The number of adverse events
Answer: Medication adherence and patient outcomes
42. A significant operational component of a specialty pharmacy is its:
- Large front-end store with consumer goods
- Call center and patient management software infrastructure
- Drive-thru window
- Compounding facility for non-sterile products
Answer: Call center and patient management software infrastructure
43. A pharmacist reviewing a patient’s case for a specialty drug prior authorization would need to check:
- The patient’s diagnosis and relevant lab work against the plan’s coverage criteria
- The patient’s credit score
- The patient’s employment history
- The pharmacy’s inventory level for the drug
Answer: The patient’s diagnosis and relevant lab work against the plan’s coverage criteria
44. The main reason for using a coinsurance (e.g., 25%) for a specialty tier instead of a copayment (e.g., $100) is that:
- It results in a lower out-of-pocket cost for the patient on a very expensive drug
- It shifts a percentage of the high drug cost to the patient
- It is simpler for the pharmacy to process
- It is required by all state laws
Answer: It shifts a percentage of the high drug cost to the patient
45. Which of the following is LEAST likely to be a service offered by a specialty pharmacy?
- 24/7 access to a clinician
- Coordination with patient assistance programs
- Adherence reminder calls
- Walk-in, non-prescription medication sales
Answer: Walk-in, non-prescription medication sales
46. A “limited distribution drug” is a specialty medication that:
- Is only available from the manufacturer and a small number of designated specialty pharmacies
- Is available at every community pharmacy
- Is in the process of being recalled
- Is soon to become available over-the-counter
Answer: Is only available from the manufacturer and a small number of designated specialty pharmacies
47. For a PharmD student, exposure to specialty pharmacy management is important because:
- It is a declining field with few job opportunities
- It is a major and growing component of the pharmacy profession and healthcare spending
- The principles do not apply to any other area of pharmacy
- It only involves working with common, low-cost medications
Answer: It is a major and growing component of the pharmacy profession and healthcare spending
48. Managing the logistics of a temperature-sensitive specialty drug (“cold chain”) is the responsibility of:
- The patient exclusively
- The specialty pharmacy and its shipping partners
- The prescriber’s office staff
- The insurance company
Answer: The specialty pharmacy and its shipping partners
49. An example of adherence management by a specialty pharmacy would be:
- Calling a patient to remind them to take their dose or schedule a refill
- Refusing to fill a prescription if a dose is missed
- Sending a patient a bill for missed doses
- Reporting the patient to their physician for non-adherence
Answer: Calling a patient to remind them to take their dose or schedule a refill
50. The ultimate goal of effective specialty pharmacy management is to:
- Create barriers to care for sick patients
- Ensure appropriate patients get access to complex therapies with the necessary support to use them safely and effectively
- Increase the net cost of drugs for health plans
- Focus only on the dispensing process and ignore clinical outcomes
Answer: Ensure appropriate patients get access to complex therapies with the necessary support to use them safely and effectively
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com