Pharmacy Specialty Pharmacy and Biologics 3

Question 1

REMS (Risk Evaluation and Mitigation Strategy) programs are FDA-required for certain specialty drugs to:

Accepted Answer

Ensure benefits outweigh risks by imposing special prescribing, dispensing, or patient monitoring requirements

Answer

Reduce the price of high-cost biologics

Answer

Speed up approval of new biosimilars

Answer

Mandate generic substitution for brand-name drugs

Question 2

Adalimumab (Humira) biosimilars have received FDA approval and interchangeable designation. A major barrier to biosimilar adoption has been:

Accepted Answer

Originator brand rebate contracts and 'pay-to-delay' strategies that reduce payer incentives to use biosimilars

Answer

FDA approval delays of more than 10 years for all biosimilars

Answer

Biosimilars being proven less effective than reference biologics in clinical trials

Answer

Pharmacy benefit managers refusing to cover any biosimilar products

Question 3

Gene therapy products like those used for hemophilia or inherited retinal dystrophy are regulated as:

Accepted Answer

Biologics under the BPCIA with BLA approval pathway

Answer

Small-molecule drugs via NDA

Answer

Controlled substances requiring DEA scheduling

Answer

Medical devices under 510(k) clearance

Question 4

Cold chain management for specialty biologics requires monitoring temperature with a calibrated device because:

Accepted Answer

Temperature excursions can cause protein denaturation, aggregation, or loss of activity, leading to patient harm

Answer

Biologics improve in potency when kept colder than required

Answer

Cold chain is a DEA requirement for all specialty products

Answer

It reduces insurance reimbursement requirements

Question 5

Specialty pharmacy accreditation (URAC, ACHC) standards require pharmacies to have programs for:

Accepted Answer

Patient safety, clinical outcomes management, and demonstrating quality metrics to payers

Answer

Manufacturing FDA-approved drugs on-site

Answer

Providing only mail-order dispensing with no clinical services

Answer

DEA Schedule II dispensing exclusively

Question 6

Which specialty pharmacy service model provides patients with a dedicated clinical pharmacist who monitors labs, manages adherence, and communicates with the care team?

Accepted Answer

Longitudinal clinical management / patient care coordination model

Answer

Central fill model

Answer

Mail-order model

Answer

Telepharmacy kiosk model