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

REMS programs impose special safety conditions — such as prescriber certification, pharmacy enrollment, pregnancy testing, or patient registries — for drugs with serious risks that would otherwise outweigh benefits.

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

Despite regulatory approval, biosimilar uptake in the US has been limited by originator rebate contracts with payers and PBMs, exclusionary formulary practices, and prescriber/patient hesitancy about non-interchangeable status.

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

Gene therapies are regulated as biologics by FDA's Center for Biologics Evaluation and Research (CBER) under the Biologics License Application (BLA) pathway, not as conventional drugs.

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

Protein-based biologics are highly sensitive to temperature. Exposure outside the recommended range can cause irreversible structural changes (denaturation, aggregation) that reduce efficacy or increase immunogenicity risk.

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

URAC and ACHC accreditation standards require specialty pharmacies to demonstrate quality programs including patient safety protocols, clinical monitoring, outcomes tracking, and quality improvement initiatives — required by many payer and GPO contracts.

Pharmacy Practice Test

Pharmacy Practice Test

Pharmacy Specialty Pharmacy and Biologics 3