Specialty Pharmacy and Biologics Flashcards
6 cards from real Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Specialty Pharmacy and Biologics flashcards as text
REMS (Risk Evaluation and Mitigation Strategy) programs are FDA-required for certain specialty drugs to:
Answer: Ensure benefits outweigh risks by imposing special prescribing, dispensing, or patient monitoring requirements
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.
Adalimumab (Humira) biosimilars have received FDA approval and interchangeable designation. A major barrier to biosimilar adoption has been:
Answer: Originator brand rebate contracts and 'pay-to-delay' strategies that reduce payer incentives to use biosimilars
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.
Gene therapy products like those used for hemophilia or inherited retinal dystrophy are regulated as:
Answer: Biologics under the BPCIA with BLA approval pathway
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.
Cold chain management for specialty biologics requires monitoring temperature with a calibrated device because:
Answer: Temperature excursions can cause protein denaturation, aggregation, or loss of activity, leading to patient harm
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.
Specialty pharmacy accreditation (URAC, ACHC) standards require pharmacies to have programs for:
Answer: Patient safety, clinical outcomes management, and demonstrating quality metrics to payers
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.
Which specialty pharmacy service model provides patients with a dedicated clinical pharmacist who monitors labs, manages adherence, and communicates with the care team?
Answer: Longitudinal clinical management / patient care coordination model
Longitudinal clinical management assigns a dedicated clinical pharmacist to high-complexity patients to provide ongoing lab monitoring, adherence calls, side effect management, and care team collaboration — the hallmark of specialty pharmacy value.