Pharmacy Specialty Pharmacy and Biologics 2

Question 1

An interchangeable biosimilar designation by the FDA means it can be substituted for the reference biologic:

Accepted Answer

At the pharmacy level without prescriber intervention, similar to generic substitution (where permitted by state law)

Answer

Only by a physician's written order

Answer

Never — interchangeable biologics still require a new prescription

Answer

Only if the patient has failed the reference biologic

Question 2

Hepatitis C treatment with direct-acting antivirals (DAAs) like sofosbuvir/ledipasvir is considered specialty pharmacy because:

Accepted Answer

It involves high drug costs, complex monitoring, and requires specialty training to ensure adherence and cure rates

Answer

It requires monthly injections administered in a clinic

Answer

It is a Schedule II controlled substance

Answer

It is only available from hospital pharmacies

Question 3

Which statement about monoclonal antibodies (mAbs) is correct?

Accepted Answer

They are highly targeted therapies ending in '-mab' that bind specific antigens

Answer

They are synthesized from petrochemicals like most small-molecule drugs

Answer

They are administered orally for systemic conditions

Answer

They have no risk of immunogenicity reactions

Question 4

Erythropoiesis-stimulating agents (ESAs) such as epoetin alfa are used in specialty pharmacy to treat:

Accepted Answer

Anemia associated with chronic kidney disease or chemotherapy

Answer

Rheumatoid arthritis

Answer

Inflammatory bowel disease

Answer

Hepatitis B infection

Question 5

Prior authorization (PA) is commonly required for specialty medications because:

Accepted Answer

Payers require clinical justification to ensure appropriate use and manage high costs

Answer

All specialty medications are controlled substances requiring DEA approval

Answer

PA is required by federal law for any drug costing over $500

Answer

Specialty drugs cannot be dispensed without a pharmacist's clinical evaluation

Question 6

Tyrosine kinase inhibitors (TKIs) like imatinib (Gleevec) used for CML represent which advancement in cancer treatment?

Accepted Answer

Targeted therapy that inhibits a specific oncogenic protein (BCR-ABL kinase)

Answer

Non-specific cytotoxic chemotherapy

Answer

Immunotherapy through checkpoint inhibition

Answer

Hormonal therapy blocking estrogen receptors