CSP CSP - Certified Specialty Pharmacist Clinical Management: Neurology and Rare Disease Questions and Answers

Question 1

Which disease-modifying therapy for multiple sclerosis (MS) requires REMS program enrollment due to risks of progressive multifocal leukoencephalopathy (PML)?

Accepted Answer

Natalizumab (Tysabri)

Answer

Interferon beta-1a (Avonex)

Answer

Glatiramer acetate (Copaxone)

Answer

Dimethyl fumarate (Tecfidera)

Question 2

A patient with spinal muscular atrophy (SMA) is prescribed nusinersen (Spinraza). What is a key specialty pharmacy role in managing this therapy?

Accepted Answer

Coordinating benefits, site-of-care logistics, and patient support for this high-cost intrathecal therapy

Answer

Compounding the intrathecal formulation on-site

Answer

Dispensing the medication to the patient for self-administration at home

Answer

Performing the lumbar puncture procedure required for administration

Question 3

Which monitoring parameter is MOST critical for patients on alemtuzumab (Lemtrada) for multiple sclerosis?

Accepted Answer

Thyroid function tests, complete blood count, and urinalysis monthly for 48 months after last dose

Answer

Liver function tests monthly

Answer

Serum creatinine weekly

Answer

Fasting lipid panel quarterly

Question 4

For a patient with Gaucher disease type 1 starting enzyme replacement therapy (ERT) with imiglucerase (Cerezyme), what is the MOST important pharmacist counseling point regarding administration?

Accepted Answer

Infusion reactions may occur, and premedication and close monitoring during infusions are recommended

Answer

The medication can be self-injected subcutaneously at home without training

Answer

The drug should be taken with food to improve absorption

Answer

The patient must avoid all live vaccines while on therapy

Question 5

A CSP is counseling a patient newly prescribed fingolimod (Gilenya) for relapsing MS. Which assessment must be completed BEFORE the first dose?

Accepted Answer

Cardiac evaluation including ECG and first-dose observation for bradycardia

Answer

Bone mineral density scan

Answer

Colonoscopy to assess GI tolerability

Answer

Pulmonary function testing

Question 6

Which orphan drug act provision is MOST relevant to specialty pharmacies dispensing rare disease therapies?

Accepted Answer

It grants manufacturers market exclusivity for 7 years, which often results in limited competition and high drug prices that specialty pharmacies must navigate with payers

Answer

It requires specialty pharmacies to dispense orphan drugs at no charge

Answer

It mandates that orphan drugs bypass FDA approval

Answer

It allows specialty pharmacies to compound orphan drugs without FDA oversight