CSP Cheat Sheet 2026

The 30 highest-yield CSP facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. What does the Controlled Substances Act (CSA) regulate? → It regulates controlled substances to prevent misuse and abuse
2. What is the importance of patient-centered care in counseling? → Incorporating the patient's values into treatment decisions
3. Which of the following is a primary role of a specialty pharmacist in managing patients on oral chemotherapy? → Proactively monitoring for and managing treatment-related adverse events and adherence.
4. What is the significance of cost-effectiveness analysis in pharmacoeconomics? → It allows healthcare providers to compare the cost and benefit of treatments
5. What is the purpose of Good Manufacturing Practices (GMP) in the pharmaceutical industry? → To ensure the quality, safety, and consistency of products
6. Under the clozapine REMS, absolute neutrophil count (ANC) monitoring is required because clozapine can cause which life-threatening condition? → Severe neutropenia (agranulocytosis)
7. What does the concept of health technology assessment (HTA) involve? → Assessing the clinical and economic impacts of health technologies
8. How frequently must a REMS sponsor typically submit the first REMS assessment to the FDA after approval? → At 18 months, 3 years, and 7 years after approval
9. Why is adherence to specialty drug therapy important in the management of chronic diseases? → It ensures the therapy remains effective and prevents complications
10. A specialty pharmacy receives a prior authorization (PA) denial for a biologic agent. What is the most appropriate FIRST step? → Initiate a peer-to-peer review request with the prescriber's office
11. How do the Centers for Medicare & Medicaid Services (CMS) impact regulatory compliance? → They ensure compliance with Medicare and Medicaid standards
12. What is HIPAA, and why is it important in healthcare? → It protects patient privacy and secures health information
13. What is the first step in patient counseling for a newly diagnosed disease? → Listening to the patient and explaining treatment options
14. Under iPLEDGE, how many forms of contraception must females of childbearing potential who are not abstinent use while taking isotretinoin? → Two forms of contraception simultaneously
15. Which metric is most commonly used to evaluate specialty pharmacy dispensing efficiency and patient safety? → Medication error rate per 1,000 prescriptions
16. Which accreditation body specifically developed standards for specialty pharmacy practice in the United States? → URAC
17. Which of the following REMS programs uses a shared system that combines multiple manufacturers' products under one program? → TIRF REMS Access
18. What is a common method used in pharmacoeconomics to assess the economic burden of a disease? → Using Quality-Adjusted Life Years (QALYs)
19. For patients with Fabry disease receiving agalsidase beta (Fabrazyme), which adverse effect requires pharmacist patient education BEFORE each infusion? → Infusion-associated reactions including fever, chills, hypertension, and urticaria
20. Which clinical finding would MOST warrant a CSP recommending a dose interruption or reduction in a patient on siponimod (Mayzent) for secondary progressive MS? → New onset of symptomatic bradycardia or second-degree AV block
21. What is the significance of a collaborative approach in patient management? → It improves patient outcomes through teamwork
22. What is one of the main barriers to medication adherence in patients with chronic diseases? → Complexity of the medication regimen
23. Why is the reimbursement process important in pharmacoeconomics? → It ensures that providers are paid for services while managing cost-effectiveness
24. Under most REMS programs with ETASU, a specialty pharmacy may NOT dispense a REMS medication if which condition exists? → The prescriber is not enrolled in the REMS program
25. A patient enrolled in the mycophenolate (CellCept/Myfortic) REMS program must be counseled about which primary risk? → Teratogenicity and pregnancy loss
26. A patient with transthyretin amyloidosis (ATTR) is prescribed patisiran (Onpattro). How is this RNA interference (RNAi) therapy administered? → IV infusion every 3 weeks
27. Under which federal law did the FDA gain formal authority to require REMS programs? → Food and Drug Administration Amendments Act (FDAAA) of 2007
28. How do biologic drugs work in disease management? → They block the immune response that causes inflammation
29. What role do pharmaceutical manufacturers play in pharmacoeconomics? → They provide cost data and support drug development
30. What are ETASU in the context of REMS programs? → Elements to Assure Safe Use