CSP Specialty Pharmacy Exam | 100% Correct And Verified Answers| Latest 2024 Version

CSP Specialty Pharmacy Exam | 100% Correct Answers | Verified | Latest 2024 Version Specialty Medicines - Answer Rx drugs that require special handling, distribution + administration Many specialty medicines are _____ - Answer biologics (instead of chemically synthesized drugs) that are delivered via injection or an infusion + are used to treat chronic, complex disease Origins of Specialty Pharmacy - Answer - came out of pharmacy compounding traditio - pharmacies began to grow home infusion operations in 1980s - supported physician offices + nursing homes - expanded in late 1990s to include orphan drugs - began to grow targeted therapy business in 2000 as mroe specialized drug therapies entered market - added discounted or low margin drugs to the mix as manufacturers focused on high margin + biotechnology products - expanded as outlet for drug manufacturers when complex + very expensive products began to enter market (biologics + high-cost injectables) - currently represent about 1/2 of market with physician-led practices shrink The largest biobank in the world is ____ - Answer the US military - to identify the remains (collecting bioswabs on every recruit for last 2 decades) Impact of Specialty Products -- Manufacturers are shifting their emphasis in drug developments from _____ - Answer primary care to specialty drugs Specialty drugs have been the fastest growing ______ - Answer segment of drug spend + expected to top 50% in 2020 ____% of new molecular entities approved by FDA in 2013 were specialty drugs - Answer 60% ___% New Drug Applications for specialty drugs will require limited distribution - Answer 86% Inc numbers of first generation specialty drugs are _____ - Answer oral ____ of the New Drug Applications are for oncolytics - Answer 1/2 ___ of the New Drug Applications will be infused - Answer 1/4 Average cost of specialty drug is _____ - Answer $2,865/month Increasingly, former ____ diseases are now treated effectively as chronic disease or cured - Answer terminal diseases (ex: cancer) Biotechnology Medicines Under Development (rank) - Answer 1) Cancer 2) ID = infectious disease 3) Auto-immune 4) CV (cardiovascular) 5) Neurologic Biotechnology Medicines Under Development --- the 5 leading therapies by Product Category - Answer 1) Monoclonal Antibodies 2) Vaccines 3) Recombinant Hormones/Proteins 4) Cell Therapy 5) Gene Therapy Route of Administration for 2010 New Drug Approvals - Answer 1) Infused 2 + 3) Clinically Admin Injections + Oral/Eye Drops 4) Self-adminstered About ___ % of claims were injectables administered in physician's office - Answer 52% About ___ % of claims were injectables administered in hospital outpatient departments - Answer 24% (one quarter) About ___ % of claims were injectables administered in inpatient settings - Answer 13% Challenges for Patients + Providers --- Specialty drugs or pharmaceuticals usually require _____ - Answer - special handling - adminsitration - unique inventory management - a high level of patient monitoring - more intense support than traditional therapies Other Challenges for Patients + Providers - Answer - High unit cost (> $5,000/pt/yr); price increases 2x as high (10%) as traditional drugs (6%) - New biopharmaceuticals (knowledge gap) - Complex care (testing, monitoring, education) - Infusion, injection, or other unique admin are moving more of the administered drugs into hospitals - storage + inventory control issues - close clinical supervision required to achieve desired outcomes (adherence) - FDA or Drug Manufacturer may require drug-specific protocols Specialty Drug Distribution Channels - Answer 1) Retail Pharmacy -- typically home infusion service - Challenges: inventory, knowledge + administration 2) Specialty Pharmacy -- central fill through unit connected to Prescription Benefit Manager (PBM) - Challenges: access + convenience 3) Hospital Pharmacy -- extension of home health care or oncologic clinic - Challenges: access + convenience 4) Physician office -- small oncology practices - Challenges: high cost + low control Specialty Pharmacy Providers -- Specialty pharmacy is often a subset of ____ - Answer Retail pharmacy in managed care - Payers often contract specifically with specialty pharmacies to provide specialty pharmaceutical services to their members - Many payers own their specialty pharmacy (ex) > Express scripts -- CuraScript Specialty Pharmacy > Humana -- RightSourceRx Specialty P