100+ Free SOBRAFO Farmácia Oncológica Practice Questions

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Key Facts: SOBRAFO Farmácia Oncológica Exam

50 Items

Five-option MCQs on the official SOBRAFO written examination

Edital Oficial SOBRAFO

4 Hours

Total duration of the theoretical objective examination

Edital Oficial SOBRAFO

60%

Minimum Passing Grade on the Objective Written Exam

Regulamento SOBRAFO / CFF

RDC 220/2004

Core ANVISA regulation governing antineoplastic therapy services in Brazil

Agência Nacional de Vigilância Sanitária (ANVISA)

Res. CFF 623/16

Establishes antineoplastic handling as exclusive pharmacist competence

Conselho Federal de Farmácia (CFF)

Permanent

Validity of the Specialist Title upon registration with Regional Pharmacy Councils

SOBRAFO / CFF

The SOBRAFO Título de Especialista em Farmácia Oncológica is Brazil's official oncology pharmacy board certification. Administered by SOBRAFO and recognized by the CFF, it certifies pharmacist competency across antineoplastic preparation biosafety (RDC 220/2004), cytotoxic pharmacology, targeted therapies, immunotherapy toxicities, oncology emergencies, and clinical pharmacotherapy.

Sample SOBRAFO Farmácia Oncológica Practice Questions

Try these sample questions to test your SOBRAFO Farmácia Oncológica exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1Under ANVISA RDC nº 220/2004 (Regulamento Técnico de Serviços de Terapia Antineoplásica), read together with the sterile-compounding requirements of RDC nº 67/2007 Anexo IV, which international cleanroom ISO classification applies to the inner work zone of the Biological Safety Cabinet (primary engineering control) and to the surrounding cleanroom preparation area (secondary engineering control), respectively?

A.ISO Class 5 (Grade A) inside the Biological Safety Cabinet and ISO Class 7 (Grade B/C) for the surrounding preparation cleanroom.

B.ISO Class 7 inside the Biological Safety Cabinet and ISO Class 8 for the surrounding preparation cleanroom.

C.ISO Class 4 inside the Biological Safety Cabinet and ISO Class 5 for the surrounding preparation cleanroom.

D.ISO Class 8 inside the Biological Safety Cabinet and unclassified controlled air for the surrounding preparation cleanroom.

Explanation: Sterile antineoplastic compounding requires an ISO Class 5 environment (maximum 3,520 particles ≥0.5 µm/m³) inside the Biological Safety Cabinet, sited within an ISO Class 7 cleanroom buffer room, with an ISO Class 8 anteroom serving as the gowning and material-staging transition zone. In the Brazilian framework, RDC nº 220/2004 is the specific technical regulation for antineoplastic therapy services; RDC nº 67/2007 Anexo IV sets the Good Practices for compounding sterile preparations, and its Anexo III (antibiotics, hormones and cytostatics) expressly defers the manipulation of antineoplastic therapy products back to RDC nº 220/2004.

2In accordance with ANVISA RDC nº 220/2004, what is the mandatory air pressure differential relationship between the antineoplastic preparation room (cleanroom) and its adjacent ante-room/staging area?

A.The antineoplastic preparation room must maintain negative differential pressure (-5 to -15 Pa) relative to the adjacent ante-room to contain hazardous aerosols.

B.The antineoplastic preparation room must maintain positive differential pressure (+15 to +30 Pa) relative to the ante-room to prevent particulate entry.

C.The antineoplastic preparation room and the ante-room must be maintained at equal atmospheric pressure (neutral differential pressure).

D.The antineoplastic preparation room must have variable positive-negative cycling pressure controlled by manual dampers.

Explanation: ANVISA RDC nº 220/2004 mandates that rooms designated for antineoplastic compounding operate under negative pressure relative to adjacent areas (typically -5 to -15 Pa or -0.02 to -0.05 inches of water). This negative pressure gradient prevents hazardous cytotoxic vapors, gases, and particulate matter from escaping into adjoining corridors and gowning areas.

3Which type of Biological Safety Cabinet (BSC / CSB) is defined as providing 100% total external exhaust of air through dedicated HEPA filtration with zero internal recirculation, making it ideal for compounding volatile hazardous antineoplastics?

A.Class II Type B2 Biological Safety Cabinet

B.Class II Type A2 Biological Safety Cabinet

C.Class I Biological Safety Cabinet

D.Horizontal Laminar Flow Clean Bench

Explanation: Class II Type B2 Biological Safety Cabinets are total exhaust hoods where 100% of downflow and inflow air is discharged directly to the external facility atmosphere through dedicated ductwork and HEPA filters without any internal recirculation. This total exhaust design prevents the accumulation of chemical vapors and volatile antineoplastic agents in the compounding zone.

4What is the primary technological mechanism by which Closed System Drug Transfer Devices (CSTDs) minimize occupational exposure during antineoplastic reconstitution and administration?

A.They mechanically prohibit the transfer of environmental contaminants into the system and prevent the escape of hazardous drug or vapor concentrations outside the system.

B.They chemically neutralize cytotoxic functional groups through reactive internal membrane filters upon fluid contact.

C.They utilize ultraviolet germicidal irradiation within the luer-lock connection to destroy chemical bonds.

D.They increase infusion line pressure to accelerate drug delivery time and minimize exposure duration.

Explanation: A Closed System Drug Transfer Device (CSTD) is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. CSTDs achieve this through physical sealed barrier membranes or internal airtight expansion chambers with 0.2 µm hydrophobic air-cleaning filters.

5According to biosafety standards and RDC nº 220/2004, what is the proper protocol for Personal Protective Equipment (PPE) gloving when compounding hazardous antineoplastic medications?

A.Double gloving with chemotherapy-tested, powder-free gloves (nitrile or neoprene), with the inner glove worn under the gown cuff and the outer glove worn over the gown cuff.

B.Single gloving with standard medical-grade powdered latex gloves pulled firmly over the gown cuff.

C.Double gloving with standard surgical latex gloves, both worn tucked completely underneath the elastic gown cuff.

D.Wearing a single heavy-duty rubber utility glove on the non-dominant hand and no glove on the dominant hand to preserve tactile dexterity.

Explanation: Safe handling guidelines mandate double gloving using powder-free gloves tested against antineoplastic permeation according to ASTM D6978. The inner glove must be placed directly against the skin underneath the knit gown cuff, while the outer glove is pulled over the gown sleeve cuff to establish a complete impermeable seal.

6What design characteristics are mandatory for protective chemotherapy gowns used in the antineoplastic compounding cleanroom under ANVISA RDC nº 220/2004?

A.Lint-free, low-permeability fabric with a solid front, long sleeves with tight-fitting elastic or knit cuffs, and back closure.

B.Front-buttoned 100% cotton laboratory coat with open wide cuffs to facilitate arm movement.

C.Standard permeable spunbond polypropylene gown with front tie closures and short sleeves.

D.Disposable plastic aprons worn over regular personal clothing without arm coverage.

Explanation: Under RDC nº 220/2004, antineoplastic compounding gowns must be made of non-linting, low-permeability materials (e.g., polyethylene-coated polypropylene) featuring a closed/solid front panel, back closure to prevent front seam leakage, and long sleeves with snug elastic or knit cuffs.

7According to CONAMA Resolução nº 358/2005 and ANVISA RDC nº 222/2018 regarding Healthcare Waste Management (PGRSS), into which waste classification group do antineoplastic and cytotoxic residues fall?

A.Group B (Chemical Waste / Resíduos Químicos)

B.Group A (Infectious Biological Waste / Resíduos Biológicos)

C.Group C (Radioactive Waste / Resíduos Radioativos)

D.Group D (Common Household Waste / Resíduos Comuns)

Explanation: Under ANVISA RDC nº 222/2018 and CONAMA nº 358/2005, antineoplastic drugs, cytotoxic residues, contaminated consumables, and expired chemotherapy vials are classified as Group B (Chemical Waste). They must be packaged in rigid, leak-proof containers identified with the hazard symbol for toxic/mutagenic substances.

8When managing chemotherapy-contaminated sharps (needles, ampoules, broken vials) in an oncology pharmacy, what is the maximum recommended fill capacity for rigid sharps disposal containers before replacement?

A.Two-thirds (2/3) to three-quarters (3/4) of the container's total capacity, or up to the manufacturer's fill line.

B.One hundred percent (100%) capacity, compacting contents manually to maximize volume.

C.No fill limit applies as long as the container lid can be taped shut under pressure.

D.One-fourth (1/4) capacity, emptying contents daily into standard plastic trash bags for reuse.

Explanation: Rigid sharps containers (Descarpack) must never be filled beyond 2/3 to 3/4 of their total volume (or past the visible fill line indicated on the container). Overfilling creates severe risk of needle-stick injuries, puncture through the opening, and cytotoxic aerosolization.

9A liquid spill of 50 mL of concentrated doxorubicin occurs on the cleanroom floor outside the biological safety cabinet. What is the correct initial sequence of actions according to the oncology spill kit protocol (Kit de Derramamento)?

A.Restrict area access, don full spill PPE (respirator PFF2/N95, eye protection, double gloves, chemo gown), cover liquid with absorbent pads working from perimeter to center, clean with detergent, and discard all materials into Group B hazardous waste bags.

B.Immediately wipe the spill vigorously with dry gauze from the center outward toward the walls, then spray 70% alcohol without wearing a respirator.

C.Rinse the area with high-pressure tap water and sweep the chemical down the municipal floor drain.

D.Leave the cleanroom immediately, seal the doors, and allow the spill to evaporate completely over 48 hours.

Explanation: Spill kit procedures require immediately isolating the area, donning comprehensive protective equipment (respiratory protection PFF2/N95, goggles, chemo gown, double gloves, shoe covers), applying absorbent sheets from the outer edges toward the center to prevent spread, decontaminating the surface with appropriate cleaning solutions, and disposing of all residue in labeled Group B hazardous containers.

10Which microbiological environmental monitoring method is utilized to assess viable fungal and bacterial particulate sedimentation on compounding surfaces inside an ISO Class 5 Biological Safety Cabinet during active compounding operations?

A.Passive air sampling using open settle plates (Tryptic Soy Agar and Sabouraud Dextrose Agar) exposed for a validated duration (typically up to 4 hours).

B.Continuous laser particle counting measuring only non-viable particulate matter.

C.Periodic chemical luminescence swabs detecting ATP with no microbial culture capability.

D.Gram staining of condensate water collected from the HVAC condenser coils.

Explanation: Passive air monitoring inside cleanrooms and BSCs utilizes open settle plates (TSA for bacteria and SDA for fungi) positioned in critical compounding zones for a validated exposure period (up to 4 hours) to capture settling viable microorganisms, followed by controlled incubation and Colony Forming Unit (CFU) enumeration.

About the SOBRAFO Farmácia Oncológica Exam

The Título de Especialista em Farmácia Oncológica is the premier professional oncology pharmacy board certification in Brazil, conferred by the Sociedade Brasileira de Farmacêuticos em Oncologia (SOBRAFO) and recognized by the Conselho Federal de Farmácia (CFF). Under CFF Resoluções nº 623/2016 and nº 640/2017, obtaining this specialist title or completing an accredited oncology pharmacy residency is the gold standard for legally validating professional competence to handle antineoplastic agents and lead clinical oncology pharmacy services. The examination assesses in-depth knowledge of ANVISA sanitary standards (RDC 220/2004, RDC 67/2007 Anexo VIII, RDC 222/2018), cleanroom engineering controls, cytotoxic compounding biosafety, molecular pharmacology, immuno-oncology, extravasation management, supportive care antiemesis protocols, and individualized clinical pharmacokinetic dosing.

Assessment

Two-phase competitive examination administered by the Sociedade Brasileira de Farmacêuticos em Oncologia (SOBRAFO) and recognized by the Conselho Federal de Farmácia (CFF). Phase 1: Curricular and Documentary Evaluation (eliminatory). Phase 2: Written Objective Examination featuring 50 multiple-choice questions covering cleanroom biosafety, cytotoxic chemotherapy, targeted therapy, immunotherapy, supportive care, oncology emergencies, and clinical oncology pharmacy (eliminatory and classificatory, minimum 60% passing mark).

Time Limit

4 hours of examination

Passing Score

Final score of at least 60% (60/100 points) on the theoretical written exam plus qualification in Phase 1 curricular evaluation

Exam Fee

Set each year in the official Edital; consult the current edital for the registration fee and any member discount. (Sociedade Brasileira de Farmacêuticos em Oncologia (SOBRAFO) — Conselho Federal de Farmácia (CFF))

SOBRAFO Farmácia Oncológica Exam Content Outline

25%

Manipulação, Biossegurança e RDC ANVISA 220/2004

Cleanroom architectural design and HVAC systems (ISO Class 5 BSC, ISO Class 7 compounding cleanroom, ISO Class 8 anteroom), differential negative pressure (-5 to -15 Pa), Class II Type B2 100% total exhaust biological safety cabinets, Closed System Drug Transfer Devices (CSTD), personal protective equipment (PPE double gloves, chemo gowns, PFF2/N95 masks), chemical spill kits, environmental and microbiological air/surface monitoring, and hazardous waste disposal (RDC 222/2018, CONAMA 358).

25%

Farmacologia Antineoplásica e Quimioterapia Citotóxica

Cytotoxic chemotherapy classifications, mechanism of action, cell cycle specificity, metabolism and excretion pathways, pharmacogenomics (DPYD, UGT1A1, TPMT), classic toxicities and organoprotection (mesna for ifosfamide/cyclophosphamide acrolein cystitis, leucovorin for high-dose methotrexate, dexamethasone for docetaxel fluid retention, hydration for cisplatin nephrotoxicity), and safe administration precautions.

20%

Terapias-Alvo, Anticorpos Monoclonais e Imunoterapia

Targeted monoclonal antibodies (trastuzumab, rituximab, cetuximab, panitumumab, bevacizumab), small molecule tyrosine kinase inhibitors (EGFR, ALK, BCR-ABL, BTK, VEGFR TKIs), antibody-drug conjugates (T-DM1, T-DXd, sacituzumab govitecan), immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4 inhibitors), and diagnosis/management of immune-related adverse events (irAEs).

15%

Terapia de Suporte, Antiemese e Neutropenia Febril

MASCC/ASCO/ESMO antiemetic guidelines for HEC and MEC (5-HT3 antagonists, NK1 receptor antagonists, dexamethasone, olanzapine), febrile neutropenia definition, MASCC risk index, myeloid growth factors (filgrastim, pegfilgrastim), cancer-related pain management (WHO ladder, opioid rotation), and oral mucositis prevention and treatment.

10%

Emergências Oncológicas e Manejo de Extravasamento

Antineoplastic extravasation classifications (vesicants, irritants, non-vesicants), localized thermal interventions (dry cold vs dry heat compresses), specific antidotes (dexrazoxane for anthracyclines, hyaluronidase for vinca alkaloids, sodium thiosulfate for mechlorethamine), Tumor Lysis Syndrome (Cairo-Bishop criteria, rasburicase, allopurinol), and oncologic hypercalcemia.

Farmácia Clínica Oncológica e Interações Medicamentosas

Prescription validation, oncology dosing calculations (Calvert formula, Mosteller BSA), renal and hepatic dose adjustments, pharmacokinetic and pharmacodynamic drug-drug interactions (CYP3A4/CYP2D6, gastric acid suppressants with oral TKIs), pharmacovigilance, and Brazilian professional regulations (CFF Res. 623/2016 e 640/2017).

How to Pass the SOBRAFO Farmácia Oncológica Exam

What You Need to Know

Passing score: Final score of at least 60% (60/100 points) on the theoretical written exam plus qualification in Phase 1 curricular evaluation
Assessment: Two-phase competitive examination administered by the Sociedade Brasileira de Farmacêuticos em Oncologia (SOBRAFO) and recognized by the Conselho Federal de Farmácia (CFF). Phase 1: Curricular and Documentary Evaluation (eliminatory). Phase 2: Written Objective Examination featuring 50 multiple-choice questions covering cleanroom biosafety, cytotoxic chemotherapy, targeted therapy, immunotherapy, supportive care, oncology emergencies, and clinical oncology pharmacy (eliminatory and classificatory, minimum 60% passing mark).
Time limit: 4 hours of examination
Exam fee: Set each year in the official Edital; consult the current edital for the registration fee and any member discount.

Keys to Passing

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SOBRAFO Farmácia Oncológica Study Tips from Top Performers

1Master ANVISA Cleanroom Engineering Standards (RDC 220/2004): Memorize ISO classifications (ISO Class 5 BSC inside ISO Class 7 cleanroom with ISO Class 8 anteroom), differential negative pressure requirements (-5 to -15 Pa), 100% total external exhaust Class II Type B2 safety cabinets, and cleanroom air change rates (≥30 ACH).

2Internalize Antineoplastic Antidote and Extravasation Protocols: Know the precise categorization of vesicants (DNA-binding anthracyclines vs non-DNA-binding vinca alkaloids), thermal therapy indications (dry cold for anthracyclines/alkylating agents vs dry heat for vinca alkaloids/taxanes), and specific antidotes (dexrazoxane for anthracyclines, hyaluronidase for vinca alkaloids, sodium thiosulfate for mechlorethamine).

3Practice Oncology Dosing Calculations: Be fluent in calculating carboplatin doses via the Calvert formula (Dose = Target AUC * [GFR + 25]) with GFR capped at 125 mL/min, and Mosteller BSA calculations (sqrt([height in cm * weight in kg] / 3600)).

4Review Immune Checkpoint Inhibitor Toxicities (irAEs): Understand the management of irAEs by CTCAE grade, including when to withhold vs permanently discontinue checkpoint inhibitors, and the standard high-dose corticosteroid regimens (prednisone 1–2 mg/kg/day) with slow tapering over at least 4 to 6 weeks to prevent rebound autoimmunity.

5Memorize Evidence-Based Antiemetic Prophylaxis: Learn MASCC/ASCO/ESMO 4-drug regimens for High Emetogenic Chemotherapy (HEC, e.g., Cisplatin, AC regimen: 5-HT3 antagonist + NK1 antagonist + Dexamethasone + Olanzapine) and delayed nausea prevention strategies.

6Understand Pharmacogenomics in Oncology: Review key biomarker-drug pairs: DPYD gene testing for 5-FU/capecitabine severe toxicity, UGT1A1*28 polymorphism for irinotecan severe neutropenia and diarrhea, and TPMT/NUDT15 for thiopurine toxicity.

Frequently Asked Questions

What is the SOBRAFO Specialist Title and why is it legally significant in Brazil?

The Título de Especialista em Farmácia Oncológica is the official oncology pharmacy specialist certification awarded by SOBRAFO and recognized by the Conselho Federal de Farmácia (CFF). Under CFF Resoluções nº 623/2016 and nº 640/2017, antineoplastic compounding and clinical oncology pharmacy are exclusive and non-delegable pharmaceutical activities. Pharmacists must hold a SOBRAFO specialist title, an accredited oncology residency, or a MEC-recognized oncology pharmacy postgraduate diploma registered with their Regional Pharmacy Council (CRF) to legally practice in this specialty.

What are the eligibility requirements to sit for the SOBRAFO specialist examination?

Candidates must be registered pharmacists in good standing with their respective Conselho Regional de Farmácia (CRF) and fulfill the curricular criteria published in the official SOBRAFO edital, which includes completing an accredited oncology pharmacy residency, holding a recognized postgraduate specialization in oncology pharmacy, or proving documented professional clinical practice in antineoplastic therapy services.

How is the SOBRAFO Specialist Examination structured?

The examination is divided into two phases: Phase 1 is an eliminatory Curricular and Documentary Evaluation (Análise de Currículo e Títulos) assessing academic degrees, clinical experience, and scientific publications; Phase 2 is a written multiple-choice examination (Prova Teórica Objetiva) comprising 50 questions evaluating cleanroom biosafety (RDC 220/2004), antineoplastic pharmacology, supportive care, immunotherapy, and clinical oncology pharmacy.

What is the passing score required to obtain the specialist title?

Candidates must obtain approval in the Phase 1 curricular evaluation (meeting the minimum score stipulated in the edital, typically 50 points) and score at least 60% (equivalent to 6.0/10.0 or 60/100 points) on the Phase 2 theoretical objective examination.

Which regulatory and clinical guidelines are tested on the SOBRAFO exam?

The exam evaluates key Brazilian regulations including ANVISA RDC nº 220/2004 (Serviços de Terapia Antineoplásica), RDC nº 67/2007 Anexo VIII (Boas Práticas de Manipulação de Preparações Estéreis), RDC nº 222/2018 (Gerenciamento de Resíduos de Serviços de Saúde), CONAMA nº 358/2005, and CFF Resoluções nº 623/2016 e nº 640/2017. In clinical pharmacy, it evaluates MASCC/ASCO/ESMO antiemetic guidelines, ASCO/NCCN febrile neutropenia and immune-related toxicity guidelines, and Brazilian clinical oncology consensus statements.

Why is this OpenExamPrep practice bank presented in English?

This practice bank is an English-language MCQ study adaptation, not a direct replica of the official SOBRAFO Portuguese paper. It provides 100 comprehensive clinical vignettes with four alternatives each to support Brazilian candidates practicing clinical reasoning as well as international oncology pharmacists studying Brazilian biosafety norms and clinical protocols. All authentic Brazilian regulatory citations, statutory terminology, and clinical dosing formulas are preserved inline.