100+ Free Fachapotheker/in FPH Spital Practice Questions

Prepare for the Fachapotheker/in FPH in Spitalpharmazie / Pharmacien/ne spécialiste FPH en pharmacie hospitalière exam with instant access — no signup required.

✓ No registration✓ No credit card✓ No hidden fees✓ Start practicing immediately

100+ Questions

100% Free

Loading practice questions...

Same family resources

Explore More Swiss FPH Pharmacy Specialist Examinations (Fachapotheker FPH)

Continue into nearby exams from the same family. Each card keeps practice questions, study guides, flashcards, videos, and articles in one place.

Fachapotheker/in FPH Offizin (Switzerland)

Practice Questions100 questions

2026 Statistics

Key Facts: Fachapotheker/in FPH Spital Exam

GSASA / FPH

Accrediting Body

GSASA & Institut FPH Regulations

Written + Oral

Exam Format

GSASA Schlussprüfung Reglement

3–6 Years

Residency Duration

FPH Spital Weiterbildungsprogramm

120 min

Written Exam Duration

GSASA Examination Standard

Lifetime

FPH Title Validity

Institut FPH / pharmaSuisse

100

Practice Questions

OpenExamPrep

The Fachapotheker/in FPH in Spitalpharmazie credential certifies hospital pharmacy specialists in Switzerland through GSASA and FPH. Examination assessment comprises two 1-hour written papers (MCQs and open clinical cases), an oral clinical board, and a diploma thesis presentation covering clinical pharmacotherapy, aseptic manufacturing, formulary management, IMPs, and medication safety.

Sample Fachapotheker/in FPH Spital Practice Questions

Try these sample questions to test your Fachapotheker/in FPH Spital exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1A 62-year-old male ICU patient (weight 75 kg, serum creatinine 110 µmol/L) with severe MRSA hospital-acquired pneumonia is receiving IV vancomycin. According to current consensus guidelines on therapeutic drug monitoring (TDM) of vancomycin, what is the primary pharmacokinetic/pharmacodynamic (PK/PD) target index for clinical efficacy and nephrotoxicity minimization in serious MRSA infections?

A.Target area under the 24-hour concentration-time curve to minimum inhibitory concentration ratio (AUC24/MIC) of 400 to 600 mg·h/L (assuming MIC by broth microdilution = 1 mg/L)

B.Target steady-state peak serum concentration (Cpeak) of 60 to 80 mg/L measured 1 hour after completing a 60-minute infusion

C.Target isolated trough serum concentration (Ctrough) of 25 to 30 mg/L measured immediately prior to the fourth dose

D.Target time above the minimum inhibitory concentration (fT>MIC) of 100% of the dosing interval with trough levels maintained below 5 mg/L

Explanation: Current international and GSASA consensus guidelines recommend area under the curve to MIC ratio (AUC24/MIC) of 400 to 600 mg·h/L (for isolates with broth microdilution MIC <= 1 mg/L) as the primary PK/PD target for serious MRSA infections. Trough-only monitoring (historically targeting 15–20 mg/L) is discouraged for serious MRSA infections because it significantly increases the risk of acute kidney injury without improving clinical outcomes compared to Bayesian-guided or two-point AUC calculation. Peak levels of 60–80 mg/L and troughs of 25–30 mg/L are associated with severe nephrotoxicity, and vancomycin displays AUC/MIC-dependent (not time-dependent fT>MIC) bactericidal activity.

2A hospital pharmacist is designing the layout for a new cleanroom suite intended for the central preparation of cytotoxic intravenous infusions in accordance with EU GMP / PIC/S Annex 1. Which configuration of airflow and pressure cascade is mandatory for the cytotoxic preparation area?

A.Grade A horizontal laminar airflow cabinet located in a Grade B background room maintained under positive pressure relative to surrounding corridors

B.Grade A Class II Type A2 or Type B2 Biological Safety Cabinet (or negative pressure isolator) with 100% external air exhaust, located in a Grade B room under negative pressure relative to the adjacent airlocks

C.Grade A open workbench situated in a Grade C cleanroom maintained under positive pressure with 100% air recirculation through HEPA filters

D.Grade B turbulent airflow room without local containment enclosures, operating under equal atmospheric pressure relative to surrounding anterooms

Explanation: For hazardous drug compounding (cytotoxics), operator and environmental protection require a Grade A local containment enclosure (Class II Type A2/B2 BSC or negative-pressure isolator) with 100% external air exhaust (no recirculation of hazardous vapors), located inside a Grade B background cleanroom. The preparation room must be maintained under negative pressure relative to surrounding ante-rooms/airlocks to prevent volatile or aerosolized cytotoxic particles from escaping into clean corridors.

3Under the Swiss Health Insurance Ordinance (Art. 71a–71d KVV / OAMal), when an oncologist requests inpatient off-label reimbursement for an expensive oncology drug outside its Swissmedic-approved indication, which criterion must be fulfilled for mandatory reimbursement by the statutory health insurer (OKP)?

A.The medication must be listed on the Swiss Specialty List (Spezialitätenliste, SL) for that specific indication with an established SwissDRG flat rebate

B.The clinical trial evaluating the drug must be fully sponsored by the Swiss National Science Foundation (SNF) and completed in a Swiss university hospital

C.The therapy is expected to provide a major therapeutic benefit against a fatal or chronic severe disease, and no approved, effective, and reimbursable alternative therapy exists

D.The hospital's Arzneimittelkommission (AMK) must unanimously vote to cover 100% of the medication acquisition costs from its general operating budget

Explanation: Articles 71a–71d of the Swiss Ordinance on Health Insurance (Krankenversicherungsverordnung, KVV / OAMal, SR 832.102 — not the KLV, which is the separate benefits ordinance) govern off-label and off-limitation drug reimbursement. Under Art. 71a/71b KVV, statutory compulsory health insurance (OKP) must cover a medicinal product on a case-by-case basis if: 1) the patient suffers from a disease that is fatal or causes severe, chronic health impairment; 2) no other effective, authorized, and reimbursable therapeutic alternative exists; and 3) a major therapeutic benefit is expected based on scientific evidence, as evaluated and approved by the health insurer's medical consultant (Vertrauensarzt).

4A clinical pharmacist reviews an adverse drug event submitted to the hospital Critical Incident Reporting System (CIRS): a nurse accidentally infused 100 mL of concentrated 7.45% Potassium Chloride IV solution instead of 0.9% NaCl, resulting in cardiac arrest. According to international and Swiss patient safety standards, what is the single most effective system-level error prevention strategy?

A.Conduct mandatory annual pharmacology quizzes for all ward nursing staff regarding the dangers of rapid potassium infusion

B.Place bright fluorescent warning stickers on all concentrated potassium chloride ampoules stored in the central ward medication room

C.Implement a double-signature verification rule whenever a nurse draws up any electrolyte solution in the clinical department

D.Completely remove concentrated potassium chloride vials/ampoules from all general ward floor stocks, restricting storage strictly to the central pharmacy or premixed commercial bags

Explanation: In human factors engineering and Reason's Swiss Cheese safety model, physical elimination/forcing functions represent the highest level of reliability. Concentrated potassium chloride is a premier high-alert medication (APINCH); the gold standard patient safety recommendation (WHO, Swiss Patient Safety Foundation, GSASA) is the total removal of concentrated potassium ampoules from all general clinical wards and stocking only premixed, diluted IV infusion bags. Educational sessions, warning stickers, and double-checks are lower-hierarchy interventions vulnerable to human fatigue and confirmation bias.

5Under the Swiss Human Research Act (HFG) and Clinical Trials Ordinance (KlinV), what regulatory authorization is required before a hospital pharmacy can manufacture and release an unapproved Investigational Medicinal Product (IMP) for a Category C clinical trial?

A.Approval from the cantonal ethics committee (Swissethics) and a formal clinical trial authorization from Swissmedic, with batch release by a Qualified Person (FPH Spital)

B.Notification to the Swiss Federal Office of Public Health (BAG) without requiring formal ethics committee approval

C.A valid cantonal retail pharmacy license (Offizinbewilligung) and written consent from the hospital medical director only

D.An Investigational New Drug (IND) approval granted exclusively by the United States Food and Drug Administration (FDA)

Explanation: Under the Swiss Clinical Trials Ordinance (KlinV), Category C clinical trials involve medicinal products not authorized in Switzerland or authorized products used outside approved labeling with new active substances. Category C trials require dual regulatory clearance: favorable opinion from the responsible Cantonal Ethics Committee (Swissethics) AND formal authorization from Swissmedic. Manufacture, testing, and QP batch release must comply with EU GMP Annex 13 / PIC/S guidelines within a licensed hospital pharmacy manufacturing facility.

6A 58-year-old critically ill patient with septic shock and acute respiratory distress syndrome is receiving continuous venovenous hemodiafiltration (CVVHDF) with an effluent flow rate of 2500 mL/h. The patient is prescribed intravenous meropenem. How does the pharmacokinetic profile of meropenem change during CVVHDF, and what is the optimal dosing strategy?

A.Meropenem clearance is unaffected by CVVHDF because it is 98% bound to plasma albumin; use standard non-renal dose of 500 mg IV q24h

B.Meropenem exhibits low protein binding (<10%) and low molecular weight (383 Da), resulting in extensive clearance (sieving coefficient ~1.0); administer 1000 mg IV every 8 hours as an extended 3- to 4-hour or continuous infusion

C.Meropenem undergoes irreversible adsorption onto polysulfone filter membranes, requiring a 5-fold dose escalation to 3000 mg IV every 4 hours

D.Meropenem is metabolized completely by hepatic CYP3A4 during extracorporeal circulation, requiring co-administration of oral ritonavir

Explanation: Meropenem is a hydrophilic beta-lactam with low molecular weight (383 Da), low volume of distribution (~0.25 L/kg), and negligible plasma protein binding (<10%). Consequently, it freely crosses high-flux CRRT dialyzer membranes with a sieving/saturation coefficient close to 1.0. In patients receiving high-intensity CVVHDF (20–35 mL/kg/h effluent), meropenem extracorporeal clearance is substantial. Underdosing is a major risk; recommended regimens are 1 g IV q8h (or continuous infusion of 3 g/day) delivered as extended infusions (over 3–4 hours) to maximize the PK/PD index fT>MIC above 4–5x the target pathogen MIC.

7When formulating a Total Parenteral Nutrition (TPN) all-in-one 3-in-1 admixture containing amino acids, glucose, lipids, electrolytes, and trace elements, what physicochemical phenomenon poses the greatest risk of catastrophic pulmonary microembolism?

A.Oxidation of ascorbic acid leading to insoluble dehydroascorbic acid crystallization

B.Hydrolysis of dextrose into 5-hydroxymethylfurfural under alkaline conditions

C.Precipitation of dibasic calcium phosphate (CaHPO4) resulting from high calcium and inorganic phosphate concentrations, elevated temperature, and high pH

D.Polymerization of branched-chain amino acids into macromolecular amyloid fibrils

Explanation: Calcium and inorganic phosphate can form insoluble dibasic calcium phosphate (CaHPO4) precipitates in TPN admixtures. Precipitation is favored by higher concentrations of calcium and phosphate, higher pH (which favors the less soluble HPO4^2- over H2PO4^-), higher ambient temperatures, and lower amino acid concentrations (amino acids form soluble complexes with calcium). If infused, these crystalline precipitates cause occlusion of in-line filters or fatal pulmonary microvascular embolization. Use of organic phosphate (e.g., sodium glycerophosphate) substantially prevents this precipitation.

8In the Swiss inpatient hospital financing system (SwissDRG), how are exceptionally expensive specialized hospital medications (such as CAR-T cell therapies, factor concentrates, or orphan biologics) reimbursed when standard case-based flat rates (Fallpauschalen) are insufficient?

A.The hospital bills the patient directly via private out-of-pocket invoice with a statutory 20% surcharge

B.The pharmaceutical manufacturer is legally obligated to provide the medication free of charge under the Swiss Epidemics Act

C.The cantonal department of health covers the invoice from cantonal tax revenues under the Swiss Discretionary Fund (Härtefallklausel)

D.The medication cost is reimbursed through separately negotiated SwissDRG add-on payments (Zusatzentgelte, ZE) defined in the national SwissDRG remuneration catalog

Explanation: Under the SwissDRG acute inpatient financing system, most routine diagnostic and therapeutic services are bundled into base DRG case payments (Fallpauschalen). However, for high-cost, specialized therapies (e.g., CAR-T cells, specific oncology biologics, expensive coagulation factors, extracorporeal membrane oxygenation), the SwissDRG remuneration structure provides distinct Add-on Payments (Zusatzentgelte, ZE), which can be billed on top of the base DRG rate to prevent disincentivizing high-quality specialized care.

9During a medication reconciliation interview on an acute geriatric hospital ward, a clinical pharmacist discovers that an 82-year-old patient with Parkinson's disease was mistakenly prescribed haloperidol for mild nocturnal agitation. What is the mechanism of this drug-drug/drug-disease contraindication, and what is the preferred alternative for acute psychotic symptoms in Parkinson's disease?

A.Haloperidol is a potent central dopamine D2 receptor antagonist that can precipitate acute akinesia or neuroleptic malignant syndrome; quetiapine or pimavanserin/clozapine is preferred due to low extrapyramidal risk

B.Haloperidol induces peripheral anticholinergic vasodilation; substitute with oral chlorpromazine

C.Haloperidol inhibits peripheral dopa-decarboxylase; substitute with oral metoclopramide

D.Haloperidol accelerates levodopa renal elimination; substitute with high-dose haloperidol decanoate depot injections

Explanation: Haloperidol is a potent central dopamine D2 receptor antagonist. In patients with Parkinson's disease (characterized by nigrostriatal dopamine deficiency), typical antipsychotics cause severe worsening of motor parkinsonism, acute akinesia, rigidity, and can trigger neuroleptic malignant syndrome. If antipsychotic therapy is required for hallucinations/psychosis in Parkinson's, low-dose quetiapine, clozapine (requiring hematologic monitoring), or pimavanserin (5-HT2A inverse agonist) are the drugs of choice because of minimal D2 receptor occupancy.

10A hospital pharmacy quality manager is validating the moist-heat terminal sterilization cycle for a 100 mL glass vial infusion product. According to the European Pharmacopoeia (Ph. Eur. 5.1.1), what is the standard reference sterilization condition to achieve an overarching Sterility Assurance Level (SAL) of 10^-6?

A.Heating at 100°C for 60 minutes at atmospheric pressure

B.Heating at minimum 121°C for at least 15 minutes (or achieving an F0 value >= 8 minutes using a bioburden-based approach)

C.Heating at 160°C for 120 minutes in a dry-heat forced convection depyrogenation oven

D.Exposure to ethylene oxide gas at 55°C for 24 hours followed by 7 days of aeration

Explanation: According to Ph. Eur. (5.1.1 Methods of Preparation of Sterile Products), the reference moist heat sterilization process for aqueous preparations consists of heating at a minimum of 121°C for 15 minutes at saturated steam pressure. When using the F0 concept (calculating the equivalent lethal time at 121°C based on a z-value of 10°C), an F0 value of at least 8 minutes (frequently >=12–15 minutes for standard overkill cycles) is required to ensure a Sterility Assurance Level (SAL) of <= 10^-6.

About the Fachapotheker/in FPH Spital Exam

The Fachapotheker/in FPH in Spitalpharmazie (Specialist in Hospital Pharmacy FPH) is the Swiss federal postgraduate title required for independent practice and leadership of a hospital pharmacy in Switzerland. Regulated by the Swiss Association of Public Health and Hospital Pharmacists (GSASA) and the Foederatio Pharmaceutica Helvetiae (FPH), the curriculum spans five fundamental competency domains: Clinical Pharmacy and Patient-Oriented Care, Aseptic Manufacturing and Compounding (GMP), Hospital Drug Supply Chain and Formulary Management (Heilmittelbewirtschaftung & AMK), Investigational Medicinal Products in Clinical Trials (IMPs under KlinV/HFG), and Patient Safety, Risk Management, and Digital Health. Assessment entails rigorous clinical and operational evaluations across written multiple-choice and open-case papers, oral examinations, and a scientific diploma thesis. Note on language and study bank format: The official Swiss GSASA examination is conducted in Swiss national languages (German or French). This 100-question practice bank is an English-language multiple-choice study adaptation created by OpenExamPrep—not an official GSASA release—specifically engineered to reinforce core clinical decision-making, aseptic compounding calculations, regulatory frameworks, and hospital pharmacy operational mastery.

Assessment

Three-part comprehensive specialist examination: 1) Written Examination Paper 1 (60 minutes multiple-choice questions covering GxP, supply chain, management, and clinical pharmacy); 2) Written Examination Paper 2 (60 minutes consisting of 4 open clinical/practical case studies); 3) Oral Board Examination (structured clinical questioning before a panel of GSASA examiners); and 4) Diploma Thesis Defense (15-minute presentation followed by structured Q&A).

Time Limit

120 minutes written (two 60-minute papers) plus approximately 45–60 minutes oral examination and diploma presentation

Passing Score

Demonstrated competence and passing scores across all examination components as evaluated by the GSASA Examination Commission in accordance with the FPH Spitalpharmazie Weiterbildungsordnung

Exam Fee

Schlussprüfung examination fee ~CHF 1,200–1,800; GSASA registration fee ~CHF 1,000–1,500; FPH Specialist Title issuance fee ~CHF 1,000–1,500 (Schweizerischer Verein der Amts- und Spitalapotheker (GSASA) under the authority of the Institut FPH / pharmaSuisse)

Fachapotheker/in FPH Spital Exam Content Outline

35%

Clinical Pharmacy & Inpatient Pharmacotherapy

Inpatient medication reconciliation (BEST-List), therapeutic drug monitoring (TDM: vancomycin AUC/MIC, aminoglycosides, immunosuppressants, voriconazole, lithium, phenytoin, methotrexate), antimicrobial stewardship (ABS, surgical prophylaxis, PK/PD optimization of beta-lactams), organ impairment dosing (CRRT/CVVH, CKD, Child-Pugh), critical care pharmacotherapy, parenteral nutrition, and oncologic supportive care.

25%

Aseptic Manufacturing, Compounding & GMP

Cleanroom classifications (EU GMP / PIC/S Annex 1 Grade A-D), cytotoxic reconstitution in negative pressure isolators / safety cabinets, Closed System Transfer Devices (CSTD), parenteral nutrition compatibility (calcium-phosphate precipitation, lipid stability), sterilization (autoclaving F0, depyrogenation, 0.22 µm filtration), environmental monitoring, media fills, and Pharmacopoeia standards (Ph. Eur. / Ph. Helv., Formula Magistralis & Hospitalis).

15%

Hospital Drug Supply Chain, AMK & Health Economics

Arzneimittelkommission (AMK / P&T committee) formulary management, off-label reimbursement (Art. 71a-d KLV), SwissDRG inpatient hospital financing and add-on payments (Zusatzentgelte), drug shortage mitigation (BWL / Swissmedic Meldestelle), cold chain and Mean Kinetic Temperature (MKT), public procurement (BöB/IVöB), and narcotic regulation (BetmG/BetmKV).

15%

Patient Safety, Medication Error Prevention & Digital Health

Critical Incident Reporting System (CIRS), root cause analysis (RCA), high-alert medication protocols (APINCH, concentrated electrolytes), CPOE / CDS alert optimization, Automated Dispensing Cabinets (ADCs), Barcode Medication Administration (BCMA), unit-dose drug distribution, GSASA drug-related problem (DRP) classification, and Swissmedic pharmacovigilance reporting.

10%

Investigational Medicinal Products & Clinical Trials

Swiss Human Research Act (HFG) and Clinical Trials Ordinance (KlinV Category A-C), ICH-GCP E6(R2), QP release and hospital pharmacy IMP management, blinding/unblinding procedures, accountability, temperature logs, trial labeling (Annex 13), and SUSAR reporting workflows.

How to Pass the Fachapotheker/in FPH Spital Exam

What You Need to Know

Passing score: Demonstrated competence and passing scores across all examination components as evaluated by the GSASA Examination Commission in accordance with the FPH Spitalpharmazie Weiterbildungsordnung
Assessment: Three-part comprehensive specialist examination: 1) Written Examination Paper 1 (60 minutes multiple-choice questions covering GxP, supply chain, management, and clinical pharmacy); 2) Written Examination Paper 2 (60 minutes consisting of 4 open clinical/practical case studies); 3) Oral Board Examination (structured clinical questioning before a panel of GSASA examiners); and 4) Diploma Thesis Defense (15-minute presentation followed by structured Q&A).
Time limit: 120 minutes written (two 60-minute papers) plus approximately 45–60 minutes oral examination and diploma presentation
Exam fee: Schlussprüfung examination fee ~CHF 1,200–1,800; GSASA registration fee ~CHF 1,000–1,500; FPH Specialist Title issuance fee ~CHF 1,000–1,500

Keys to Passing

Work through all 100 available questions
Review every answer and explanation
Track weak areas and revisit them
Use our AI tutor for tough concepts

Fachapotheker/in FPH Spital Study Tips from Top Performers

1Master Clinical Pharmacokinetics & TDM Calculations: Be proficient with vancomycin Bayesian AUC24/MIC dosing (target 400–600 mg·h/L), aminoglycoside once-daily Hartford nomograms, voriconazole non-linear CYP2C19 kinetics, Sheiner-Tozer phenytoin corrections, and methotrexate leucovorin rescue protocols.

2Understand Cleanroom Engineering & PIC/S Annex 1: Know the air velocity requirements (0.36–0.54 m/s in Grade A), particle limits (>=0.5 µm and >=5.0 µm at rest and in operation), pressure cascades (+10–15 Pa positive for non-hazardous vs negative pressure isolators for cytotoxics), and media fill validation protocols.

3Review Parenteral Nutrition Compatibility Chemistry: Understand calcium-phosphate solubility curves, the difference between organic (sodium glycerophosphate) and inorganic phosphate, pH effects, lipid emulsion zeta potential (<500 nm mean droplet size), and in-line filter sizing (0.22 µm for 2-in-1 vs 1.2 µm for 3-in-1 lipid admixtures).

4Memorize Swiss Legal & Regulatory Frameworks: Learn the Swiss Therapeutic Products Act (HMG), Medicinal Products Ordinance (VAM Art. 48/49 import rules), Clinical Trials Ordinance (KlinV Category A/B/C), BetmG narcotic recordkeeping, and SwissDRG inpatient reimbursement structures.

5Practice Root Cause Analysis & Medication Safety Tools: Understand CIRS reporting frameworks, Reason's Swiss Cheese model, APINCH high-alert protocols (especially concentrated IV potassium chloride bans on general wards), and GSASA drug-related problem (DRP) documentation taxonomy.

Frequently Asked Questions

What is the Fachapotheker/in FPH in Spitalpharmazie title?

The Fachapotheker/in FPH in Spitalpharmazie is the federally recognized specialist title for hospital pharmacists in Switzerland. Conferred by the Institut FPH in collaboration with GSASA, it qualifies pharmacists to assume independent professional leadership and technical management of hospital pharmacies across all Swiss cantons.

How is the GSASA final specialist examination (Schlussprüfung) structured?

The examination consists of three main parts: 1) Two 1-hour written papers (Paper 1 consists of multiple-choice questions covering GxP, supply chain, and management; Paper 2 consists of 4 complex open case studies); 2) An oral clinical questioning session before senior GSASA examiners; and 3) A 15-minute oral defense and cross-examination of the candidate's postgraduate diploma thesis.

What languages are used in the official Swiss hospital pharmacy examination?

The official GSASA examination can be completed in either German or French. Candidates must declare their preferred language upon registration with the GSASA examination office. This OpenExamPrep practice bank provides an English-language study adaptation to master core concepts, international evidence, and clinical calculations.

What is the role of the academic DAS Spitalpharmazie?

The Diploma of Advanced Studies (DAS) in Spitalpharmazie (offered e.g. by the University of Basel in cooperation with GSASA) provides the required theoretical foundation for residency training, covering advanced biopharmaceutics, clinical pharmacokinetics, hospital logistics, pharmacoeconomics, and quality management.

What is the difference between the FPH Spitalpharmazie title and the Fähigkeitsausweis FPH in Klinischer Pharmazie?

The Fachapotheker FPH in Spitalpharmazie is a comprehensive 3–6 year specialist title encompassing manufacturing, logistics, supply chain, hospital management, and clinical pharmacy. The Fähigkeitsausweis FPH Klinische Pharmazie is a specialized certificate of competence focusing specifically on clinical ward rounds, bedside consultations, and patient-centered pharmacotherapy.

How are off-label drugs reimbursed in Swiss hospitals under Art. 71a-d KLV?

Under Articles 71a to 71d of the Swiss Ordinance on Health Insurance (KLV), off-label or unlicensed drug therapies can be reimbursed on a case-by-case basis by compulsory health insurance (OKP) if a major therapeutic benefit is expected for a severe or life-threatening disease with no authorized therapeutic alternative, following evaluation and approval by the insurer's medical officer (Vertrauensarzt).