Fachapotheker/in FPH Spital cheat sheet

HMG (Heilmittelgesetz, SR 812.21) governs authorisation, manufacture, import, export, distribution and advertising of medicinal products; Swissmedic is the competent authority enforcing it, with cantonal authorities responsible for dispensing and hospital pharmacy supervision.

BetmVV-EDI (SR 812.212.22) regulates narcotics handling: a narcotics prescription is valid for a maximum of 30 days, must be in writing (or qualified electronic form), and must state the exact quantity in numbers and words.

Narcotics in a hospital must be stored under lock and key; dispensing and receipt are recorded in a narcotics register (Betäubungsmittelbuch) with date, quantity, supplier/recipient, and running balance; discrepancies are reported to Swissmedic.

Hospital formulary decisions follow a defined governance path: application by a clinician, evaluation of efficacy/safety/cost by the pharmacy or a drug committee, then approval, temporary use, or rejection; decisions are reviewed periodically.

Off-label use in hospitals requires documented rationale, patient-level consent where feasible, and internal approval; unlicensed (compounded or imported) products require a Swissmedic import authorisation or a cantonal exemption.

Prescription-only status: Abgabekategorie A (one-time), B (pharmacy with advice), C (pharmacy with advice, no prescription needed), D (drugstore), E (general retail) - hospital dispensing is generally limited to A/B and narcotics.

Professional ethics: patient welfare and autonomy take precedence over institutional or commercial interest; conflicts of interest in formulary or procurement decisions must be declared and managed.

Pharmacist dispensing in hospitals is governed by cantonal health law and the professional code (Berufsordnung); the hospital pharmacist is responsible for the quality of dispensing, storage and documentation.

Medication reconciliation at admission and discharge compares the pre-admission list (patient interview, community pharmacy, GP records) with the hospital order; discrepancies are classified as omission, duplication, dose error, or interaction and resolved with the prescriber.

Best Possible Medication History (BPMH) requires at least two sources: patient/carer interview plus at least one objective source (community pharmacy record, GP letter, blister packs, electronic record).

Structured drug therapy review follows a system: indication, effectiveness, safety, adherence, and interactions, then a documented recommendation to the prescriber with a clear priority (immediate, next round, routine).

On ward rounds, the clinical pharmacist reports findings in a standard format: patient, problem, finding, recommendation, and follow-up; recommendations are recorded in the medical record and their acceptance is tracked as a quality indicator.

High-risk patients for reconciliation include those with ≥5 drugs, polypharmacy, anticoagulants, insulin, opioids, transplant immunosuppressants, and those with renal or hepatic impairment.

Discharge counselling covers indication, dose, timing, duration, missed doses, and who to contact; a written medication plan is provided and the community pharmacy or GP is informed.

Therapeutic duplication is detected by comparing active ingredients and ATC classes, not just brand names; combination products and OTC/herbal products must be included in the review.

Clinical pharmacy documentation must be traceable: date, time, patient identifier, finding, recommendation, and outcome; verbal recommendations alone are insufficient for audit purposes.

Sepsis: broad-spectrum antibiotics within 1 hour of recognition, blood cultures before antibiotics, lactate and fluid resuscitation, and daily de-escalation based on culture results and clinical response.

Community-acquired pneumonia: CURB-65 (confusion, urea >7 mmol/L, respiratory rate ≥30/min, blood pressure <90/60 mmHg, age ≥65) guides site of care; severity and local resistance patterns guide empiric choice.

Acute coronary syndrome: aspirin loading plus a P2Y12 inhibitor and anticoagulation; high-dose statin; beta-blocker and ACE inhibitor once stable; dual antiplatelet duration depends on stent type and bleeding risk.

Heart failure with reduced ejection fraction: four pillars - ACE inhibitor/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist, SGLT2 inhibitor - titrated to target or maximum tolerated dose.

Atrial fibrillation anticoagulation: CHA2DS2-VASc guides indication; DOACs are preferred over vitamin K antagonists in most non-valvular cases; dose reduction criteria (age, weight, renal function) must be verified.

Oncology: cytotoxic doses are calculated on body surface area (Mosteller formula) or fixed dosing; dose reductions follow organ function and toxicity grade (CTCAE); antiemetic prophylaxis is matched to emetogenic risk.

Intensive care: sedation and analgesia are titrated to a target (e.g., RASS); daily sedation interruption and spontaneous breathing trials shorten ventilation; renal dosing is adjusted to measured creatinine clearance.

Pediatric dosing is weight-based (mg/kg) with maximum adult dose caps; neonates require age-adjusted dosing due to immature hepatic and renal clearance.

Geriatrics: apply Beers or STOPP/START criteria to identify potentially inappropriate medications; anticholinergics, benzodiazepines, and long-acting sulfonylureas are common targets.

Sterile compounding requires a controlled environment: ISO 5 zone at the critical site, ISO 7 background for aseptic processing, and validated air quality, pressure differentials, and particle counts.

Cytotoxic compounding is performed in a negative-pressure isolator or biosafety cabinet with HEPA filtration and external exhaust; personal protective equipment includes double gloves, gown, and eye protection.

The pharmacopoeia (Ph. Eur. / Swiss Pharmacopoeia) defines monographs, assay limits, and general methods; deviations require documented justification and validation.

Compounding records must include formula, batch size, ingredients with lot numbers, weighing, equipment, operator, in-process controls, and final release by a qualified person.

Beyond-use dates for sterile preparations depend on the preparation type (immediate, low-risk, medium-risk, high-risk) and storage conditions; they must not exceed stability data or pharmacopoeial limits.

Non-sterile compounding requires risk assessment for hazardous substances, appropriate containment, and cleaning validation; weighing accuracy is verified with calibrated balances.

GMP requires validation of processes, equipment qualification (IQ/OQ/PQ), environmental monitoring, and a documented change control and deviation system.

Quality control of compounded preparations includes appearance, pH, osmolality, assay, sterility, and endotoxin testing where applicable; results are reviewed before release.

Procurement decisions consider price, quality, supply reliability, and registration status; tenders are evaluated against defined criteria and documented for audit.

Storage conditions: room temperature 15–25 °C, cool 8–15 °C, refrigerator 2–8 °C, freezer −15 to −25 °C; cold chain excursions are assessed against stability data and documented.

Distribution models include unit-dose, floor stock, and automated dispensing cabinets (ADCs); ADCs require user access control, inventory reconciliation, and override auditing.

Narcotics handling: locked storage, restricted access, running balance register, witnessed waste disposal, and periodic reconciliation; losses are reported to Swissmedic.

Inventory management uses ABC/VED analysis, reorder points based on lead time and consumption, and expiry tracking (FEFO - first expired, first out).

Recalls are managed by identifying affected lots, quarantining stock, tracing to patients where necessary, and documenting the response.

Returns and expired stock are segregated, labelled, and disposed of according to hazardous-waste regulations; controlled substances require witnessed destruction.

Cold-chain monitoring uses calibrated data loggers with alarm thresholds and documented corrective actions for excursions.

ADR reporting in Switzerland goes to Swissmedic via the electronic reporting portal; serious and unexpected ADRs, and those for new drugs, must be reported, and causality is assessed (e.g., WHO-UMC scale).

Medication error types include prescribing, dispensing, administration, and monitoring errors; a just-culture approach separates system failures from individual accountability.

High-alert medications (insulin, anticoagulants, opioids, concentrated electrolytes, chemotherapy) require double checks, standard concentrations, and clear labelling.

Look-alike/sound-alike drugs are managed by tall-man lettering, physical separation, and barcode verification at dispensing and administration.

Hygiene: hand disinfection is the single most effective measure; compliance is audited; sterile compounding follows aseptic technique with gowning and glove disinfection.

Cytotoxic safety includes closed-system transfer devices, spill kits, separate waste streams, and medical surveillance of exposed staff.

Pharmacovigilance signal detection uses spontaneous reports, literature, and periodic safety update reports; signals are evaluated for causality, severity, and frequency.

Risk management uses FMEA and root-cause analysis for critical incidents, and corrective actions are tracked to closure with effectiveness checks.

Clearance CL = dose rate / steady-state concentration; volume of distribution Vd = amount / concentration; half-life t½ = 0.693 × Vd / CL.

Steady state is reached after approximately 4–5 half-lives; loading dose = Vd × target concentration / bioavailability.

Renal dosing uses Cockcroft-Gault creatinine clearance: CrCl (mL/min) = (140 − age) × weight / (72 × serum creatinine), ×0.85 for women.

TDM indications: narrow therapeutic index (vancomycin, aminoglycosides, digoxin, lithium, tacrolimus, phenytoin), suspected toxicity, non-response, and drug interactions.

Vancomycin AUC-guided dosing (AUC/MIC 400–600) is preferred over trough-only monitoring; sampling timing depends on the dosing interval.

Aminoglycosides show concentration-dependent killing; extended-interval dosing uses peak/MIC and trough monitoring to limit nephrotoxicity and ototoxicity.

Cytochrome P450 interactions: CYP3A4 inhibitors (azoles, macrolides, grapefruit) increase levels of substrates; inducers (rifampicin, carbamazepine, St John's wort) reduce them.

Protein binding affects interpretation: only free drug is active; hypoalbuminaemia increases free fraction of highly bound drugs (e.g., phenytoin).

Hierarchy of evidence: systematic reviews/meta-analyses of RCTs > RCTs > cohort studies > case-control > case series > expert opinion.

Randomisation reduces selection bias; blinding reduces performance and detection bias; intention-to-treat analysis preserves randomisation benefits.

Effect measures: relative risk (RR), odds ratio (OR), hazard ratio (HR), absolute risk reduction (ARR), number needed to treat (NNT = 1/ARR).

Confidence intervals convey precision; a 95% CI excluding the null value corresponds to p < 0.05 for the same effect measure.

p-value is the probability of observing data at least as extreme given the null hypothesis is true; it is not the probability that the null is true.

Sensitivity, specificity, positive and negative predictive values depend on prevalence; PPV rises with prevalence.

Systematic reviews follow PRISMA; risk of bias is assessed with tools such as Cochrane RoB 2 or ROBINS-I.

Scientific communication: report according to CONSORT (trials), STROBE (observational), PRISMA (reviews); declare conflicts of interest and funding.

Situational leadership adapts style (directing, coaching, supporting, delegating) to the competence and commitment of the team member.

SMART goals are specific, measurable, achievable, relevant, and time-bound; progress is reviewed at defined intervals.

Change management follows a structured model (e.g., Kotter's eight steps or Lewin's unfreeze-change-refreeze) with stakeholder analysis and communication plan.

Interprofessional collaboration requires defined roles, shared goals, and structured communication (e.g., SBAR: situation, background, assessment, recommendation).

Teaching uses constructive alignment: learning objectives, activities, and assessment must match; feedback is specific, timely, and behaviour-focused.

Quality indicators for pharmacy services include medication reconciliation completion, intervention acceptance rate, ADR reporting rate, and dispensing error rate.

Budget management distinguishes fixed and variable costs; drug expenditure is monitored by ATC group and benchmarked against peers.

Conflict resolution separates positions from interests; escalation follows defined governance channels with documentation.

HMG (Heilmittelgesetz, SR 812.21) governs authorisation, manufacture, import, export, distribution and advertising of medicinal products; Swissmedic is the competent authority enforcing it, with cantonal authorities responsible for dispensing and hospital pharmacy supervision.

BetmVV-EDI (SR 812.212.22) regulates narcotics handling: a narcotics prescription is valid for a maximum of 30 days, must be in writing (or qualified electronic form), and must state the exact quantity in numbers and words.

Narcotics in a hospital must be stored under lock and key; dispensing and receipt are recorded in a narcotics register (Betäubungsmittelbuch) with date, quantity, supplier/recipient, and running balance; discrepancies are reported to Swissmedic.

Hospital formulary decisions follow a defined governance path: application by a clinician, evaluation of efficacy/safety/cost by the pharmacy or a drug committee, then approval, temporary use, or rejection; decisions are reviewed periodically.

Off-label use in hospitals requires documented rationale, patient-level consent where feasible, and internal approval; unlicensed (compounded or imported) products require a Swissmedic import authorisation or a cantonal exemption.

Prescription-only status: Abgabekategorie A (one-time), B (pharmacy with advice), C (pharmacy with advice, no prescription needed), D (drugstore), E (general retail) - hospital dispensing is generally limited to A/B and narcotics.

Professional ethics: patient welfare and autonomy take precedence over institutional or commercial interest; conflicts of interest in formulary or procurement decisions must be declared and managed.

Pharmacist dispensing in hospitals is governed by cantonal health law and the professional code (Berufsordnung); the hospital pharmacist is responsible for the quality of dispensing, storage and documentation.

Medication reconciliation at admission and discharge compares the pre-admission list (patient interview, community pharmacy, GP records) with the hospital order; discrepancies are classified as omission, duplication, dose error, or interaction and resolved with the prescriber.

Best Possible Medication History (BPMH) requires at least two sources: patient/carer interview plus at least one objective source (community pharmacy record, GP letter, blister packs, electronic record).

Structured drug therapy review follows a system: indication, effectiveness, safety, adherence, and interactions, then a documented recommendation to the prescriber with a clear priority (immediate, next round, routine).

On ward rounds, the clinical pharmacist reports findings in a standard format: patient, problem, finding, recommendation, and follow-up; recommendations are recorded in the medical record and their acceptance is tracked as a quality indicator.

High-risk patients for reconciliation include those with ≥5 drugs, polypharmacy, anticoagulants, insulin, opioids, transplant immunosuppressants, and those with renal or hepatic impairment.

Discharge counselling covers indication, dose, timing, duration, missed doses, and who to contact; a written medication plan is provided and the community pharmacy or GP is informed.

Therapeutic duplication is detected by comparing active ingredients and ATC classes, not just brand names; combination products and OTC/herbal products must be included in the review.

Clinical pharmacy documentation must be traceable: date, time, patient identifier, finding, recommendation, and outcome; verbal recommendations alone are insufficient for audit purposes.

Sepsis: broad-spectrum antibiotics within 1 hour of recognition, blood cultures before antibiotics, lactate and fluid resuscitation, and daily de-escalation based on culture results and clinical response.

Community-acquired pneumonia: CURB-65 (confusion, urea >7 mmol/L, respiratory rate ≥30/min, blood pressure <90/60 mmHg, age ≥65) guides site of care; severity and local resistance patterns guide empiric choice.

Acute coronary syndrome: aspirin loading plus a P2Y12 inhibitor and anticoagulation; high-dose statin; beta-blocker and ACE inhibitor once stable; dual antiplatelet duration depends on stent type and bleeding risk.

Heart failure with reduced ejection fraction: four pillars - ACE inhibitor/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist, SGLT2 inhibitor - titrated to target or maximum tolerated dose.

Atrial fibrillation anticoagulation: CHA2DS2-VASc guides indication; DOACs are preferred over vitamin K antagonists in most non-valvular cases; dose reduction criteria (age, weight, renal function) must be verified.

Oncology: cytotoxic doses are calculated on body surface area (Mosteller formula) or fixed dosing; dose reductions follow organ function and toxicity grade (CTCAE); antiemetic prophylaxis is matched to emetogenic risk.

Intensive care: sedation and analgesia are titrated to a target (e.g., RASS); daily sedation interruption and spontaneous breathing trials shorten ventilation; renal dosing is adjusted to measured creatinine clearance.

Pediatric dosing is weight-based (mg/kg) with maximum adult dose caps; neonates require age-adjusted dosing due to immature hepatic and renal clearance.

Geriatrics: apply Beers or STOPP/START criteria to identify potentially inappropriate medications; anticholinergics, benzodiazepines, and long-acting sulfonylureas are common targets.

Sterile compounding requires a controlled environment: ISO 5 zone at the critical site, ISO 7 background for aseptic processing, and validated air quality, pressure differentials, and particle counts.

Cytotoxic compounding is performed in a negative-pressure isolator or biosafety cabinet with HEPA filtration and external exhaust; personal protective equipment includes double gloves, gown, and eye protection.

The pharmacopoeia (Ph. Eur. / Swiss Pharmacopoeia) defines monographs, assay limits, and general methods; deviations require documented justification and validation.

Compounding records must include formula, batch size, ingredients with lot numbers, weighing, equipment, operator, in-process controls, and final release by a qualified person.

Beyond-use dates for sterile preparations depend on the preparation type (immediate, low-risk, medium-risk, high-risk) and storage conditions; they must not exceed stability data or pharmacopoeial limits.

Non-sterile compounding requires risk assessment for hazardous substances, appropriate containment, and cleaning validation; weighing accuracy is verified with calibrated balances.

GMP requires validation of processes, equipment qualification (IQ/OQ/PQ), environmental monitoring, and a documented change control and deviation system.

Quality control of compounded preparations includes appearance, pH, osmolality, assay, sterility, and endotoxin testing where applicable; results are reviewed before release.

Procurement decisions consider price, quality, supply reliability, and registration status; tenders are evaluated against defined criteria and documented for audit.

Storage conditions: room temperature 15–25 °C, cool 8–15 °C, refrigerator 2–8 °C, freezer −15 to −25 °C; cold chain excursions are assessed against stability data and documented.

Distribution models include unit-dose, floor stock, and automated dispensing cabinets (ADCs); ADCs require user access control, inventory reconciliation, and override auditing.

Narcotics handling: locked storage, restricted access, running balance register, witnessed waste disposal, and periodic reconciliation; losses are reported to Swissmedic.

Inventory management uses ABC/VED analysis, reorder points based on lead time and consumption, and expiry tracking (FEFO - first expired, first out).

Recalls are managed by identifying affected lots, quarantining stock, tracing to patients where necessary, and documenting the response.

Returns and expired stock are segregated, labelled, and disposed of according to hazardous-waste regulations; controlled substances require witnessed destruction.

Cold-chain monitoring uses calibrated data loggers with alarm thresholds and documented corrective actions for excursions.

ADR reporting in Switzerland goes to Swissmedic via the electronic reporting portal; serious and unexpected ADRs, and those for new drugs, must be reported, and causality is assessed (e.g., WHO-UMC scale).

Medication error types include prescribing, dispensing, administration, and monitoring errors; a just-culture approach separates system failures from individual accountability.

High-alert medications (insulin, anticoagulants, opioids, concentrated electrolytes, chemotherapy) require double checks, standard concentrations, and clear labelling.

Look-alike/sound-alike drugs are managed by tall-man lettering, physical separation, and barcode verification at dispensing and administration.

Hygiene: hand disinfection is the single most effective measure; compliance is audited; sterile compounding follows aseptic technique with gowning and glove disinfection.

Cytotoxic safety includes closed-system transfer devices, spill kits, separate waste streams, and medical surveillance of exposed staff.

Pharmacovigilance signal detection uses spontaneous reports, literature, and periodic safety update reports; signals are evaluated for causality, severity, and frequency.

Risk management uses FMEA and root-cause analysis for critical incidents, and corrective actions are tracked to closure with effectiveness checks.

Clearance CL = dose rate / steady-state concentration; volume of distribution Vd = amount / concentration; half-life t½ = 0.693 × Vd / CL.

Steady state is reached after approximately 4–5 half-lives; loading dose = Vd × target concentration / bioavailability.

Renal dosing uses Cockcroft-Gault creatinine clearance: CrCl (mL/min) = (140 − age) × weight / (72 × serum creatinine), ×0.85 for women.

TDM indications: narrow therapeutic index (vancomycin, aminoglycosides, digoxin, lithium, tacrolimus, phenytoin), suspected toxicity, non-response, and drug interactions.

Vancomycin AUC-guided dosing (AUC/MIC 400–600) is preferred over trough-only monitoring; sampling timing depends on the dosing interval.

Aminoglycosides show concentration-dependent killing; extended-interval dosing uses peak/MIC and trough monitoring to limit nephrotoxicity and ototoxicity.

Cytochrome P450 interactions: CYP3A4 inhibitors (azoles, macrolides, grapefruit) increase levels of substrates; inducers (rifampicin, carbamazepine, St John's wort) reduce them.

Protein binding affects interpretation: only free drug is active; hypoalbuminaemia increases free fraction of highly bound drugs (e.g., phenytoin).

Hierarchy of evidence: systematic reviews/meta-analyses of RCTs > RCTs > cohort studies > case-control > case series > expert opinion.

Randomisation reduces selection bias; blinding reduces performance and detection bias; intention-to-treat analysis preserves randomisation benefits.

Effect measures: relative risk (RR), odds ratio (OR), hazard ratio (HR), absolute risk reduction (ARR), number needed to treat (NNT = 1/ARR).

Confidence intervals convey precision; a 95% CI excluding the null value corresponds to p < 0.05 for the same effect measure.

p-value is the probability of observing data at least as extreme given the null hypothesis is true; it is not the probability that the null is true.

Sensitivity, specificity, positive and negative predictive values depend on prevalence; PPV rises with prevalence.

Systematic reviews follow PRISMA; risk of bias is assessed with tools such as Cochrane RoB 2 or ROBINS-I.

Scientific communication: report according to CONSORT (trials), STROBE (observational), PRISMA (reviews); declare conflicts of interest and funding.

Situational leadership adapts style (directing, coaching, supporting, delegating) to the competence and commitment of the team member.

SMART goals are specific, measurable, achievable, relevant, and time-bound; progress is reviewed at defined intervals.

Change management follows a structured model (e.g., Kotter's eight steps or Lewin's unfreeze-change-refreeze) with stakeholder analysis and communication plan.

Interprofessional collaboration requires defined roles, shared goals, and structured communication (e.g., SBAR: situation, background, assessment, recommendation).

Teaching uses constructive alignment: learning objectives, activities, and assessment must match; feedback is specific, timely, and behaviour-focused.

Quality indicators for pharmacy services include medication reconciliation completion, intervention acceptance rate, ADR reporting rate, and dispensing error rate.

Budget management distinguishes fixed and variable costs; drug expenditure is monitored by ATC group and benchmarked against peers.

Conflict resolution separates positions from interests; escalation follows defined governance channels with documentation.